Comparing robotic and traditional laparoscopic surgery for 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
This study is testing whether robotic surgery works better than traditional laparoscopic surgery for morbidly obese patients with early endometrial cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 566 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05974995 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of robotic-assisted surgery compared to conventional laparoscopic surgery in morbidly obese patients diagnosed with early-stage endometrial cancer. The study will involve a randomized controlled multicentric approach to determine which minimally invasive surgical technique offers better outcomes in terms of safety and efficacy. Given the rising incidence of endometrial cancer among obese women, this research seeks to address the surgical challenges posed by obesity and improve peri-operative results. The trial will include patients with a BMI of 30 or higher and will assess various surgical parameters and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese women aged over 18 with histologically confirmed early-stage endometrial cancer.
Not a fit: Patients with a high likelihood of requiring open surgery due to uterine size or those with significant concomitant pelvic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for obese patients undergoing surgery for endometrial cancer.
How similar studies have performed: While there is existing literature suggesting benefits of robotic surgery in this patient population, this trial is among the first randomized studies specifically addressing this comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome
- Policlinico Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Fanfani, MD — Policlinico Gemelli IRCCS
- Study coordinator: Francesco Fanfani, MD
- Email: francesco.fanfani@policlinicogemelli.it
- Phone: 0630153421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.