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

NCT06964594 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-09

No results posted yet for this study

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

Interventions

PROCEDURE

vNOTES adnexal surgery

New minimalinvasive technique

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2028-01-01
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964594 on ClinicalTrials.gov