EndometriosisENDO-RASNCT06445179
ENDOmetriosis Robotic Assisted Surgery
A study testing Total Laparoscopic Hysterectomy and Ureterolysis in people with Endometriosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Total Laparoscopic Hysterectomy and Ureterolysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- Digestive tract involvement.
- Adenomyosis only.
- Contraindications to surgery.
- Participants who are under guardianship, curatorship, or deprivation of liberty.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Privé de Provence
Aix-en-Provence, 13080
Jean-Philippe ESTRADE, MD, jeanphilippeestrade@me.com
- Recruiting
Hôpital Privé le Bois
Lille, 59000
Pierre MD COLLINET, pierre.collinet@hotmail.fr
About this study
Official title: Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Total Laparoscopic Hysterectomy, Ureterolysis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Laparoscopic HysterectomyProcedure or surgery
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.
UreterolysisDevice
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
| Study group | Role | What they receive |
|---|---|---|
| without Robotic-Assisted | Active comparator | 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. Receives: Procedure: Total Laparoscopic Hysterectomy; Device: Ureterolysis |
| Robotic-Assisted | Experimental | 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. Receives: Procedure: Total Laparoscopic Hysterectomy; Device: Ureterolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra and post-operative complication rates
Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).
Measured: 3 months
Secondary outcomes (13)
Short Form Health Survey (SF-36)
Patients' quality of life COmpletion of hte Endometriosis-related quality of life
Measured: 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.
Measured: 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.
Measured: Time from incision to closure (12 months)
Intraoperative and postoperative complications
Rate of intraoperative and postoperative complications, according to the Clavien-Dindo classification
Measured: At 1, 6, and 12 months
Blood loss
Volume of blood loss (mL)
Measured: During the intervention
Pain symptoms
Mean numeric rating scale (NRS) from 0 to 10 where 10 is extreme pain.
Measured: At 30 days, and at 3, 6, and 12 months postoperatively.
Length of hospital stay
Total number of days in the hospital
Measured: From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)
Hospital readmissions
Rate of hospital readmissions
Measured: 30 days after surgery
Reoperation
Rate of reoperation
Measured: 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
Measured: 1 year
Completion of Questionnaires Borg CR-10 Scale
Perceived exertion by surgeons of laparoscopic and robotic intervention.
Measured: Day 0 (surgery)
Endometriosis Health Profile-30 (EHP30)
Patients' quality of life COmpletion of hte Endometriosis-related quality of life
Measured: At baseline and at 3, 6, and 12 month.
Completion of Questionnaires NASA-TLX
Perceived exertion by surgeons of laparoscopic and robotic intervention.
Measured: Day 0 (surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start16 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized into two parallel groups.
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445179
- Sponsor's protocol ID
- 2024-A00350-47
- Acronym
- ENDO-RAS
- Status last verified
- Jan 2026
- First submitted
- 27 May 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 41314847
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06445179
- Acronym / sponsor ID
- ENDO-RAS / 2024-A00350-47
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized into two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| without Robotic-Assisted | Active comparator | Procedure: Total Laparoscopic Hysterectomy, Device: UreterolysisIn the control group, all patients will undergo a Total Laparoscopic Hysterectomy. The number of ports needed for the laparoscope and assistants will be reported. |
| Robotic-Assisted | Experimental | Procedure: Total Laparoscopic Hysterectomy, Device: UreterolysisAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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.
Key exclusion criteria (4 listed)
- Digestive tract involvement.
- Adenomyosis only.
- Contraindications to surgery.
- Participants who are under guardianship, curatorship, or deprivation of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Laparoscopic HysterectomyThe 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. | Procedure or surgery | Robotic-Assisted, without Robotic-Assisted |
| Ureterolysisunilateral or bilateral ureterolysis with or without bilateral adnexectomy | Device | Robotic-Assisted, without Robotic-Assisted |
Primary outcome
Intra and post-operative complication rates
Time frame: 3 months
Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).
13 secondary outcomes
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.
Completion of Questionnaires NASA-TLX
Time frame: Day 0 (surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 41314847Renso 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.
- Individual participant dataSharing planned: 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.
Related trials for Endometriosis
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
RecruitingPhase 1
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
Endometriosis
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Laparoscopic Hysterectomy and Ureterolysis in people with Endometriosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre MD COLLINET (677707402 ext. +33, pierre.collinet@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra and post-operative complication rates (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.