NCT05557084

Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Obesity, Abdominal
• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2022-09-27
• Last updated: 2022-09-27

Locations

2 sites across 1 country: Italy