Barrett EsophagusNCT04587310
Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
An observational study of Barrett Esophagus, run by Eliana Al Haddad.
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… Read more about this study
- Who is it for?
- Ages 24 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Laparoscopic Sleeve Gastrectomy
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2008to 20 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature
Who may be able to join
- patients eligible to sleeve gastrectomy that had an EGD pre and 5 years post-op
Who cannot join
- missing or implausible data, had multiple surgeries, and suffered from the common post-sleeve complications, such as leaks, strictures and hiatal hernias
About this 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
- Conditions
- Barrett Esophagus
- Being tested
- Laparoscopic Sleeve Gastrectomy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyDiagnostic test
bariatric surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Oct 2008
- Primary completion1 Oct 2013
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eliana Al Haddad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eliana Al Haddad, Jaber Al Ahmad Al Sabah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587310
- Sponsor's protocol ID
- IJS-S-20-02914
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04587310
- Acronym / sponsor ID
- IJS-S-20-02914
- Conditions
- Barrett Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Eliana Al HaddadUniversity, hospital or other
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- 1 Oct 2013 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature
Key inclusion criteria (1 listed)
- patients eligible to sleeve gastrectomy that had an EGD pre and 5 years post-op
Key exclusion criteria (1 listed)
- missing or implausible data, had multiple surgeries, and suffered from the common post-sleeve complications, such as leaks, strictures and hiatal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Sleeve Gastrectomybariatric surgery | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus, run by Eliana Al Haddad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopy performed on patients (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.