ENDOmetriosis Robotic Assisted Surgery (ENDO-RAS)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Not yet enrolling

Conditions: Endometriosis

Treatments: Procedure: Total Laparoscopic Hysterectomy; Device: Ureterolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06445179

2024-A00350-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

without Robotic-Assisted

Active Comparator group

Description:

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.

Treatment:

Device: Ureterolysis

Procedure: Total Laparoscopic Hysterectomy

Robotic-Assisted

Experimental group

Description:

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.

Treatment:

Device: Ureterolysis

Procedure: Total Laparoscopic Hysterectomy