Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Completed

• Conditions: Obesity; Obesity, Abdominal; Surgery

• Registration Number: NCT05557084
• Lead Sponsor: University of Rome Tor Vergata

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 Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-18
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% Excess Weight Loss	1 year	Weight loss after laparoscopic vertical clip gastroplasty during the follow-up

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	1 year	Complications occurred after laparoscopic vertical clip gastroplasty during the follow-up

Trial Locations

Locations (2)

Michela Campanelli; 🇮🇹 Rome, RM, Italy

Department of Bariatric and Metabolic Surgery, San Carlo of Nancy Hospital and University of Rome "Tor Vergata", Rome, Italy; 🇮🇹 Roma, Italy