ENDOmetriosis Robotic Assisted Surgery (ENDO-RAS)

January 15, 2026 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial

The purpose of this study is to compare the robot-assisted approach with the laparoscopic approach in terms of reducing the rates of intraoperative and postoperative complications in patients undergoing total hysterectomy for DIE and adenomyosis without digestive tract involvement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The ENDO-RAS trial aims to evaluate the safety and effectiveness of robot-assisted laparoscopy compared to conventional laparoscopy for hysterectomy in patients with Deep infiltrating endometriosis and adenomyosis without digestive tract involvement, as verified by magnetic resonance imaging and classified using both the ENZIAN and Deep Pelvic Endometriosis Index classifications. These classifications are used to evaluate Deep infiltrating endometriosis and reproducibly predict the occurrence of postoperative complications.

Eligible patients will be recruited from the gynecological surgery department after meeting the inclusion and non-inclusion criteria and signed informed consent forms. Participants will then be randomly assigned to receive either robot-assisted total laparoscopic hysterectomy or total laparoscopic hysterectomy.

The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study. Eligible patients will be randomized into two parallel groups.

Study Type

Interventional

Enrollment (Estimated)

224

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 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 years of age.
  • Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) per the Enzian and dPEI classifications.
  • Diagnosed deep infiltrating endometriosis per the Enzian and dPEI classifications, without the involvement of the digestive tract.
  • Failure of first- and second-line medical treatment.
  • Eligibility for total hysterectomy with complete removal of endometriosis lesions.
  • Participants covered by entitled to social security.
  • All participants must provide written informed consent before undergoing the surgical procedure.

Exclusion Criteria:

  • Digestive tract involvement.
  • Adenomyosis only.
  • Contraindications to surgery.
  • Participants who are under guardianship, curatorship, or deprivation of liberty.

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
Active Comparator: without Robotic-Assisted
In the control group, all patients will undergo a Total Laparoscopic Hysterectomy. The number of ports needed for the laparoscope and assistants will be reported.
Procedure: Total Laparoscopic Hysterectomy

The standard procedure for performing total hysterectomy will also follow the Querleu and Morrow classification system, which divides the procedure into four types based on the extent of resection:

  • Type A: minimum resection of paracervix.
  • Type B: transection of the paracervix and the ureter.
  • Type C: Transection of paracervix at the junction with the internal iliac vascular system
  • Type D: Laterally extended resection. Furthermore, bilateral ureterolysis will be performed with the option of bilateral concomitant salpingo-oophorectomy.
Device: Ureterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Experimental: Robotic-Assisted
All patients in the experimental group will undergo a Robotic-Assisted Total Laparoscopic Hysterectomy using either the HugoTM Robot-Assisted Surgery system (Medtronic©), the Da Vinci® Xi or X Surgical System, or CMR versus (if available). The number of ports required for the laparoscope, robotic arms, and assistants will be documented.
Procedure: Total Laparoscopic Hysterectomy

The standard procedure for performing total hysterectomy will also follow the Querleu and Morrow classification system, which divides the procedure into four types based on the extent of resection:

  • Type A: minimum resection of paracervix.
  • Type B: transection of the paracervix and the ureter.
  • Type C: Transection of paracervix at the junction with the internal iliac vascular system
  • Type D: Laterally extended resection. Furthermore, bilateral ureterolysis will be performed with the option of bilateral concomitant salpingo-oophorectomy.
Device: Ureterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra and post-operative complication rates
Time Frame: 3 months
Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form Health Survey (SF-36)
Time Frame: At baseline and at 3, 6, and 12 month.
Patients' quality of life COmpletion of hte Endometriosis-related quality of life
At baseline and at 3, 6, and 12 month.
Patients' sexual quality of life
Time Frame: At baseline and at 3, 6, and 12 months.
Completion of the Sexual quality-of-life using the Female Sexual Function Index (FSFI) A 19-point questionnaire with a scale from 0 to 5.
At baseline and at 3, 6, and 12 months.
Duration of the intervention
Time Frame: Time from incision to closure (12 months)
The mean operative time (minutes) which will be defined as the time from incision to closure.
Time from incision to closure (12 months)
Intraoperative and postoperative complications
Time Frame: At 1, 6, and 12 months
Rate of intraoperative and postoperative complications, according to the Clavien-Dindo classification
At 1, 6, and 12 months
Blood loss
Time Frame: During the intervention
Volume of blood loss (mL)
During the intervention
Pain symptoms
Time Frame: At 30 days, and at 3, 6, and 12 months postoperatively.
Mean numeric rating scale (NRS) from 0 to 10 where 10 is extreme pain.
At 30 days, and at 3, 6, and 12 months postoperatively.
Length of hospital stay
Time Frame: From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)
Total number of days in the hospital
From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)
Hospital readmissions
Time Frame: 30 days after surgery
Rate of hospital readmissions
30 days after surgery
Reoperation
Time Frame: Within 30 days after surgery
Rate of reoperation
Within 30 days after surgery
Robotic and complex laparoscopic expertise of the surgeons
Time Frame: 1 year
Number of robotic and complex laparoscopic procedures performed by the surgeons involved and in the hospitals involved
1 year
Completion of Questionnaires Borg CR-10 Scale
Time Frame: Day 0 (surgery)
Perceived exertion by surgeons of laparoscopic and robotic intervention.
Day 0 (surgery)
Endometriosis Health Profile-30 (EHP30)
Time Frame: At baseline and at 3, 6, and 12 month.
Patients' quality of life COmpletion of hte Endometriosis-related quality of life
At baseline and at 3, 6, and 12 month.
Completion of Questionnaires NASA-TLX
Time Frame: Day 0 (surgery)
Perceived exertion by surgeons of laparoscopic and robotic intervention.
Day 0 (surgery)

Collaborators and Investigators

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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

Euraxi Pharma

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)

April 16, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00350-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only data that is strictly relevant and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be transmitted.

IPD Sharing Time Frame

Starting from 2028 for one year

IPD Sharing Access Criteria

Data will be made available upon reasonable request from the journal of the published article, strictly for reanalysis of the published results. In such instances, requests should be directed via email to the corresponding author. The statistical code employed for the original analyses may also be shared if deemed necessary. Depending on the nature of the request, the original authors may be invited to participate in the reanalysis.

Data will be shared in the form of an anonymized Excel file, in full compliance with applicable data protection regulations. No information will permit the direct or indirect identification of patients. The shared data may only be used for the specific purpose defined in the initial request. No secondary use or data transfer agreement will be considered or negotiated. Please let us know if any further clarification is required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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