Laparoscopic Gynecologic Surgery, Ovarian Cysts, vNOTES
Conditions
Keywords
ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy
Brief summary
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.
Interventions
PROCEDUREvNOTES adnexal surgery
New minimalinvasive technique
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pragmatic multicentre two-armed superiority randomized controlled trail. No blinding.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Patients with chronic pelvic pain. * Patients with surgical contraindication; previous hysterectomy, history of rectal surgery, suspected or confirmed endometriosis, suspected malignancy, suspected obliteration of the pouch of Douglas following severe PID or other causes, active lower genital tract infection, pregnancy. * Failure to provide written informed consent prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain postoperatively by a VAS-scale | 7 days postoperative | To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Painkillers used (amount) | 7 days postoperatively | Units of non-opioid analgesics Units of postoperative opioids |
| Perioperatively complications | Perioperatively | 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. |
| Operation time | Perioperatively | 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. |
| Readmission | 6 weeks after surgery | 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. |
| Conversion rate | Perioperatively | 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 |
| Surgeon's experience | Perioperatively | Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale |
| Postoperative complications | 6 weeks postoperatively | 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. |
Contacts
Primary ContactAndrea E Stuart, M.D Associate Professor
Outcome results
None listed