ENDOmetriosis Robotic Assisted Surgery

Endometriosis Clinical Trial

— ENDO-RAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445179
• Other study ID #: 2024-A00350-47
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Pierre MD COLLINET
• Phone: 677707402
• Email: pierre.collinet[@]hotmail.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé le Bois	Lille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra and post-operative complication rates	Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).	3 months