Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.

Condition(s) studied

Investigational drug(s) / intervention(s)

Robot-assisted laparoscopy: The experimental procedure corresponds to robot-assisted laparoscopy.

conventional laparoscopy: The "control" procedure corresponds to conventional laparoscopy.

Prospective cohort study: 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 cohort study: 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: information and consent

randomization: Randomization

Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence

Surgical data collection: Surgical data collection at Day 0

Biological data collection: Biological data collection at Day 1

Collection of histological data from the surgical specimen: Collection of histological data from the surgical specimen et Day 42

Phone calls: Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3

Pain assessment: Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3

Collect of data on non-reimbursed transport: 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: 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: Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6

SF36 questionnaire: SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6

Questionnaire EQ5D-5L: Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6

FIGO Stadium: FIGO Stadium at inclusion and Day 42

Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.): 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: Collection of adjuvant treatments at month 6

Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one: 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: Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used

Study 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

Primary outcome measure(s)

• Cost-utility ratio expressed in terms of costs / QALY — 6 weeks post-operatively
  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.

Trial sites (15)

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