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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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.

Locations
Other Locations
France
Hôpital Privé de Provence
RECRUITING
Aix-en-provence
Hôpital Privé le Bois
NOT_YET_RECRUITING
Lille
Contact Information
Primary
Pierre MD COLLINET
pierre.collinet@hotmail.fr
677707402
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2027-06
Participants
Target number of participants: 224
Treatments
Active_comparator: without Robotic-Assisted
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.
Experimental: Robotic-Assisted
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.
Sponsors
Leads: GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators: Euraxi Pharma

This content was sourced from clinicaltrials.gov