NCT06445179

ENDOmetriosis Robotic Assisted Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-16
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-06-06
• Last updated: 2026-01-20

Locations

2 sites across 1 country: France