NCT03724513

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 15, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

15 days

First QC Date

October 26, 2018

Last Update Submit

October 30, 2018

Conditions

Gastric Perforation

Keywords

High AltitudeGastric Antrum PerforationMucosal AtrophyIntra Luminal Pressure

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Young soldiers located in High Altitude Area

You may qualify if:

  • Individuals located in High Altitude Area (\>10,000ft).
  • presented as perforation peritonitis.
  • intra-operatively found to be perforated peptic ulcers.

You may not qualify if:

  • Not located in High Altitude Area.
  • intra-operatively perfoarations sites other then stomach and duodenum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

403 Military Field Hospital

Leh, Jammu and Kashmir, 194401, India

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Aditya Pawar, MS

    403 MILITARY FIELD HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2018

First Posted

October 30, 2018

Study Start

September 15, 2018

Primary Completion

September 30, 2018

Study Completion

October 10, 2018

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)