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.

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.

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.

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.

Starting from 2028 for one year

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.

The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study.