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Search / Trial NCT05974995

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 25, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is comparing two types of surgery for women who are morbidly obese (with a body mass index of 30 or higher) and have early-stage endometrial cancer. The goal is to find out whether robotic-assisted surgery or traditional laparoscopic surgery is better for these patients. So far, some studies suggest that robotic surgery might be more beneficial for patients with obesity, but this is the first time researchers are directly comparing the two methods in a randomized trial.

To participate in this trial, women must be over 18 years old, have confirmed early-stage endometrial cancer, and meet certain health criteria. They should also be willing to provide written consent to join the study. Participants will undergo either robotic-assisted surgery or conventional laparoscopic surgery and will be monitored throughout the process. This trial is currently recruiting participants, and it aims to provide valuable insights into the best surgical options for this specific group of patients.

Gender

FEMALE

Eligibility 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

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Francesco Fanfani, MD

Principal Investigator

Policlinico Gemelli IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported