vNOTES shows non-inferiority to laparoscopy for ovarian cystectomy in pilot trial

This was a pilot randomized controlled trial comparing vaginal natural orifice transluminal endoscopic surgery (vNOTES) to conventional laparoscopy for ovarian cystectomy in 64 patients with benign ovarian tumors. The primary outcome was the proportion of patients successfully treated by the allocated procedure. vNOTES demonstrated non-inferiority to laparoscopy, with a stratified risk difference lower limit of the one-sided 95% confidence interval of -12.7%. The successful treatment rate was 96.9% (31/32) in the vNOTES group versus 100% (32/32) in the laparoscopy group.

For secondary outcomes, the vNOTES group had significantly lower postoperative pain scores, with a median difference of -1 (95% CI: -1 to -1, p < 0.001). Other secondary outcomes included operative time, estimated blood loss, time for specimen retrieval, use of analgesics, time to first flatus, and perioperative complications, but specific results for these were not reported in the abstract.

Safety and tolerability data, including adverse events, serious adverse events, and discontinuations, were not reported. Key limitations include the open-label design, where both patients and surgeons were aware of treatment allocation, and the fact that this was a pilot trial. The study does not report on long-term outcomes, recurrence rates, fertility outcomes, or specific measures for cosmetic advantages mentioned in the practice relevance statement.

For clinical practice, vNOTES appears to be a viable alternative to conventional laparoscopy for ovarian cystectomy in selected patients, based on this preliminary evidence of non-inferior procedural success and reduced postoperative pain. However, clinicians should interpret these findings cautiously due to the pilot nature of the trial, lack of safety reporting, and absence of long-term outcome data.