- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04587310
Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IJS-S-20-02914
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Barrett Esophagus
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University Medical Center GroningenCompletedEsophageal Cancer | Barrett Esophagus | Dysplasia in Barrett EsophagusNetherlands
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Mayo ClinicTerminatedBarretts Esophagus With High Grade Dysplasia | Barrett AdenocarcinomaUnited States
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Portsmouth Hospitals NHS TrustUniversity of PortsmouthUnknownBarrett Esophagus | Barrett Adenocarcinoma | Barrett Metaplasia | Barrett Oesophagitis With DysplasiaUnited Kingdom
-
Professor Michael BourkeWithdrawn
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Medical University of South CarolinaCompletedBarretts Esophagus With DysplasiaUnited States
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Allegheny Singer Research Institute (also known...Integra LifeSciences CorporationTerminatedBarrett Esophagus | High Grade Dysplasia | EsophagusUnited States
Clinical Trials on Laparoscopic Sleeve Gastrectomy
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King Saud UniversityNew You Medical CenterCompleted
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Umraniye Education and Research HospitalCompletedPostoperative Complications | Bleeding | Postoperative Nausea and VomitingTurkey
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Sengkang General HospitalSingapore General HospitalRecruitingObesity | Gastroesophageal Reflux | Bariatric Surgery Candidate | Esophagus InjurySingapore
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University of FoggiaCompletedBleeding | Obesity, Morbid | Bariatric Surgery Candidate | Leak, AnastomoticItaly
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Kahramanmaras Sutcu Imam UniversityElazig Special Eastern Anatolian HospitalCompletedMorbid Obesity | Laparoscopic Sleeve Gastrectomy | Post Operative ComplicaitonTurkey
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Shanghai 10th People's HospitalCompletedPolycystic Ovary Syndrome
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Centre Hospitalier Universitaire, AmiensCompleted
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Centre Hospitalier Universitaire, AmiensCompleted
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Shanghai 10th People's HospitalRecruiting