Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Oulu
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- NRS (Numeric rating scale) Score for pain
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Robot-assisted laparoscopy
Surgery for deep endometriosis using robot-assisted laparoscopy.
Intervention: Minimally invasive surgery (Procedure)
Conventional laparoscopy
Surgery for deep endometriosis using conventional laparoscopy.
Intervention: Minimally invasive surgery (Procedure)
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
- 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)
- General 15 dimensional health-related quality-of-life questionnaire(6, 12 and 24 months)
- 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)
Investigators
Sari Koivurova
Assistant Chief of Gynecology
University of Oulu