Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Operative time
Study Overview
Brief Summary
Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.
Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines
Exclusion Criteria
- •Previous bariatric or abdominal surgery
Arms & Interventions
Laparoscopic sleeve gastrectomy
Patients undergoing traditional sleeve gastrectomy
Intervention: Sleeve gastrectomy (Procedure)
Robotic sleeve gastrectomy
Sleeve gastrectomy with DaVinci robot
Intervention: Sleeve gastrectomy (Procedure)
Outcomes
Primary Outcomes
Operative time
Time Frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Operative time in minutes (Docking plus console time for the robotic procedures)
Secondary Outcomes
- Intraoperative bleeding(From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich)
- Postoperative bleeding(From the end of the procedure to postoperative day 30)
- Conversion to Laparoscopy(From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich)
- Conversion to Laparotomy(From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich)
- Postoperative Leak(From the end of the procedure to postoperative day 30)
- Postoperative Bowel Obstruction(From the end of the procedure to postoperative day 30)
- Postoperative nausea(From the end of the procedure to postoperative hour 24)
- Postoperative vomit(From the end of the procedure to postoperative hour 24)
Investigators
Antonio Vitiello
MD PhD Researcher
University of Naples