Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse

Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse Sebastian Ludwig, Joshy Madukkakuzhy, Alberto Vega Hernandez, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2232934/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life. Conservative treatment options are limited. Surgical interventions are characterized by a variety of individual approaches. This study standardized laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) in an interdisciplinary setting. Additionally, offering both synthetic mesh (SM) and biological mesh (BM) material for L-SCP is a novel treatment alternative, particularly for premenopausal women. Methods Women with ODS combined with POP underwent surgery using an interdisciplinary approach. The primary endpoint was postoperative morbidity and mortality measured by the Clavien-Dindo classification (CDC). Further endpoints were improvement in bowel evacuation, POP, and urinary incontinence at a median follow-up period of > 12 months. Results Of a total of 44 patients, 36 patients were treated with L-RRP combined with L-SCP (28 patients with SM, 8 patients with BM). CDC grades and the frequency of postoperative complications were low. Clinical outcomes for ODS, bowel dysfunction, and fecal control improved significantly. Anatomical outcome for POP was significantly better with 28 (78%) patients having POP-Q stage 0 after surgery. 17 patients (47%) had urinary incontinence before surgery, which was restored in 14 patients (82%). No de-novo urinary incontinence appeared. Conclusion The interdisciplinary surgical approach with L-RRP and L-SCP is safe, feasible, and effective in treating women with ODS and POP. The use of a biomesh was established as an effective alternative to the SM and offers an additional and new uterine-preserving option. Obstructed defecation syndrome pelvic organ prolapse resection rectopexy sacrocolpopexy mesh biological mesh Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Take-home Message Novel standardized interdisciplinary surgical approach for laparoscopic resection rectopexy and sacropexy in women with obstructed defecation syndrome and pelvic organ prolapse. Introduction Obstructive defecation syndrome (ODS) defines a disturbed defecation process caused by the protrusion of the lower rectum (rectocele) or the telescoping within the rectum (intussusception) (1–3). The patients have to exert pressure frequently and strongly to evacuate the rectum and manual manipulation may be required (4). The unsuccessful attempts to defecate are associated with a feeling of incomplete rectal voiding. ODS affects approximately 10–25% of the population and is mainly related to female sex (5). The condition is frequently associated with POP and almost 20% of the women require surgery during their lifetime (6,7). Individual aspects, such as pregnancy, childbirth, connective tissue disorders, the physiological descending of the pelvic floor at an older age, and pelvine surgical interventions further contribute to the condition (5,8,9). Almost 60% of the female population develop POP during their lifetime and 1/3 of them have bowel dysfunction presenting as constipation and ODS (10,11). The women experience extreme frustration due to their disturbed defecation, compromising their quality of life substantially. Conservative treatment options such as dietary modifications, sufficient fluid intake, laxative medication, physical exercise, pelvic floor training, pelvic floor biofeedback therapy, and pessary treatment are limited and do not achieve the desired long-term effect (12,13). The surgical treatment aims at the anatomic reconstruction of the bowel and pelvic floor (14,15) and has been characterized by individual approaches. By ignoring the complexity of the underlying condition, the desired results are often missed (oder besseres Wort ?) (13,16). A standardized treatment option for evidence-based advice to women with ODS and POP is missing (17–20). Furthermore, there is only insufficient data on interdisciplinary approaches. Of the 40 registered clinical trials evaluating this medical condition none includes an interdisciplinary surgical approach or offers a biological mesh material. This pilot study standardizes an interdisciplinary surgical approach of combining laparoscopic resection rectopexy (L-RRP) with laparoscopic sacrocolpopexy (L-SCP) for women with ODS and POP. Additionally, as a novel treatment option, an absorbable biological mesh (BM) for L-SCP is offered to avoid mesh erosion and migration and to preserve the uterus in cases of a planned pregnancy. Methods In the period February 2020 and August 2021, a total of 44 women with ODS and POP presented at our tertiary center pelvic floor unit, consisting of the Departments of Visceral Surgery, Gynecology, and Urology. 36 patients were scheduled for combined L-RRP with pelvic floor reconstruction. Inclusion criteria were women with ODS and POP over 18 years of age and being eligible for laparoscopic surgery. Informed consent for the planned procedure, the mesh material used, the data collection, and the publication of the results was obtained from all patients before surgery (Fig. 1 ). All patients underwent preoperative and postoperative urogynecological and surgical examinations at the outpatient clinics. These examinations included taking the medical history of clinical symptoms, pelvic organ prolapse (POP) according to the POP quantification system (POP-Q), the subjective symptom questionnaires for the defecation disorder (Altomare score, modified Longo score, rectal toxicity score, and Wexner incontinence score WIS) (21–25). Magnetic resonance image defecography (MRI-D) (Fig. 2 ) as well as presentation to our pelvic floor board were obligatory before surgery. Women who wished to preserve their uterus or who declined the use of synthetic mesh (SM) material for the L-SCP were offered a biological mesh (BM). The patients´ anesthesiologic operability was assessed using the ASA score (American Society of Anesthesiologists, ASA) (26). The primary study outcome parameters were the safety and efficacy of the combined laparoscopic procedure. The primary endpoint was postoperative morbidity and mortality measured using the Clavien-Dindo classification (CDC) as a measure of the safety of the procedure (27). The secondary outcome parameters were clinical and anatomical outcomes as measured by the aforementioned scores. All scores are routinely collected before the surgery and at follow-up examinations at 6 and 12 months after surgery, and every 12 months thereafter. The 12 months values were used for statistical analysis. Surgical procedure For the laparoscopic procedure, after induction of general anesthesia, patients were maintained in dorsal lithotomy position and head-down position of 18°. CO 2 pneumoperitoneum was established according to institutional standards, and trocars were placed. The procedure began with the preparation of the rectum down to the pelvic floor by opening the retrorectal Waldeyer space and the rectovaginal space to ensure the mobilization of the rectocele and the rectal intussusception. An anterior rectal resection was performed in cases of elongation or functional kinking of the sigmoid and rectum (Fig. 3 A and B). Suture rectopexy fixed the rectum to the sacral vertebrae at the left side of the promontory with nonabsorbable sutures grasping the perirectal peritoneal tissue. The apical fixation of the middle pelvic organ compartment was performed unilaterally in analogy to the previously published cervicosacropexy and vaginosacropexy technique, as well as hysteropexy respectively, as published previously (Fig. 3 C) (28,29). The synthetic mesh material (SM) consisted of polyvinylidene-fluoride (DynaMesh VASA, FEG Textiltechnik mbH Aachen, Germany). In selected cases a biological mesh (BM) substituted the SM. We used either the Biodesign® Rectopexy Graft derived from small-intestinal submucosa and remodeled into an avascularized tissue (Cook Biotech Incorporated, USA) or the Phasix™ mesh, a knitted monofilament mesh scaffold by using poly-4-hydroxybutyrate from biologically derived, resorbable material (Becton, Dickinson and Company, USA). A pelvine peritoneoplasty covered the mesh material and obliterated the small pelvis and the Douglas pouch. The procedure is summarized in the attached video file (Video 1). The surgical procedure is summarized in a video file ( www.youtu.be!A3F_SxdOINE ). Data management and statistical analysis The necessary clinical data were collected preoperatively, during the hospital stay, and during the follow-up examinations. All scores were documented on paper and transferred to a data bank. Data were analyzed using the SPSS statistical package, version 29.0.0.1. (IBM Corp., Armonk, NY, USA). Quantitative variables are described as means (± standard deviation) and were compared using the Kruskal–Wallis H test and Mann–Whitney U test. Qualitative variables are summarized using count, percentage, median, and interquartile range and were compared using the Fisher’s exact test. A two-sided p value of < 0.05 was considered statistically significant. Because no adjustments for multiple testing were performed, the analyses were exploratory. Ethical approval This retrospective study was registered and approved by the Ethical Committee of the Aerztekammer Nordrhein in Düsseldorf, Germany (Registration No.: 2022-070). Results Of the 44 women with ODS and POP treated with surgery eight patients were excluded from further analysis because the pelvic floor was reconstructed transvaginally. In total, 36 patients were operated on in the interdisciplinary manner combining L-RRP with L-SCP as described above. The median follow-up period was 19 months (12–32 months) with 33 patients to be analyzed at 12 months. For L-SCP a SM was used in 28 patients and a BM was used in 8 patients. The decision was based on patients’ preference and in cases planning for future pregnancies. One patient in the SM group was lost to follow-up. In two patients of the SM group the 12 months data were incomplete and were marked as missing values for statistical analysis of the follow-up (Fig. 1). Patients´ characteristics Patients’ median age was 57.5 years (range: 26–83 years), and the mean body mass index (BMI, kg/m 2 ) was 23 (18–35) with no statistically significant differences between the two subgroups, SM and BM. The ASA score ranged from ASA I (n = 2) to ASA III (n = 12), with most of the patients having ASA II (n = 22). The BM group consisted only of patients with ASA I (n = 1) and ASA II (n = 7), whereas in the SM group, 12 patients had ASA III. The difference was statistically significant (p = 0.029). Table 1 summarizes the baseline clinical characteristics of the operated patients. Surgical outcome All patients were operated laparoscopically with no conversion to open surgery. Operating time averaged 263 minutes (min; range: 165–418 min) and postoperative hospital stay was 8.2 days (range: 4–15 days), with no differences between the subgroups (Table 2). In 19 of the 36 patients (52%), a concomitant anterior/posterior colporrhaphy was added to the combined laparoscopic surgical procedure. The details are listed in Table 2, as well. Morbidity and Mortality In total, 5 patients experienced postoperative complications, one of them in the BM group. Most of the complications were mild (CDC 1–3a). Superficial wound infection (CDC 1) in one patient required no further treatment. One Urinary tract infection, diarrhea in one patient, and one lung embolism 5 days after surgery, all of which could be treated with medication (all CDC 2). One patient in the SM group developed an anastomotic leakage and required surgical revision with a temporary loop ileostomy (CDC 3b). The procedure was easier due to a previously placed Ghost stoma, a silicone loop marking a suitable ileum loop during the primary operation (30). Further recovery was uneventful, and the patient was discharged on day 10 (for further details see Table 3). Clinical and Functional Outcome after Surgery Obstructed defecation syndrome (ODS) All patients enrolled had ODS, which was classified clinically by using scores before and after surgery. The Altomare score (maximum 30 points) averaged 10 points preoperatively and dropped to 5 points at 12 months (p = 0.006) (Fig. 4). Between the two subgroups the difference of the scores after surgery was significant for the SM group (p = 0.023), but not for the BM group (p = 0.074). The categorial analysis showed an improvement for the BM group, which did not reach significance due to the small sample size. The mean results in the modified Longo score (maximum 24 points) reached 12 points preoperatively and 7 points after 12 months (p = 0.003) (Fig. 4). The results in the mesh subgroups showed the same result, as for the Altomare score. In the SM group the results differed (p = 0.015), whereas the analysis of the BM subgroup was not statistically significant (p = 0.09). Some patients had bowel dysfunction symptoms, such as diarrhea, meteorism, and pain upon defecation, which was measured using the rectal toxicity score (maximum 32 points). In the total cohort, 15 points were measured preoperatively and 7 points 12 months (p < 0.01) (Fig. 4). Both subgroups were statistically lower after surgery, with higher values for the SM group (15 and 10 points before and after surgery, respectively; p = 0.004) than for the BM group (8 and 5 points before and after surgery, respectively; p = 0.04). The Wexner incontinence score (WIS) as a parameter for the control of flatus and stool improved after surgery. The WIS documented 7 points preoperatively and 4 points at 12 months (p = 0.035) (Fig. 4). The results differed significantly between the subgroups. In the SM group, the median was 9 and 2 points before and after surgery, respectively (p = 0.01). In the BM group, the values were 7 and 3 points before and after surgery (p = 0.5). Pelvic organ prolapse (POP) Postoperative anatomical results were compared with preoperative evaluation by using the POP-Q score. Before surgery, 13 (36%) patients had POP-Q stage 1 and 23 (64%) patients had POP-Q stages 2–3. Postoperatively, 28 (78%) patients had POP-Q stage 0. Of these 7 patients (19%) with POP-Q stage 1, 5 patients had improved from higher grade POP-Q. One (3%) patient had POP-Q stage 2 relapse after 6 months due to insufficient fixation of the BM; the patient underwent laparoscopic apical refixation with an SM. The difference between these results was statistically significant (p < 0.001, Fig. 5). Urinary incontinence symptoms Of all 36 patients who underwent L-RRP and L-SCP, 17 (47%) patients suffered from urinary incontinence before surgery (mixed urinary incontinence). Postoperatively continence was restored in 14 patients (82%). No de-novo stress or urgency urinary incontinence symptoms appeared. The results were statistically significant (p < 0.001, Fig. 5). In the subgroup analysis the results after the use of a SM were significantly different (p < 0.001), whereas the difference in the BM group could not be shown due to the low number of patients (p = 1). Discussion To date, the treatment of ODS with POP has been characterized by individual approaches. Sufficient data on standardized treatment options and particularly a combined interdisciplinary approach for evidence-based advice to women with ODS and POP is missing (17–20) (31,32). This study is the first to establish an interdisciplinary laparoscopic surgical approach, combining a resection rectopexy (with anastomosis and without protective stoma) and a sacrocolpopexy in one surgical procedure as a standard treatment option for women with ODS and POP. All affected women with that defined medical condition received this laparoscopic combined surgical procedure in our setting. Both, anatomical and functional outcomes were evaluated after surgery in this novel interdisciplinary setting at our institution. The procedure proved to be easy to establish and to be technically feasible and safe. The morbidity was low - with only one surgical re-intervention in the SM group because of an anastomotic leakage requiring subsequent protective stoma. The synthetic mesh was not adjacent to the leakage and remained intraabdominally. No further complications occurred within a mean of 19 months after surgery. Excellent functional outcomes for ODS were achieved in a significant lowering of the assessed scores. Additional bowel discomforting symptoms, as diarrhea and meteorism as well as fecal incontinence were also improved as a positive side effect. Furthermore, excellent anatomical outcomes were obtained after this surgical procedure with a significant lowering of the POP-Q scores. The improvement of urinary incontinence was observed in 82% of patients with no postoperative de-novo incontinence. At the moment, 40 registered clinical trials are evaluating the medical condition of either ODS and/or POP with none of these trials including an interdisciplinary surgical approach. Neither do they offer an alternative mesh material considering the known risk of a synthetic mesh (33). Because of multiple synthetic mesh associated complications like infections, erosion, and migration with serious consequences e.g., a lifelong diverting stoma years after surgery the use of SMs for transvaginal POP surgery was restricted in the United States by the Food and Drug Administration (FDA) (20,33–36). In addition to standardizing surgical care for patients with ODS with POP, an alternative to SMs must also be offered. The use of a BM for these conditions is an interesting alternative reducing and eliminating the risks of synthetic material. It has already proved its efficacy with excellent results in laparoscopic ventral mesh rectopexy (17,18,36–40). Although BMs are currently not recommended for L-SCP in urogynecological surgery according to the German guidelines for POP, the underlying scientific evidence is scarce and the biological and resorbable mesh material has been improved since then. Even though the risk of recurrence after mesh degradation may be associated with the use of a BM the lifelong risk after using synthetic material, particularly in surgery of younger women, must also be considered (19). For the first time, this study offered a biological mesh material for apical fixation as an alternative to the synthetic mesh in selected cases, as in a later planned pregnancy and if required by the patient. The results after surgery with this new option were convincing and did not differ significantly from the results with the synthetic material. The morbidity was even lower, than in the SM group, highlighting the reduced risks for infection, erosion, and migration as the major benefits, particularly in combination with a simultaneous colorectal resection (L-RRP). Thus, the early safety and functional results of the L-SCP were excellent. A drawback of the study is the small number of patients in the group with the biological material not allowing to draw definitive conclusions. Furthermore, the decision to implant a BM was patient driven and thus inherits a selection bias. Additionally, the follow-up period of 12 months for the total cohort is still too short to propagate our procedure as a standard alternative for SM. Nevertheless, the safety and efficacy of a BM in this study proved to be an additional uterus-preserving treatment option, particularly for younger women of child-bearing age and in times of FDA warnings and the need for a more conscious implantation of synthetic materials. As a next step, a prospective randomized pilot study has already been designed to prove the concept, which will then be followed by a larger multicenter trial with long-term follow-up aspects. In conclusion, this study is the first known trial combining an interdisciplinary laparoscopic resection rectopexy with sacrocolpopexy as a standard treatment option for women with ODS and POP, additionally offering either a synthetic or biological mesh for simultaneous apical fixation. This surgical approach is safe and feasible and early follow-up results are promising. Declarations Authors´ contribution Sebastian Ludwig: project and protocol development, data collection and analysis, manuscript writing and editing Joshy Madukkakuzhy: protocol development, data collection and analysis, manuscript writing Alberto Vega Hernandez: data collection and analysis, manuscript writing and editing Jakob Otten: data collection and analysis Christoph Ulrici: protocol development and data collection Leonidas Karapanos: project development Claudia Rudroff: project and protocol development, data collection and analysis, manuscript writing and editing Funding There was no funding of this study. Consent to participate Informed consent was obtained from all individual participants included in the study. Consent to publish The authors affirm that human research participants provided informed consent for publication of the images in Figures 2 and 3. Acknowledgments The Authors thank Mrs. Desire Paul and Mrs. Elvira Brovkova for their efforts in the outpatient ward. Our special thanks goes to Mrs. Carina Heider for her continuous help in data monitoring and maintaining contact with the study patients. Conflict of interests Sebastian Ludwig receives honoraria for speaking at symposia from the FEG Textiltechnik mbH Aachen, Germany. The other authors declare that they have no conflict of interest with this study. References Hedrick TL, Friel CM. Constipation and pelvic outlet obstruction. Vol. 42, Gastroenterology Clinics of North America. 2013. Andromanakos N, Skandalakis P, Troupis T, Filippou D. 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J Med Dent Sci. 1997;44(4). Baeßler K, Aigmüller T, Albrich S, Anthuber C, Finas D, Fink T, et al. Diagnostik und Therapie des weiblichen Descensus genitalis. Leitlinie der DGGG, SGGG und OEGGG (S2e-Level, AWMF-Registernummer 015/006, April 2016). Geburtshilfe Frauenheilkd. 2016;76(12). Tables Table 1. Patient’s characteristics of the 36 patients with obstructive defecation syndrome (ODS) and pelvic organ prolapse (POP) operated with combined laparoscopic resection rectopexy (L-RRP) and sacrocolpopexy (L-SCP). P-Values showed a significant difference between the two subgroups for the ASA classification. all patients (n= 36) biomesh (n= 8) synthetic mesh (n= 28) p-value Age, y, median (IQR) 57.5 (26 – 83) 47 (26 – 77) 59 (37 – 83) 0.189 ASA, n (%) 0.029 1 2 (5.6%) 1 (2.8%) 1 (2.8%) 2 22 (61.1%) 7 (19.4%) 15 (41.7%) 3 4 12 (33.3%) 0 0 0 12 (33.3%) 0 BMI (kg/m 2 ), median (IQR) 23 (18 – 35) 23.5 (20 – 31) 23 (18 – 35) 0.646 Distributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data Table 2. Surgical outcome of the patients including operating time and duration of hospital stay. P-Values show no difference between the two subgroups. The surgical procedure was further stratified into the different apical fixations to the vaginal stump (sacrocolpopexy, SColP), to the cervical stump (sacrocervicopexy, SCerP), and to the uterus (sacrohysteropexy, SHP). Furthermore, cases with an additional colporrhaphia (+Col) are listed below. all patients (n= 36) biomesh (n= 8) synthetic mesh (n= 28) p-value Operation time in min, median/IQR 263 (165 – 418) 245 (165 – 331) 264 (177 – 418) 0.253 Duration of hospital stay in days, Mean/range 8.2 (4-15) 8.4 (5-11) 8.2 (4-15) 0.671 Surgical Procedure RRP + SColP 11 (30.6%) 3 (8.3%) 8 (22.2%) RRP + SCerP 3 (8.3%) 0 3 (8.3%) RRP + SHP 2 (5.6%) 2 (5.6%) 0 RRP + SColP + Col 5 (13.9%) 0 4 (11.1%) RRP + SCerP + Col 12 (33.3%) 1 (2.8%) 11 (30.6%) RRP + SHP + Col 3 (8.3%) 2 (5.6%) 1 (2.8%) Distributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data Table 3. Patient’s morbidity and mortality according to the Clavien Dindo Classification (CDC) was listed and further stratified into minor complications (CDC 1-3a) and major complications (CDC 3b-5). Furthermore, the individual complications were counted and classified clinically. all patients (n= 36) biomesh (n= 8) synthetic mesh (n= 28) p-value Overall morbidity, n (%) 5 (13.89) 1 (2.8%) 4 (11.1%) 0.170 Minor (CDC 1 – 3a), n (%) 3 (8.3%) 1 (2.8%) 2 (5.6%) Major (CDC 3b – 5), n (%) 2 (5.6%) 0 2 (5.6%) Mortality, n (%) 0 0 0 Anastomotic Leakage 1 (2.8%) 0 1 (2.8%) Lung embolism 1 (2.8%) 0 1 (2.8%) Wound infection 1 (2.8%) 1 (2.8%) 0 Gastrointestinal 1 (2.8%) 0 1 (2.8%) Urologic 1 (2.8%) 0 1 (2.8%) Distributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2232934","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":150009200,"identity":"d9aee666-9088-4fc0-838e-c5f1e16e0728","order_by":0,"name":"Sebastian Ludwig","email":"","orcid":"https://orcid.org/0000-0002-1627-1871","institution":"University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"Sebastian","middleName":"","lastName":"Ludwig","suffix":""},{"id":150009201,"identity":"ece9a28f-a40e-48ad-a01f-53621cd97f4e","order_by":1,"name":"Joshy Madukkakuzhy","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Joshy","middleName":"","lastName":"Madukkakuzhy","suffix":""},{"id":150009202,"identity":"2acf302c-a77e-4531-b384-ae8d72125a4c","order_by":2,"name":"Alberto Vega Hernandez","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Alberto","middleName":"Vega","lastName":"Hernandez","suffix":""},{"id":150009203,"identity":"59eee7ba-8043-445a-8183-bbb3c40aff21","order_by":3,"name":"Jakob Otten","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Jakob","middleName":"","lastName":"Otten","suffix":""},{"id":150009204,"identity":"12bdc7c3-e4a3-4f1a-93bc-cb632408d4a6","order_by":4,"name":"Christoph Ulrici","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Christoph","middleName":"","lastName":"Ulrici","suffix":""},{"id":150009205,"identity":"cbee08ae-20a0-437f-90e8-cce5362c0ed5","order_by":5,"name":"Leonidas Karapanos","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Leonidas","middleName":"","lastName":"Karapanos","suffix":""},{"id":150009206,"identity":"d515eaa1-25ac-4c3b-b680-e09d74d819d5","order_by":6,"name":"Claudia Rudroff","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyUlEQVRIiWNgGAWjYDACdiDmMWCQA1IGDAw2ckRoYYZoMYZoSTMmVgsDQ2ID0Vr4m5mfSbwpsEvfPiN524cPCQYM/O3dCXi1SBxmM5OcY5CcO+dGWvHMGUAtEmfObsCrxYCZwUyax4A5d4ZEjjEz748/DAYSuYS0sH8DaqlPlwBp4QHaQoQWHpAthxOI1yJxmKfYco7BccMZPM+KGYF+4SHoF/729o033vyplpdgT97MAAwxOf72XvxaMAAPacpHwSgYBaNgFGAFAJ2gObbuXM0QAAAAAElFTkSuQmCC","orcid":"","institution":"","correspondingAuthor":true,"prefix":"","firstName":"Claudia","middleName":"","lastName":"Rudroff","suffix":""}],"badges":[],"createdAt":"2022-11-03 07:41:00","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2232934/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2232934/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":28868957,"identity":"d4b5ed3b-ba7d-480f-b5f9-bf0f57b1be76","added_by":"auto","created_at":"2022-11-09 18:10:01","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":689680,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of this pilot study. 44 women suffering from obstructed defecation syndrome (ODS) and pelvic organ prolapse (POP) were enrolled in this study. 36 out of the 44 enrolled patients received laparoscopic resection rectopexy (L-RRP) and sacropexy (L-SCP). In 28 out of these 36 patients, a synthetic mesh (SM) was used for L-SCP; in 8 patients a biological / absorbable mesh (BM) was used.\u003c/p\u003e","description":"","filename":"Fig01.jpg","url":"https://assets-eu.researchsquare.com/files/rs-2232934/v1/1643ef48700f6e642a8aae91.jpg"},{"id":28869288,"identity":"e80c6045-d2d8-4c4e-a7c1-de9fe0533dc7","added_by":"auto","created_at":"2022-11-09 18:18:01","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1148895,"visible":true,"origin":"","legend":"\u003cp\u003eMagnetic resonance image defecography (MRI-D) in sagittal view of a female pelvis with obstructed defecation syndrome (ODS) and pelvic organ prolapse (POP) before surgery. The red dotted arrow marks the pubo-coccygeal line. The white asterisk marks the uterus, the black star marks the filled rectum (ultrasound gel), and the white star marks the excreted ultrasound gel. Figure 2A shows the position at rest, 2B shows the defecation process and descending of the rectum and uterus, and 2C shows the excreted ultrasound gel.\u003c/p\u003e","description":"","filename":"Fig2AC.jpg","url":"https://assets-eu.researchsquare.com/files/rs-2232934/v1/7b76a697b3771ccfc4c5a2cc.jpg"},{"id":28868955,"identity":"129195dc-cf0f-41de-96be-996992124874","added_by":"auto","created_at":"2022-11-09 18:10:01","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":89097,"visible":true,"origin":"","legend":"\u003cp\u003eSagittal view of the female pelvis with obstructed defecation syndrome (ODS) and pelvic organ prolapse (POP) before and after the combined laparoscopic resection rectopexy (L-RRP) and sacrocolpopexy (L-SCP) as well as intraoperative laparoscopic pictures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eA.\u003c/strong\u003e The black dotted arrow marks the elongated and descending sigma, and the black star marks the descending uterus before the combined surgical procedure. The right picture shows the elongated sigma completely filling the small pelvis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB.\u003c/strong\u003e The black arrow marks the sigma anastomosis after resection, but before rectopexy. The black star marks the descending uterus.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eC.\u003c/strong\u003e The black arrow marks the sigma after L-RRP. The black asterisk marks the synthetic mesh for L-SCP, in the depict case a hysteropexy. On the laparoscopic picture a white asterisk marks the synthetic mesh. The mesh is placed unilaterally on the right side of the small pelvis, fixed at the posterior cervix and the sacrum at the level of promontory / S1. The black star marks the elevated uterus after apical fixation.\u003c/p\u003e","description":"","filename":"Fig3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-2232934/v1/a57b8e7e01aa2b75ef354998.jpg"},{"id":28868956,"identity":"089a545e-0142-40ec-ba73-e748ec1ee47e","added_by":"auto","created_at":"2022-11-09 18:10:01","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":165510,"visible":true,"origin":"","legend":"\u003cp\u003eFollow-up results of the 36 patients for bowel evacuation symptoms, obstructed defecation syndrome (ODS) and incontinence are shown. The results of the subjective symptom questionnaires for Altomare score, modified Longo score, rectal toxicity score, and Wexner incontinence score were depicted as boxplots pre- and postoperative (at 12 months follow-up) after laparoscopic resection rectopexy (L-RRP) and sacropexy (L-SCP).\u003c/p\u003e","description":"","filename":"Fig04.jpg","url":"https://assets-eu.researchsquare.com/files/rs-2232934/v1/7a60b2a90be6b98e841d5f57.jpg"},{"id":28868959,"identity":"4322f90c-0df5-45a5-8ced-23d44e2b5993","added_by":"auto","created_at":"2022-11-09 18:10:01","extension":"jpg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":166822,"visible":true,"origin":"","legend":"\u003cp\u003eThe clinical outcome for pelvic organ prolapse quantification system (POP-Q) stages (0 – III) and urinary incontinence of the 36 patients are shown. The results are depicted pre- and postoperatively at 12 months follow-up after laparoscopic resection rectopexy (L-RRP) and sacropexy (L-SCP).\u003c/p\u003e","description":"","filename":"Fig05.jpg","url":"https://assets-eu.researchsquare.com/files/rs-2232934/v1/f00a9ea5aba6fa35b85d7976.jpg"},{"id":29739411,"identity":"697008df-ed41-495b-8737-345933761361","added_by":"auto","created_at":"2022-11-30 19:50:07","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":686408,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2232934/v1/a9a379ae-0563-4d5e-9e3c-22c73609e4a9.pdf"}],"financialInterests":"","formattedTitle":"Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse","fulltext":[{"header":"Take-home Message","content":"\u003cp\u003eNovel standardized interdisciplinary surgical approach for laparoscopic resection rectopexy and sacropexy in women with obstructed defecation syndrome and pelvic organ prolapse.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eObstructive defecation syndrome (ODS) defines a disturbed defecation process caused by the protrusion of the lower rectum (rectocele) or the telescoping within the rectum (intussusception) (1\u0026ndash;3). The patients have to exert pressure frequently and strongly to evacuate the rectum and manual manipulation may be required (4). The unsuccessful attempts to defecate are associated with a feeling of incomplete rectal voiding. ODS affects approximately 10\u0026ndash;25% of the population and is mainly related to female sex (5). The condition is frequently associated with POP and almost 20% of the women require surgery during their lifetime (6,7).\u003c/p\u003e \u003cp\u003eIndividual aspects, such as pregnancy, childbirth, connective tissue disorders, the physiological descending of the pelvic floor at an older age, and pelvine surgical interventions further contribute to the condition (5,8,9). Almost 60% of the female population develop POP during their lifetime and 1/3 of them have bowel dysfunction presenting as constipation and ODS (10,11). The women experience extreme frustration due to their disturbed defecation, compromising their quality of life substantially. Conservative treatment options such as dietary modifications, sufficient fluid intake, laxative medication, physical exercise, pelvic floor training, pelvic floor biofeedback therapy, and pessary treatment are limited and do not achieve the desired long-term effect (12,13).\u003c/p\u003e \u003cp\u003eThe surgical treatment aims at the anatomic reconstruction of the bowel and pelvic floor (14,15) and has been characterized by individual approaches. By ignoring the complexity of the underlying condition, the desired results are often missed (oder besseres Wort ?) (13,16). A standardized treatment option for evidence-based advice to women with ODS and POP is missing (17\u0026ndash;20). Furthermore, there is only insufficient data on interdisciplinary approaches. Of the 40 registered clinical trials evaluating this medical condition none includes an interdisciplinary surgical approach or offers a biological mesh material.\u003c/p\u003e \u003cp\u003eThis pilot study standardizes an interdisciplinary surgical approach of combining laparoscopic resection rectopexy (L-RRP) with laparoscopic sacrocolpopexy (L-SCP) for women with ODS and POP. Additionally, as a novel treatment option, an absorbable biological mesh (BM) for L-SCP is offered to avoid mesh erosion and migration and to preserve the uterus in cases of a planned pregnancy.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eIn the period February 2020 and August 2021, a total of 44 women with ODS and POP presented at our tertiary center pelvic floor unit, consisting of the Departments of Visceral Surgery, Gynecology, and Urology. 36 patients were scheduled for combined L-RRP with pelvic floor reconstruction. Inclusion criteria were women with ODS and POP over 18 years of age and being eligible for laparoscopic surgery. Informed consent for the planned procedure, the mesh material used, the data collection, and the publication of the results was obtained from all patients before surgery (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAll patients underwent preoperative and postoperative urogynecological and surgical examinations at the outpatient clinics. These examinations included taking the medical history of clinical symptoms, pelvic organ prolapse (POP) according to the POP quantification system (POP-Q), the subjective symptom questionnaires for the defecation disorder (Altomare score, modified Longo score, rectal toxicity score, and Wexner incontinence score WIS) (21\u0026ndash;25).\u003c/p\u003e \u003cp\u003eMagnetic resonance image defecography (MRI-D) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) as well as presentation to our pelvic floor board were obligatory before surgery. Women who wished to preserve their uterus or who declined the use of synthetic mesh (SM) material for the L-SCP were offered a biological mesh (BM). The patients\u0026acute; anesthesiologic operability was assessed using the ASA score (American Society of Anesthesiologists, ASA) (26).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe primary study outcome parameters were the safety and efficacy of the combined laparoscopic procedure. The primary endpoint was postoperative morbidity and mortality measured using the Clavien-Dindo classification (CDC) as a measure of the safety of the procedure (27). The secondary outcome parameters were clinical and anatomical outcomes as measured by the aforementioned scores. All scores are routinely collected before the surgery and at follow-up examinations at 6 and 12 months after surgery, and every 12 months thereafter. The 12 months values were used for statistical analysis.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eSurgical procedure\u003c/h2\u003e \u003cp\u003eFor the laparoscopic procedure, after induction of general anesthesia, patients were maintained in dorsal lithotomy position and head-down position of 18\u0026deg;. CO\u003csub\u003e2\u003c/sub\u003e pneumoperitoneum was established according to institutional standards, and trocars were placed. The procedure began with the preparation of the rectum down to the pelvic floor by opening the retrorectal Waldeyer space and the rectovaginal space to ensure the mobilization of the rectocele and the rectal intussusception. An anterior rectal resection was performed in cases of elongation or functional kinking of the sigmoid and rectum (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eA and B). Suture rectopexy fixed the rectum to the sacral vertebrae at the left side of the promontory with nonabsorbable sutures grasping the perirectal peritoneal tissue. The apical fixation of the middle pelvic organ compartment was performed unilaterally in analogy to the previously published cervicosacropexy and vaginosacropexy technique, as well as hysteropexy respectively, as published previously (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eC) (28,29).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe synthetic mesh material (SM) consisted of polyvinylidene-fluoride (DynaMesh VASA, FEG Textiltechnik mbH Aachen, Germany). In selected cases a biological mesh (BM) substituted the SM. We used either the Biodesign\u0026reg; Rectopexy Graft derived from small-intestinal submucosa and remodeled into an avascularized tissue (Cook Biotech Incorporated, USA) or the Phasix\u0026trade; mesh, a knitted monofilament mesh scaffold by using poly-4-hydroxybutyrate from biologically derived, resorbable material (Becton, Dickinson and Company, USA). A pelvine peritoneoplasty covered the mesh material and obliterated the small pelvis and the Douglas pouch. The procedure is summarized in the attached video file (Video 1). The surgical procedure is summarized in a video file (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003ca href=\"http://www.youtu.be!A3F_SxdOINE\" target=\"_blank\"\u003ewww.youtu.be!A3F_SxdOINE\u003c/a\u003e\u003c/span\u003e\u003cspan address=\"http://www.youtu.be!A3F_SxdOINE\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eData management and statistical analysis\u003c/h2\u003e \u003cp\u003eThe necessary clinical data were collected preoperatively, during the hospital stay, and during the follow-up examinations. All scores were documented on paper and transferred to a data bank. Data were analyzed using the SPSS statistical package, version 29.0.0.1. (IBM Corp., Armonk, NY, USA). Quantitative variables are described as means (\u0026plusmn;\u0026thinsp;standard deviation) and were compared using the Kruskal\u0026ndash;Wallis H test and Mann\u0026ndash;Whitney \u003cem\u003eU\u003c/em\u003e test. Qualitative variables are summarized using count, percentage, median, and interquartile range and were compared using the Fisher\u0026rsquo;s exact test. A two-sided p value of \u0026lt;\u0026thinsp;0.05 was considered statistically significant. Because no adjustments for multiple testing were performed, the analyses were exploratory.\u003c/p\u003e \u003c/div\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eEthical approval\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis retrospective study was registered and approved by the Ethical Committee of the Aerztekammer Nordrhein in D\u0026uuml;sseldorf, Germany (Registration No.: 2022-070).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eOf the 44 women with ODS and POP treated with surgery eight patients were excluded from further analysis because the pelvic floor was reconstructed transvaginally. In total, 36 patients were operated on in the interdisciplinary manner combining L-RRP with L-SCP as described above. The median follow-up period was 19 months (12\u0026ndash;32 months) with 33 patients to be analyzed at 12 months. For L-SCP a SM was used in 28 patients and a BM was used in 8 patients. The decision was based on patients\u0026rsquo; preference and in cases planning for future pregnancies. One patient in the SM group was lost to follow-up. In two patients of the SM group the 12 months data were incomplete and were marked as missing values for statistical analysis of the follow-up (Fig. 1).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePatients\u0026acute; characteristics\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePatients\u0026rsquo; median age was 57.5 years (range: 26\u0026ndash;83 years), and the mean body mass index (BMI, kg/m\u003csup\u003e2\u003c/sup\u003e) was 23 (18\u0026ndash;35) with no statistically significant differences between the two subgroups, SM and BM. The ASA score ranged from ASA I (n\u0026thinsp;=\u0026thinsp;2) to ASA III (n\u0026thinsp;=\u0026thinsp;12), with most of the patients having ASA II (n\u0026thinsp;=\u0026thinsp;22). The BM group consisted only of patients with ASA I (n\u0026thinsp;=\u0026thinsp;1) and ASA II (n\u0026thinsp;=\u0026thinsp;7), whereas in the SM group, 12 patients had ASA III. The difference was statistically significant (p\u0026thinsp;=\u0026thinsp;0.029). Table\u0026nbsp;1 summarizes the baseline clinical characteristics of the operated patients.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSurgical outcome\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll patients were operated laparoscopically with no conversion to open surgery. Operating time averaged 263 minutes (min; range: 165\u0026ndash;418 min) and postoperative hospital stay was 8.2 days (range: 4\u0026ndash;15 days), with no differences between the subgroups (Table\u0026nbsp;2). In 19 of the 36 patients (52%), a concomitant anterior/posterior colporrhaphy was added to the combined laparoscopic surgical procedure. The details are listed in Table\u0026nbsp;2, as well.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMorbidity and Mortality\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn total, 5 patients experienced postoperative complications, one of them in the BM group. Most of the complications were mild (CDC 1\u0026ndash;3a). Superficial wound infection (CDC 1) in one patient required no further treatment. One Urinary tract infection, diarrhea in one patient, and one lung embolism 5 days after surgery, all of which could be treated with medication (all CDC 2). One patient in the SM group developed an anastomotic leakage and required surgical revision with a temporary loop ileostomy (CDC 3b). The procedure was easier due to a previously placed Ghost stoma, a silicone loop marking a suitable ileum loop during the primary operation (30). Further recovery was uneventful, and the patient was discharged on day 10 (for further details see Table\u0026nbsp;3).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eClinical and Functional Outcome after Surgery\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eObstructed defecation syndrome (ODS)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll patients enrolled had ODS, which was classified clinically by using scores before and after surgery. The Altomare score (maximum 30 points) averaged 10 points preoperatively and dropped to 5 points at 12 months (p\u0026thinsp;=\u0026thinsp;0.006) (Fig.\u0026nbsp;4). Between the two subgroups the difference of the scores after surgery was significant for the SM group (p\u0026thinsp;=\u0026thinsp;0.023), but not for the BM group (p\u0026thinsp;=\u0026thinsp;0.074). The categorial analysis showed an improvement for the BM group, which did not reach significance due to the small sample size.\u003c/p\u003e\n\u003cp\u003eThe mean results in the modified Longo score (maximum 24 points) reached 12 points preoperatively and 7 points after 12 months (p\u0026thinsp;=\u0026thinsp;0.003) (Fig.\u0026nbsp;4). The results in the mesh subgroups showed the same result, as for the Altomare score. In the SM group the results differed (p\u0026thinsp;=\u0026thinsp;0.015), whereas the analysis of the BM subgroup was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.09).\u003c/p\u003e\n\u003cp\u003eSome patients had bowel dysfunction symptoms, such as diarrhea, meteorism, and pain upon defecation, which was measured using the rectal toxicity score (maximum 32 points). In the total cohort, 15 points were measured preoperatively and 7 points 12 months (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) (Fig.\u0026nbsp;4). Both subgroups were statistically lower after surgery, with higher values for the SM group (15 and 10 points before and after surgery, respectively; p\u0026thinsp;=\u0026thinsp;0.004) than for the BM group (8 and 5 points before and after surgery, respectively; p\u0026thinsp;=\u0026thinsp;0.04).\u003c/p\u003e\n\u003cp\u003eThe Wexner incontinence score (WIS) as a parameter for the control of flatus and stool improved after surgery. The WIS documented 7 points preoperatively and 4 points at 12 months (p\u0026thinsp;=\u0026thinsp;0.035) (Fig.\u0026nbsp;4). The results differed significantly between the subgroups. In the SM group, the median was 9 and 2 points before and after surgery, respectively (p\u0026thinsp;=\u0026thinsp;0.01). In the BM group, the values were 7 and 3 points before and after surgery (p\u0026thinsp;=\u0026thinsp;0.5).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePelvic organ prolapse (POP)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePostoperative anatomical results were compared with preoperative evaluation by using the POP-Q score. Before surgery, 13 (36%) patients had POP-Q stage 1 and 23 (64%) patients had POP-Q stages 2\u0026ndash;3. Postoperatively, 28 (78%) patients had POP-Q stage 0. Of these 7 patients (19%) with POP-Q stage 1, 5 patients had improved from higher grade POP-Q. One (3%) patient had POP-Q stage 2 relapse after 6 months due to insufficient fixation of the BM; the patient underwent laparoscopic apical refixation with an SM. The difference between these results was statistically significant (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, Fig.\u0026nbsp;5).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eUrinary incontinence symptoms\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOf all 36 patients who underwent L-RRP and L-SCP, 17 (47%) patients suffered from urinary incontinence before surgery (mixed urinary incontinence). Postoperatively continence was restored in 14 patients (82%). No de-novo stress or urgency urinary incontinence symptoms appeared. The results were statistically significant (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, Fig.\u0026nbsp;5). In the subgroup analysis the results after the use of a SM were significantly different (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), whereas the difference in the BM group could not be shown due to the low number of patients (p\u0026thinsp;=\u0026thinsp;1).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo date, the treatment of ODS with POP has been characterized by individual approaches. Sufficient data on standardized treatment options and particularly a combined interdisciplinary approach for evidence-based advice to women with ODS and POP is missing (17\u0026ndash;20) (31,32).\u003c/p\u003e\n\u003cp\u003eThis study is the first to establish an interdisciplinary laparoscopic surgical approach, combining a resection rectopexy (with anastomosis and without protective stoma) and a sacrocolpopexy in one surgical procedure as a standard treatment option for women with ODS and POP. All affected women with that defined medical condition received this laparoscopic combined surgical procedure in our setting.\u003c/p\u003e\n\u003cp\u003eBoth, anatomical and functional outcomes were evaluated after surgery in this novel interdisciplinary setting at our institution. The procedure proved to be easy to establish and to be technically feasible and safe. The morbidity was low - with only one surgical re-intervention in the SM group because of an anastomotic leakage requiring subsequent protective stoma. The synthetic mesh was not adjacent to the leakage and remained intraabdominally. No further complications occurred within a mean of 19 months after surgery.\u003c/p\u003e\n\u003cp\u003eExcellent functional outcomes for ODS were achieved in a significant lowering of the assessed scores. Additional bowel discomforting symptoms, as diarrhea and meteorism as well as fecal incontinence were also improved as a positive side effect. Furthermore, excellent anatomical outcomes were obtained after this surgical procedure with a significant lowering of the POP-Q scores. The improvement of urinary incontinence was observed in 82% of patients with no postoperative de-novo incontinence.\u003c/p\u003e\n\u003cp\u003eAt the moment, 40 registered clinical trials are evaluating the medical condition of either ODS and/or POP with none of these trials including an interdisciplinary surgical approach. Neither do they offer an alternative mesh material considering the known risk of a synthetic mesh (33). Because of multiple synthetic mesh associated complications like infections, erosion, and migration with serious consequences e.g., a lifelong diverting stoma years after surgery the use of SMs for transvaginal POP surgery was restricted in the United States by the Food and Drug Administration (FDA) (20,33\u0026ndash;36). In addition to standardizing surgical care for patients with ODS with POP, an alternative to SMs must also be offered. The use of a BM for these conditions is an interesting alternative reducing and eliminating the risks of synthetic material. It has already proved its efficacy with excellent results in laparoscopic ventral mesh rectopexy (17,18,36\u0026ndash;40). Although BMs are currently not recommended for L-SCP in urogynecological surgery according to the German guidelines for POP, the underlying scientific evidence is scarce and the biological and resorbable mesh material has been improved since then. Even though the risk of recurrence after mesh degradation may be associated with the use of a BM the lifelong risk after using synthetic material, particularly in surgery of younger women, must also be considered (19).\u003c/p\u003e\n\u003cp\u003eFor the first time, this study offered a biological mesh material for apical fixation as an alternative to the synthetic mesh in selected cases, as in a later planned pregnancy and if required by the patient.\u003c/p\u003e\n\u003cp\u003eThe results after surgery with this new option were convincing and did not differ significantly from the results with the synthetic material. The morbidity was even lower, than in the SM group, highlighting the reduced risks for infection, erosion, and migration as the major benefits, particularly in combination with a simultaneous colorectal resection (L-RRP). Thus, the early safety and functional results of the L-SCP were excellent.\u003c/p\u003e\n\u003cp\u003eA drawback of the study is the small number of patients in the group with the biological material not allowing to draw definitive conclusions. Furthermore, the decision to implant a BM was patient driven and thus inherits a selection bias. Additionally, the follow-up period of 12 months for the total cohort is still too short to propagate our procedure as a standard alternative for SM. Nevertheless, the safety and efficacy of a BM in this study proved to be an additional uterus-preserving treatment option, particularly for younger women of child-bearing age and in times of FDA warnings and the need for a more conscious implantation of synthetic materials. As a next step, a prospective randomized pilot study has already been designed to prove the concept, which will then be followed by a larger multicenter trial with long-term follow-up aspects.\u003c/p\u003e\n\u003cp\u003eIn conclusion, this study is the first known trial combining an interdisciplinary laparoscopic resection rectopexy with sacrocolpopexy as a standard treatment option for women with ODS and POP, additionally offering either a synthetic or biological mesh for simultaneous apical fixation. This surgical approach is safe and feasible and early follow-up results are promising.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthors\u0026acute; contribution\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSebastian Ludwig: project and protocol development, data collection and analysis, manuscript writing and editing\u003c/p\u003e\n\u003cp\u003eJoshy Madukkakuzhy: protocol development, data collection and analysis, manuscript writing\u003c/p\u003e\n\u003cp\u003eAlberto Vega Hernandez: data collection and analysis, manuscript writing and editing\u003c/p\u003e\n\u003cp\u003eJakob Otten: data collection and analysis\u003c/p\u003e\n\u003cp\u003eChristoph Ulrici: protocol development and data collection\u003c/p\u003e\n\u003cp\u003eLeonidas Karapanos: project development\u003c/p\u003e\n\u003cp\u003eClaudia Rudroff: project and protocol development, data collection and analysis, manuscript writing and editing\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere was no funding of this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to publish\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors affirm that human research participants provided informed consent for publication of the images in Figures 2 and 3.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Authors thank Mrs. Desire Paul and Mrs. Elvira Brovkova for their efforts in the outpatient ward. Our special thanks goes to Mrs. Carina Heider for her continuous help in data monitoring and maintaining contact with the study patients.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSebastian Ludwig receives honoraria for speaking at symposia from the FEG Textiltechnik mbH Aachen, Germany. The other authors declare that they have no conflict of interest with this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eHedrick TL, Friel CM. Constipation and pelvic outlet obstruction. Vol. 42, Gastroenterology Clinics of North America. 2013.\u003c/li\u003e\n \u003cli\u003eAndromanakos N, Skandalakis P, Troupis T, Filippou D. Constipation of anorectal outlet obstruction: Pathophysiology, evaluation and management. Journal of Gastroenterology and Hepatology (Australia). 2006;21(4).\u003c/li\u003e\n \u003cli\u003eYagi Y, Tsunoda A, Takahashi T, Kusanagi H. 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Obstetrics and Gynecology. 2013;122(6).\u003c/li\u003e\n \u003cli\u003eCallewaert G, Housmans S, Cattani L, Pacqu\u0026eacute;e S, D\u0026rsquo;Hoore A, Wyndaele J, et al. Medium-term outcome of laparoscopic sacrocolpopexy using polivinylidene fluoride as compared to a hybrid polyglecaprone and polypropylene mesh: A matched control study. Neurourol Urodyn. 2019;38(7).\u003c/li\u003e\n \u003cli\u003eMaher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Vol. 2016, Cochrane Database of Systematic Reviews. 2016.\u003c/li\u003e\n \u003cli\u003eBrunner M, Roth H, G\u0026uuml;nther K, Gr\u0026uuml;tzmann R, Matzel KE. Ventral rectopexy with biological mesh for recurrent disorders of the posterior pelvic organ compartment. Int J Colorectal Dis. 2019;34(10).\u003c/li\u003e\n \u003cli\u003eNichols RL, Smith JW, Garcia RY, Waterman RS, Holmes JWC. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clinical Infectious Diseases. 1997;24(4).\u003c/li\u003e\n \u003cli\u003eYabata E, Okabe S, Endo M. A prospective, randomized clinical trial of preoperative bowel preparation for elective colorectal surgery - Comparison among oral, systemic, and intraoperative luminal antibacterial preparations -. J Med Dent Sci. 1997;44(4).\u003c/li\u003e\n \u003cli\u003eBae\u0026szlig;ler K, Aigm\u0026uuml;ller T, Albrich S, Anthuber C, Finas D, Fink T, et al. Diagnostik und Therapie des weiblichen Descensus genitalis. Leitlinie der DGGG, SGGG und OEGGG (S2e-Level, AWMF-Registernummer 015/006, April 2016). Geburtshilfe Frauenheilkd. 2016;76(12).\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e Patient\u0026rsquo;s characteristics of the 36 patients with obstructive defecation syndrome (ODS) and pelvic organ prolapse (POP) operated with combined laparoscopic resection rectopexy (L-RRP) and sacrocolpopexy (L-SCP). P-Values showed a significant difference between the two subgroups for the ASA classification.\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"621\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e\u003cstrong\u003eall patients\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 36)\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e\u003cstrong\u003ebiomesh\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 8)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.256038647342994%\"\u003e\n \u003cp\u003e\u003cstrong\u003esynthetic mesh\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 28)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003eAge, y, median (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e\u0026nbsp;57.5 (26 \u0026ndash; 83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e47 (26 \u0026ndash; 77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e59 (37 \u0026ndash; 83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e0.189\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003eASA, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e0.029\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e22 (61.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e7 (19.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e15 (41.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e12 (33.3%)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e\u0026nbsp;0\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e12 (33.3%)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.375201288244767%\"\u003e\n \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e), median (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e23 (18 \u0026ndash; 35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.806763285024154%\"\u003e\n \u003cp\u003e23.5 (20 \u0026ndash; 31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.256038647342994%\"\u003e\n \u003cp\u003e23 (18 \u0026ndash; 35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"10.305958132045088%\"\u003e\n \u003cp\u003e0.646\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" width=\"100%\"\u003e\n \u003cp\u003e\u003cem\u003eDistributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2.\u003c/strong\u003e Surgical outcome of the patients including operating time and duration of hospital stay. P-Values show no difference between the two subgroups. The surgical procedure was further stratified into the different apical fixations to the vaginal stump (sacrocolpopexy, SColP), to the cervical stump (sacrocervicopexy, SCerP), and to the uterus (sacrohysteropexy, SHP). Furthermore, cases with an additional colporrhaphia (+Col) are listed below.\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"621\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u003cstrong\u003eall patients\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 36)\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e\u003cstrong\u003ebiomesh\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 8)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u003cstrong\u003esynthetic mesh\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 28)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOperation time in min, median/IQR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e263 (165 \u0026ndash; 418)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e245 (165 \u0026ndash; 331)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e264 (177 \u0026ndash; 418)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.253\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDuration of hospital\u003c/p\u003e\n \u003cp\u003estay in days,\u003c/p\u003e\n \u003cp\u003eMean/range\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e8.2 (4-15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e8.4 (5-11)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e8.2 (4-15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.671\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eSurgical Procedure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eRRP + SColP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e11 (30.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e3 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e8 (22.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eRRP + SCerP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e3 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e3 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eRRP + SHP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eRRP + SColP + Col\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e5 (13.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e4 (11.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eRRP + SCerP + Col\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e12 (33.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e11 (30.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"27.697262479871174%\"\u003e\n \u003cp\u003eRRP + SHP + Col\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e3 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.96779388083736%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.578099838969404%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"9.178743961352657%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" width=\"100%\"\u003e\n \u003cp\u003e\u003cem\u003eDistributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3.\u003c/strong\u003e Patient\u0026rsquo;s morbidity and mortality according to the Clavien Dindo Classification (CDC) was listed and further stratified into minor complications (CDC 1-3a) and major complications (CDC 3b-5). Furthermore, the individual complications were counted and classified clinically.\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"621\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e\u003cstrong\u003eall patients\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 36)\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e\u003cstrong\u003ebiomesh\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 8)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.43393148450245%\"\u003e\n \u003cp\u003e\u003cstrong\u003esynthetic mesh\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n= 28)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOverall morbidity, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5 (13.89)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4 (11.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.170\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eMinor (CDC 1 \u0026ndash; 3a), n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e3 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eMajor (CDC 3b \u0026ndash; 5), n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e2 (5.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eMortality, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eAnastomotic Leakage\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eLung embolism\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eWound infection\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eGastrointestinal\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.973898858075042%\"\u003e\n \u003cp\u003eUrologic\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"21.533442088091356%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.0652528548124%\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.43393148450245%\"\u003e\n \u003cp\u003e1 (2.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"7.993474714518761%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" width=\"100%\"\u003e\n \u003cp\u003e\u003cem\u003eDistributions are presented as median and interquartile range (IQR) for continuous, and total number and percentages (%) for binary data\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Obstructed defecation syndrome, pelvic organ prolapse, resection rectopexy, sacrocolpopexy, mesh, biological mesh ","lastPublishedDoi":"10.21203/rs.3.rs-2232934/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2232934/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eObstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life. Conservative treatment options are limited. Surgical interventions are characterized by a variety of individual approaches. This study standardized laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) in an interdisciplinary setting. Additionally, offering both synthetic mesh (SM) and biological mesh (BM) material for L-SCP is a novel treatment alternative, particularly for premenopausal women.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWomen with ODS combined with POP underwent surgery using an interdisciplinary approach. The primary endpoint was postoperative morbidity and mortality measured by the Clavien-Dindo classification (CDC). Further endpoints were improvement in bowel evacuation, POP, and urinary incontinence at a median follow-up period of \u0026gt;\u0026thinsp;12 months.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOf a total of 44 patients, 36 patients were treated with L-RRP combined with L-SCP (28 patients with SM, 8 patients with BM). CDC grades and the frequency of postoperative complications were low. Clinical outcomes for ODS, bowel dysfunction, and fecal control improved significantly. Anatomical outcome for POP was significantly better with 28 (78%) patients having POP-Q stage 0 after surgery. 17 patients (47%) had urinary incontinence before surgery, which was restored in 14 patients (82%). No de-novo urinary incontinence appeared.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe interdisciplinary surgical approach with L-RRP and L-SCP is safe, feasible, and effective in treating women with ODS and POP. The use of a biomesh was established as an effective alternative to the SM and offers an additional and new uterine-preserving option.\u003c/p\u003e","manuscriptTitle":"Early Safety and Efficiency Outcomes of a Novel Standardized Interdisciplinary Procedure of Combined Laparoscopic Resection Rectopexy with Laparoscopic Sacrocolpopexy to Treat Obstructive Defecation Syndrome in Women with Pelvic Organ Prolapse","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-11-09 18:09:56","doi":"10.21203/rs.3.rs-2232934/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"24ab9d47-74c3-428d-8fe7-7c1cd7f9c8f1","owner":[],"postedDate":"November 9th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2022-11-30T19:50:00+00:00","versionOfRecord":[],"versionCreatedAt":"2022-11-09 18:09:56","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-2232934","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2232934","identity":"rs-2232934","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}