Laparoscopic Clip-Gastroplasty With The Use Of Bariclip
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- % Excess Weight Loss
Study Overview
Brief Summary
Sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries limitations both short-term including postoperative complications such as hemorrhage and gastric fistula and long-term such as weight regain and gastro-esophageal reflux. A new procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip. Primary outcome were major postoperative complications. Secondary outcomes included weight loss, incidence of de-novo GERD and comorbidity resolution.
Detailed Description
Methods. The investigators performed a review of data from a prospectively collected database. All patients submitted to primary LVCG were examined. Patients were submitted to LVCG Between July 2021 and March 2022. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI > 40 BMI > 35 and comorbidities BMI > 30 with poorly controlled Diabetes mellitus II or hypertension
Exclusion Criteria
- •Alcoholism Drug addiction Psychiatric Disease
Outcomes
Primary Outcomes
% Excess Weight Loss
Time Frame: 1 year
Weight loss after laparoscopic vertical clip gastroplasty during the follow-up
Secondary Outcomes
- Post-operative complications(1 year)
Investigators
Paolo Gentileschi
Head of Department of Bariatric and Metabolic Surgery
University of Rome Tor Vergata