Status:
NOT_YET_RECRUITING
A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
Lead Sponsor:
Region Skane
Conditions:
Ovarian Cysts
Laparoscopic Gynecologic Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
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 gyn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06964594
Start Date
October 1 2025
End Date
December 1 2028
Last Update
May 9 2025
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