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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03490305
Other study ID # ExlapErbil
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2017
Est. completion date October 10, 2018

Study information

Verified date October 2018
Source Vrinnevi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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. 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 studied.


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date October 10, 2018
Est. primary completion date October 9, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Procedure:
Exploratory laparotomy
Findings and procedures done at exploratory laparotomy

Locations

Country Name City State
Iraq Emergency Hospital Erbil Kurdistan

Sponsors (4)

Lead Sponsor Collaborator
Vrinnevi Hospital Center for Disaster Medicine and Traumatology, Linköping University, Emergency Hospital, Erbil, Iraq, Karolinska Institutet

Country where clinical trial is conducted

Iraq, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants. an average of 3 weeks
Secondary Differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment. an average of 3 weeks
Secondary 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. an average of 3 weeks
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