Comparing robot-assisted and traditional laparoscopic surgery for endometriosis
Official title: Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT06445179 · Data updated 2026-11-12
This study is testing whether robot-assisted surgery is safer and more effective than traditional surgery for women with deep endometriosis who need a total hysterectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 224 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 2 sites (Aix-en-Provence and 1 other locations) |
| Status | Recruiting |
| Started | April 16, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06445179 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older diagnosed with deep infiltrating endometriosis and adenomyosis, without digestive tract involvement.
✕Probably not a fit
Patients with digestive tract involvement or those who only have adenomyosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The ENDO-RAS trial evaluates the safety and effectiveness of robot-assisted laparoscopy versus conventional laparoscopy for total hysterectomy in patients with deep infiltrating endometriosis and adenomyosis, without digestive tract involvement. Patients will be randomly assigned to one of the two surgical approaches after meeting specific eligibility criteria and providing informed consent. The study aims to reduce intraoperative and postoperative complications by utilizing advanced robotic technology in surgical procedures. This multicenter, randomized, controlled, and open-label study will utilize established classifications to assess the severity of endometriosis and predict potential complications.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing hysterectomy for endometriosis.
How similar studies have gone: Previous studies have shown promising results with robotic-assisted surgical techniques, suggesting potential benefits in similar surgical contexts.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hôpital Privé de Provence
Aix-en-Provence, France Recruiting -
Hôpital Privé le Bois
Lille, France Recruiting
Study contacts
- Study coordinator: Pierre MD COLLINET
- Email: pierre.collinet@hotmail.fr
- Phone: 677707402
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Imaging endometriosis with a special PET tracer in adult women
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Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
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Atypical Endometriosis: Histology, Immunophenotype and Molecular Features
Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.