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

NCT05974995 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Obesity, Morbid
  • Gynecologic Cancer
  • Gynecologic Disease

Interventions

PROCEDURE

Robot-assisted surgery

Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi

PROCEDURE

Laparoscopic surgery

Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Francesco Fanfani, MD · Policlinico Gemelli IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-09-01
Completion
2029-09-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974995 on ClinicalTrials.gov