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More info
You can access this
clinical trial
if you have
Natural Orifice Endoscopic Surgery, Disease, Adnexal or Laparoscopic Surgery
and you are
between 18 and 70
years old
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Procedure: vNOTES adnexectomy
  • Procedure: Laparoscopic adnexectomy

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02630329. The sponsor of the trial is Imelda Hospital, Bonheiden and it is looking for 66 volunteers for the current phase.
Official trial title:
Adnexectomy for Benign Gynaecological Pathology by Natural Orifice Transluminal Endoscopy or Laparoscopy