Device that safely closes the incisions made with trocars in laparoscopic surgery

Device that safely closes the incisions made with trocars in laparoscopic surgery | 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 Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Device that safely closes the incisions made with trocars in laparoscopic surgery Luis Padilla, Jesús Montoya-Ramírez, Oscar Aguilar-Soto, Fanny Stella Herran-Motta, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4784149/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 Objective: To describe and demonstrate the safety and efficacy of an OcluPad (OP) that closes surgical incisions in the abdominal wall, made with trocars in laparoscopic surgery in obese patients, avoiding hernias. Material and methods: After preclinical studies in rats and pigs, we obtained authorization from the Research, Ethics, and Biosafety commissions of the "20 de Noviembre" National Medical Center to develop a clinical trial and apply the OP device to 40 of the 80 patients subjected to Gastric bypass or gastric sleeve surgery as a surgical treatment for morbid obesity. The patients were divided into two groups: Group I, 40 patients with three OP devices applied to close the trocar holes, and Group II, 40 patients without surgical closure of the three trocar holes. Results: The groups were evaluated two years after the bariatric surgery procedure using abdominal tomography. Obtaining zero hernias in group I and 14 hernias in group II generated a 35% prevalence. (p = 0.001) (OR = 0.04) CI = 0.005–0.38. Conclusions: OP is a device that prevents the formation of trocar hernias in obese patients. It is efficient, simple, quick to apply, economical, and meets the concept of safety and effectiveness since it has excellent biocompatibility; generating a layer of neo-mesothelium induces minimal adhesions. Laparoscopic surgery hernias bariatric surgical procedure Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 INTRODUCTION There is no doubt about the significant advantages of laparoscopic surgery; however, as with all advances, the technique has some disadvantages, such as the formation of hernias at the sites of application of the trocars. ( 1 , 2 ) Before 2012, a prevalence between 1 and 2% was reported in the literature, although this figure could be considered underestimated since many patients with a trocar hernia are asymptomatic. In recent studies, it is known that in obese patients, it has increased from 30 to 40%. ( 3 , 4 ) Karampinis' group, using abdominal ultrasound to detect trocar hernias in 359 patients undergoing bariatric surgery, found that 124 patients had hernias, reporting a prevalence of 34.5%. ( 5 ) Rossi et al. studied 123 patients undergoing laparoscopic gastric bypass, finding seven trocar hernias upon physical examination of the abdominal wall, but 56 hernias were diagnosed when applying ultrasound. ( 6 ) Also, 5mm trocars can cause a hernia and create a real clinical problem. In non-obese patients, correct closure of the aponeurosis with direct sutures or with needle and guide devices such as the Lasky trocar for port closure in laparoscopic surgery. ( 7 ) In the case of obese patients or patients with bleeding at the trocar site who have technical difficulty in closing, the use of a medical grade polypropylene and silicone device called OcluPad (OP) is proposed, which is introduced through the trocar after the surgical procedure and which, under direct vision on the monitor, is placed inside the abdominal cavity. OP has a long polypropylene suture that serves as traction to fix and prevent device displacement. We put an absorbable polylactic acid star between the aponeurosis and the subcutaneous cellular tissue. (Fig. 1 ) In previous studies, our group had experience with medical-grade silicone tubes implanted in the subcutaneous cellular tissue of rats and dogs, observing that they induced an external layer of vascularized fibro-collagen, which were used as vascular micro prostheses and conduits to transplant hematopoietic stem cells to induce angiogenesis. ( 8 , 9 , 10 ) The results of these studies led us to use medical-grade silicone in the OP device on the face in visceral contact, waiting for the formation of a fibro collagenous layer and, subsequently, a neo-mesothelium (Neo-peritoneum). MATERIAL AND METHODS OcluPad Device Description It is constructed from a polypropylene cylinder 1 cm high by 0.5 cm in diameter, attached to a circular sheet of polypropylene 2.5 cm in diameter to which a second circular sheet of medical-grade silicone is adhered. It has a long polypropylene suture that serves as traction; an absorbable polylactic acid star is placed to fix it and prevent its displacement. OP devices are available to close trocar ports of 5, 10, and 12 mm in diameter with intraperitoneal medical-grade silicone sheets of 1.5, 2.5, and 3.5 cm. (Figure 2) The patent application was made to the Mexican Institute of Industrial Property on September 23, 2014, obtaining the Utility Model Registration Title No. 3511 on July 13, 2016, signed by the Divisional Director of Patents. Based on the good preclinical results, the research, Ethics, and Biosafety committees of the National Medical Center “November 20” will approve a protocol for a Controlled Clinical Trial in patients with morbid obesity who underwent Bariatric Surgery (Gastric Bypass and Sleeve gastric). All patients were duly informed of their process, and the device application procedure and the respective consent forms were signed. Preclinical studies in rats and pigs In Mexico, to register a class III medical device that is introduced into the body and remains in it for more than 30 days, it is necessary to comply with the regulations on health supplies, chapter IX Art. 83, which requires preclinical and biocompatibility studies to demonstrate safety and efficacy. In Wistar rats, two materials were applied intraperitoneally: polypropylene, and medical-grade silicone to evaluate the extent of adhesions with the Diamond scale. (Table 1-A). We applied the OP device to 20 pigs of the Danish Landrace breed with two different intraperitoneal surfaces: Group I–10 pigs with polypropylene and Group II–10 pigs with medical-grade silicone. The results of extension, severity, and density of adhesions are summarized in Table 1-B, demonstrating that medical-grade silicone generates the fewest intraperitoneal adhesions in both rats and pigs. BIOCOMPATIBILITY STUDIES The three components of the OP device (Silicone, Polypropylene, and Polylactic Acid) have the biocompatibility guides required by the US Food and Drug Administration (FDA); these are cell culture tests, mutagenicity tests, hemolysis tests, skin sensitivity tests, and pyrogen tests. Fragments of the three components of the OP device were applied intramuscularly to the abdominal wall of 12 male Wistar rats weighing 250 g. (Supplementary figure 1) The animals were sacrificed at 2, 4, 6, 12, and 18 months to obtain tissue samples. The pathology report concluded that the degrees of inflammation, fibrosis, and vascular proliferation were as expected according to the experience of the patient's histopathological analysis who had tissues removed with the same materials and according to what has been reported in the literature. (Figure 3) CONTROLLED CLINICAL TRIAL Based on the good preclinical results, a Controlled Clinical Trial (CCT) was designed and approved by the Research, Ethics, and Biosafety commissions of the "20 de Noviembre" National Medical Center. This ECC included 80 patients with morbid obesity who underwent Bariatric Surgery by the same surgeon (gastric bypass or gastric sleeve) and divided into two groups of 40 patients (Registration No.: 323.2020). In group I, 40 patients underwent Surgery, and at the end of the procedure, three OP devices were placed to close the trocar holes. In group II, 40 patients (control group) underwent Surgery without surgical closure of the three trocar holes. All patients were duly informed of their process, and the device application procedure and their respective informed consent was signed. The protocol was registered at ClinicalTrials.gov. SURGICAL TECHNIQUE Gastric bypass All patients underwent the same simplified technique originally described by Hans Lonroth in 1996. This technique corresponds to Roux-en-Y bypass anastomoses, with a biliary loop length between 100 and 129 cm and a food length between 80 and 100 cm. Gastric sleeve The gastric antrum is preserved, and gastric resection is performed with a linear stapler starting at the prepyloric 4-6 cm. Calibration was performed using a 36 Fr. probe without staple line reinforcement. (11,12) After the bypass or gastric sleeve procedure, the corresponding OP was introduced through the right upper quadrant trocar (generally an OP device of 2.5 cm in diameter) mounted on laparoscopic forceps; when the polypropylene and silicone sheets reached the abdominal cavity, they opened and distended automatically. Under direct vision on the monitor, the suture attached to the cylinder is pulled until the hermetic closure of the peritoneum is verified. Finally, the device is fixed by applying the absorbable polylactic acid star, remaining between the cellular tissue and the aponeurosis. (Figure 4) Subsequently, through the trocar in the left hypochondrium, a second device 2.5 cm in diameter is introduced and placed in the patient with gastric bypass and a 3.5 cm in diameter in the case of a gastric sleeve (generally corresponding to the exit orifice of the gastric remnant). Finally, to close the port where the laparoscope lens works, a third 2.5 cm diameter device mounted on a laparoscopic clamp is removed and inserted, calculating to reach the abdominal cavity. The laparoscope is reintroduced to locate the device, and the suture attached to the cylinder is pulled to guide it toward the lumen of the trocar. The suture is fixed by applying the absorbable polylactic acid star. RESULTS A total of 80 patients were included and divided into two groups. Their clinical-demographic characteristics were analyzed (Table 2) with no statistical differences. The two groups were evaluated using simple abdominal tomography two years after the bariatric surgical procedure. In group No. I, no hernias or displacement of the devices per trocar were observed. (Figure 5 A-B-C-D-E) None of the 40 patients presented pain, seroma, hematoma, and infection in the trocar wounds. Only one case presented a superficial wound dehiscence resolved without affecting the rest of the device. As an additional advantage, it was observed that during the OP device application (in pigs and patients), hemostasis is achieved in the trocar hole by fixing the polylactic acid star and applying compression. In contrast, in group No. II, 14 trocar hernias were detected. (Figure 5 F-G-H-I-J) A Chi-square test was performed to determine the behavior of the variables, obtaining a prevalence of 35% with statistical differences with the use of OP to prevent trocar hernias (p=0.001). The odds ratio was calculated, showing that the OP protects up to 96 times against the probability of developing a hernia compared to patients for whom the device was not applied (OR= 0.04). The cylinder and the circular polypropylene sheet adhered and formed fibrosis in the tunnel and parietal peritoneum. The circular sheet of medical-grade silicone faced the abdominal cavity, forming a fibro collagenous layer and a proper neo-mesothelial layer (neo-peritoneum). This was corroborated in preclinical studies and in one of the patients in group I, who presented acute appendicitis eight months after the gastric bypass procedure and application of the three OP devices. At the time of the laparoscopic approach for the appendectomy, it was possible to see that the devices were covered with a vascularized neo-mesothelial membrane and without adhesions. (Supplementary figure 2) It was demonstrated that the device achieves a triple repair: it closes the trocar channel, closes the peritoneal orifice (without tension), and offers hemostasis by compression when bleeding. DISCUSSION The complication called trocar hernia can lead to a new surgical intervention to resolve an intestinal obstruction with perforation and peritoneal sepsis with a risk of death, in addition to the need to repair the abdominal wall. The risk factors that generate a trocar hernia are clinical and technical. The clinical symptoms include female sex, age over 60 years, multiparity, obesity, diabetes, chronic bronchitis, malnutrition, anemia, and kidney failure. Technical factors include the Hasson trocar, number and diameter of trocars, incision location, procedure duration, technique, and the effect of pneumoperitoneum during removal. (2) Before 2012, trocar hernia was reported to have a prevalence between 1 and 2%; however, this figure is considered underestimated since many patients are asymptomatic. In recent studies, it is reported that it has increased from 30 to 40% in obese patients. (3)(4) Trocar hernias were avoided during the two-year follow-up period with the OP device. Without the OP device, 14 hernias were reported in the 40 patients studied, resulting in a 35% prevalence, which agrees with what Karampinis (5) and Ross (6) reported. Direct suturing techniques of the aponeurosis or the introduction of needles that cross the two aponeurosis should continue to be used, but in the case of obese patients or patients with bleeding at the trocar site and who present technical difficulty in closing, we recommend the application of the OP device. This study shows that the device achieves a triple repair, closing the trocar channel, closing the peritoneal orifice without tension, and providing compression hemostasis when bleeding occurs at the trocar orifice. On the other hand, it was observed in preclinical studies in rats and pigs that the intraperitoneal circular sheet of medical-grade silicone is covered with a vascularized fibro collagenous membrane and subsequently forms a proper neo-mesothelial layer.vascularizada y que posteriormente forma una verdadera capa neo-mesotelial. This phenomenon could be corroborated by direct intraoperative vision in a patient who presented with acute appendicitis eight months after the gastric bypass procedure and application of the three OP devices. At the time of the laparoscopic approach for the appendectomy, we could see that the devices were covered with a vascularized neo-mesothelial membrane (Neo-peritoneum) without adhesions. (Supplementary figure 2) (Video No. 4) Based on our results, to avoid trocar hernias, we recommend always trying to close the aponeurosis with suture, using closure devices with a needle and guide, and using the OP device in obese patients, in case of bleeding from the trocar hole, in 5 mm diameter holes, and when it is necessary to reduce surgical time. CONCLUSIONS OP is an efficient, simple, easy-to-apply, economical, and safe device. It has excellent biocompatibility and induces minimal intraperitoneal adhesions, preventing the formation of trocar hernias in obese patients. A loose, soft, low-diameter adhesion is preferable to an open hole that allows tissue entry and causes visceral strangulation that requires urgent Surgery. Declarations Disclosure statement All authors declare no conflict of interest. Financial support statement No financial support was received. Author Contribution PL, conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, writing original draft; MRJ, data curation, formal analysis, investigation, methodology. ASO, formal analysis, investigation, methodology; HMFS, investigation, supervision, validation; LYT, investigation, methodology, supervision, validation; LGJ, data curation, investigation, methodology; CCPH, data curation, formal analysis, investigation, methodology, writing original draft; NNL, conceptualization, investigation, writing, review & editing; OSJA, investigation, methodology, supervision, validation; OFM, data curation, formal analysis, investigation, methodology; DSM, data curation, formal analysis, investigation, methodology, supervision, validation; MJEE, conceptualization, data curation, investigation, writing, review & editing. Acknowledgement To Dr. Alfredo Cortes Algara for the patent, Dr. Carolina García Zavala and Dr. Sebastian González for the tomography scans, to the Teacher Antonieta Castro for the illustrations, and to Araceli Martinez Sánchez for the editing. References Crist D.W., Gadaez T.R. Complications of laparoscopic surgery. Surg. Clin. North Am. 73: 265-89, 1993. Moreno-Egea A. Prevención de las hernias en el sitio del trocar: un problema pendiente de solución. Revisión y experiencia personal. Rev. Hispanoam Hernia 3(1):27-32, 2015. Swank HA, Mulder IM, la Chapelle CF, Reitsma JB, Lange JF, Bemelman WA. Systematic review of trocar-site hernia. Br. J. Surg. 99: 315-323, 2012 Mikhail E, Hart S. Laparoscopic port closure. Surg Technol Int. 24:27-33, 2014. Karsmpinis I, Lion E, Hetjens S, Vassilev G, Galata Ch, ReissfelderCh, Otto M. Trocar Site Hernias After Bariatric Laparoscopic Surgery: a Prospoective Cohort Study. Obesity Surgery 30:1820-1826, 2020. Rossi F.M.B, Moreno R, Druziani A.L., Moreira Pérez M., Possari E., R. B. Ferreira Da-Silva, Rossi M. Incisional Hernia After Bariatric Surgery: Only The Physical Examanation is Enough? ABCD Arq Bras Cir Dig. 35: e 1673, 2022. Lasky D., Benbassat M., Rescala E., Cervantes F., Greenspun M. Trocar de Lasky para cierres de puertos en cirugía laparoscópica. Ann Med Hosp ABC 43(1):10-14, 1998. Padilla S.L., Krötzsch E., Schalch P., Figueroa B. s., Miranda A., Rojas E., Esperante S., Villegas F., de la Garza A., Di Silvio M. Admnistration of bone marrow cells into surgically induced Fibrocollagenous tunnels induces angiogénesis in ischemic rat hindlimb model. Microsurgery 23: 568-574, 2003. Padilla L., Krotzsch E., de la Garza A., Figueroa S., Rodríguez J., Ávila G., Schalch P., Escotto I., Glennie G., Villegas F., Di Silvio M. Bone marrow mononuclear cells stimulate angiogenesis when transplanted into surgically induced fibrocollagenous tunnels: Results from a canine ischemic hindlimb model. Microsurgery 27: 91-97, 2007. Padilla L., Rodriguez J., Escotto I., De Diego J., Rodríguez N., Tapia J., Landero T., Carranza P., Lecuona N., Olguín H., Di Silvio M. Long-term effect of autologous progenitor cell therapy to induce neo angiogénesis in patients with critical limb ischemia transplantated via intramuscular vs combined intramuscular and distal retrograde intra venous. Stemm Cell. Disc. 2: 155-162, 2012. Aguilar-Espinoza F., Montoya-Ramírez J., Gutiérrez-Salinas J., Blas-Azotla R., Aguilar-Soto O., Becerra-Gutiérrez L.P. Conversión por técnica hibrida robótica a bypass gástrico en y de Roux posterior a falla de manga gástrica: Resultados a corto plazo. Rev. Gastroent. Mex. 85: 160-172, 2020. Carrillo-Casarín V.A. Torices-Dardón E., Montoya-Ramírez J. Bypass gástrico asistido por robot versus laparoscópica en superobesidad (Índice de masa corporal > 50 Kg. /m 2 ). (Experiencia de cuatro años de un centro). Rev. Mex. Cir. End. 21: 133-138, 2020. Tables Table 1. Extension, severity, and degree of adhesions. A RATS n=16 Extension of adhesions 50% Polypropylene 2 14 Silicone G.M. 12 4 c 2 =9.75 (p=0.0076) B PIGS n=20 Extension of adhesions 50% Polypropylene 0 20 Silicone G.M. 18 2 c 2 =29.19 (p=0.0001) Severity Polypropylene 0 20 Silicone G.M. 19 1 c 2 =32.48 (p=0.0001) Density Polypropylene 0 20 Silicone G.M. 20 0 c 2 =36.1(p=0.0001) Table 2. Demographic clinical characteristics of the study groups. With OCLUPAD n=40 (I) Without OCLUPAD n=40 (II) Age ( years ) 43.8±10 47.2±10 BMI pre Qx ( kg/m² ) 46.4±4 45.40±4 BMI post Qx ( kg/m² ) 30.68±4 31.27±4 HAS 15 (37.5%) 11 (27.5%) Diabetes 26 (65%) 10 (25%) Hypothyroidism 5 (12.5%) 6 (15%) Gastric sleeve 30 (75%) 30 (75%) Gastric bypass 10 (25%) 10 (25%) Gender ( women ) 31 29 Trocar hernia prevalence 0/40 (0%) 14/40 (35%) p=0.001 OR=0.04 IC=0.005-0.33 Videos Videos 1-4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files SuppFig1.jpg Supplementary figure 1. OcluPad materials (G.M. silicone, polypropylene, polylactic acid,) used for histological analysis in experimental tests carried out in rats. SuppFig2.jpg Supplementary figure 2. Neo-mesothelial membrane vascularized and without adhesions. 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Also discoverable on Platform About Our Team In Review Editorial Policies 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-4784149","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":337769831,"identity":"851c0952-fd7b-4022-b165-ad318986e05c","order_by":0,"name":"Luis Padilla","email":"","orcid":"","institution":"Centro Médico Nacional \"20 de Noviembre","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Luis","middleName":"","lastName":"Padilla","suffix":""},{"id":337769832,"identity":"74b5f8bf-8a3f-411b-86c4-150feabbd349","order_by":1,"name":"Jesús Montoya-Ramírez","email":"","orcid":"","institution":"Centro Médico Nacional \"20 de 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Placement.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/42231bb9d3f24971bee783f6.png"},{"id":64005075,"identity":"35ae3ed6-f591-4307-a9ec-f6edddaa7277","added_by":"auto","created_at":"2024-09-04 21:35:40","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1283595,"visible":true,"origin":"","legend":"\u003cp\u003eOcluPad device composed of Medical Grade silicone, polypropylene mesh and polylactic acid star.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/57eb060796f7a10fcaeffbb2.png"},{"id":64005077,"identity":"217d0b7b-c027-4249-bc5a-a341d511991d","added_by":"auto","created_at":"2024-09-04 21:35:40","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":227190,"visible":true,"origin":"","legend":"\u003cp\u003eHistological images of the materials used to make the OcluPad from experimental tests in rats.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/6c25f1e5b6926b416d1bd167.png"},{"id":64005074,"identity":"07a1976b-2915-4476-a446-7b42d878c004","added_by":"auto","created_at":"2024-09-04 21:35:40","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":1124950,"visible":true,"origin":"","legend":"\u003cp\u003eIllustrative description of the the OcluPad placement in the peritoneal cavity.\u003c/p\u003e","description":"","filename":"Figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/5abaaea85e31a8c9520a89c4.png"},{"id":64005080,"identity":"b7b93b7a-cac2-4ea4-99b8-1e179e9453c1","added_by":"auto","created_at":"2024-09-04 21:35:40","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":874681,"visible":true,"origin":"","legend":"\u003cp\u003eExample of simple abdominal tomography for group I (A-D) and group II (E-J).\u003c/p\u003e","description":"","filename":"Figure5.png","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/307d06179afc9708be461395.png"},{"id":82263057,"identity":"b6733bd0-b22a-4f2a-aa34-3e8ee151396f","added_by":"auto","created_at":"2025-05-08 12:32:09","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":6897168,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/7a84b861-fa34-4940-8f2a-d1762864b041.pdf"},{"id":64005970,"identity":"bb715058-ea22-4f52-b980-0378a1546d62","added_by":"auto","created_at":"2024-09-04 21:43:40","extension":"jpg","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":360448,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary figure 1. OcluPad materials (G.M. silicone, polypropylene, polylactic acid,) used for histological analysis in experimental tests carried out in rats.\u003c/p\u003e","description":"","filename":"SuppFig1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/82c82524b2a53009982169a8.jpg"},{"id":64005969,"identity":"2b460045-ebe3-425c-98f2-10e477acdbf7","added_by":"auto","created_at":"2024-09-04 21:43:40","extension":"jpg","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":382509,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary figure 2. Neo-mesothelial membrane vascularized and without adhesions.\u003c/p\u003e","description":"","filename":"SuppFig2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/d82209f6f38ee7d8287d4496.jpg"},{"id":64005968,"identity":"5c876060-f4da-4de3-a276-570d2b57ae9a","added_by":"auto","created_at":"2024-09-04 21:43:40","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":134352,"visible":true,"origin":"","legend":"","description":"","filename":"Video14.docx","url":"https://assets-eu.researchsquare.com/files/rs-4784149/v1/c3bb5f54ccd64da6081eaedd.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Device that safely closes the incisions made with trocars in laparoscopic surgery","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eThere is no doubt about the significant advantages of laparoscopic surgery; however, as with all advances, the technique has some disadvantages, such as the formation of hernias at the sites of application of the trocars. (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Before 2012, a prevalence between 1 and 2% was reported in the literature, although this figure could be considered underestimated since many patients with a trocar hernia are asymptomatic. In recent studies, it is known that in obese patients, it has increased from 30 to 40%. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eKarampinis' group, using abdominal ultrasound to detect trocar hernias in 359 patients undergoing bariatric surgery, found that 124 patients had hernias, reporting a prevalence of 34.5%. (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Rossi et al. studied 123 patients undergoing laparoscopic gastric bypass, finding seven trocar hernias upon physical examination of the abdominal wall, but 56 hernias were diagnosed when applying ultrasound. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eAlso, 5mm trocars can cause a hernia and create a real clinical problem. In non-obese patients, correct closure of the aponeurosis with direct sutures or with needle and guide devices such as the Lasky trocar for port closure in laparoscopic surgery. (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eIn the case of obese patients or patients with bleeding at the trocar site who have technical difficulty in closing, the use of a medical grade polypropylene and silicone device called OcluPad (OP) is proposed, which is introduced through the trocar after the surgical procedure and which, under direct vision on the monitor, is placed inside the abdominal cavity. OP has a long polypropylene suture that serves as traction to fix and prevent device displacement. We put an absorbable polylactic acid star between the aponeurosis and the subcutaneous cellular tissue. (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eIn previous studies, our group had experience with medical-grade silicone tubes implanted in the subcutaneous cellular tissue of rats and dogs, observing that they induced an external layer of vascularized fibro-collagen, which were used as vascular micro prostheses and conduits to transplant hematopoietic stem cells to induce angiogenesis. (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) The results of these studies led us to use medical-grade silicone in the OP device on the face in visceral contact, waiting for the formation of a fibro collagenous layer and, subsequently, a neo-mesothelium (Neo-peritoneum).\u003c/p\u003e"},{"header":"MATERIAL AND METHODS","content":"\u003cp\u003e\u003cstrong\u003eOcluPad Device Description\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIt is constructed from a polypropylene cylinder 1 cm high by 0.5 cm in diameter, attached to a circular sheet of polypropylene 2.5 cm in diameter to which a second circular sheet of medical-grade silicone is adhered. It has a long polypropylene suture that serves as traction; an absorbable polylactic acid star is placed to fix it and prevent its displacement. OP devices are available to close trocar ports of 5, 10, and 12 mm in diameter with intraperitoneal medical-grade silicone sheets of 1.5, 2.5, and 3.5 cm. (Figure 2)\u003c/p\u003e\n\u003cp\u003eThe patent application was made to the Mexican Institute of Industrial Property on September 23, 2014, obtaining the Utility Model Registration Title No. 3511 on July 13, 2016, signed by the Divisional Director of Patents.\u003c/p\u003e\n\u003cp\u003eBased on the good preclinical results, the research, Ethics, and Biosafety committees of the National Medical Center \u0026ldquo;November 20\u0026rdquo; will approve a protocol for a Controlled Clinical Trial in patients with morbid obesity who underwent Bariatric Surgery (Gastric Bypass and Sleeve gastric). All patients were duly informed of their process, and the device application procedure and the respective consent forms were signed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePreclinical studies in rats and pigs\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn Mexico, to register a class III medical device that is introduced into the body and remains in it for more than 30 days, it is necessary to comply with the regulations on health supplies, chapter IX Art. 83, which requires preclinical and biocompatibility studies to demonstrate safety and efficacy.\u003c/p\u003e\n\u003cp\u003eIn Wistar rats, two materials were applied intraperitoneally: polypropylene, and medical-grade silicone to evaluate the extent of adhesions with the Diamond scale. (Table 1-A).\u003c/p\u003e\n\u003cp\u003eWe applied the OP device to 20 pigs of the Danish Landrace breed with two different intraperitoneal surfaces: Group I\u0026ndash;10 pigs with polypropylene and Group II\u0026ndash;10 pigs with medical-grade silicone. The results of extension, severity, and density of adhesions are summarized in Table 1-B, demonstrating that medical-grade silicone generates the fewest intraperitoneal adhesions in both rats and pigs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBIOCOMPATIBILITY STUDIES\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe three components of the OP device (Silicone, Polypropylene, and Polylactic Acid) have the biocompatibility guides required by the US Food and Drug Administration (FDA); these are cell culture tests, mutagenicity tests, hemolysis tests, skin sensitivity tests, and pyrogen tests.\u003c/p\u003e\n\u003cp\u003eFragments of the three components of the OP device were applied intramuscularly to the abdominal wall of 12 male Wistar rats weighing 250 g. (Supplementary figure 1) The animals were sacrificed at 2, 4, 6, 12, and 18 months to obtain tissue samples.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe pathology report concluded that the degrees of inflammation, fibrosis, and vascular proliferation were as expected according to the experience of the patient\u0026apos;s histopathological analysis who had tissues removed with the same materials and according to what has been reported in the literature. (Figure 3)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTROLLED CLINICAL TRIAL\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBased on the good preclinical results, a Controlled Clinical Trial (CCT) was designed and approved by the Research, Ethics, and Biosafety commissions of the \u0026quot;20 de Noviembre\u0026quot; National Medical Center. This ECC included 80 patients with morbid obesity who underwent Bariatric Surgery by the same surgeon (gastric bypass or gastric sleeve) and divided into two groups of 40 patients (Registration No.: 323.2020).\u003c/p\u003e\n\u003cp\u003eIn group I, 40 patients underwent Surgery, and at the end of the procedure, three OP devices were placed to close the trocar holes. In group II, 40 patients (control group) underwent Surgery without surgical closure of the three trocar holes. All patients were duly informed of their process, and the device application procedure and their respective informed consent was signed. The protocol was registered at ClinicalTrials.gov.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSURGICAL TECHNIQUE\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eGastric bypass\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll patients underwent the same simplified technique originally described by Hans Lonroth in 1996. This technique corresponds to Roux-en-Y bypass anastomoses, with a biliary loop length between 100 and 129 cm and a food length between 80 and 100 cm.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eGastric sleeve\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe gastric antrum is preserved, and gastric resection is performed with a linear stapler starting at the prepyloric 4-6 cm. Calibration was performed using a 36 Fr. probe without staple line reinforcement. (11,12)\u003c/p\u003e\n\u003cp\u003eAfter the bypass or gastric sleeve procedure, the corresponding OP was introduced through the right upper quadrant trocar (generally an OP device of 2.5 cm in diameter) mounted on laparoscopic forceps; when the polypropylene and silicone sheets reached the abdominal cavity, they opened and distended automatically. Under direct vision on the monitor, the suture attached to the cylinder is pulled until the hermetic closure of the peritoneum is verified. Finally, the device is fixed by applying the absorbable polylactic acid star, remaining between the cellular tissue and the aponeurosis. (Figure 4) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSubsequently, through the trocar in the left hypochondrium, a second device 2.5 cm in diameter is introduced and placed in the patient with gastric bypass and a 3.5 cm in diameter in the case of a gastric sleeve (generally corresponding to the exit orifice of the gastric remnant).\u003c/p\u003e\n\u003cp\u003eFinally, to close the port where the laparoscope lens works, a third 2.5 cm diameter device mounted on a laparoscopic clamp is removed and inserted, calculating to reach the abdominal cavity. The laparoscope is reintroduced to locate the device, and the suture attached to the cylinder is pulled to guide it toward the lumen of the trocar. The suture is fixed by applying the absorbable polylactic acid star.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of 80 patients were included and divided into two groups. Their clinical-demographic characteristics were analyzed (Table 2) with no statistical differences. The two groups were evaluated using simple abdominal tomography two years after the bariatric surgical procedure.\u003c/p\u003e\n\u003cp\u003eIn group No. I, no hernias or displacement of the devices per trocar were observed. (Figure 5 A-B-C-D-E) None of the 40 patients presented pain, seroma, hematoma, and infection in the trocar wounds. Only one case presented a superficial wound dehiscence resolved without affecting the rest of the device. As an additional advantage, it was observed that during the OP device application (in pigs and patients), hemostasis is achieved in the trocar hole by fixing the polylactic acid star and applying compression. In contrast, in group No. II, 14 trocar hernias were detected. (Figure 5 F-G-H-I-J)\u003c/p\u003e\n\u003cp\u003eA Chi-square test was performed to determine the behavior of the variables, obtaining a prevalence of 35% with statistical differences with the use of OP to prevent trocar hernias (p=0.001). The odds ratio was calculated, showing that the OP protects up to 96 times against the probability of developing a hernia compared to patients for whom the device was not applied (OR= 0.04).\u003c/p\u003e\n\u003cp\u003eThe cylinder and the circular polypropylene sheet adhered and formed fibrosis in the tunnel and parietal peritoneum. The circular sheet of medical-grade silicone faced the abdominal cavity, forming a fibro collagenous layer and a proper neo-mesothelial layer (neo-peritoneum). This was corroborated in preclinical studies and in one of the patients in group I, who presented acute appendicitis eight months after the gastric bypass procedure and application of the three OP devices. At the time of the laparoscopic approach for the appendectomy, it was possible to see that the devices were covered with a vascularized neo-mesothelial membrane and without adhesions. (Supplementary figure 2)\u003c/p\u003e\n\u003cp\u003eIt was demonstrated that the device achieves a triple repair: it closes the trocar channel, closes the peritoneal orifice (without tension), and offers hemostasis by compression when bleeding.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe complication called trocar hernia can lead to a new surgical intervention to resolve an intestinal obstruction with perforation and peritoneal sepsis with a risk of death, in addition to the need to repair the abdominal wall.\u003c/p\u003e\n\u003cp\u003eThe risk factors that generate a trocar hernia are clinical and technical. The clinical symptoms include female sex, age over 60 years, multiparity, obesity, diabetes, chronic bronchitis, malnutrition, anemia, and kidney failure. Technical factors include the Hasson trocar, number and diameter of trocars, incision location, procedure duration, technique, and the effect of pneumoperitoneum during removal. (2)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBefore 2012, trocar hernia was reported to have a prevalence between 1 and 2%; however, this figure is considered underestimated since many patients are asymptomatic. In recent studies, it is reported that it has increased from 30 to 40% in obese patients. (3)(4)\u003c/p\u003e\n\u003cp\u003eTrocar hernias were avoided during the two-year follow-up period with the OP device. Without the OP device, 14 hernias were reported in the 40 patients studied, resulting in a 35% prevalence, which agrees with what Karampinis (5) and Ross (6) reported.\u003c/p\u003e\n\u003cp\u003eDirect suturing techniques of the aponeurosis or the introduction of needles that cross the two aponeurosis should continue to be used, but in the case of obese patients or patients with bleeding at the trocar site and who present technical difficulty in closing, we recommend the application of the OP device. This study shows that the device achieves a triple repair, closing the trocar channel, closing the peritoneal orifice without tension, and providing compression hemostasis when bleeding occurs at the trocar orifice.\u003c/p\u003e\n\u003cp\u003eOn the other hand, it was observed in preclinical studies in rats and pigs that the intraperitoneal circular sheet of medical-grade silicone is covered with a vascularized fibro collagenous membrane and subsequently forms a proper neo-mesothelial layer.vascularizada y que posteriormente forma una verdadera capa neo-mesotelial. This phenomenon could be corroborated by direct intraoperative vision in a patient who presented with acute appendicitis eight months after the gastric bypass procedure and application of the three OP devices. At the time of the laparoscopic approach for the appendectomy, we could see that the devices were covered with a vascularized neo-mesothelial membrane (Neo-peritoneum) without adhesions. (Supplementary figure 2) (Video No. 4)\u003c/p\u003e\n\u003cp\u003eBased on our results, to avoid trocar hernias, we recommend always trying to close the aponeurosis with suture, using closure devices with a needle and guide, and using the OP device in obese patients, in case of bleeding from the trocar hole, in 5 mm diameter holes, and when it is necessary to reduce surgical time.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eOP is an efficient, simple, easy-to-apply, economical, and safe device. It has excellent biocompatibility and induces minimal intraperitoneal adhesions, preventing the formation of trocar hernias in obese patients. A loose, soft, low-diameter adhesion is preferable to an open hole that allows tissue entry and causes visceral strangulation that requires urgent Surgery.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eDisclosure statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors declare no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial support statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo financial support was received.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003ePL, conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, writing original draft; MRJ, data curation, formal analysis, investigation, methodology. ASO, formal analysis, investigation, methodology; HMFS, investigation, supervision, validation; LYT, investigation, methodology, supervision, validation; LGJ, data curation, investigation, methodology; CCPH, data curation, formal analysis, investigation, methodology, writing original draft; NNL, conceptualization, investigation, writing, review \u0026amp; editing; OSJA, investigation, methodology, supervision, validation; OFM, data curation, formal analysis, investigation, methodology; DSM, data curation, formal analysis, investigation, methodology, supervision, validation; MJEE, conceptualization, data curation, investigation, writing, review \u0026amp; editing.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eTo Dr. Alfredo Cortes Algara for the patent, Dr. Carolina Garc\u0026iacute;a Zavala and Dr. Sebastian Gonz\u0026aacute;lez for the tomography scans, to the Teacher Antonieta Castro for the illustrations, and to Araceli Martinez S\u0026aacute;nchez for the editing.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eCrist D.W., Gadaez T.R. Complications of laparoscopic surgery. Surg. Clin. North Am. 73: 265-89, 1993.\u003c/li\u003e\n\u003cli\u003eMoreno-Egea A. Prevenci\u0026oacute;n de las hernias en el sitio del trocar: un problema pendiente de soluci\u0026oacute;n. Revisi\u0026oacute;n y experiencia personal. Rev. Hispanoam Hernia 3(1):27-32, 2015.\u003c/li\u003e\n\u003cli\u003eSwank HA, Mulder IM, la Chapelle CF, Reitsma JB, Lange JF, Bemelman WA. Systematic review of trocar-site hernia. Br. J. Surg. 99: 315-323, 2012\u003c/li\u003e\n\u003cli\u003eMikhail E, Hart S. Laparoscopic port closure. Surg Technol Int. 24:27-33, 2014.\u003c/li\u003e\n\u003cli\u003eKarsmpinis I, Lion E, Hetjens S, Vassilev G, Galata Ch, ReissfelderCh, Otto M. Trocar Site Hernias After Bariatric Laparoscopic Surgery: a Prospoective Cohort Study. Obesity Surgery 30:1820-1826, 2020.\u003c/li\u003e\n\u003cli\u003eRossi F.M.B, Moreno R, Druziani A.L., Moreira P\u0026eacute;rez M., Possari E., R. B. Ferreira Da-Silva, Rossi M. Incisional Hernia After Bariatric Surgery: Only The Physical Examanation is Enough? ABCD Arq Bras Cir Dig. 35: e 1673, 2022.\u003c/li\u003e\n\u003cli\u003eLasky D., Benbassat M., Rescala E., Cervantes F., Greenspun M. Trocar de Lasky para cierres de puertos en cirug\u0026iacute;a laparosc\u0026oacute;pica. Ann Med Hosp ABC 43(1):10-14, 1998.\u003c/li\u003e\n\u003cli\u003ePadilla S.L., Kr\u0026ouml;tzsch E., Schalch P., Figueroa B. s., Miranda A., Rojas E., Esperante S., Villegas F., de la Garza A., Di Silvio M. Admnistration of bone marrow cells into surgically induced Fibrocollagenous tunnels induces angiog\u0026eacute;nesis in ischemic rat hindlimb model. Microsurgery 23: 568-574, 2003.\u003c/li\u003e\n\u003cli\u003ePadilla L., Krotzsch E., de la Garza A., Figueroa S., Rodr\u0026iacute;guez J., \u0026Aacute;vila G., Schalch P., Escotto I., Glennie G., Villegas F., Di Silvio M. Bone marrow mononuclear cells stimulate angiogenesis when transplanted into surgically induced fibrocollagenous tunnels: Results from a canine ischemic hindlimb model. Microsurgery 27: 91-97, 2007.\u003c/li\u003e\n\u003cli\u003ePadilla L., Rodriguez J., Escotto I., De Diego J., Rodr\u0026iacute;guez N., Tapia J., Landero T., Carranza P., Lecuona N., Olgu\u0026iacute;n H., Di Silvio M. Long-term effect of autologous progenitor cell therapy to induce neo angiog\u0026eacute;nesis in patients with critical limb ischemia transplantated via intramuscular vs combined intramuscular and distal retrograde intra venous. Stemm Cell. Disc. 2: 155-162, 2012.\u003c/li\u003e\n\u003cli\u003eAguilar-Espinoza F., Montoya-Ram\u0026iacute;rez J., Guti\u0026eacute;rrez-Salinas J., Blas-Azotla R., Aguilar-Soto O., Becerra-Guti\u0026eacute;rrez L.P. Conversi\u0026oacute;n por t\u0026eacute;cnica hibrida rob\u0026oacute;tica a bypass g\u0026aacute;strico en y de Roux posterior a falla de manga g\u0026aacute;strica: Resultados a corto plazo. Rev. Gastroent. Mex. 85: 160-172, 2020.\u003c/li\u003e\n\u003cli\u003eCarrillo-Casar\u0026iacute;n V.A. Torices-Dard\u0026oacute;n E., Montoya-Ram\u0026iacute;rez J. Bypass g\u0026aacute;strico asistido por robot versus laparosc\u0026oacute;pica en superobesidad (\u0026Iacute;ndice de masa corporal \u003cu\u003e\u0026gt; \u003c/u\u003e 50 Kg. /m\u003cstrong\u003e\u003csup\u003e2\u003c/sup\u003e\u003c/strong\u003e). (Experiencia de cuatro a\u0026ntilde;os de un centro). Rev. Mex. Cir. End. 21: 133-138, 2020.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1.\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eExtension, severity, and degree of adhesions.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eRATS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003en=16\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eExtension of adhesions\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026lt;50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026gt;50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePolypropylene\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSilicone G.M.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ec\u003csup\u003e2\u003c/sup\u003e=9.75 (p=0.0076)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eB\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePIGS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003en=20\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eExtension of adhesions\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026lt;50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026gt;50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePolypropylene\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSilicone G.M.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ec\u003csup\u003e2\u003c/sup\u003e=29.19 (p=0.0001)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eSeverity\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePolypropylene\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSilicone G.M.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ec\u003csup\u003e2\u003c/sup\u003e=32.48 (p=0.0001)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eDensity\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePolypropylene\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSilicone G.M.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ec\u003csup\u003e2\u003c/sup\u003e=36.1(p=0.0001)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2. Demographic clinical characteristics of the study groups.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eWith OCLUPAD\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003en=40 (I)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eWithout OCLUPAD\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003en=40 (II)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eAge (\u003cem\u003eyears\u003c/em\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e43.8\u0026plusmn;10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e47.2\u0026plusmn;10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eBMI pre Qx (\u003cem\u003ekg/m\u0026sup2;\u003c/em\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e46.4\u0026plusmn;4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e45.40\u0026plusmn;4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eBMI post Qx (\u003cem\u003ekg/m\u0026sup2;\u003c/em\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e30.68\u0026plusmn;4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e31.27\u0026plusmn;4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eHAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e15 (37.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e11 (27.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eDiabetes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e26 (65%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e10 (25%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eHypothyroidism\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e5 (12.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e6 (15%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eGastric sleeve\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e30 (75%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e30 (75%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eGastric bypass\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e10 (25%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e10 (25%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eGender (\u003cem\u003ewomen\u003c/em\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eTrocar hernia prevalence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e0/40 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e14/40 (35%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003ep=0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eOR=0.04\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eIC=0.005-0.33\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Videos","content":"\u003cp\u003eVideos 1-4 are available in the Supplementary Files section.\u003c/p\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":"Laparoscopic surgery, hernias, bariatric surgical procedure","lastPublishedDoi":"10.21203/rs.3.rs-4784149/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4784149/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective:\u003c/h2\u003e \u003cp\u003eTo describe and demonstrate the safety and efficacy of an OcluPad (OP) that closes surgical incisions in the abdominal wall, made with trocars in laparoscopic surgery in obese patients, avoiding hernias.\u003c/p\u003e\u003ch2\u003eMaterial and methods:\u003c/h2\u003e \u003cp\u003eAfter preclinical studies in rats and pigs, we obtained authorization from the Research, Ethics, and Biosafety commissions of the \"20 de Noviembre\" National Medical Center to develop a clinical trial and apply the OP device to 40 of the 80 patients subjected to Gastric bypass or gastric sleeve surgery as a surgical treatment for morbid obesity. The patients were divided into two groups: Group I, 40 patients with three OP devices applied to close the trocar holes, and Group II, 40 patients without surgical closure of the three trocar holes.\u003c/p\u003e\u003ch2\u003eResults:\u003c/h2\u003e \u003cp\u003eThe groups were evaluated two years after the bariatric surgery procedure using abdominal tomography. Obtaining zero hernias in group I and 14 hernias in group II generated a 35% prevalence. (p\u0026thinsp;=\u0026thinsp;0.001) (OR\u0026thinsp;=\u0026thinsp;0.04) CI\u0026thinsp;=\u0026thinsp;0.005\u0026ndash;0.38.\u003c/p\u003e\u003ch2\u003eConclusions:\u003c/h2\u003e \u003cp\u003eOP is a device that prevents the formation of trocar hernias in obese patients. It is efficient, simple, quick to apply, economical, and meets the concept of safety and effectiveness since it has excellent biocompatibility; generating a layer of neo-mesothelium induces minimal adhesions.\u003c/p\u003e","manuscriptTitle":"Device that safely closes the incisions made with trocars in laparoscopic surgery","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-09-04 21:35:35","doi":"10.21203/rs.3.rs-4784149/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":"aad1e5ab-7d3b-4c5a-8a60-efb0316f5a6f","owner":[],"postedDate":"September 4th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-05-08T12:23:58+00:00","versionOfRecord":[],"versionCreatedAt":"2024-09-04 21:35:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4784149","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4784149","identity":"rs-4784149","version":["v1"]},"buildId":"zQwnuV7TCBrMSSSToR1PI","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}