Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT05974995

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-03

566

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • High probability of laparotomy due to uterine volume (ultrasound estimated weight >250 g)
  • Presence of other pelvic diseases or anatomical features affecting surgery
  • Use of uterine manipulator
  • Age >75 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Policlinico Gemelli IRCCS

Rome, Italy, 00167

Actively Recruiting

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Research Team

F

Francesco Fanfani, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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