Penetrating Abdominal TraumaExlapNCT03490305
Penetrating Abdominal Injuries From the Battle of Mosul
An observational study of Penetrating Abdominal Trauma and War Injury, run by Vrinnevi Hospital at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Penetrating Abdominal Trauma, War Injury
- What is being tested?
- Exploratory laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteIraq
- Study dates
- 11 Nov 2017to 10 Oct 2018
- How long will I take part?
- 4 Weeks
- 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: 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.
Who may be able to join
- Penetrating abdominal injury
- Subjected to an exploratory laparotomy at Emergency Hospital, Erbil, Iraq
- Between October 17, 2016 and July 16, 2017
Who cannot join
- Patients who received treatment several times will only be counted as one patient
- Between October 17, 2016 and July 16, 2017
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Penetrating Abdominal Trauma, War Injury
- Being tested
- Exploratory laparotomy
- Keywords
- War injury, Penetrating abdominal trauma, Exploratory laparotomy, Improvised explosive device, Mosul
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploratory laparotomyProcedure or surgery
Findings and procedures done at exploratory laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Combatants | Men 16-50 years old or combatants by own admission. Receives: Procedure: Exploratory laparotomy | |
| Civilians | Children <16 years, all women and men ≥50 years. Receives: Procedure: Exploratory laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.
Measured: an average of 3 weeks
Secondary outcomes (2)
Differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment.
Measured: 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.
Measured: an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start11 Nov 2017
- Primary completion9 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Penetrating 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Vrinnevi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Hospital, Erbil, Iraq, Karolinska Institutet, Center for Disaster Medicine and Traumatology, Linköping University
- Responsible party
- Principal investigator, Måns Muhrbeck, Vrinnevi Hospital
- Investigators
- Johan von Schreeb, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490305
- Sponsor's protocol ID
- ExlapErbil
- Acronym
- Exlap
- Status last verified
- Oct 2018
- First submitted
- 22 Mar 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 1749028Coupland 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.
PubMed 10445921Sikic 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.
PubMed 11263024Cairns 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.
PubMed 7717780Muhrbeck M, Egelko A, Haweizy RM, von Schreeb J, Alga A. Exploratory laparotomy during the battle of Mosul, 2016-2017: results from a tertiary civilian hospital in Erbil, Iraqi Kurdistan. BMC Emerg Med. 2023 Sep 23;23(1):113. doi: 10.1186/s12873-023-00882-y.
PubMed 37741988
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03490305
- Acronym / sponsor ID
- Exlap / ExlapErbil
- Conditions
- Penetrating Abdominal Trauma, War Injury
- Keywords
- War injury, Penetrating abdominal trauma, Exploratory laparotomy, Improvised explosive device, Mosul
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Vrinnevi HospitalUniversity, hospital or other
- Collaborators
- Emergency Hospital, Erbil, Iraq, Karolinska Institutet, Center for Disaster Medicine and Traumatology, Linköping University
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 6 Apr 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combatants | – | Procedure: Exploratory laparotomyMen 16-50 years old or combatants by own admission. |
| Civilians | – | Procedure: Exploratory laparotomyChildren <16 years, all women and men ≥50 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Penetrating abdominal injury
- Subjected to an exploratory laparotomy at Emergency Hospital, Erbil, Iraq
- Between October 17, 2016 and July 16, 2017
Key exclusion criteria (2 listed)
- Patients who received treatment several times will only be counted as one patient
- Between October 17, 2016 and July 16, 2017
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 |
|---|---|---|
| Exploratory laparotomyFindings and procedures done at exploratory laparotomy | Procedure or surgery | Civilians, Combatants |
Primary outcome
Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.
Time frame: an average of 3 weeks
2 secondary outcomes
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
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
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 16 Oct 2018.
- Background: PubMed 1749028Nassoura 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.
- Background: PubMed 10445921Coupland 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.
- Background: PubMed 11263024Sikic 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.
- Background: PubMed 7717780Cairns 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.
- Derived from this study: PubMed 37741988Muhrbeck M, Egelko A, Haweizy RM, von Schreeb J, Alga A. Exploratory laparotomy during the battle of Mosul, 2016-2017: results from a tertiary civilian hospital in Erbil, Iraqi Kurdistan. BMC Emerg Med. 2023 Sep 23;23(1):113. doi: 10.1186/s12873-023-00882-y.
- Individual participant dataSharing planned: Undecided
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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.
Johan von Schreeb, MD, PhD principal investigator
Karolinska Institutet
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 Penetrating Abdominal Trauma and War Injury, run by Vrinnevi Hospital at 1 site in Iraq.
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 3 inclusion and 2 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 16 Oct 2018. 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 Iraq. 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?
Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants. (time frame: an average of 3 weeks). 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 NCT03490305, which also lists 5 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 16 Oct 2018.