Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
Recruiting · NCT05974995 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
Laparoscopic surgeryRobot-assisted surgery
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Policlinico Gemelli IRCCS - Rome, Italy