Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 12:15 PM
Study NCT ID:
NCT00980369
Status:
UNKNOWN
Last Update Posted:
2009-09-21
First Post:
2009-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-18', 'studyFirstSubmitDate': '2009-09-18', 'studyFirstSubmitQcDate': '2009-09-18', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lateral internal sphincterotomy', 'Anal fissure', 'Surgical technique', 'Incision', 'Wound healing'], 'conditions': ['Anal Fissure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.', 'detailedDescription': 'The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique. The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing open lateral internal sphincterotomy for chronic anal fissure\n\nExclusion Criteria:\n\n* Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.'}, 'identificationModule': {'nctId': 'NCT00980369', 'briefTitle': 'The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical', 'organization': {'class': 'OTHER', 'fullName': 'SB Istanbul Education and Research Hospital'}, 'officialTitle': 'Incision Type for Lateral Internal Sphincterotomy', 'orgStudyIdInfo': {'id': 'SBIstanbul'}, 'secondaryIdInfos': [{'id': '2. General Surgery'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic anal fissures', 'description': 'Group A: with vertical incision Group B: with parallel incision'}, {'label': 'Parallel incision, vertical insicion'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'SB Istanbul Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Feyzullah Ersoz', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul Education and Research Hospital, General surgery clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Istanbul Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Feyzullah Ersoz - Serkan Sarı', 'oldOrganization': 'Istanbul Education and Research Hospital'}}}}