Clinical trial NCT06445179: ENDOmetriosis Robotic Assisted Surgery
Official title: Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-06-06
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized into two parallel groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra and post-operative complication rates
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Hôpital Privé de Provence
city: Lille
country: France
facility: Hôpital Privé le Bois
Study officials:
References: