Clinical trial · Interventional
A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopic Gynecologic Surgery | — | UNRESOLVED | — |
| Ovarian Cysts | — | UNRESOLVED | — |
| vNOTES | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vNOTES adnexal surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic Adnexal surgery
- interventionNames
- Procedure: vNOTES adnexal surgery
Primary outcomes (1)
- measure
- Pain postoperatively by a VAS-scale
- timeFrame
- 7 days postoperative
- description
- To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy
Secondary outcomes (7)
- measure
- Painkillers used (amount)
- timeFrame
- 7 days postoperatively
- description
- Units of non-opioid analgesics Units of postoperative opioids
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOlsson 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