NCT04587310

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

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

October 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

5 years

First QC Date

October 2, 2020

Last Update Submit

October 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

bariatric surgery

Eligibility Criteria

Age24 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
post-doc research fellow

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 14, 2020

Study Start

October 1, 2008

Primary Completion

October 1, 2013

Study Completion

September 20, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10