Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- University of Oulu
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- NRS (Numeric rating scale) Score for pain
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.
Detailed Description
The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.
Investigators
Sari Koivurova
Assistant Chief of Gynecology
University of Oulu
Eligibility Criteria
Inclusion Criteria
- •ASA (American Society of Anesthesiologists physical status classification) 1-3
- •Diagnosed deep endometriosis (MRI)
- •Patient has symptoms
- •Operative treatment is indicated
- •Patient is able to give informed consent
Exclusion Criteria
- •Recurring rectosigmoid endometriosis
Outcomes
Primary Outcomes
NRS (Numeric rating scale) Score for pain
Time Frame: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups.
Secondary Outcomes
- Endometriosis-related quality-of-life(6, 12 and 24 months)
- Intraoperative measures(Up to 300 minutes (intraoperative))
- Sexual quality-of-life questionnaire(6, 12 and 24 months)
- General 15 dimensional health-related quality-of-life questionnaire(6, 12 and 24 months)
- Factors concerning ERAS (Enhanced recovery after surgery)(Up to 7 days (Hospital stay))
- Cost(Primary hospital stay and 24 months, for both study groups.)
- Complications(30 days)