Residual Gastric Area and Weight Loss After Sleeve Gastrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: 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).

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

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Italy
  • Foggia, Italy
    • Nicola Tartaglia
  • Foggia, Italy, 71122
    • Giovanna Pavone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

56 patients underwent sleeve gastrectomy with a mean age of 43,5± 11 years of which 40 were female.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Foggia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No