Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer: Multicentre Randomised Controlled Trial
Rennes University Hospital
1,680 participants
Sep 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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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
Locations(15)
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NCT06348719