ROBEndo: Robotic Versus Laparoscopic Surgery for Deep Endometriosis

Sponsor

University of Oulu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05179109

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Deep Endometriosis Surgery	Procedure: Minimally invasive surgery	N/A

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

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot-assisted laparoscopy Surgery for deep endometriosis using robot-assisted laparoscopy.	Procedure: Minimally invasive surgery Minimally invasive surgery for severe deep endometriosis
Active Comparator: Conventional laparoscopy Surgery for deep endometriosis using conventional laparoscopy.	Procedure: Minimally invasive surgery Minimally invasive surgery for severe deep endometriosis

Arm

Intervention/Treatment

Experimental: Robot-assisted laparoscopy

Surgery for deep endometriosis using robot-assisted laparoscopy.

Procedure: Minimally invasive surgery

Minimally invasive surgery for severe deep endometriosis

Active Comparator: Conventional laparoscopy

Surgery for deep endometriosis using conventional laparoscopy.

Procedure: Minimally invasive surgery

Minimally invasive surgery for severe deep endometriosis

Outcome Measures

Primary Outcome Measures

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

Intraoperative measures [Up to 300 minutes (intraoperative)]
Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
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.
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.
General 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Oulu

Investigators

Principal Investigator: Sari Koivurova, MD, PhD, Oulu University Hospital, Department of Obstetrics and Gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sari Koivurova, Assistant Chief of Gynecology, University of Oulu

ClinicalTrials.gov Identifier:

NCT05179109

Other Study ID Numbers:

ROBtrial1

First Posted:

Jan 5, 2022

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sari Koivurova, Assistant Chief of Gynecology, University of Oulu

Endometriosis surgery

Deep endometriosis surgery

Robotic surgery

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jan 5, 2022