ENDOmetriosis Robotic Assisted Surgery

NCT06445179 | Recruiting

• 1 other identifier: 2024-A00350-47
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Intra and post-operative complication rates

  Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).

  3 months

Secondary Outcomes (13)

• Short Form Health Survey (SF-36)

  At baseline and at 3, 6, and 12 month.

• Patients' sexual quality of life

  At baseline and at 3, 6, and 12 months.

• Duration of the intervention

  Time from incision to closure (12 months)

• Intraoperative and postoperative complications

  At 1, 6, and 12 months

• Blood loss

  During the intervention

Study Arms (2)

without Robotic-Assisted

ACTIVE COMPARATOR

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; Device: Ureterolysis

Robotic-Assisted

EXPERIMENTAL

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; Device: Ureterolysis

Interventions

Total Laparoscopic Hysterectomy PROCEDURE

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.

Robotic-Assisted; without Robotic-Assisted

Ureterolysis DEVICE

unilateral or bilateral ureterolysis with or without bilateral adnexectomy

Robotic-Assisted; without Robotic-Assisted

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

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

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (2)

Hôpital Privé de Provence

Aix-en-Provence, 13080, France

RECRUITING

Hôpital Privé le Bois

Lille, 59000, France

RECRUITING

Related Publications (1)

• Renso M, Bendifallah S, Estrade JP, Merlot B, Roman H, Vidal F, Collinet P. Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e108125. doi: 10.1136/bmjopen-2025-108125.

  PMID: 41314847 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Pierre MD COLLINET

CONTACT

677707402; pierre.collinet@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomized into two parallel groups.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 6, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting from 2028 for one year
• 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.

Locations

FR (2)