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RECRUITING
NCT06348719
NA

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

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

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.

Official title: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer: Multicentre Randomised Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1680

Start Date

2024-09-23

Completion Date

2028-03

Last Updated

2025-09-15

Healthy Volunteers

No

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

Locations (15)

CHU de Lille, Hôpital Jeanne de Flandre

Lille, France

CHU LIMOGES, Hôpital Mère-Enfant

Limoges, France

Hôpital Lariboisière/Hôpital Saint Louis

Paris, France

Hôpital Cochin

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital Bichat

Paris, France

Hôpital Tenon AP-HP

Paris, France

Hôpital Pitié Salpêtrière

Paris, France

Hôpital Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, France

Hôpital privé des côtes d'Armor

Plérin, France

CHU de Rennes

Rennes, France

CHU de Rouen

Rouen, France

CHU de Saint Etienne

Saint-Etienne, France

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

CHU de Tours - Hôpital Bretonneau

Tours, France