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Not yet recruiting NCT06964594

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

No phase Interventional Ovarian Cysts Laparoscopic Gynecologic Surgery vNOTES

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vNOTES adnexal surgery.
Who it may be relevant to
Registry conditions: Ovarian Cysts, Laparoscopic Gynecologic Surgery, vNOTES. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure vNOTES adnexal surgery
    New minimalinvasive technique

Primary outcome measures

  • Pain postoperatively by a VAS-scale [Time frame: 7 days postoperative]
Secondary outcome measures (7)
  • Painkillers used (amount) [Time frame: 7 days postoperatively]
  • Perioperatively complications [Time frame: Perioperatively]
  • Operation time [Time frame: Perioperatively]
  • Postoperative complications [Time frame: 6 weeks postoperatively]
  • Readmission [Time frame: 6 weeks after surgery]
  • Conversion rate [Time frame: Perioperatively]
  • Surgeon's experience [Time frame: Perioperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Olsson KS, Baekelandt JF, Kallen K, Matak L, Caretto M, Wassen MMLH, Simoncini T, Stuart A. ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy. BMJ Open. 2026 May 26;16(5):e112126. doi: 10.1136/bmjopen-2025-112126. PMID 42191199

Identifiers

NCT: NCT06964594 · 2025-00965-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗