Trials / Completed
CompletedNCT05151107
Residual Gastric Area and Weight Loss After Sleeve Gastrectomy
Relationship Between Residual Gastric Area and Weight Loss After Sleeve Gastrectomy: a Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (actual)
- Sponsor
- University of Foggia · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
BACKGROUND: The aim of this study is to evaluate the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss after LSG. MATERIALS AND METHODS: From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy. UGI tract radiography was performed on day two after the operation to rule out leakage.
Detailed description
Study design and setting From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy. UGI tract radiography with water-soluble contrast medium was performed on the second day after the operation to rule out leakage. The radiographic images were collected through a software program called "PACS" which combined with a viewer for image processing, allows for the calculation of the residual stomach area (RSA). RSA was correlated with postoperative weight (EWL) at 1, 6, and 12 months. Eligibility criteria Adult patients of both genders with morbid obesity defined as BMI\>40 kg/m2 or BMI\>35 kg/m2 with at least one associated major comorbidity were included. We excluded patients with secondary obesity due to endocrine and psychological disorders, patients with previous bariatric procedures and patients unwilling to comply with postoperative diet and exercise program. Statistical analysis Continuous data were expressed as mean and standard deviation (SD) and they were analyzed using Student's T test. The correlation between gastric volume before and after LSG and BMI and weight loss was measured using Pearson correlation coefficient test. Correlation coefficients were classified as strong (-1.0 to -0.5 or 0.5 to 1.0), moderate (-0.5 to -0.3 or 0.3 to 0.5), and weak (-0.3 to -0.1 or 0.1 to 0.3). P\<0.05 was considered statistically significant. This work is fully compliant with the STROCSS criteria
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | The radiographic images were collected through a software called "PACS" which combined with a viewer for image processing, that allows the calculation of the residual stomach area (RSA). | Upper gastrointestinal radiographie |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2020-12-01
- Completion
- 2021-07-01
- First posted
- 2021-12-09
- Last updated
- 2021-12-09
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT05151107. Inclusion in this directory is not an endorsement.