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

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.

Conditions

• Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma

Interventions

PROCEDURE

Robot-assisted laparoscopy

The experimental procedure corresponds to robot-assisted laparoscopy.

PROCEDURE

conventional laparoscopy

The "control" procedure corresponds to conventional laparoscopy.

OTHER

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.

OTHER

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.

OTHER

information and consent

information and consent

OTHER

randomization

Randomization

OTHER

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

OTHER

Surgical data collection

Surgical data collection at Day 0

OTHER

Biological data collection

Biological data collection at Day 1

OTHER

Collection of histological data from the surgical specimen

Collection of histological data from the surgical specimen et Day 42

OTHER

Phone calls

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

OTHER

Pain assessment

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

OTHER

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

OTHER

Collect of everyday help

Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6

OTHER

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

OTHER

SF36 questionnaire

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

OTHER

Questionnaire EQ5D-5L

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

OTHER

FIGO Stadium

FIGO Stadium at inclusion and Day 42

OTHER

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

OTHER

Collection of adjuvant treatments

Collection of adjuvant treatments at month 6

OTHER

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

OTHER

Collection of data

Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used

Sponsors & Collaborators

• Rennes University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-23

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• France

Study Locations