Abdominal TraumaNCT05538390
Assessment of Pattern of Abdominal Injury
An observational study of Abdominal Trauma, run by St. Paul's Hospital Millennium Medical College, Ethiopia at 1 site in Ethiopia.
Trial summary
This hospital-based cross-sectional study was done at SPHMMC and AaBET hospitals from January 2018 to December 2019.The study aimed to assess the pattern of abdominal injury at St Paul's Hospital Millennium Medical College (SPHMMC) and Addis Ababa Burn, Emergency and Trauma (AaBET) hospital, Addis Ababa Ethiopia.Data… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Trauma
- How many people
- 165 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Sep 2019to 10 Jun 2020
- How long will I take part?
- 2 Years
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients who presented to the AaBET and SPHMMC Hospital emergency department with a clinical diagnosis of abdominal trauma during the study period.
Who may be able to join
- All patients who are diagnosed clinically to have abdominal trauma
Who cannot join
- Patients who died before diagnosis
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
St Paul's Hospital Millennium Medical College
Addis Ababa, 1000
About this study
Official title: Assesment of Pattern of Abdominal Injury Over a Two Year Period at St Paul's Hospital Millennium Medical College and AaBET Hospital, Addis Ababa, Ethiopia: A Retrospective Study
This hospital-based cross-sectional study was done at SPHMMC and AaBET hospitals from January 2018 to December 2019.The study aimed to assess the pattern of abdominal injury at St Paul's Hospital Millennium Medical College (SPHMMC) and Addis Ababa Burn, Emergency and Trauma (AaBET) hospital, Addis Ababa Ethiopia.Data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors.The collected data was entered and analyzed using statistical software SPSS version 25.0.
Read the detailed description
Data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors. The questionnaire was categorized into socio-demographics (age, sex, residency, and address), clinical profile (triage, v/s, type of injury, associated injury), management, and outcome (management, complication, disposition, and mortality). Completeness of data was checked by the principal investigator.
- Conditions
- Abdominal Trauma
- Keywords
- Abdominal Injury, Road traffic injury, Emergency department
- Medical subject headings
- Abdominal Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of Abdominal Injury
Frequency was analyzed in respective to socio-demographics (age, sex, residency, address), clinical profile(triage, v/s, type of injury, associated injury), management and outcome (management, complication, disposition and mortality) in patients presented with Abdominal injury in the study period.
Measured: Over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Sep 2019
- Primary completion30 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abdominal TraumaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital Millennium Medical College, Ethiopia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kassaye D Altaye, Principal investigator, University of Gondar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538390
- Sponsor's protocol ID
- StPaulsHMMc
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data used to support the findings of this study are available from the Principal investigator upon request.
Publications
Alastair, C.J., Pierre, J.G. Abdominal trauma. In: John M, Graeme D, Kevin OM, editors. Surgical Emergencies, 1st edition. Italy: Blackwell Science Ltd. 1999. 224-236
Adesanya AA, Afolabi IR, da Rocha-Afodu JT. Civilian abdominal gunshot wounds in Lagos. J R Coll Surg Edinb. 1998 Aug;43(4):230-4.
PubMed 9735644Long MK, Vohra MK, Bonnette A, Parra PDV, Miller SK, Ayub E, Wang HE, Cardenas-Turanzas M, Gordon R, Ugalde IT, Allukian M, Smith HE. Focused assessment with sonography for trauma in predicting early surgical intervention in hemodynamically unstable children with blunt abdominal trauma. J Am Coll Emerg Physicians Open. 2022 Jan 27;3(1):e12650. doi: 10.1002/emp2.12650. eCollection 2022 Feb.
PubMed 35128532Abebe K, Bekele M, Tsehaye A, Lemmu B, Abebe E. Laparotomy for Abdominal Injury Indication & Outcome of patients at a Teaching Hospital in Addis Ababa, Ethiopia. Ethiop J Health Sci. 2019 Jul;29(4):503-512. doi: 10.4314/ejhs.v29i4.12.
PubMed 31447524Chalya PL, Mabula JB. Abdominal trauma experience over a two-year period at a tertiary hospital in north-western Tanzania: a prospective review of 396 cases. Tanzan J Health Res. 2013 Oct;15(4):230-9.
PubMed 26591698AdejumoAA,ThairuY,EgentiN.Profile of abdominal trauma in federal teaching hospital, Gombe, North-east, Nigeria: A cross sectional study. Int J Innov Med Health Sci 2015; 4: 41-5
Bashah DT, Dachew BA, Tiruneh BT. Prevalence of injury and associated factors among patients visiting the Emergency Departments of Amhara Regional State Referral Hospitals, Ethiopia: a cross-sectional study. BMC Emerg Med. 2015 Aug 25;15:20. doi: 10.1186/s12873-015-0044-3.
PubMed 26302780
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Pattern of Abdominal Injury Over a Two Year Period at St Paul's Hospital Millennium Medical College and AaBET Hospital, Addis Ababa, Ethiopia: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05538390
- Acronym / sponsor ID
- StPaulsHMMc
- Conditions
- Abdominal Trauma
- Keywords
- Abdominal Injury, Road traffic injury, Emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- St. Paul's Hospital Millennium Medical College, EthiopiaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 13 Sep 2022 (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 hospital-based cross-sectional study was done at SPHMMC and AaBET hospitals from January 2018 to December 2019.The study aimed to assess the pattern of abdominal injury at St Paul's Hospital Millennium Medical College (SPHMMC) and Addis Ababa Burn, Emergency and Trauma (AaBET) hospital, Addis Ababa Ethiopia.Data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors.The collected data was entered and analyzed using statistical software SPSS version 25.0.
Detailed description
Data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors. The questionnaire was categorized into socio-demographics (age, sex, residency, and address), clinical profile (triage, v/s, type of injury, associated injury), management, and outcome (management, complication, disposition, and mortality). Completeness of data was checked by the principal investigator.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients who presented to the AaBET and SPHMMC Hospital emergency department with a clinical diagnosis of abdominal trauma during the study period.
Key inclusion criteria (1 listed)
- All patients who are diagnosed clinically to have abdominal trauma
Key exclusion criteria (1 listed)
- Patients who died before diagnosis
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 |
|---|---|---|
| Other | – |
Primary outcome
Pattern of Abdominal Injury
Time frame: Over 2 years
Frequency was analyzed in respective to socio-demographics (age, sex, residency, address), clinical profile(triage, v/s, type of injury, associated injury), management and outcome (management, complication, disposition and mortality) in patients presented with Abdominal injury in the study period.
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 13 Sep 2022.
- Results publicationAlastair, C.J., Pierre, J.G. Abdominal trauma. In: John M, Graeme D, Kevin OM, editors. Surgical Emergencies, 1st edition. Italy: Blackwell Science Ltd. 1999. 224-236
- Results publication: PubMed 9735644Adesanya AA, Afolabi IR, da Rocha-Afodu JT. Civilian abdominal gunshot wounds in Lagos. J R Coll Surg Edinb. 1998 Aug;43(4):230-4.
- Results publication: PubMed 35128532Long MK, Vohra MK, Bonnette A, Parra PDV, Miller SK, Ayub E, Wang HE, Cardenas-Turanzas M, Gordon R, Ugalde IT, Allukian M, Smith HE. Focused assessment with sonography for trauma in predicting early surgical intervention in hemodynamically unstable children with blunt abdominal trauma. J Am Coll Emerg Physicians Open. 2022 Jan 27;3(1):e12650. doi: 10.1002/emp2.12650. eCollection 2022 Feb.
- Results publication: PubMed 31447524Abebe K, Bekele M, Tsehaye A, Lemmu B, Abebe E. Laparotomy for Abdominal Injury Indication & Outcome of patients at a Teaching Hospital in Addis Ababa, Ethiopia. Ethiop J Health Sci. 2019 Jul;29(4):503-512. doi: 10.4314/ejhs.v29i4.12.
- Results publication: PubMed 26591698Chalya PL, Mabula JB. Abdominal trauma experience over a two-year period at a tertiary hospital in north-western Tanzania: a prospective review of 396 cases. Tanzan J Health Res. 2013 Oct;15(4):230-9.
- Results publicationAdejumoAA,ThairuY,EgentiN.Profile of abdominal trauma in federal teaching hospital, Gombe, North-east, Nigeria: A cross sectional study. Int J Innov Med Health Sci 2015; 4: 41-5
- Results publication: PubMed 26302780Bashah DT, Dachew BA, Tiruneh BT. Prevalence of injury and associated factors among patients visiting the Emergency Departments of Amhara Regional State Referral Hospitals, Ethiopia: a cross-sectional study. BMC Emerg Med. 2015 Aug 25;15:20. doi: 10.1186/s12873-015-0044-3.
- Individual participant dataSharing planned: No. The data used to support the findings of this study are available from the Principal investigator upon request.
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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.
Kassaye D Altaye principal investigator
University of Gondar
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 Abdominal Trauma, run by St. Paul's Hospital Millennium Medical College, Ethiopia at 1 site in Ethiopia.
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 13 Sep 2022. 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 Ethiopia. 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?
Pattern of Abdominal Injury (time frame: Over 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538390, which also lists 7 linked publications.
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 13 Sep 2022.