Residual Gastric Area and Weight Loss After Sleeve Gastrectomy

Sponsor
University of Foggia (Other)
Overall Status
Completed
CT.gov ID
NCT05151107
Collaborator
(none)
56
2
48
28
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Relationship Between Residual Gastric Area and Weight Loss After Sleeve Gastrectomy: a Cohort Study
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Jul 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Postoperative EWL % correlated with the Residual Stomach Area [2017-2019]

    the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Giovanna Pavone Foggia Italy 71122
2 Nicola Tartaglia Foggia Italy

Sponsors and Collaborators

  • University of Foggia

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Giovanna Pavone, Medical doctor, University of Foggia
ClinicalTrials.gov Identifier:
NCT05151107
Other Study ID Numbers:
  • 1
First Posted:
Dec 9, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2021