Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT03490305
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2018-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Penetrating Abdominal Injuries From the Battle of Mosul
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-01', 'size': 2422745, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-09T08:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2018-03-22', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.', 'timeFrame': 'an average of 3 weeks'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['War injury', 'Penetrating abdominal trauma', 'Exploratory laparotomy', 'Improvised explosive device', 'Mosul'], 'conditions': ['Penetrating Abdominal Trauma', 'War Injury']}, 'referencesModule': {'references': [{'pmid': '1749028', 'type': 'BACKGROUND', '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.'}, {'pmid': '10445921', 'type': 'BACKGROUND', '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.'}, {'pmid': '11263024', 'type': 'BACKGROUND', '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.'}, {'pmid': '7717780', 'type': 'BACKGROUND', '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.'}, {'pmid': '37741988', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAim To assess whether civilians obtain more extensive abdominal injuries than combatants in an urban battle characterized by the use of indiscriminate weapons.\n\nStudy Design An observational retrospective cohort study with longitudinal data collection.\n\nAll 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.\n\nPrimary Objective Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.\n\nSecondary 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.\n\nDifferences 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.\n\nStatistical methods Differences between groups will be analysed using t-test and regression models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (all must be fulfilled):\n\n* Penetrating abdominal injury\n* Subjected to an exploratory laparotomy at Emergency Hospital, Erbil, Iraq\n* Between October 17, 2016 and July 16, 2017\n\nExclusion Criteria (all must be fulfilled):\n\n* Patients who received treatment several times will only be counted as one patient\n* Between October 17, 2016 and July 16, 2017'}, 'identificationModule': {'nctId': 'NCT03490305', 'acronym': 'Exlap', 'briefTitle': 'Penetrating Abdominal Injuries From the Battle of Mosul', 'organization': {'class': 'OTHER', 'fullName': 'Vrinnevi Hospital'}, 'officialTitle': 'Exploratory Laparotomy Following Penetrating Abdominal Injuries From the Battle of Mosul: a Cohort Study From a Referral Hospital in Erbil, Kurdistan Region in Iraq', 'orgStudyIdInfo': {'id': 'ExlapErbil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combatants', 'description': 'Men 16-50 years old or combatants by own admission.', 'interventionNames': ['Procedure: Exploratory laparotomy']}, {'label': 'Civilians', 'description': 'Children \\<16 years, all women and men ≥50 years.', 'interventionNames': ['Procedure: Exploratory laparotomy']}], 'interventions': [{'name': 'Exploratory laparotomy', 'type': 'PROCEDURE', 'description': 'Findings and procedures done at exploratory laparotomy', 'armGroupLabels': ['Civilians', 'Combatants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erbil', 'state': 'Kurdistan', 'country': 'Iraq', 'facility': 'Emergency Hospital', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}], 'overallOfficials': [{'name': 'Johan von Schreeb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrinnevi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emergency Hospital, Erbil, Iraq', 'class': 'UNKNOWN'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Center for Disaster Medicine and Traumatology, Linköping University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Måns Muhrbeck', 'investigatorAffiliation': 'Vrinnevi Hospital'}}}}