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Bariatric Surgery and Modulation of Perceived Satiety (BAR_SAZ)

Primary Purpose

Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sleeve gastrectomy
OverStitch™ Endoscopic Suturing System
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring obesity, satiety, Sleeve gastrectomy ,OverStitch

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: subjects who are eligible for sleeve gastrectomy according to the SICOB criteria subjects, previously undergoing Sleeve Gastrectomy or gastric bypass, who, for weight regain, have been scheduled for revision surgery with the OverStitch™ Endoscopic Suturing System Exclusion Criteria: none

Sites / Locations

  • Istituto Auxologico ItalianoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleeve gastrectomy group

OverStitch™ Endoscopic Suturing System group

Arm Description

Subjects with obesity candidates for sleeve gastrectomy

Subjects candidates for a revision bariatric surgery with Overstitch endoscopic

Outcomes

Primary Outcome Measures

Change in satiety evaluated by water load test
Change in volume of water ingested during water load test

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05777928
Brief Title
Bariatric Surgery and Modulation of Perceived Satiety
Acronym
BAR_SAZ
Official Title
Sleeve Gastrectomy and OverStitch™ Endoscopic Suturing System in the Modulation of Perceived Satiety
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Bariatric surgery is the ideal therapeutic strategy for patients with severe obesity when lifestyle interventions have failed. Unfortunately, weight recovery after surgery affects one third of patients and is due to several factors, such as recovery of incorrect eating behaviour, reduction of physical activity or hormonal factors. Dilation of gastro-jejunal anastomosis is one of the main causes as it determines reduction of satiety in the patient and consequent increase of the portions of food consumed. In these cases it is necessary to make a review of gastro-jejunal anastomosis and to reduce surgical complications in recent years has been developed a method that allows the execution of sutures through a totally endoscopic way (OverStitch™ Endoscopic Suturing System). Literature studies to assess hunger-satiety in patients undergoing bariatric surgery, suggest that surgery results in weight loss due to a series of changes in gastrointestinal physiology which impact on the feeling of hunger-satiety, and on the modification of the secretion of hormones involved in the regulation of gastric emptying such as the reduction of ghrelin secretion and the increase in postprandial cholecystokinin and GLP-1. There are no data in the literature on satiety in patients in previous bariatric surgery with weight recovery secondary to dilation of the gastro-jejunal anastomosis. There are various methods to assess satiety, most of which are invasive and difficult to perform in routine clinical settings. A recently proposed method to evaluate the perception of satiety and validated on healthy adults, is the Water Load Tests (WLTs). The test consists in making the subject drink a quantity of water until he feels "pleasantly" full. The volume of water ingested is a valid indicator of the subjective feeling of satiety. The aim of yhe study is to assess perceived satiety (measured by Water Load Test) after intervention of Sleeve Gastrectomy or a revision surgery with OverStitch™ Endoscopic Suturing System in obese individuals suitable for bariatric surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
obesity, satiety, Sleeve gastrectomy ,OverStitch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleeve gastrectomy group
Arm Type
Experimental
Arm Description
Subjects with obesity candidates for sleeve gastrectomy
Arm Title
OverStitch™ Endoscopic Suturing System group
Arm Type
Experimental
Arm Description
Subjects candidates for a revision bariatric surgery with Overstitch endoscopic
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
Sleeve gastrectomy involves vertical resection of a major part of the stomach, and a tubular remnant is retained along the lesser curvature.
Intervention Type
Procedure
Intervention Name(s)
OverStitch™ Endoscopic Suturing System
Intervention Description
Overstitch endoscopic procedure makes a review of gastro-jejunal anastomosis reducing surgical complications
Primary Outcome Measure Information:
Title
Change in satiety evaluated by water load test
Description
Change in volume of water ingested during water load test
Time Frame
At baseline and 6 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects who are eligible for sleeve gastrectomy according to the SICOB criteria subjects, previously undergoing Sleeve Gastrectomy or gastric bypass, who, for weight regain, have been scheduled for revision surgery with the OverStitch™ Endoscopic Suturing System Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luisa Gilardini, MD
Phone
+390261911
Ext
2561
Email
l.gilardini@auxologico.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Bertoli, MD
Organizational Affiliation
Istituto Auxologico Italiano
Official's Role
Study Chair
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Milano
ZIP/Postal Code
20145
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa Gilardini, MD
Phone
+390261911
Ext
2561
Email
l.gilardini@auxologico.it

12. IPD Sharing Statement

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Bariatric Surgery and Modulation of Perceived Satiety

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