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Trial record 2 of 33 for:    eliana

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

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ClinicalTrials.gov Identifier: NCT04587310
Recruitment Status : Completed
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Eliana Al Haddad, Jaber Al Ahmad Al Sabah Hospital

Tracking Information
First Submitted Date October 2, 2020
First Posted Date October 14, 2020
Last Update Posted Date October 14, 2020
Actual Study Start Date October 1, 2008
Actual Primary Completion Date October 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 13, 2020)
endoscopy performed on patients [ Time Frame: 5 years ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Official Title Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Brief 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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature
Condition Barrett Esophagus
Intervention Diagnostic Test: Laparoscopic Sleeve Gastrectomy
bariatric surgery
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2020)
92
Original Actual Enrollment Same as current
Actual Study Completion Date September 20, 2020
Actual Primary Completion Date October 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Years to 36 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04587310
Other Study ID Numbers IJS-S-20-02914
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Eliana Al Haddad, Jaber Al Ahmad Al Sabah Hospital
Study Sponsor Eliana Al Haddad
Collaborators Not Provided
Investigators Not Provided
PRS Account Jaber Al Ahmad Al Sabah Hospital
Verification Date October 2020