An interventional study of Total Laparoscopic Hysterectomy and Ureterolysis in Endometriosis, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
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.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 224 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the control group, all patients will undergo a Total Laparoscopic Hysterectomy. The number of ports needed for the laparoscope and assistants will be reported.
Procedure: Total Laparoscopic Hysterectomy · Device: Ureterolysis
All patients in the experimental group will undergo a Robotic-Assisted Total Laparoscopic Hysterectomy using either the HugoTM Robot-Assisted Surgery system (Medtronic©), the Da Vinci® Xi or X Surgical System, or CMR versus (if available). The number of ports required for the laparoscope, robotic arms, and assistants will be documented.
Procedure: Total Laparoscopic Hysterectomy · Device: Ureterolysis
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
Intra and post-operative complication rates
Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).
Time frame: 3 months
Short Form Health Survey (SF-36)
Patients' quality of life COmpletion of hte Endometriosis-related quality of life
Time frame: At baseline and at 3, 6, and 12 month.
Patients' sexual quality of life
Completion of the Sexual quality-of-life using the Female Sexual Function Index (FSFI) A 19-point questionnaire with a scale from 0 to 5.
Time frame: At baseline and at 3, 6, and 12 months.
Duration of the intervention
The mean operative time (minutes) which will be defined as the time from incision to closure.
Time frame: Time from incision to closure (12 months)
Intraoperative and postoperative complications
Rate of intraoperative and postoperative complications, according to the Clavien-Dindo classification
Time frame: At 1, 6, and 12 months
Blood loss
Volume of blood loss (mL)
Time frame: During the intervention
Pain symptoms
Mean numeric rating scale (NRS) from 0 to 10 where 10 is extreme pain.
Time frame: At 30 days, and at 3, 6, and 12 months postoperatively.
Length of hospital stay
Total number of days in the hospital
Time frame: From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)
Hospital readmissions
Rate of hospital readmissions
Time frame: 30 days after surgery
Reoperation
Rate of reoperation
Time frame: Within 30 days after surgery
Robotic and complex laparoscopic expertise of the surgeons
Number of robotic and complex laparoscopic procedures performed by the surgeons involved and in the hospitals involved
Time frame: 1 year
Completion of Questionnaires Borg CR-10 Scale
Perceived exertion by surgeons of laparoscopic and robotic intervention.
Time frame: Day 0 (surgery)
Endometriosis Health Profile-30 (EHP30)
Patients' quality of life COmpletion of hte Endometriosis-related quality of life
Time frame: At baseline and at 3, 6, and 12 month.
Completion of Questionnaires NASA-TLX
Perceived exertion by surgeons of laparoscopic and robotic intervention.
Time frame: Day 0 (surgery)
Plan to share: Yes — Only data that is strictly relevant and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be transmitted.
Supporting information: Study protocol, Sap, Analytic code
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GCS Ramsay Santé pour l'Enseignement et la Recherche