Residual Gastric Area and Weight Loss After Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

Official title:

Relationship Between Residual Gastric Area and Weight Loss After Sleeve Gastrectomy: a Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05151107
• Other study ID #: 1
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2021
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients of both genders with morbid obesity defined as BMI>40 kg/m2

• Adult patients of both genders with morbid obesity defined as BMI>35 kg/m2 with at least one associated major comorbidity

Exclusion Criteria:

• Patients with secondary obesity due to endocrine and psychologic disorders

• Patients whit previous bariatric procedures

• Patients unwilling to comply with postoperative diet regimen and exercise program.

Related Conditions & MeSH terms

• Obesity, Morbid
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Italy	Giovanna Pavone	Foggia
Italy	Nicola Tartaglia	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative EWL % correlated with the Residual Stomach Area	the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss	2017-2019