Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT01990833
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007412', 'term': 'Intestinal Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasmas and fistula tissues'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula closure after glue application', 'timeFrame': '7 days', 'description': 'No fistula output'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Enterocutaneous Fistulas']}, 'descriptionModule': {'briefSummary': 'For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients\' condition and fitness for GAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Low-output enterocutaneous fistulas receiving glue application', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years old;\n* single tubular (tract length \\>2 cm) ECF;\n* low output volume (\\<200 ml/24h);\n\nExclusion Criteria:\n\n* fistulas of cancer-infiltrated;\n* associated abscess;\n* foreign bodies;\n* distal bowel obstruction;'}, 'identificationModule': {'nctId': 'NCT01990833', 'briefTitle': 'Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'orgStudyIdInfo': {'id': '20120101'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jianan Ren', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice president', 'investigatorFullName': 'Jianan Ren', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}