Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

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.

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Key information

Conditions

Obesity Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michela Campanelli, Rome, RM, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic vertical clip gastroplasty (LVCG) with Bariclip.

Procedure

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.

Other names: Bariclip

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

Time frame: 1 year

Complications occurred after laparoscopic vertical clip gastroplasty during the follow-up

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Acronym: B-Clamp

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 27, 2022
Registry last updated: Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed