Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT06243302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula healing', 'timeFrame': 'January 2024', 'description': 'No leakage at all'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': 'January 2024', 'description': 'No re-occuring symptoms'}, {'measure': 'perianal abscess/fistula', 'timeFrame': 'January 2024', 'description': 're-occuring abscess or fistula'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VAAFT', 'OTSC', 'diathermy Ablation of Fistula Tract'], 'conditions': ['Anal Fistula']}, 'referencesModule': {'references': [{'pmid': '24509459', 'type': 'BACKGROUND', 'citation': 'Meinero P, Mori L, Gasloli G. Video-assisted anal fistula treatment: a new concept of treating anal fistulas. Dis Colon Rectum. 2014 Mar;57(3):354-9. doi: 10.1097/DCR.0000000000000082.'}]}, 'descriptionModule': {'briefSummary': 'This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.', 'detailedDescription': 'Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults. Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason. Anteriorly located, high and trans-sphincteric fistulae are at more risk.\n\nAblating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.\n\nOur aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males and females with trans-sphincteric perianal fistulas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients with trans-sphincteric and inter-sphincteric perianal fistulae\n\n\\-\n\nExclusion Criteria:\n\n* Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula'}, 'identificationModule': {'nctId': 'NCT06243302', 'acronym': 'VAAFT-OTSC', 'briefTitle': 'Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration', 'orgStudyIdInfo': {'id': 'KRKAP-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Arm', 'description': 'VAAFT followed by OTSC clip inserted to close the inner opening of the anal fistula', 'interventionNames': ['Procedure: OTSC Closure After VAAFT']}], 'interventions': [{'name': 'OTSC Closure After VAAFT', 'type': 'PROCEDURE', 'description': 'Under general anesthesia,the fistulas will be drained at least for 8 weeks. Then a video camera will be inserted through the external opening to fulgurate the fistula tract under direct vision. Finally the internal fistula opening will be closed water tight by a circular clip. The patients will be followed up for complications as well as short and long term recurrences', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Cebeci', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Hospital,Dept of Surgery', 'geoPoint': {'lat': 39.95497, 'lon': 32.89577}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'September 2024', 'ipdSharing': 'YES', 'description': 'Present it in the ESCP Meeting', 'accessCriteria': 'Primary and secondary outcomes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr', 'investigatorFullName': 'I Ethem Gecim', 'investigatorAffiliation': 'Ankara University'}}}}