Robotic Versus Laparoscopic Surgery for Deep Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial

Conditions
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Endometriosis, Deep Endometriosis, Surgery

Intervention / Treatment
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* Procedure: Minimally invasive surgery


Participation Criteria
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Eligibility Criteria
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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: ASA > 3 Recurring rectosigmoid endometriosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted laparoscopy<br>Surgery for deep endometriosis using robot-assisted laparoscopy. | Procedure: Minimally invasive surgery<br>* Minimally invasive surgery for severe deep endometriosis<br>|
| Active Comparator: Conventional laparoscopy<br>Surgery for deep endometriosis using conventional laparoscopy. | Procedure: Minimally invasive surgery<br>* Minimally invasive surgery for severe deep endometriosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (Numeric rating scale) Score for pain | The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups. | Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative measures | Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups. | Up to 300 minutes (intraoperative) | 
| Factors concerning ERAS (Enhanced recovery after surgery) | Nausea (yes/no), vomiting (yes/no), peroral intake (minutes from surgery), mobilization (minutes from surgery), bowel movement (minutes from surgery), time of discharge (hours after surgery), complications (classified according to Clavien-Dindo) for both study groups. | Up to 7 days (Hospital stay) | 
| Cost | Cost, euros. | Primary hospital stay and 24 months, for both study groups. | 
| Complications | Complications (classified according to Clavien-Dindo), readmissions to hospital. | 30 days | 
| Endometriosis-related quality-of-life | Quality-of-life questionnaire (EHP-30, Endometriosis-related health profile) described as absolute scores and change from the baseline. Scale 0-100. Score 0 equals the best outcome and score 100 equals the worst outcome. | 6, 12 and 24 months | 
| General 15 dimensional health-related quality-of-life questionnaire | Quality-of-life questionnaire (15D, general quality-of-life questionnaire) described as absolute scores and change from baseline for both study groups. Scale 0-1. Score 0 equals the worst outcome and score 1 equals the best outcome. | 6, 12 and 24 months | 
| Sexual quality-of-life questionnaire | Quality-of-life (FSFI, female sexual function index) described as absolute scores and change from baseline for both study groups. Scale 2,0-36,0. Score 2,0 equals the worst outcome and score 36,0 equals the best outcome. | 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis surgery, Deep endometriosis surgery, Robotic surgery