Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00937118
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2009-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mayberrj@ohsu.edu', 'phone': '503-494-5300', 'title': 'John Mayberry, MD', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Injury Management', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duodenal-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Diversion Decompression or Exclusion', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques'}, {'id': 'OG001', 'title': 'Diversion Decompression or Exclusion', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques'}, {'id': 'OG002', 'title': 'Damage Control', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique'}, {'id': 'OG003', 'title': 'Fascial Closure', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 years', 'description': 'Duodenal-related complications including leak, obstruction, and abscess', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with duodenal related complications'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Injury Management', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Inpatients requiring laparotomy for trauma with duodenal injury years 1989 - 2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Injury Management', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2009-07-09', 'resultsFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-13', 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duodenal-related Complications', 'timeFrame': '20 years', 'description': 'Duodenal-related complications including leak, obstruction, and abscess'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparotomy', 'duodenal injury', 'pancreatic injury', 'trauma'], 'conditions': ['Injury of Duodenum', 'Pancreatic Injury']}, 'referencesModule': {'references': [{'pmid': '448769', 'type': 'BACKGROUND', 'citation': 'Stone HH, Fabian TC. Management of duodenal wounds. J Trauma. 1979 May;19(5):334-9. doi: 10.1097/00005373-197905000-00006.'}, {'pmid': '7362449', 'type': 'BACKGROUND', 'citation': 'Snyder WH 3rd, Weigelt JA, Watkins WL, Bietz DS. The surgical management of duodenal trauma. Precepts based on a review of 247 cases. Arch Surg. 1980 Apr;115(4):422-9. doi: 10.1001/archsurg.1980.01380040050009.'}, {'pmid': '7123496', 'type': 'BACKGROUND', 'citation': 'Kashuk JL, Moore EE, Cogbill TH. Management of the intermediate severity duodenal injury. Surgery. 1982 Oct;92(4):758-64.'}, {'pmid': '15972052', 'type': 'BACKGROUND', 'citation': 'Rickard MJ, Brohi K, Bautz PC. Pancreatic and duodenal injuries: keep it simple. ANZ J Surg. 2005 Jul;75(7):581-6. doi: 10.1111/j.1445-2197.2005.03351.x.'}, {'pmid': '16547621', 'type': 'BACKGROUND', 'citation': 'Talving P, Nicol AJ, Navsaria PH. Civilian duodenal gunshot wounds: surgical management made simpler. World J Surg. 2006 Apr;30(4):488-94. doi: 10.1007/s00268-005-0245-0.'}, {'pmid': '17426536', 'type': 'BACKGROUND', 'citation': 'Seamon MJ, Pieri PG, Fisher CA, Gaughan J, Santora TA, Pathak AS, Bradley KM, Goldberg AJ. A ten-year retrospective review: does pyloric exclusion improve clinical outcome after penetrating duodenal and combined pancreaticoduodenal injuries? J Trauma. 2007 Apr;62(4):829-33. doi: 10.1097/TA.0b013e318033a790.'}, {'pmid': '8371295', 'type': 'BACKGROUND', 'citation': "Rotondo MF, Schwab CW, McGonigal MD, Phillips GR 3rd, Fruchterman TM, Kauder DR, Latenser BA, Angood PA. 'Damage control': an approach for improved survival in exsanguinating penetrating abdominal injury. J Trauma. 1993 Sep;35(3):375-82; discussion 382-3."}, {'pmid': '9291979', 'type': 'BACKGROUND', 'citation': 'Rotondo MF, Zonies DH. The damage control sequence and underlying logic. Surg Clin North Am. 1997 Aug;77(4):761-77. doi: 10.1016/s0039-6109(05)70582-x.'}, {'pmid': '9841741', 'type': 'BACKGROUND', 'citation': 'Moore EE, Burch JM, Franciose RJ, Offner PJ, Biffl WL. Staged physiologic restoration and damage control surgery. World J Surg. 1998 Dec;22(12):1184-90; discussion 1190-1. doi: 10.1007/s002689900542.'}, {'pmid': '21679632', 'type': 'RESULT', 'citation': 'Mayberry J, Fabricant L, Anton A, Ham B, Schreiber M, Mullins R. Management of full-thickness duodenal laceration in the damage control era: evolution to primary repair without diversion or decompression. Am Surg. 2011 Jun;77(6):681-5.'}]}, 'descriptionModule': {'briefSummary': "The management of significant duodenal injuries and combined duodenal-pancreatic injuries continues to be challenging and controversial, and several techniques have been advocated over the years. One technique surgeons employ is the damage control/planned reoperation strategy. At the trauma center, the advent of damage control and other planned re-operation strategies has resulted in an evolution in the investigators management of duodenal lacerations and combined duodenal-pancreatic injuries. In this retrospective review, the investigators intend to quantify the investigators change in practice and to report its outcome compared to previous practice.\n\nUsing the OHSU Trauma Laparotomy Outcomes Database, the investigators will identify all patients receiving trauma laparotomy for a duodenal or duodenal/pancreatic injury for a period of 20 years, from 1989-2009. A number of data points will be retrieved from patients' medical records, including but not limited to grade of duodenal injury, mechanism of injury, Injury Severity Score, and others.", 'detailedDescription': 'The management of significant duodenal injuries and combined duodenal-pancreatic injuries continues to be challenging and controversial. Several techniques have been advocated over the years to prevent the dreaded complications of repair breakdown, fistulization, and intra-abdominal sepsis. These include duodenal diverticulization, triple tube ostomy, tube duodenostomy, and pyloric exclusion. These techniques are all designed to decompress, heal without undue intraluminal pressure or flow. Recently, surgeons have questioned whether aggressive adjunctive diversion is truly necessary, especially for less severe injuries, and many have noted complications associated with the reconstructions apart from the injury.\n\nAn alternative to routine diversion/decompression/exclusion is the damage control/planned reoperation strategies following laparotomy for severe visceral injuries that have become prevalent in the past two decades. Instead of performing a primary duodenal repair with enteral diversion or decompression in a single operation, many surgeons employ a surveillance and "touch-up" strategy over the course of 2-4 abdominal explorations. The abdominal fascia is not closed until the healing phase has commenced and the surgeon feels confident the repair will hold.\n\nAt the trauma center, the advent of damage control and other planned re-operation strategies as resulted in an evolution in our management of duodenal lacerations and combined duodenal-pancreatic injuries. The investigators perform noticeably fewer decompression, diversion, or exclusion procedures and have increasingly relied on serial abdominal explorations for surveillance of the repair.\n\nIn this retrospective review, we intend to quantify our change in practice and to report its outcome compared to previous practice.\n\nUsing the OHSU Trauma Laparotomy Outcomes Database, we will identify all patients receiving trauma laparotomy in which a duodenal or combined duodenal-pancreatic injury was identified in a 20-year period from 1989-2009. The medical records of these patients will be reviewed to confirm duodenal injury and to tabulate other factors.\n\nThe patients will be categorized based on management of the duodenal injury, e.g. primary repair, decompression, diversion, or exclusion. Patients will also be categorized according to laparotomy strategy, e.g. damage control, planned reoperation, or primary fascial closure without planned reoperation. Duodenal-related complications will be tabulated and the various groups compared. The investigators anticipate including up to 50 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Trauma patients who received a trauma laparotomy for a duodenal or combined duodenal/pancreatic injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma patients who received a trauma laparotomy for a duodenal or combined duodenal/pancreatic injury\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00937118', 'briefTitle': 'Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Damage Control for Severe Duodenal and Combined Duodenal-Pancreatic Injuries: A Retrospective Review', 'orgStudyIdInfo': {'id': 'IRB # 5128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Injury Management', 'description': 'Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'John C Mayberry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'John C. Mayberry', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}