Bariatric Surgery and Modulation of Perceived Satiety

Obesity, Morbid Clinical Trial

— BAR_SAZ  

Official title:

Sleeve Gastrectomy and OverStitch™ Endoscopic Suturing System in the Modulation of Perceived Satiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777928
• Other study ID #: 43C102
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Luisa Gilardini, MD
• Phone: +390261911
• Email: l.gilardini[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• Sleeve gastrectomy
Sleeve gastrectomy involves vertical resection of a major part of the stomach, and a tubular remnant is retained along the lesser curvature.
• OverStitch™ Endoscopic Suturing System
Overstitch endoscopic procedure makes a review of gastro-jejunal anastomosis reducing surgical complications

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in satiety evaluated by water load test	Change in volume of water ingested during water load test	At baseline and 6 months after the surgery