Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06348719

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

Led by Rennes University Hospital · Updated on 2025-09-15

1680

Participants Needed

15

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patient with low- or intermediate-risk endometrial carcinoma confirmed by pre-operative biopsy and MRI
  • Indication for minimally invasive total hysterectomy with bilateral adnexectomy given by the surgeon
  • Patient aged 18 years or older
  • Patient accepts data matching with the French National Health Data System
  • Patient informed about the protocol and has signed consent for participation
  • For retrospective cohort: patient underwent surgery during inclusion period and did not object to data collection
  • Surgeons and first surgical assistants performing hysterectomy on study patients who consent to data collection
Not Eligible

You will not qualify if you...

  • Patient operated on by surgeon with less than 30 robotic surgeries in the past year or less than 50 total robotic surgeries
  • Patient refuses participation or randomization in the trial
  • Surgeon refuses patient participation
  • Center lacks robotic equipment or laparoscopic column with fluorescence
  • Patient under legal protection or deprived of liberty
  • Patient not affiliated with French social security
  • Patient participating in other conflicting clinical trials
  • Pregnant or breastfeeding patients
  • Minimally invasive surgery contraindicated by anesthesia
  • Patient operated with non-intuitive robotic systems other than Si, X, or Xi

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 15 locations

1

CHU de Lille, Hôpital Jeanne de Flandre

Lille, France, 59000

Not Yet Recruiting

2

CHU LIMOGES, Hôpital Mère-Enfant

Limoges, France, 87042

Actively Recruiting

3

Hôpital Lariboisière/Hôpital Saint Louis

Paris, France, 75010

Not Yet Recruiting

4

Hôpital Cochin

Paris, France, 75014

Not Yet Recruiting

5

Hôpital Européen Georges Pompidou

Paris, France, 75015

Actively Recruiting

6

Hôpital Bichat

Paris, France, 75018

Not Yet Recruiting

7

Hôpital Tenon AP-HP

Paris, France, 75020

Not Yet Recruiting

8

Hôpital Pitié Salpêtrière

Paris, France

Not Yet Recruiting

9

Hôpital Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, France, 69495

Actively Recruiting

10

Hôpital privé des côtes d'Armor

Plérin, France, 22190

Not Yet Recruiting

11

CHU de Rennes

Rennes, France, 35200

Actively Recruiting

12

CHU de Rouen

Rouen, France, 76031

Actively Recruiting

13

CHU de Saint Etienne

Saint-Etienne, France, 42055

Not Yet Recruiting

14

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, France, 67200

Not Yet Recruiting

15

CHU de Tours - Hôpital Bretonneau

Tours, France, 37044

Not Yet Recruiting

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Research Team

V

Vincent Lavoué

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

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