Bariatric Surgery and Modulation of Perceived Satiety

NCT05777928 | Recruiting

• 1 other identifier: 43C102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity, Morbid

Keywords

obesity, satiety, Sleeve gastrectomy ,OverStitch

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sleeve gastrectomy group

EXPERIMENTAL

Subjects with obesity candidates for sleeve gastrectomy

Procedure: Sleeve gastrectomy

OverStitch™ Endoscopic Suturing System group

EXPERIMENTAL

Subjects candidates for a revision bariatric surgery with Overstitch endoscopic

Procedure: OverStitch™ Endoscopic Suturing System

Interventions

Sleeve gastrectomy PROCEDURE

Sleeve gastrectomy involves vertical resection of a major part of the stomach, and a tubular remnant is retained along the lesser curvature.

Sleeve gastrectomy group

OverStitch™ Endoscopic Suturing System PROCEDURE

Overstitch endoscopic procedure makes a review of gastro-jejunal anastomosis reducing surgical complications

OverStitch™ Endoscopic Suturing System group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simona Bertoli, MD

  Istituto Auxologico Italiano

  STUDY CHAIR

Central Study Contacts

Luisa Gilardini, MD

CONTACT

+390261911; l.gilardini@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 21, 2023
• Study Start: June 3, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

IT (1)