Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Obesity Clinical Trial

— B-Clamp  

Official title:

Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05557084
• Other study ID #: UNRome1
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2022
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Bariatric and Metabolic Surgery, San Carlo of Nancy Hospital and University of Rome "Tor Vergata", Rome, Italy	Roma
Italy	Michela Campanelli	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Noel P, Eddbali I, Nedelcu M. Laparoscopic Clip Gastroplasty with the BariClip. Obes Surg. 2020 Dec;30(12):5182-5183. doi: 10.1007/s11695-020-04803-x. — View Citation

Noel P, Nedelcu AM, Eddbali I, Zundel N. Laparoscopic vertical clip gastroplasty - quality of life. Surg Obes Relat Dis. 2018 Oct;14(10):1587-1593. doi: 10.1016/j.soard.2018.07.013. Epub 2018 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Excess Weight Loss	Weight loss after laparoscopic vertical clip gastroplasty during the follow-up	1 year
Secondary	Post-operative complications	Complications occurred after laparoscopic vertical clip gastroplasty during the follow-up	1 year