Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparo
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
| Condition(s) | Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 hyste |
| Who can participate | Randomized Study: Inclusion Criteria: * Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patients with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI. * Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation. * Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS) * Major patient. * Patient having received information on the protocol and having signed a consent form, thus accepting randomization in the robot-assisted intervention group versus conventional laparoscopy. Non Inclus |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Rennes University Hospital |
| Locations | Lille, France; Limoges, France; Paris, France; Paris, France; Paris, France; Paris, France (+9 more sites) |
| Start date | 2024-09-23 |
| NCT ID | NCT06348719 |
| Official listing | https://clinicaltrials.gov/study/NCT06348719 |