Viewing Study NCT06445179



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06445179
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-06
First Post: 2024-05-27

Brief Title: ENDOmetriosis Robotic Assisted Surgery
Sponsor: GCS Ramsay Santé pour lEnseignement et la Recherche
Organization: GCS Ramsay Santé pour lEnseignement et la Recherche

Study Overview

Official Title: Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis A Multicenter Open-label Randomized Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ENDO-RAS
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
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None