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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT05974995
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Robot-assisted surgery — PROCEDURE
    Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi
  • Laparoscopic surgery — PROCEDURE
    Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach

Study Details

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.

Key Dates

First listed
Aug 3, 2023
Start date
Sep 1, 2023
Status verified
Oct 2024
Primary completion
Sep 1, 2026
Completion
Sep 1, 2029

Study Design

Enrollment
566 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic surgery
  • Active Comparator: Laparoscopic surgery

Primary Outcome Measure

Conversion rate [ Time Frame: At the end of the enrollment phase ]

Central Contacts

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