Actively Recruiting
Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.
Led by University of Naples · Updated on 2025-04-03
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing robotic and laparoscopic sleeve gastrectomy approaches for patients with obesity to understand their outcomes. Sleeve gastrectomy is a common bariatric surgery, and while robotic surgery offers more precision, it may take longer to perform. The study aims to evaluate these two surgical methods through a prospective, randomized design. Participants will be randomly assigned to undergo either traditional laparoscopic sleeve gastrectomy or sleeve gastrectomy using the DaVinci robotic system. Both procedures involve removing a portion of the stomach but differ in the surgical technique used. The study will focus on operative time and other measures related to surgery and recovery. During the study, researchers will record the total operative time from the start of surgery to the final skin stitch. They will also monitor bleeding during and after surgery, any need to switch to other surgical methods, and postoperative complications such as leaks, bowel obstruction, nausea, and vomiting. Participants will be followed closely up to 30 days after surgery to assess these outcomes.
CONDITIONS
Brief Title
Robotic Versus Laparoscopic Sleeve Gastrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the International Federation for the Surgery of Obesity (IFSO) and American Society for Metabolic and Bariatric Surgery (ASMBS) 2023 guidelines for bariatric surgery
You will not qualify if you...
- Previous bariatric surgery
- Previous abdominal surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours post-surgery
Participants undergo sleeve gastrectomy using either a laparoscopic or robotic approach, followed by immediate post-operative care.
1 surgical visit and in-hospital monitoring
Duration - Up to 30 days post-surgery
Participants are monitored for recovery and any complications such as bleeding, leaks, bowel obstruction, nausea, and vomiting.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
University of Naples Federico II
Naples, Italy, Italy, 80131
Actively Recruiting
Research Team
A
Antonio Vitiello, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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