Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
Robotic-assisted Versus Conventional Laparoscopic Surgery in the Management of Obese Patients With Early Endometrial Cancer in the Sentinel Lymph Node Era: a Randomized Controlled Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
566 participants
Sep 1, 2023
INTERVENTIONAL
Conditions
Summary
Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI \>= 30) patients with endometrial carcinoma.
Eligibility
Inclusion Criteria7
- BMI \>=30
- Age \> 18
- Histologically confirmed endometrioid endometrial cancer
- Clinical early stage (stage I)
- No contraindication for minimally invasive surgery
- ASA\<4
- Written informed consent.
Exclusion Criteria4
- High probability of laparotomy related to uterine volume (US estimated weight \>250 g)
- Concomitant pelvic disease, or anatomical characteristics of the patient
- (Use of uterine manipulator)
- Age \>75 years
Interventions
Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi
Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05974995