Comparing robot-assisted and traditional laparoscopic surgery for endometriosis
Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 2 sites (Aix-en-Provence and 1 other locations) |
| Trial ID | NCT06445179 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older diagnosed with deep infiltrating endometriosis and adenomyosis, without digestive tract involvement.
Not a fit: Patients with digestive tract involvement or those who only have adenomyosis may not benefit from this study.
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 performed: Previous studies have shown promising results with robotic-assisted surgical techniques, suggesting potential benefits in similar surgical contexts.
Eligibility criteria
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 this trial is running
Aix-en-Provence and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.