Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02229695
Status:
UNKNOWN
Last Update Posted:
2014-09-01
First Post:
2014-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-08-28', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra abdominal hypertension', 'timeFrame': '48 hours', 'description': 'measured via a Foley catheter'}], 'secondaryOutcomes': [{'measure': 'Abdominal compartment syndrome', 'timeFrame': '48 hours', 'description': 'According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trauma', 'Sepsis', 'Temporary abdominal closure', 'Bogota bag', 'Vacuum assisted closure'], 'conditions': ['Intra Abdominal Hypertension', 'Abdominal Compartment Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.\n\nPatients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:\n\n1. Vacuum-assisted closure (VAC)\n2. "Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon\'s discretion.\n\nIntra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the General Intensive Care Unit (GICU).\n\nPatients will be evaluated for the development of acute intra abdominal hypertension with or without abdominal compartment syndrome.', 'detailedDescription': 'Comparison of intra-Abdominal hypertension development after bogota bag or VAC abdominal closure Protocol\n\nTrial objective:\n\nTo investigate and compare in a standardized manner the development of intra-abdominal hypertension (IAH) following VAC closure and "Bogota bag".\n\nStudy design:\n\nThis is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.\n\nPatients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:\n\n1. VAC closure\n2. "Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon\'s discretion.\n\nIntra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the GICU. It will be carried out by a nurse who will be blinded as to the type of the abdominal closure.\n\nPatients will be evaluated for the development of acute and significant respiratory compromise, including an elevated inspiratory pressure of \\>35 mbar and a decreased partial oxygen pressure / fraction of inspired oxygen (PaO2/FIO2) of \\<150 torr, hypotension (\\<90 mmHg systolic pressure not due to hemorrhagic, septic, or neurogenic causes), renal dysfunction (urine output, \\<30 mL/hr), and a clinically determined rigid, tense abdomen, and increased abdominal circumference.\n\nThe following data will be recorded. Hemodynamics (mean arterial pressure, heart rate), lactate, PaO2, partial carbonic dioxide pressure (PaCO2), tidal volume, peak airway pressure) and renal (urine output) functions will be registered at 24 and 48 hours following surgery).\n\nData on the indication for operation, type of trauma, its severity and the operative procedures.\n\nAcute Physiologic and Chronic Health Evaluation II (APACHE II) and fluid balance at 24 and 48 hours.\n\nReoperations. Time in ICU and time to final abdominal closure.\n\nStudy population:\n\nAll patients with severe abdominal trauma or none traumatic acute abdomen, that at the end of operation the surgeon will decide to use temporary abdominal closure (TAC).\n\nInclusion Criteria Adults male or female over 18 years old. The surgeon decides the need for TAC at the end of operation.\n\nExclusion Criteria Patients that the surgeon estimates they will not survive 24 hours.\n\nEnd points:\n\nDevelopment of IAH Development of abdominal compartment syndrome (ACS) Need for reoperation of decompressive laparotomy during first 48 hours. Time to final (on discharge from hospital) abdominal closure and the type of closure.\n\nStatistical methodology The calculated sample size based on power of 0.80, alpha 0.05, known incidence of 0.25 and estimated incidence of 0.10 is 42 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that undergo emergent laparotomy for trauma or non-traumatic surgical emergency condition, and that according to the surgeon decision get their abdominal wall closed by a temporary closure technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique.\n\nExclusion Criteria:\n\n* Patients that according to the surgeon estimates will not survive 24 hours.'}, 'identificationModule': {'nctId': 'NCT02229695', 'acronym': 'TACACS', 'briefTitle': 'The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.', 'orgStudyIdInfo': {'id': 'SOR-0167-14'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gad Shaked', 'role': 'CONTACT', 'email': 'shakedg@bgu.ac.il'}], 'overallOfficials': [{'name': 'Gad Shaked, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gad Shaked MD', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}