Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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