ENDOmetriosis Robotic Assisted Surgery

Last updated: April 18, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

Ureterolysis

Total Laparoscopic Hysterectomy

Clinical Study ID

NCT06445179
2024-A00350-47
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years of age.

  • Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) perthe 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 thesurgical procedure.

Exclusion

Exclusion Criteria:

  • Digestive tract involvement.

  • Adenomyosis only.

  • Contraindications to surgery.

  • Participants who are under guardianship, curatorship, or deprivation of liberty.

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Ureterolysis
Phase:
Study Start date:
April 16, 2025
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Hôpital Privé de Provence

    Aix-en-Provence, 13080
    France

    Active - Recruiting

  • Hôpital Privé le Bois

    Lille, 59000
    France

    Site Not Available

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