Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
ROBOT-ECO-GYN
1 other identifier
interventional
1,680
1 country
15
Brief Summary
The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study. Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy. Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient. The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedStudy Start
First participant enrolled
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
September 15, 2025
August 1, 2025
3.4 years
March 19, 2024
September 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cost-utility ratio expressed in terms of costs / QALY
Incremental cost-utility ratio expressed in terms of costs / QALY (Quality-Adjusted Life-Year) gained with robot-assisted laparoscopy versus conventional laparoscopy in patients undergoing THR for low-risk or intermediate-risk endometrial carcinoma (i. e ; endometrioid adenocarcinoma of the endometrium grade 1 or 2 and FIGO stage 1 (FIGO 2023 classification)) in pre-therapeutic MRI) following a collective perspective at 6 weeks post-operatively.
6 weeks post-operatively
Secondary Outcomes (50)
Operating time
Day 0
Conversion rate
month 6
Rate and nature of intraoperative complications
Day 0
Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
Day 42
Post-operative complication rate and nature at M6 (Clavien-Dindo classification)
Month 6
- +45 more secondary outcomes
Study Arms (4)
Randomized study: Robot-assisted laparoscopy
EXPERIMENTALRobot-assisted laparoscopic hysterectomy
Randomized study: conventional laparoscopy
ACTIVE COMPARATORConventional laparoscopic hysterectomy
Prospective cohort study
OTHERProspective cohort study backed by randomized controlled trial (for patients not included in the trial due to surgeon refusal, absence of learning curve criteria for the surgeon or patient refusal, center unable to participate in the randomized study).
Retrospective cohort study
OTHERa retrospective cohort will be set up to provide an exhaustive overview of the approaches used for endometrial cancer, according to patient characteristics (age and BMI). It will include all patients not included in the randomized controlled trial and in the prospective cohort because the surgeon did not propose it to them, because they did not wish to be followed up for the study for 6 months, or because the surgeon considered that minimally invasive surgery was not indicated; up to a limit of 1000 inclusions.
Interventions
The experimental procedure corresponds to robot-assisted laparoscopy.
The "control" procedure corresponds to conventional laparoscopy.
A prospective cohort of patients will be set up to support the randomized controlled trial. Patients will be offered participation in this cohort if the center is unable to participate in the randomized trial (i.e., does not have a robot, or does not have a laparoscopic column with fluorescence), if the patient refuses randomization in the randomized controlled trial, if the surgeon refuses to randomize the patient, or if the surgeon does not meet the learning curve criteria required for robotic surgery. These patients will be followed in exactly the same way as patients included in the randomized controlled trial, once their consent has been obtained.
Retrospective data collection from the medical records of all patients who underwent hysterectomy for low- or intermediate-risk endometrial cancer during the inclusion period at a participating center and who were not included in the randomized controlled trial or prospective cohort; up to a limit of 1000 inclusions. For this retrospective cohort, only data concerning initial age, BMI, histological type of cancer and surgical approach used will be collected.
information and consent
Randomization
Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Surgical data collection at Day 0
Biological data collection at Day 1
Collection of histological data from the surgical specimen et Day 42
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium at inclusion and Day 42
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Collection of adjuvant treatments at month 6
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one at Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used
Eligibility Criteria
You may qualify if:
- Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patients with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI.
- Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.
- Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS)
- Major patient.
- Patient having received information on the protocol and having signed a consent form, thus accepting randomization in the robot-assisted intervention group versus conventional laparoscopy.
- Patient refuses to participate in randomized controlled trial (refuses randomization)
- The surgeon refuses the patient's participation in the randomized controlled trial (does not wish to randomize the patient).
- The center does not have a robot
- The center does not have a laparoscopic column with fluorescence
- Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;
- Patient not affiliated to a French social security scheme
- Patient participating in another interventional trial or in Jardé off-label research that impacts study data, or in RIPH3 that impacts study data
- Pregnant or breast-feeding patient
You may not qualify if:
- Minimally invasive procedure contraindicated by pre-operative anesthesia.
- Patient operated on by a robot other than one of the intuitive robot variants (Si, X and Xi).
- Prospective cohort:
- Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patient with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI .
- Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.
- Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS)
- Major patient.
- Patient not included in randomized controlled trial because :
- Patient refuses to participate in randomized controlled trial (refusing randomization)
- The surgeon refuses the patient's participation in the randomized controlled trial (does not wish to randomize the patient)
- The center does not have a robot
- The center does not have a laparoscopic column with fluorescence
- Patient has been informed about the protocol and has signed a consent form.
- Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;
- Patient not affiliated to a French social security scheme
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
CHU de Lille, Hôpital Jeanne de Flandre
Lille, 59000, France
CHU LIMOGES, Hôpital Mère-Enfant
Limoges, 87042, France
Hôpital Lariboisière/Hôpital Saint Louis
Paris, 75010, France
Hôpital Cochin
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Hôpital Bichat
Paris, 75018, France
Hôpital Tenon AP-HP
Paris, 75020, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, 69495, France
Hôpital privé des côtes d'Armor
Plérin, 22190, France
CHU de Rennes
Rennes, 35200, France
CHU de Rouen
Rouen, 76031, France
CHU de Saint Etienne
Saint-Etienne, 42055, France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200, France
CHU de Tours - Hôpital Bretonneau
Tours, 37044, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
April 5, 2024
Study Start
September 23, 2024
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
September 15, 2025
Record last verified: 2025-08