Obesity, Obesity, Abdominal, Surgery
Conditions
Keywords
Bariclip, B-clamp, GERD, Bariatric Surgery, Obesity Surgery
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.
Interventions
PROCEDURElaparoscopic 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.
Sponsors
University of Rome Tor Vergata
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Excess Weight Loss | 1 year | Weight loss after laparoscopic vertical clip gastroplasty during the follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | 1 year | Complications occurred after laparoscopic vertical clip gastroplasty during the follow-up |
Countries
Italy
Outcome results
None listed