NCT05151107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

3.4 years

First QC Date

November 15, 2021

Last Update Submit

November 25, 2021

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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).DIAGNOSTIC_TEST

Upper gastrointestinal radiographie

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Giovanna Pavone

Foggia, 71122, Italy

Location

Nicola Tartaglia

Foggia, Italy

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 9, 2021

Study Start

July 1, 2017

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations

IT(2)