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

Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy.

A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon's experience.

The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.

NCT06964594.