- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724513
High Altitude Area- A Risk Factor For Gastric Perforation?
Study Overview
Status
Conditions
Detailed Description
INTRODUCTION : This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest.
DISCUSSION : High altitude associated dyspepsia is a common phenomenon and some studies done in high altitude population have recorded high incidence of antral gastritis and mucosal atrophy on histo-pathological evaluation. This is also supported by high incidence of H.pylori infection. The presence of atrophic gastric mucosa associated with antral gastritis, when exposed to hypobaric hypoxemic conditions faced by soldiers posted to heights above 15000ft , may leads to increased intra-luminal pressure and ischemia which probably predisposes individuals for gastric antrum perforations.
CONCLUSION : This is a relatively untouched topic as we have not found studies on high altitude related gastric perforations and probably this is the first case series of its kind. The acknowledgement of this phenomenon may pave way for further studies for defining the role of high altitude in gastric perforations.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jammu AND Kashmir
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Leh, Jammu AND Kashmir, India, 194401
- 403 Military Field Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals located in High Altitude Area (>10,000ft).
- presented as perforation peritonitis.
- intra-operatively found to be perforated peptic ulcers.
Exclusion Criteria:
- Not located in High Altitude Area.
- intra-operatively perfoarations sites other then stomach and duodenum.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of site of perforated peptic ulcers by intra-operative observation in cases evacuated from High Altitude Area.
Time Frame: 1 year
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Study aims at recording the site of perforated peptic ulcers in cases being evacuated in individuals posted at High Altitude Area.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aditya Pawar, MS, 403 Military Field Hospital
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
Other Study ID Numbers
- 403HAAPPU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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