Status:
RECRUITING
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Endometrial Cancer
Endometrial Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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 confi...
Detailed Description
Background: Endometrial cancer is the fourth cancer in women, the most common gynecologic cancer in high-income countries and the second most common gynecologic cancer worldwide. The high incidence ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT05974995
Start Date
September 1 2023
End Date
September 1 2029
Last Update
October 3 2024
Active Locations (1)
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1
Policlinico Gemelli IRCCS
Rome, Italy, 00167