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NCT04587310 Clinical Trial

Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study

Barrett Esophagus Clinical Trial

Official title:
Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04587310
Other study ID # IJS-S-20-02914
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2008
Est. completion date September 20, 2020

Study information
Verified date October 2020
Source Jaber Al Ahmad Al Sabah Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction Laparoscopic Sleeve Gastrectomy (LSG) is one of the most prevalent approaches to tackle obesity and its co-morbidities. The main complication following the LSG is Gastro-esophageal reflux disease (GERD), with most patients developing worsening symptoms of GERD, and a small number progressing to Barrett's esophagus. This retrospective analysis aims to assess the rate of GERD pre- and post- LSG as well as the rate of progression to Barrett's.

Methods Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date September 20, 2020
Est. primary completion date October 1, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 36 Years
Eligibility Inclusion Criteria:

- patients eligible to sleeve gastrectomy that had an EGD pre and 5 years post-op

Exclusion Criteria:

- missing or implausible data, had multiple surgeries, and suffered from the common post-sleeve complications, such as leaks, strictures and hiatal hernias

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Laparoscopic Sleeve Gastrectomy
bariatric surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eliana Al Haddad

Outcome
Type Measure Description Time frame Safety issue
Primary endoscopy performed on patients endoscopy will be performed on patients 5 years after undergoing sleeve gastrectomy due to the fact that sleeve tends to lead to reflux which causes dysplasia of esophageal cells, which eventually can lead to barrett's esophagus and cancer. 5 years
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