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.
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.
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).
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.
Parallel
Robot-assisted laparoscopy
Procedure/SurgeryThe experimental procedure corresponds to robot-assisted laparoscopy.
conventional laparoscopy
Procedure/SurgeryThe "control" procedure corresponds to conventional laparoscopy.
Prospective cohort study
Other interventionA 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 cohort study
Other interventionRetrospective 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
Other interventioninformation and consent
randomization
Other interventionRandomization
Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other interventionCollection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Surgical data collection
Other interventionSurgical data collection at Day 0
Biological data collection
Other interventionBiological data collection at Day 1
Collection of histological data from the surgical specimen
Other interventionCollection of histological data from the surgical specimen et Day 42
Phone calls
Other interventionPhone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment
Other interventionPain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Collect of data on non-reimbursed transport
Other interventionCollect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Collect of everyday help
Other interventionCollect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Collection of the business resumption date
Other interventionCollection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
SF36 questionnaire
Other interventionSF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L
Other interventionQuestionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium
Other interventionFIGO Stadium at inclusion and Day 42
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Other interventionCollection 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
Other interventionCollection of adjuvant treatments at month 6
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Other interventionRecording 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
Other interventionCollection of data on age, baseline, BMI, histological type of cancer and surgical approach used
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.
Operating time
Operating time
Conversion rate
Conversion rate
Rate and nature of intraoperative complications
Rate and nature of intraoperative complications
Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
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