ENDOmetriosis Robotic Assisted Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Laparoscopic Hysterectomy, Ureterolysis.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
Overview
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.
Interventions
- 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 - Device Ureterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Primary outcome measures
- Intra and post-operative complication rates [Time frame: 3 months]
Secondary outcome measures (12)
- Short Form Health Survey (SF-36) [Time frame: At baseline and at 3, 6, and 12 month.]
- Patients' sexual quality of life [Time frame: At baseline and at 3, 6, and 12 months.]
- Duration of the intervention [Time frame: Time from incision to closure (12 months)]
- Intraoperative and postoperative complications [Time frame: At 1, 6, and 12 months]
- Blood loss [Time frame: During the intervention]
- Pain symptoms [Time frame: At 30 days, and at 3, 6, and 12 months postoperatively.]
- Length of hospital stay [Time frame: From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)]
- Hospital readmissions [Time frame: 30 days after surgery]
- Reoperation [Time frame: Within 30 days after surgery]
- Robotic and complex laparoscopic expertise of the surgeons [Time frame: 1 year]
- Completion of Questionnaires Borg CR-10 Scale [Time frame: Day 0 (surgery)]
- Endometriosis Health Profile-30 (EHP30) [Time frame: At baseline and at 3, 6, and 12 month.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Hôpital Privé de Provence — Aix-en-Provence
- Hôpital Privé le Bois — Lille
Publications
- Renso M, Bendifallah S, Estrade JP, Merlot B, Roman H, Vidal F, Collinet P. Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e108125. doi: 10.1136/bmjopen-2025-108125. PMID 41314847
Identifiers
NCT: NCT06445179 · 2024-A00350-47