Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Conditions
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Surgery, Obesity, Abdominal, Obesity

Intervention / Treatment
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* Procedure: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip.|The investigator performed laparoscopic vertical clip gastroplasty, This procedure consists of a nonadjustable clip that is vertically placed around the stomach, parallel to the lesser curvature, mimicking the effect of sleeve gastrectomy. The clip restricts oral intake, the anatomy of the stomach is not permanently changed, the small bowel remains untouched, the digestive pathway is not diverted, no stapling or resection are required and the magnitude of restriction is supposed to remain constant during the years. The vertical clip is thus placed without risks of staple line leak, malabsorption side effects, changes in anatomy, and is potentially reversible [9]. creating a 4-cm window to enter the lesser sac while lifting the stomach to create sufficient space to be able to suture. Plication of the antrum for 3-5 cm is performed. Fluid testing for patency is performed with methylene blue or normal saline and the procedure is terminate.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Excess Weight Loss | Weight loss after laparoscopic vertical clip gastroplasty during the follow-up | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Complications occurred after laparoscopic vertical clip gastroplasty during the follow-up | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariclip, B-clamp, GERD, Bariatric Surgery, Obesity Surgery