Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer

Recruiting now · Not applicable

Conditions studied: Endometrial Cancer, Endometrial Neoplasms, Obesity, Morbid, Gynecologic Cancer, Gynecologic Disease

In brief

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.

Key facts

Study ID

NCT05974995

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

566

Starts

2023-09-01

Expected to finish

2029-09-01

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Policlinico Gemelli IRCCS — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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