Clinical trial NCT06964594: A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
Official title: A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Cysts
Laparoscopic Gynecologic Surgery
vNOTES
Keywords: ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic multicentre two-armed superiority randomized controlled trail. No blinding.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain postoperatively by a VAS-scale
timeFrame: 7 days postoperative
Secondary outcomes:
measure: Painkillers used (amount)
timeFrame: 7 days postoperatively
measure: Perioperatively complications
timeFrame: Perioperatively
measure: Operation time
timeFrame: Perioperatively
measure: Postoperative complications
timeFrame: 6 weeks postoperatively
measure: Readmission
timeFrame: 6 weeks after surgery
measure: Conversion rate
timeFrame: Perioperatively
measure: Surgeon's experience
timeFrame: Perioperatively
Other outcomes:
Locations:
Study officials:
References: