Notes Adnexectomy for Benign Pathology Compared to Laparoscopic Excision

Summary

Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and established laparoscopic removal of benign adnexal masses Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.

Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal masses detected by clinical examination and ultrasound.

Randomization: Women will be randomly allocated to undergo one of two techniques for removal of the benign adnexal mass immediately before surgery by using a computer generated randomization list. The investigators will use stratified randomization according to the cyst diameter.

Intervention: Women will be treated by a surgeon who is not blinded to the treatment allocation and who is equally skilled in performing both techniques. In the intervention group a vNOTES technique will be used.

Control: In the control group surgery will be done by a classical laparoscopic technique.

Participants, nursing staff and outcome assessors will be blinded.

Main study parameters/endpoints:

Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary outcomes: the proportion of women discharged the same day based on their own preference; postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7 by the participating women following surgery and the total amount of analgesics used as described in the standardized pain treatment protocol between day 1 till 7; postoperative infection defined by lower abdominal pain with fever \> 38°C and positive clinical signs or laboratory findings; per- or postoperative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery; duration of the surgical procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6 months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale); direct costs associated up to 6 weeks after the surgical intervention with both procedures.

Conditions

• Natural Orifice Endoscopic Surgery
• Disease, Adnexal
• Laparoscopic Surgery

Interventions

PROCEDURE

vNOTES adnexectomy

Surgical removal of one or both adnexa by a natural orifice transluminal endoscopic surgical technique using a colpotomy (transvaginal incision)

PROCEDURE

Laparoscopic adnexectomy

Surgical removal of one or both adnexa by transabdominal laparoscopy

Sponsors & Collaborators

• Imelda Hospital, Bonheiden

  lead OTHER

Principal Investigators

• Jan Baekelandt, MD · Imelda Hospital, Bonheiden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-02-03

Primary Completion

2020-04-16

Completion

2020-04-16

Countries

• Belgium

Study Locations