Complex vaginal natural orifice transluminal endoscopic surgery hysterectomy for symptomatic giant polymyomatous uteri in nulliparous women.

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Abstract

PurposeStudies on vaginal natural orifice transluminal endoscopic surgery (vNOTES), which provides enhanced endoscopic vision via the vaginal route, are limited. Therefore, this study aimed to evaluate the feasibility, safety, and perioperative outcomes of vNOTES hysterectomy in symptomatic patients with giant polymyomatous uteri and no prior vaginal delivery.MethodsA prospective single-centre case series was conducted between July 2023 and July 2025. Patients with symptomatic uterine myomatosis and a uterine size equivalent to a gestational age of ≥ 20 weeks with no prior vaginal deliveries were included. The operation time, preoperative and postoperative haemoglobin levels, uterine weight, complications, and length of hospital stay were analysed.ResultsForty patients met the inclusion criteria. The mean operative time was 95 ± 28 min. The mean preoperative haemoglobin concentration was 11.8 ± 1.2 g/dL, whereas it was 10.9 ± 1.1 g/dL postoperatively. The mean uterine weight was 1,012 ± 312 g. The complication rate was 8%. The major complication rate was 4%. No procedures were converted to laparotomy. The median hospitalisation duration was 23.1 h.ConclusionvNOTES hysterectomy appears to be a feasible minimally invasive approach for giant polymyomatous uteri in patients with no prior vaginal deliveries, with favourable perioperative outcomes in this prospective case series.
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What

This prospective study expands the current clinical evidence on vNOTES hysterectomy by demonstrating its feasibility in patients with giant polymyomatous uteri and no prior vaginal deliveries, a group traditionally considered unsuitable for vaginal surgery. The results show that even very large uteri can be safely managed using a transvaginal endoscopic approach, with low complication rates, minimal haemoglobin decrease, and rapid postoperative recovery. These findings suggest that vNOTES may broaden the indications for minimally invasive hysterectomy in complex gynecologic cases and could represent a valuable alternative to conventional laparoscopic or abdominal approaches in carefully selected patients.

Methods

This study employed a prospective, single-university centre case series design to assess the application of VH in managing symptomatic giant polymyomatous uteri in patients with no prior vaginal deliveries. The primary endpoint of the study was the feasibility of vNOTES hysterectomy, defined as completion of the procedure through the vaginal endoscopic approach without conversion to laparoscopy or laparotomy. The secondary endpoints included operative time, perioperative haemoglobin change, intraoperative and postoperative complications according to the Clavien–Dindo classification, uterine weight, and length of hospital stay [ 14 ]. This design allowed for a detailed examination of surgical feasibility, safety, and perioperative outcomes in a challenging patient cohort, contributing valuable insights into the evolving literature on vNOTES in complex gynaecological pathologies. The study protocol was approved by the institutional ethics committee (Vithas Las Palmas Ethics Committee), and all participants provided informed consent before enrolment in accordance with the ethical standards for clinical research. The manuscript was prepared according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for observational studies. Patient selection criteria were rigorously applied to ensure homogeneity within the study group, with a focus on individuals with symptomatic uterine myomatosis and a uterine size equivalent to a gestational age of ≥ 20 weeks who also had no prior vaginal deliveries. All eligible patients who presented during the study period were consecutively included to minimise selection bias. This focussed selection aimed to evaluate the efficacy and safety of vNOTES in a cohort traditionally considered challenging for vaginal approaches, thereby allowing for a more precise assessment of its applicability in such cases. Patients with large uteri (equivalent to a size ≥ 20 weeks of gestation) and no prior vaginal deliveries were included, regardless of prior caesarean delivery, obesity, or previous uterine surgery. Demographic data, surgical outcomes, and complications were also analysed. This prospective case series was conducted at Vithas University Hospital, Las Palmas, from July 2023 to July 2025. The inclusion criterion was symptomatic uterine myomatosis (bleeding, bulk symptoms, or pelvic pain) with a uterine size ≥ 20 weeks of gestation. In addition, a giant uterus was defined as a uterine size ≥ 20 weeks of gestation according to a previously published surgical series [ 15 ]. No patients with previous vaginal deliveries were included (those with previous caesarean section deliveries were accepted). Absolute contraindications included suspected malignancy, rectovaginal endometriosis, severe pelvic inflammatory disease, previous reconstructive pelvic surgery, and pelvic radiotherapy. Relative contraindications included previous rectal surgery, high body mass index (BMI) (> 30) and prior repeat caesarean section, but they were not exclusion criteria; however, these conditions increased procedural difficulty [ 16 – 18 ]. All procedures were performed under spinal anaesthesia by a single vNOTES team. Prophylactic antibiotics (2 g cefazolin sala. Reig Jofre SA. Spain) were administered intravenously, and bladder evacuation was performed using a Foley catheter (silicone Foley catheter. Bexen Medical. OIARSO, S. COOP. Spain) following disinfection before initiating the surgical procedure. The patients were placed in the lithotomy position. The VH procedure itself closely mirrors conventional vaginal hysterectomy in its initial stages, with dissection of the most caudal aspect of the uterus performed under direct visualisation, followed by the endoscopic completion of subsequent steps. After ropivacaine infiltration (Ropivacaine Kabi 2 mg/ml Fresenius Kabi sau. Spain), the vaginal mucosa was circumferentially incised around the cervix, anterior and posterior colpotomies were performed, and bladder dissection was completed. Anterior colpotomy allows access to the vesicouterine space. In cases where opening of the anterior peritoneum was technically difficult, particularly in patients with previous caesarean sections and dense adhesions in the vesicouterine fold, entry into the peritoneal cavity was achieved through a lateral window approach, or a uterine twisting manoeuvre was performed to save the bladder [ 19 ]. The uterosacral ligaments were then coagulated and divided. A GelPOINT ® V-Path (Applied Medical, UK) was inserted to create a sealed field with CO₂ insufflation (Fig.  1 ). Fig. 1 GelPOINT V-Path platform inserted through the vaginal route to establish the transvaginal access GelPOINT V-Path platform inserted through the vaginal route to establish the transvaginal access A 30° endoscope (Karl Storz GmbH & Co., KG, Germany) was used. The broad ligaments and uterine vessels were coagulated using a 5-mm LigaSure ® (Covidien, Minneapolis, USA) (Figs. 2 , 3 , 4 ). Fig. 2 Giant polymyomatous uterus visualized intraoperatively Fig. 3 Dissection of a giant polymyomatous uterus using a 5-mm LigaSure device during hysterectomy Fig. 4 Continued hysterectomy dissection of the giant polymyomatous uterus using a 5-mm LigaSure device Giant polymyomatous uterus visualized intraoperatively Dissection of a giant polymyomatous uterus using a 5-mm LigaSure device during hysterectomy Continued hysterectomy dissection of the giant polymyomatous uterus using a 5-mm LigaSure device The uterus was removed transvaginally by wedge morcellation to facilitate specimen extraction [ 10 , 20 – 22 ] (Figs. 5 , 6 , 7 , 8 ). Fig. 5 Wedge morcellation of the uterine specimen Fig. 6 Transvaginal extraction of the specimen following wedge morcellation Fig. 7 Resected uterine specimen Fig. 8 Final view of the uterine specimen after complete extraction Wedge morcellation of the uterine specimen Transvaginal extraction of the specimen following wedge morcellation Resected uterine specimen Final view of the uterine specimen after complete extraction Contained morcellation was not used because no preoperative suspicion of malignancy existed, and all the cases were confirmed to be benign on final histopathological examination. Peritoneum and vault closures were performed with 2/0 Vicryl ® sutures (Ethicon, Johnson & Johnson, New Jersey, USA). Oral intake and catheter removal were allowed 6 h postoperatively. The patients were discharged within 24 h after complications were excluded. Follow-up visits were conducted at 2 and 6 weeks. Variables: operative time (skin-to-skin), preoperative and postoperative haemoglobin concentrations (24 h), uterine weight, intraoperative or postoperative complications, conversion rate and length of hospital stay. Continuous variables are presented as the mean ± standard deviation. The Shapiro–Wilk test was used to assess normality. A paired t test was used to compare preoperative and postoperative haemoglobin levels. Statistical significance was set at p  < 0.05. The Statistical Package for the Social Sciences v26 (IBM, Armonk, NY, USA) was used for all the statistical analyses.

Results

Forty patients met the inclusion criteria and were prospectively analysed. The mean age was 45.8 ± 5.6 years (34–55), and the mean BMI was 28.1 ± 3.4 kg/m 2 (22–35). None of the patients had a history of vaginal delivery; 53% had undergone at least one caesarean section, and 16% had undergone a prior abdominal myomectomy. The surgical indications included menorrhagia ( n  = 29, 72%), bulk-related symptoms ( n  = 6, 15%) and pelvic pain ( n  = 5, 12%). Thirty-four patients (85%) underwent hysterectomy with bilateral salpingectomy, and two (5%) underwent salpingo-oophorectomy. Ten percent underwent hysterectomy alone. The mean operative time was 95 ± 28 (85–140) min. The mean haemoglobin concentration decreased from 11.8 ± 1.2 g/dL preoperatively to 10.9 ± 1.1 g/dL postoperatively; however, this difference did not reach statistical significance ( p  = 0.08). The mean uterine weight was 1012 ± 312 (803–1,838) g. Histopathological examination confirmed the presence of benign disease in all the patients. The overall complication rate was 8% (four patients). One case of transfusion and one of fever were reported (2% each). Two major complications were observed (4%): vesical trauma and ureteral injury. Vesical trauma occurred in a patient with three previous caesarean sections and was repaired intraoperatively. A patient with endometriomal cysts was diagnosed with ureteral injury several days after surgery. The mean hospital stay was 23.1 ± 5.7 h (12–48). No conversions or other complications occurred within 6 weeks of surgery.

Conclusion

VH appears to be a feasible minimally invasive alternative for managing giant polymyomatous uteri in patients without prior vaginal deliveries, even in the presence of previous caesarean sections or obesity. In this prospective study, all procedures were completed vaginally without conversion, with low complication rates, minimal blood loss, and rapid postoperative recovery. These findings support the expanding role of vNOTES in complex gynaecological surgery. However, larger comparative and randomised studies are needed to further define the role of vNOTES relative to laparoscopic and abdominal hysterectomy in this challenging patient population.

Discussion

Hysterectomy remains among the most frequently performed gynaecological procedures for benign diseases. Minimally invasive approaches are associated with reduced blood loss and postoperative pain and faster recovery than open surgery [ 23 , 24 ]. However, vaginal hysterectomy rates remain low worldwide, particularly in patients with large uteri or in those without prior vaginal deliveries, who are traditionally considered unsuitable for a vaginal approach [ 25 ]. vNOTES has emerged as an innovative technique that combines the advantages of vaginal surgery with enhanced endoscopic visualisation [ 23 – 25 ]. Comparative studies have demonstrated that, compared with laparoscopic or abdominal hysterectomy, vNOTES is associated with reduced blood loss, a shorter operative time, and a shorter hospital stay while avoiding abdominal incisions and trocar-related complications [ 1 , 6 ]. These advantages may be particularly relevant in cases of enlarged uteri, where the limited pelvic space and distorted anatomy increase surgical complexity [ 26 – 29 ]. This prospective case series specifically evaluated the feasibility and safety of VH in patients with symptomatic giant polymyomatous uteri and no prior vaginal deliveries, a cohort historically managed using laparotomy or laparoscopy-assisted techniques [ 29 ]. Despite the substantial size of the uterus, the procedure was completed vaginally in all cases without conversion, demonstrating the technical feasibility of vNOTES even in anatomically challenging scenarios [ 20 ]. Conversion and complication rates of 7% and 2%, respectively, were observed [ 19 ]. The operative time and estimated blood loss remained within acceptable ranges and were comparable to or lower than those reported for laparoscopic or open hysterectomy in similarly sized uteri [ 21 ]. The minimal decrease in postoperative haemoglobin levels and the low transfusion rate suggest that early uterine artery control and stepwise debulking may effectively mitigate the risk of haemorrhage in these complex cases. Importantly, the absence of conversion contrasts with reports of higher conversion rates with other minimally invasive approaches for large uteri [ 28 ]. The overall complication rate observed in this study is consistent with that in a previously published vNOTES series. We observed a 4% rate of minor complications (one case of fever that was treated and resolved with antibiotics and one blood transfusion). Furthermore, the rate of major complications was 4%, which is due to the complexity of the surgery. Two major complications occurred; however, both were associated with well-recognised risk factors, including multiple prior caesarean sections and concomitant endometriosis. These findings underscore the importance of careful patient selection and surgical expertise when vNOTES is adopted for complex cases, rather than representing the inherent limitations of the technique itself [ 17 , 28 – 30 ]. Recent studies by Matak et al. [ 30 ] have also evaluated the application of vNOTES hysterectomy in technically challenging populations. In a comparative study including obese patients, vNOTES demonstrated perioperative outcomes comparable to those of laparoscopic hysterectomy, with low complication rates and rapid postoperative recovery [ 30 ]. Rapid postoperative recovery, reflected by a median hospital stay of less than 1 day, further highlights the advantages of vNOTES. The avoidance of abdominal incisions likely contributes to reduced postoperative pain, earlier mobilisation, and a faster return to normal activity, as consistently reported in the literature. These benefits may translate to improved patient satisfaction and reduced health care resource utilisation [ 29 , 31 – 34 ]. This advantage is particularly pronounced in procedures involving larger uteri, in which the absence of abdominal wall constraints allows for more efficient extraction of surgical specimens [ 35 – 37 ]. This study was limited by its single-centre design and the absence of a comparative control group. Nevertheless, it represents one of the few prospective evaluations of VH in patients with giant uteri and no previous vaginal delivery, thus addressing a significant gap in the current literature. Previous studies have confirmed that vNOTES is a reliable and safe technique for hysterectomy and adnexectomy [ 38 ]. Both abdominal and laparoscopic approaches to hysterectomy in the setting of an enlarged uterus can be challenging owing to difficulties in uterine mobilisation and limited visualisation of the surgical field [ 37 ]. If a large uterus is combined with the absence of previous vaginal deliveries, surgery becomes challenging. This study confirmed the feasibility and safety of vNOTES for giant uteri and demonstrated minimal haemoglobin reduction and no conversion [ 39 ]. Stepwise debulking and early uterine artery ligation may contribute to reduced blood loss. Laparoscopic series for large uteri often report higher transfusion rates [ 40 , 41 ]. Rapid patient recovery, evidenced by a median hospital stay of 23.1 h, represents a significant advantage. This duration is considerably shorter than that associated with traditional abdominal or even laparoscopic hysterectomies for uteri of comparable size, highlighting the capacity of vNOTES to expedite recuperation and optimise health care resource utilisation [ 42 ].

Introduction

Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a minimally invasive approach that uses the vaginal route for endoscopic access, eliminating the need for an abdominal incision [ 1 , 2 ]. It is associated with reduced postoperative pain, better cosmetic outcomes, and shorter hospitalisation times while maintaining safety comparable to that of laparoscopic hysterectomy (LH) [ 3 , 4 ]. Originally introduced for hysterectomies and adnexectomies, vNOTES has expanded to applications in urogynaecology, oncology, and fertility surgery [ 5 , 6 ]. Giant polymyomatous uteri pose specific challenges owing to limited pelvic space and increased vascularity [ 7 , 8 ]. Conventional laparotomy or laparoscopy-assisted techniques may increase morbidity [ 9 , 10 ]. Surgical difficulties are greater in women without previous vaginal deliveries [ 11 – 13 ]. vNOTES provides enhanced endoscopic vision via the vaginal route, which may minimise intraoperative complications. However, the evidence remains limited, particularly for giant uteri, prompting this prospective evaluation. Therefore, this study aimed to evaluate the feasibility, safety, and perioperative outcomes of vNOTES hysterectomy (VH) in symptomatic patients with giant polymyomatous uteri and no prior vaginal delivery.

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