A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegion Skane
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- vNOTES adnexal surgery
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov