NCT03490305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

March 22, 2018

Last Update Submit

October 15, 2018

Conditions

Penetrating Abdominal TraumaWar Injury

Keywords

War injuryPenetrating abdominal traumaExploratory laparotomyImprovised explosive deviceMosul

Outcome Measures

Primary Outcomes (1)

  • Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.

    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.

    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.

    an average of 3 weeks

Study Arms (2)

Combatants

Men 16-50 years old or combatants by own admission.

Procedure: Exploratory laparotomy

Civilians

Children \<16 years, all women and men ≥50 years.

Procedure: Exploratory laparotomy

Interventions

Exploratory laparotomyPROCEDURE

Findings and procedures done at exploratory laparotomy

CiviliansCombatants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Penetrating abdominal injury
  • Subjected to an exploratory laparotomy at Emergency Hospital, Erbil, Iraq
  • Between October 17, 2016 and July 16, 2017

You may not qualify if:

  • Patients who received treatment several times will only be counted as one patient
  • Between October 17, 2016 and July 16, 2017

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Hospital

Erbil, Kurdistan, Iraq

Location

Related Publications (5)

  • 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.

    PMID: 1749028BACKGROUND

  • 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.

    PMID: 10445921BACKGROUND

  • 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.

    PMID: 11263024BACKGROUND

  • 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.

    PMID: 7717780BACKGROUND

  • Muhrbeck 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.

    PMID: 37741988DERIVED

MeSH Terms

Interventions

Laparotomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Johan von Schreeb, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 6, 2018

Study Start

November 11, 2017

Primary Completion

October 9, 2018

Study Completion

October 10, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

IR(1)