Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-03 @ 8:31 AM
Study NCT ID:
NCT01391169
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2011-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-08', 'studyFirstSubmitDate': '2011-07-06', 'studyFirstSubmitQcDate': '2011-07-08', 'lastUpdatePostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anastomotic leak', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': '2 hours'}, {'measure': 'wound complications', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peritonitis']}, 'descriptionModule': {'briefSummary': 'This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.', 'detailedDescription': '30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with high risk anastomoses'}, 'identificationModule': {'nctId': 'NCT01391169', 'briefTitle': 'Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses', 'orgStudyIdInfo': {'id': 'seromuscular flap'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1sup group', 'description': 'enforcement of the anastomoses with seromuscular flap', 'interventionNames': ['Other: seromuscular flap enforcement']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2nd group', 'description': 'primary anastomosis without enforcement', 'interventionNames': ['Other: seromuscular flap enforcement']}], 'interventions': [{'name': 'seromuscular flap enforcement', 'type': 'OTHER', 'otherNames': ['primary anastomosis only'], 'description': 'seromuscular flap enforcement', 'armGroupLabels': ['1sup group', '2nd group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Mansoura', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'ramadan ellithy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'mansoura university', 'oldOrganization': 'mansoura university'}}}}