Clinical trial NCT03490305: Penetrating Abdominal Injuries From the Battle of Mosul
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penetrating Abdominal Trauma
War Injury
Keywords: War injury
Penetrating abdominal trauma
Exploratory laparotomy
Improvised explosive device
Mosul
Lead sponsor: Vrinnevi Hospital
Sponsor class: OTHER
Collaborators: name: Emergency Hospital, Erbil, Iraq
name: Karolinska Institutet
name: Center for Disaster Medicine and Traumatology, Linköping University
First posted: 2018-04-06
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.
timeFrame: an average of 3 weeks
Secondary outcomes:
measure: Differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment.
timeFrame: an average of 3 weeks
measure: 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.
timeFrame: an average of 3 weeks
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Emergency Hospital
state: Kurdistan
Study officials:
affiliation: Karolinska Institutet
name: Johan von Schreeb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00005373-199112000-00005.
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. doi: 10.1136/bmj.319.7207.410.
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.
citation: 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.