Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05590520
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2022-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing of fissure', 'timeFrame': 'Within 6 weeks', 'description': 'All the patients will undergo a pretreatment evaluation that will include clinical inspection of the fissure based on evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter and symptoms including post-defecatory or nocturnal pain, bleeding, or both. Then they will be randomized to receive treatment with either botulinum toxin or 0.2 percent nitroglycerin ointment applied twice daily for six weeks. The outcome in each group will be evaluated clinically.The end point of the study would be complete healing after treatment. The treatment will be considered successful if the fissure healed. Persistence of the fissure in the absence of symptoms will be considered as symptomatic improvement.The Secondary endpoints will measurement of post defecatory pain on Visual analogue scale (VAS) at each visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fissure, botulinum toxin, Gtn ointment'], 'conditions': ['Fissure in Ano']}, 'descriptionModule': {'briefSummary': 'Patients will be randomized to receive treatment with either a total of 20 U of botulinum toxin(diluted in saline to a concentration of 50 U per milliliter.', 'detailedDescription': 'Lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. We compared two nonsurgical treatments that avert the risk of fecal incontinence.treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter\n* symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months.\n\nExclusion Criteria:\n\n* Patients with acute fissure\n* fissure associated with other conditions (i.e., inflammatory bowel diseases, HIV infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer)\n* those who had undergone previous surgical procedures in the anal canal.\n* known hypersensitivity to component of the formulations of type A BTX\n* pregnant or breast-feeding women 6-refusal of consent'}, 'identificationModule': {'nctId': 'NCT05590520', 'briefTitle': 'Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure', 'organization': {'class': 'OTHER', 'fullName': 'Pak Emirates Military Hospital'}, 'officialTitle': 'A Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure :A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FIS 1cpsp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum group', 'description': 'The internal anal sphincter to be palpated and injected with a 27-gauge needle while the patient lying on his or her left side. Each patient will receive 0.4 ml of solution containing botulinum toxin (for a total of 20 U), administered as two injections of equal volume (0.2 ml), one on each side of the anterior midline of the internal anal sphincter. No sedation or local anesthesia to be used during the procedure)', 'interventionNames': ['Procedure: Botulinum injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GTN group', 'description': '0.2 percent nitroglycerin ointment applied twice daily for six weeks.', 'interventionNames': ['Drug: GTN OINTMENT']}], 'interventions': [{'name': 'Botulinum injection', 'type': 'PROCEDURE', 'otherNames': ['Botox inj'], 'description': 'Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application', 'armGroupLabels': ['Botulinum group']}, {'name': 'GTN OINTMENT', 'type': 'DRUG', 'otherNames': ['0. 2% GTN'], 'description': '0.2%GTN applied on anal canal.', 'armGroupLabels': ['GTN group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Mubashra Badar, MBBS, FCPS', 'role': 'CONTACT'}], 'facility': 'Pak-Emirates Military Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Mubashra Badar', 'role': 'CONTACT', 'email': 'mubashrabadar@gmail.com', 'phone': '03145274242'}], 'overallOfficials': [{'name': 'Mubashra Badar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available once published and will also be available as open source review', 'ipdSharing': 'YES', 'description': "I'll publish the article and all data will be available for researchers", 'accessCriteria': 'All researchers will be allowed to buildup on this research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pak Emirates Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Mubashra Badar', 'investigatorAffiliation': 'Pak Emirates Military Hospital'}}}}