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Objective: To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy. Design: Parallel group, 1:1 single‐centre single‐blinded randomised trial, designed as non‐inferiority study with a margin of 15%. Setting: Belgian teaching hospital. Population: Non‐pregnant non‐virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria. Methods: Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions. Main outcome measures: The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events. Results: We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary end point was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one‐sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non‐inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group. Conclusions: vNOTES is non‐inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events. This article includes Author Insights, a video abstract available at: https://vimeo.com/bjog/authorinsights16838 [ABSTRACT FROM AUTHOR]

Objective: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure.Design: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%.Setting: Belgian teaching hospital.Population: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications.Methods: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors.Main Outcome Measures: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes.Results: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004.Conclusions: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting.Tweetable Abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery. [ABSTRACT FROM AUTHOR]

Objective: To present the rates of intra- and postoperative complications and conversions in a large cohort of unselected vNOTES hysterectomies, performed by surgeons with different levels of expertise., Design: International register-based cohort study., Setting: Hysterectomies in the iNOTESs registry, 2015 to January 2024, performed by 201 surgeons from multiple countries., Population: 4565 patients undergoing vNOTES hysterectomy., Methods: Descriptive data are presented in frequencies (n) and percent (%)., Main Outcome Measure: Intra- and postoperative complications. Conversions., Results: Intraoperative and postoperative complication rates were 3.2% (n = 144) and 2.5% (n = 115), respectively. Conversions occurred in 1.6% (n = 72), of which 10 (0.2%) to laparotomy, and 82% of the conversions occurred within the first 50 cases of the surgeon's learning curve. The most common intraoperative complication was cystotomy, occurring in 1.3%, and almost half were performed by inexperienced surgeons. Other intraoperative organ injuries occurred in 20 cases (0.44%). Postoperatively, the most common complications were haemorrhage (n = 28), vault complications (n = 26) including 11 infected vault hematomas, cystitis (n = 18) and non-specific infections (n = 14). The vNOTES hysterectomies were performed by 201 surgeons, of which 9.5% had performed more than 50 vNOTES cases, representing 70% of the registered cases in the registry. The remaining 30% of the hysterectomies mainly represent learning curve data from 90% of the included surgeons. The complication rate decreased with increasing surgical experience., Conclusions: The largest study population of vNOTES hysterectomies is presented, including both learning curve data and data from experienced surgeons, with acceptable rates of intra- and postoperative complications. No implication was found of vNOTES being inferior to other minimally invasive methods., (© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: Vaginal hysterectomy (VH) rate is declining despite being considered as the optimal minimally invasive option for hysterectomy with reduced operative time and length of stay compared with laparoscopic hysterectomy (LH). Vaginal assisted natural orifice transluminal endoscopic surgery hysterectomy (VANH) combines the advantages of both vaginal and endoscopic approach to surgery., Aims: To report feasibility and early experience of a single surgeon adopting VANH at a tertiary Australian hospital., Materials and Methods: Prospective review of the first 20 VANH cases with complete data set collected retrospectively including patient demographics, indication for surgery and perioperative outcomes., Results: The median age of the first 20 participants was 51.5 years (47-57 years of age) and the median body mass index was 33.5 kg/m 2 (27.8-38.3 kg/m 2 ). The predominant indication was complex hyperplasia with atypia (12/20, 60%). The median parity was two (1-3) where four patients were nulliparous. The median blood loss was 125 mL (100-200 mL) with an operative time of 149 min (138-198 min) and median weight of the specimen of 181.5 g (66.5-219 g). The mean length of stay was 1.4 days (1-2 days). Five cases had conversion to laparoscopy and the majority (80%) occurred within the first ten cases., Conclusions: VANH is feasible but there is a learning curve to achieve competence in this technique, which requires adequate training in the early stages of adoption with careful case selection. Until further robust data is available to determine the clinical benefit and safety profile of VANH, patients should be carefully counselled and the decision on mode of hysterectomy be individualised., (© 2024 The Author(s). Australian and New Zealand Journal of Obstetrics and Gynaecology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Objective: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure., Design: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%., Setting: Belgian teaching hospital., Population: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications., Methods: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors., Main Outcome Measures: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes., Results: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004., Conclusions: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting., Tweetable Abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery., (© 2018 Royal College of Obstetricians and Gynaecologists.)