ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or...

Area of Science:

• Minimally invasive gynecologic surgery
• Surgical innovation
• Endoscopic procedures

Background:

• Adnexal surgery is a common procedure in women.
• Minimally invasive techniques reduce surgical morbidity compared to abdominal surgery.
• Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is an emerging innovation combining vaginal and endoscopic approaches.

Purpose of the Study:

• To compare outcomes between vNOTES and conventional laparoscopy for adnexal surgery.
• To evaluate postoperative pain as the primary outcome.
• To assess secondary outcomes including analgesic use and complications.

Main Methods:

• A multicentre pragmatic randomised controlled trial (RCT) involving 200 women aged 18+ undergoing adnexal surgery.
• Randomization to either vNOTES or laparoscopy groups.
• Recruitment from Q4 2025 to 2028, with primary outcome of postoperative pain.

Main Results:

• Postoperative pain is the primary outcome measure.
• Secondary outcomes include analgesic consumption, perioperative complications, operation time, and readmission rates.
• Surgeon experience will also be evaluated.

Conclusions:

• This pragmatic RCT will provide crucial data on the efficacy and safety of vNOTES compared to laparoscopy.
• Findings will inform clinical practice regarding the adoption of vNOTES for adnexal surgery.
• The study addresses the current lack of large-scale comparative trials.