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
GCS Ramsay Santé pour l'Enseignement et la Recherche
224 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- ≥ 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 Criteria4
- Digestive tract involvement.
- Adenomyosis only.
- Contraindications to surgery.
- Participants who are under guardianship, curatorship, or deprivation of liberty.
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Interventions
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.
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06445179