B-Clamp: Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Sponsor

University of Rome Tor Vergata (Other)

Overall Status

Completed

CT.gov ID

NCT05557084

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Obesity, Abdominal Surgery	Procedure: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip.

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Mar 31, 2022

Actual Study Completion Date :

Mar 31, 2022

Outcome Measures

Primary Outcome Measures

% Excess Weight Loss [1 year]
Weight loss after laparoscopic vertical clip gastroplasty during the follow-up

Secondary Outcome Measures

Post-operative complications [1 year]
Complications occurred after laparoscopic vertical clip gastroplasty during the follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michela Campanelli	Rome	RM	Italy	00133
2	Department of Bariatric and Metabolic Surgery, San Carlo of Nancy Hospital and University of Rome "Tor Vergata", Rome, Italy	Roma		Italy	00133