Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05797220
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2022-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D004110', 'term': 'Diltiazem'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fissure healing at 1 month', 'timeFrame': '1 month', 'description': 'Evaluation of complete epithelization of the fissure by the principal investigator by rectal examination'}, {'measure': 'Days to pain-free defecation', 'timeFrame': '1 month', 'description': 'Patient reported time until pain-free defecation. This will be evaluated on 3rd day, 10th day and 1-month outpatient visits.'}], 'secondaryOutcomes': [{'measure': 'Complete healing at 48 months', 'timeFrame': '48 months', 'description': 'Any recurrent symptoms evaluated by the surgeon within 2 months in the outpatient clinic and reported by the patient at phone call follow-up at 6 months, 12 months, 24 months, and 48 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['botulinum toxin, anal fissure, diltiazem'], 'conditions': ['Anal Fissure Chronic']}, 'descriptionModule': {'briefSummary': 'Anal fissure (AF) is a painful tear extending from the anal canal to the dentate line. Although the exact pathophysiology is not known, an increase in anal tonus, decreased ano-dermal blood flow and local ischemia are possible mechanisms. The most effective treatment modality in chronic AF is lateral internal sphincterotomy however, incontinence rates are still reported as high as 8-30%. Topical diltiazem and botulinum toxin (BT) injection are good alternatives to surgery with lack of persistent side effects, easy applicability, and reproducibility, however, recurrence rates were reported up to 50% for each. A combination of BT with topical diltiazem may provide better results in terms of healing and recurrence. In this retrospective analysis a comparison of BT injection alone and BT injection combined with topical diltiazem treatment was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and males older than 18 years old', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with complaints longer than 8 weeks (chronic anal fissure)\n* Patients who completed at least 24 months of follow-up (3rd day, 10th day, 1st-month, and 2nd-month face-to-face clinic visits and 6, 12, and 24 months phone calls)\n* Patients who received conservative treatments including topical diltiazem and nitrites\n\nExclusion Criteria:\n\n* Patients with previous anal surgery (lateral internal sphincterotomy, hemorrhoidectomy, anal fistula)\n* Patients with inflammatory bowel diseases\n* Patients with accompanying anorectal disease (hemorrhoids, anal fistula, abscess)\n* Patients who underwent botulinum toxin injection within 1 year before recruitment\n* Patients with anterior, lateral, or multiple fissures\n* Comorbidities (AIDS, sexually transmitted disease, tuberculosis, leukemia)\n* Pregnancy\n* Prescription of calcium canal blockers or nitrites\n* Hypersensitivity to diltiazem or botulinum toxin\n* Patients without anal pain'}, 'identificationModule': {'nctId': 'NCT05797220', 'briefTitle': 'The Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Retrospective Analysis on the Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure: Short and Long-term Outcomes From a Single Center', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-786'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Botulinum toxin group', 'description': 'The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters.', 'interventionNames': ['Drug: Botulinum Toxin Type A Injection [Botox]']}, {'label': 'Botulinum toxin plus topical diltiazem group', 'description': 'The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters. After BT injection, topical 2% diltiazem gel was prescribed, applied 2 times per day for 10 days (2 doses of 1 gr each per day). No selection criteria were used when recommending this treatment; it was randomly suggested to some for a while during the cohort since the surgeon believed it might enhance the efficacy of BT.', 'interventionNames': ['Drug: Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel']}], 'interventions': [{'name': 'Botulinum Toxin Type A Injection [Botox]', 'type': 'DRUG', 'armGroupLabels': ['Botulinum toxin group']}, {'name': 'Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel', 'type': 'DRUG', 'armGroupLabels': ['Botulinum toxin plus topical diltiazem group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34196', 'city': 'Istanbul', 'state': 'Other (Non U.s.)', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Naciye Cigdem Arslan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'I don not have a website to share IPD however if required I can share datasets, protocols and other information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Surgeon', 'investigatorFullName': 'Cigdem Arslan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}