A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy

NCT06964594 | Not Yet Recruiting

• 1 other identifier: 2025-00965-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim with the study is to compare postoperative pain after vNOTES adnexal surgery versus laparoscopic adnexal surgery. Women aged 18 and above with an indication for adnexal surgery for benign gynecological pathology or prophylactic reasons will be able to participate. After surgery the participants will answer a questioner, twice a day in seven days, about postoperative pain and how many units of analgesics they used. Adnexal surgery is one of the most common surgical procedures performed in women and can either be performed to treat pathology as ovarian cysts or prophylactically in case of hereditary genetic alterations. A laparoscopic technique is currently considered as gold standard for adnexal procedures. The latest advancement in minimally invasive surgery is vNOTES (vaginal natural orifice transluminal endoscopy), in which the entrance to the abdomen is performed by an anterior or more commonly posterior colpotomy rather than via the abdominal wall. The NOTABLE trial was a RCT showing that vNOTES adnexectomy was non-inferior to laparoscopy for successful removal of benign adnexa without conversion (Baekelandt). vNOTES adnexectomy had shorter surgical time, less use of analgesics and lower self-assessed VAS scores the first week post-operatively. The aim with our study is to compare postoperative pain after vNOTES versus laparoscopic adnexal surgery.

Conditions

Ovarian Cysts; Laparoscopic Gynecologic Surgery; vNOTES

Keywords

ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy

Outcome Measures

Primary Outcomes (1)

• Pain postoperatively by a VAS-scale

  To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy

  7 days postoperative

Secondary Outcomes (7)

• Painkillers used (amount)

  7 days postoperatively

• Perioperatively complications

  Perioperatively

• Operation time

  Perioperatively

• Postoperative complications

  6 weeks postoperatively

• Readmission

  6 weeks after surgery

Study Arms (1)

Laparoscopic Adnexal surgery

ACTIVE COMPARATOR

Procedure: vNOTES adnexal surgery

Interventions

vNOTES adnexal surgery PROCEDURE

New minimalinvasive technique

Laparoscopic Adnexal surgery

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• Female aged 18 years or above.
• Diagnosed with adnexal pathology or subject for prophylactic BSO.

You may not qualify if:

• Female participant who is pregnant or planning pregnancy during course of the trial.
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Patients taking opioids or other painkillers routinely pre-operatively.
• Patients with chronic pelvic pain.
• Patients with surgical contraindication; previous hysterectomy, history of rectal surgery, suspected or confirmed endometriosis, suspected malignancy, suspected obliteration of the pouch of Douglas following severe PID or other causes, active lower genital tract infection, pregnancy.
• Failure to provide written informed consent prior to surgery

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Andrea E Stuart, M.D Associate Professor

CONTACT

0046736400760; andrea.stuart@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pragmatic multicentre two-armed superiority randomized controlled trail. No blinding.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share