Robotic Versus Laparoscopic Surgery for Deep Endometriosis (ROBEndo)

May 11, 2023 updated by: Sari Koivurova, University of Oulu

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

The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative measures
Time Frame: Up to 300 minutes (intraoperative)
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)
Time Frame: 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.
Up to 7 days (Hospital stay)
Cost
Time Frame: Primary hospital stay and 24 months, for both study groups.
Cost, euros.
Primary hospital stay and 24 months, for both study groups.
Complications
Time Frame: 30 days
Complications (classified according to Clavien-Dindo), readmissions to hospital.
30 days
Endometriosis-related quality-of-life
Time Frame: 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.
6, 12 and 24 months
General 15 dimensional health-related quality-of-life questionnaire
Time Frame: 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.
6, 12 and 24 months
Sexual quality-of-life questionnaire
Time Frame: 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.
6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROBtrial1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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