NCT06348719

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,680 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As part of this project, the investigators are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort. This research will therefore consist of 3 complementary studies : A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups: * Group 1: laparoscopic robot-assisted THR * Group 2: conventional laparoscopic STH A prospective cohort based on the randomized controlled trial A retrospective cohort Qualitative analysis of perceptions of the benefits and limitations of the surgical robot, and of the obstacles and levers to its deployment: focus groups with a sample of gynecology surgical teams from volunteer centers. Budget impact analysis

Conditions

• Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-23
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2024-04-05
• Last updated: 2025-09-15

Locations

15 sites across 1 country: France