Health Trials

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

ConditionsEndometrial CancerEndometrial NeoplasmsObesity, MorbidGynecologic CancerGynecologic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

Qualifiers

BMI >=30

Age > 18

Histologically confirmed endometrioid endometrial cancer

Clinical early stage (stage I)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Robot-assisted surgery
  • Laparoscopic surgery

Treatment groups

566 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov