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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cysts; vNOTES; Laparoscopic Gynecologic Surgery
• Intervention / Treatment: Procedure: vNOTES adnexal surgery

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea E Stuart, M.D Associate Professor; Phone Number: 0046736400760; Email: andrea.stuart@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Adnexal surgery	Procedure: vNOTES adnexal surgery; New minimalinvasive technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain postoperatively by a VAS-scale	To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy	7 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Painkillers used (amount)	Units of non-opioid analgesics Units of postoperative opioids	7 days postoperatively
Perioperatively complications	The incidence of intra-operative complications, i.e. any adverse event before the end of the surgical intervention including injury to the bladder, ureter, bowel, or intrapelvic/intra-abdominal vessels, as a dichotomous outcome.	Perioperatively
Operation time	Operation time, measured as the time in minutes from the insertion of the bladder catheter to the end of vaginal/abdominal wound closure, as a continuous outcome.	Perioperatively
Postoperative complications	Postoperative complications: major bleeding or pelvic hematoma requiring transfusion. Infections of the vaginal incision, abdominal wall or wound, urinary tract, chest, or febrile episodes/unspecified infections. Thromboembolism. Postoperative ileus or wound dehiscence. Classified according to the Clavien- Dindo, classification as a dichotomous outcome.	6 weeks postoperatively
Readmission	The rates of readmission requiring hospitalization for at least 24 hours for any adverse event causally related to the gynaecological intervention during the first six weeks after surgery, as a dichotomous outcome.	6 weeks after surgery
Conversion rate	Conversion rates: the proportion of women treated by any other approach than the allocated technique as randomized, as a dichotomous outcome. vNOTES will most likely be converted to LSC and LSC to open surgery	Perioperatively
Surgeon's experience	Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale	Perioperatively

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cysts; Ovarian Cysts
• Other Study ID Numbers: 2025-00965-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No