RecruitingNot ApplicableNCT05974995

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

566 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Gynecologic Cancer Endometrial Neoplasms Obesity, Morbid Gynecologic Disease

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares robotic-assisted surgery versus conventional laparoscopic surgery for obese women with early-stage endometrial (uterine) cancer. Both are minimally invasive approaches, and researchers want to know if robotics offers advantages for heavier patients. **You may be eligible if...** - You are over 18 years old (but under 75) - You have a BMI of 30 or higher (classified as obese) - You have been diagnosed with early-stage (stage I) endometrioid endometrial cancer confirmed by biopsy - You have no medical reason that prevents minimally invasive surgery **You may NOT be eligible if...** - Your uterus is very large (estimated weight over 250g on ultrasound), making minimally invasive surgery difficult - You have another pelvic condition or anatomy that complicates surgery - You are 75 or older Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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