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vNOTES shows non-inferiority to laparoscopy for ovarian cystectomy in pilot trialCan a gentler surgery remove ovarian cysts with less pain?

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Key Takeaway
Consider vNOTES as a non-inferior alternative to laparoscopy for cystectomy in selected patients, noting this is preliminary data from a 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.

When a benign ovarian cyst needs to be removed, surgeons typically use laparoscopy, inserting instruments through small cuts in the belly. A new study asked if a different approach—operating entirely through the vagina—could work just as well and be easier on patients. The research involved 64 women with benign ovarian tumors. It found that the vaginal surgery was just as successful at completing the procedure as the standard method. Women who had the vaginal surgery also reported less pain in the hours after their operation. However, this was a small, early-stage pilot trial. Both the patients and surgeons knew which surgery was being performed, which can influence how pain is reported. The study abstract did not share any information on complications or safety issues, and it doesn't tell us anything about how patients fare in the long run or if cysts come back.

What this means for you:
Vaginal surgery for ovarian cysts shows promise for less pain, but it's an early finding.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
PURPOSE: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is an innovative minimally invasive procedure. The study aimed to evaluate whether vNOTES achieves non-inferior results compared to conventional laparoscopy in patients undergoing ovarian cystectomy. METHODS: Participants with benign ovarian tumors were randomly assigned (1:1) to undergo laparoscopy or vNOTES. Randomization was stratified based on the size of the ovarian tumor. Patients and surgeons were aware of the allocated procedures. The primary outcome was the proportion of patients successfully treated by the allocated procedure (non-inferiority hypothesis, margin of 15%). The secondary outcomes included operative time, estimated blood loss, time for specimen retrieval, postoperative pain score, use of analgesics, time to first flatus, and perioperative complications. RESULTS: Sixty-four patients were randomly assigned to laparoscopy (n = 32) and vNOTES (n = 32) and were included in the intention-to-treat analysis. The success rates were 100% and 96.9%, respectively. Non-inferiority of vNOTES was demonstrated, as the lower limit of the one-sided 95% confidence interval for the stratified risk difference was -12.7%, which lies above the pre-specified non-inferiority margin of -15%. The vNOTES group exhibited lower pain scores, with a median difference of -1 (95% CI -1 - -1, p < 0.001). CONCLUSION: vNOTES demonstrates non-inferiority to laparoscopy for ovarian cystectomy in selected patients, with notable advantages in cosmetic outcomes and reduced postoperative pain. CLINICAL TRIAL IDENTIFICATION NUMBER: ChiCTR2300070890.
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