A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy

Launched by REGION SKANE · May 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods for treating conditions related to ovarian cysts: vNOTES (vaginal natural orifice transluminal endoscopy) and traditional laparoscopy. Both techniques aim to remove the ovaries or related tissue, but the trial will focus on comparing how much pain patients experience after surgery and how much pain medication they need. Women aged 18 and older who are having surgery for non-cancerous gynecological issues or for preventive reasons may be eligible to participate.

If you join the study, you will be asked to complete a simple questionnaire twice a day for a week after your surgery. This will help researchers understand your pain levels and how much pain relief medicine you use during your recovery. It’s important to note that some women may not qualify for the trial, such as those who are pregnant, have chronic pain, or have had certain surgeries in the past. Overall, this study aims to provide more information on which surgical method may lead to less pain after surgery, helping doctors make better choices for their patients in the future.

Gender

FEMALE

Eligibility criteria

• 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