- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03490305
Penetrating Abdominal Injuries From the Battle of Mosul (Exlap)
Exploratory Laparotomy Following Penetrating Abdominal Injuries From the Battle of Mosul: a Cohort Study From a Referral Hospital in Erbil, Kurdistan Region in Iraq
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Rationale The battle of Mosul was characterized by the use of improvised explosive devices, human shields and suicide bombers in an urban setting. It is unclear whether this type of warfare cause more extensive abdominal injuries to civilians than combatants. Understanding of the correlation between the severity of abdominal injuries, type of warfare and population affected is of importance when planning for surgical care in a conflict setting.
Aim To assess whether civilians obtain more extensive abdominal injuries than combatants in an urban battle characterized by the use of indiscriminate weapons.
Study Design An observational retrospective cohort study with longitudinal data collection.
All patients admitted with penetrating abdominal injury subjected to an exploratory laparotomy at Emergency Hospital, Erbil, between October 17, 2016 and July 16, 2017 will be included. Differences in demographics, injury mechanism, time since injury, clinical status on arrival, intraoperative findings, postoperative complications and outcome will be analysed.
Primary Objective Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.
Secondary Objectives Differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment.
Differences in surgical treatment given, postoperative complications and outcome between patients who receive surgical treatment less than 24 hours from injury and patients who receive surgical treatment more than 24 hours from injury will be analysed.
Statistical methods Differences between groups will be analysed using t-test and regression models.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kurdistan
-
Erbil, Kurdistan, Iraq
- Emergency Hospital
-
-
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 (all must be fulfilled):
- Penetrating abdominal injury
- Subjected to an exploratory laparotomy at Emergency Hospital, Erbil, Iraq
- Between October 17, 2016 and July 16, 2017
Exclusion Criteria (all must be fulfilled):
- Patients who received treatment several times will only be counted as one patient
- Between October 17, 2016 and July 16, 2017
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Combatants
Men 16-50 years old or combatants by own admission.
|
Findings and procedures done at exploratory laparotomy
|
Civilians
Children <16 years, all women and men ≥50 years.
|
Findings and procedures done at exploratory laparotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.
Time Frame: an average of 3 weeks
|
an average of 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment.
Time Frame: an average of 3 weeks
|
an average of 3 weeks
|
Differences in surgical treatment given, postoperative complications and outcome between patients who receive surgical treatment less than 24 hours from injury and patients who receive surgical treatment more than 24 hours from injury will be analysed.
Time Frame: an average of 3 weeks
|
an average of 3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan von Schreeb, MD, PhD, Karolinska Institutet
Publications and helpful links
General Publications
- Nassoura Z, Hajj H, Dajani O, Jabbour N, Ismail M, Tarazi T, Khoury G, Najjar F. Trauma management in a war zone: the Lebanese war experience. J Trauma. 1991 Dec;31(12):1596-9. doi: 10.1097/00005373-199112000-00005.
- Coupland RM, Samnegaard HO. Effect of type and transfer of conventional weapons on civilian injuries: retrospective analysis of prospective data from Red Cross hospitals. BMJ. 1999 Aug 14;319(7207):410-2. doi: 10.1136/bmj.319.7207.410.
- Sikic N, Korac Z, Krajacic I, Zunic J. War abdominal trauma: usefulness of Penetrating Abdominal Trauma Index, Injury Severity Score, and number of injured abdominal organs as predictive factors. Mil Med. 2001 Mar;166(3):226-30.
- Cairns BA, Oller DW, Meyer AA, Napolitano LM, Rutledge R, Baker CC. Management and outcome of abdominal shotgun wounds. Trauma score and the role of exploratory laparotomy. Ann Surg. 1995 Mar;221(3):272-7. doi: 10.1097/00000658-199503000-00009.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ExlapErbil
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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