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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
vNOTES adnexal surgery
Procedure/SurgeryNew minimalinvasive technique
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Laparoscopic Adnexal surgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain postoperatively by a VAS-scale
To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy
Time frame
7 days postoperativeSecondary outcomes
1
Painkillers used (amount)
Units of non-opioid analgesics Units of postoperative opioids
Time frame
7 days postoperatively2
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.
Time frame
Perioperatively3
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.
Time frame
Perioperatively4
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.
Time frame
6 weeks postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: