Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-28 @ 7:10 AM
Study NCT ID:
NCT07268261
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Method of Surgical Treatment of Anal Fissure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment. Comparative, randomized, prospective, single-center. clinical trial. Patients in the main group undergo excision of the fissure in combination with injection into internal sphincter Botulinum toxin type A In the control group, excision of the fissure was performed in combination with injection into internal sphincter Botulinum toxin type A with excision in combination with platelet rich plasma'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anal sphincter insufficiency', 'timeFrame': '60 days', 'description': 'Frequency of anal sphincter insufficiency according to the Wexner scale'}], 'secondaryOutcomes': [{'measure': '2-item pain intensity (P2)', 'timeFrame': 'On day 15, 30, 45 and 60', 'description': 'Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).'}, {'measure': 'Non-Healing Wound', 'timeFrame': 'On day 15, 30, 45, 60', 'description': 'Frequency of post-operative wound epithelialization'}, {'measure': 'Profilometry /sphincterometry findings', 'timeFrame': 'On day 30, 60 and 365', 'description': 'Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry'}, {'measure': 'Temporary disability', 'timeFrame': 'Up to 60 days', 'description': 'Duration of temporary disability'}, {'measure': 'Relap', 'timeFrame': 'Up to 60 days', 'description': 'Frequency of relapses'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fissure in Ano', 'Anal fissure', 'botulinum toxin A', 'Chronic anal pain', 'Fecal incontinence', 'Spasm of the internal sphincter', 'Anal sphincter insufficiency'], 'conditions': ['Chronic Anal Fissure']}, 'referencesModule': {'references': [{'pmid': '8351556', 'type': 'BACKGROUND', 'citation': 'Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016.'}, {'pmid': '8416784', 'type': 'BACKGROUND', 'citation': 'Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.'}, {'pmid': '22336789', 'type': 'BACKGROUND', 'citation': 'Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.'}, {'pmid': '10528760', 'type': 'BACKGROUND', 'citation': 'Zetterstrom J, Mellgren A, Jensen LL, Wong WD, Kim DG, Lowry AC, Madoff RD, Congilosi SM. Effect of delivery on anal sphincter morphology and function. Dis Colon Rectum. 1999 Oct;42(10):1253-60. doi: 10.1007/BF02234209.'}, {'pmid': '1511644', 'type': 'BACKGROUND', 'citation': 'Delechenaut P, Leroi AM, Weber J, Touchais JY, Czernichow P, Denis P. Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry. Dis Colon Rectum. 1992 Sep;35(9):847-9. doi: 10.1007/BF02047871.'}, {'pmid': '24500725', 'type': 'BACKGROUND', 'citation': 'Chen HL, Woo XB, Wang HS, Lin YJ, Luo HX, Chen YH, Chen CQ, Peng JS. Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials. Tech Coloproctol. 2014 Aug;18(8):693-8. doi: 10.1007/s10151-014-1121-4. Epub 2014 Feb 6.'}, {'pmid': '22430300', 'type': 'BACKGROUND', 'citation': 'Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20.'}, {'pmid': '27539490', 'type': 'BACKGROUND', 'citation': 'Bobkiewicz A, Francuzik W, Krokowicz L, Studniarek A, Ledwosinski W, Paszkowski J, Drews M, Banasiewicz T. Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis. World J Surg. 2016 Dec;40(12):3064-3072. doi: 10.1007/s00268-016-3693-9.'}, {'pmid': '7934496', 'type': 'BACKGROUND', 'citation': 'Gui D, Cassetta E, Anastasio G, Bentivoglio AR, Maria G, Albanese A. Botulinum toxin for chronic anal fissure. Lancet. 1994 Oct 22;344(8930):1127-8. doi: 10.1016/s0140-6736(94)90633-5.'}, {'pmid': '27926552', 'type': 'BACKGROUND', 'citation': 'Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.', 'detailedDescription': 'A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance.\n\nThe main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early postoperative period.\n\nBotulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with chronic anal fissure with spasm of anal sphincter\n\nExclusion Criteria:\n\n* • Inflammatory diseases of the colon\n\n * Pectenosis\n * Previous surgical interventions on the anal canal\n * IV grade internal and external hemorrhoids\n * Rectal fistula\n * Severe somatic diseases at the decompensation stage\n * Pregnancy and lactation\n * Anal sphincter insufficiency\n * Chronic paraproctitis\n * Individual intolerance and hypersensitivity to botulinum toxin\n * Myasthenia gravis and myasthenic syndromes\n * History of allergic reaction to anticoagulants.\n * Blood diseases (thrombocytopenia, splenomegaly, etc.)'}, 'identificationModule': {'nctId': 'NCT07268261', 'briefTitle': 'Combined Method of Surgical Treatment of Anal Fissure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'State Scientific Centre of Coloproctology, Russian Federation'}, 'officialTitle': 'Combined Method of Surgical Treatment of Anal Fissure', 'orgStudyIdInfo': {'id': '56IG701SSCC980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'main group', 'description': 'Patients of the main group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each)', 'interventionNames': ['Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'Patients in the control group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each)', 'interventionNames': ['Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A']}], 'interventions': [{'name': 'excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A', 'type': 'PROCEDURE', 'description': 'patients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added', 'armGroupLabels': ['control group', 'main group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123423', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey A Frolov, phd', 'role': 'CONTACT', 'email': 'DrZharkow@mail.ru', 'phone': '+79039689739', 'phoneExt': '89039689739'}, {'name': 'Evgeny E Zharkov', 'role': 'CONTACT', 'email': 'drzharkov@mail.ru', 'phone': '+79039689739', 'phoneExt': '+79039689739'}], 'facility': 'SSCCRussia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Evgeny E. Zharkov, MD', 'role': 'CONTACT', 'email': 'drzharkov@mail.ru', 'phone': '+79039689739'}, {'name': 'Ekaterina Yu. Lebedeva', 'role': 'CONTACT', 'email': 'katerina.lebedeva.1997@mail.ru', 'phone': '+79779558920'}], 'overallOfficials': [{'name': 'Sergey A. Frolov, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Scientific Centre of Coloproctology, Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}