Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
224 participants
INTERVENTIONAL
2025-04-16
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
NCT06348719
Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
NCT03373513
Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
NCT01761721
Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy
NCT00485355
Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer
NCT01480999
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
without Robotic-Assisted
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.
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 of bilateral concomitant salpingo-oophorectomy.
Ureterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Robotic-Assisted
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.
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 of bilateral concomitant salpingo-oophorectomy.
Ureterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 of bilateral concomitant salpingo-oophorectomy.
Ureterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Adenomyosis only.
* Contraindications to surgery.
* Participants who are under guardianship, curatorship, or deprivation of liberty.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Euraxi Pharma
INDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Privé de Provence
Aix-en-Provence, , France
Hôpital Privé le Bois
Lille, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-A00350-47
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.