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
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Policlinico Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Francesco Fanfani, MD
francesco.fanfani@policlinicogemelli.it
0630153421
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 566
Treatments
Experimental: Robotic surgery
Active_comparator: Laparoscopic surgery
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS