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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituto Auxologico Italiano
RECRUITING
Milan
Contact Information
Primary
Luisa Gilardini, MD
l.gilardini@auxologico.it
+390261911
Time Frame
Start Date: 2021-06-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Sleeve gastrectomy group
Subjects with obesity candidates for sleeve gastrectomy
Experimental: OverStitch™ Endoscopic Suturing System group
Subjects candidates for a revision bariatric surgery with Overstitch endoscopic
Related Therapeutic Areas
Sponsors
Leads: Istituto Auxologico Italiano

This content was sourced from clinicaltrials.gov