Gastric PerforationNCT03724513
High Altitude Area- A Risk Factor For Gastric Perforation?
An observational study of Gastric Perforation, run by ADITYA PAWAR at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Gastric Perforation
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2018to 10 Oct 2018
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Young soldiers located in High Altitude Area
Who may be able to join
- Individuals located in High Altitude Area (>10,000ft).
- presented as perforation peritonitis.
- intra-operatively found to be perforated peptic ulcers.
Who cannot join
- Not located in High Altitude Area.
- intra-operatively perfoarations sites other then stomach and duodenum.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gastric Perforation
- Keywords
- High Altitude, Gastric Antrum Perforation, Mucosal Atrophy, Intra Luminal Pressure
- Medical subject headings
- Altitude Sickness
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of site of perforated peptic ulcers by intra-operative observation in cases evacuated from High Altitude Area.
Study aims at recording the site of perforated peptic ulcers in cases being evacuated in individuals posted at High Altitude Area.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start15 Sep 2018
- Primary completion30 Sep 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric PerforationStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADITYA PAWAR
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, ADITYA PAWAR, 403 Military Field Hospital, India
- Investigators
- Aditya Pawar, MS, Principal investigator, 403 MILITARY FIELD HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724513
- Sponsor's protocol ID
- 403HAAPPU
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Altitude Area- A Risk Factor For Gastric Perforation?
- ClinicalTrials.gov ID
- NCT03724513
- Acronym / sponsor ID
- 403HAAPPU
- Conditions
- Gastric Perforation
- Keywords
- High Altitude, Gastric Antrum Perforation, Mucosal Atrophy, Intra Luminal Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ADITYA PAWAROther government
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 30 Oct 2018 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young soldiers located in High Altitude Area
Key inclusion criteria (3 listed)
- Individuals located in High Altitude Area (>10,000ft).
- presented as perforation peritonitis.
- intra-operatively found to be perforated peptic ulcers.
Key exclusion criteria (2 listed)
- Not located in High Altitude Area.
- intra-operatively perfoarations sites other then stomach and duodenum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of site of perforated peptic ulcers by intra-operative observation in cases evacuated from High Altitude Area.
Time frame: 1 year
Study aims at recording the site of perforated peptic ulcers in cases being evacuated in individuals posted at High Altitude Area.
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 31 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Aditya Pawar, MS principal investigator
403 MILITARY FIELD HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Perforation, run by ADITYA PAWAR at 1 site in India.
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 3 inclusion and 2 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of site of perforated peptic ulcers by intra-operative observation in cases evacuated from High Altitude Area. (time frame: 1 year). 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 31 Oct 2018.