NCT05777928Recruiting
Bariatric Surgery and Modulation of Perceived Satiety
Sleeve Gastrectomy and OverStitch™ Endoscopic Suturing System in the Modulation of Perceived Satiety
Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Mar 2023
- Start date
- 3 Jun 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Istituto Auxologico Italiano
- Diseases
- Obesity
- NCT number
- NCT05777928
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 3 Jun 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- none
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.