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
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.