Robotic Versus Laparoscopic Surgery for Deep Endometriosis

Not Applicable

Recruiting

• Conditions: Endometriosis; Surgery; Deep Endometriosis
• Interventions: Procedure: Minimally invasive surgery

• Registration Number: NCT05179109
• Lead Sponsor: University of Oulu

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 Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-05
• Study Start: 2022-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted laparoscopy	Minimally invasive surgery	Surgery for deep endometriosis using robot-assisted laparoscopy.
Conventional laparoscopy	Minimally invasive surgery	Surgery for deep endometriosis using conventional laparoscopy.

Primary Outcome Measures

Name	Time	Method
NRS (Numeric rating scale) Score for pain	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 Outcome Measures

Name	Time	Method
Endometriosis-related quality-of-life	6, 12 and 24 months	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.
Intraoperative measures	Up to 300 minutes (intraoperative)	Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
Sexual quality-of-life questionnaire	6, 12 and 24 months	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.
Factors concerning ERAS (Enhanced recovery after surgery)	Up to 7 days (Hospital stay)	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.
Cost	Primary hospital stay and 24 months, for both study groups.	Cost, euros.
Complications	30 days	Complications (classified according to Clavien-Dindo), readmissions to hospital.
General 15 dimensional health-related quality-of-life questionnaire	6, 12 and 24 months	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.

Trial Locations

Locations (1)

Northern Ostrobothnia Hospital District; 🇫🇮 Oulu, Finland