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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
New minimalinvasive technique
Pain postoperatively by a VAS-scale
To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy
Time frame: 7 days postoperative
Painkillers used (amount)
Units of non-opioid analgesics Units of postoperative opioids
Time frame: 7 days postoperatively
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: Perioperatively
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: Perioperatively
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 postoperatively
Readmission
The rates of readmission requiring hospitalization for at least 24 hours for any adverse event causally related to the gynaecological intervention during the first six weeks after surgery, as a dichotomous outcome.
Time frame: 6 weeks after surgery
Conversion rate
Conversion rates: the proportion of women treated by any other approach than the allocated technique as randomized, as a dichotomous outcome. vNOTES will most likely be converted to LSC and LSC to open surgery
Time frame: Perioperatively
Surgeon's experience
Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale
Time frame: Perioperatively
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