Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00735605
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in bowel habit (regarding the straining severity, anorectal pain,number of weakly bowel movement,sensation of incomplete defecation and need of digitation or enema and using constipation score)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obstructed defecation', 'constipation', 'puborectalis'], 'conditions': ['Obstructed Defecation', 'Anismus', 'Constipation']}, 'referencesModule': {'references': [{'pmid': '18719924', 'type': 'BACKGROUND', 'citation': 'Farid M, El Monem HA, Omar W, El Nakeeb A, Fikry A, Youssef T, Yousef M, Ghazy H, Fouda E, El Metwally T, Khafagy W, Ahmed S, El Awady S, Morshed M, El Lithy R. Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients. Int J Colorectal Dis. 2009 Jan;24(1):115-20. doi: 10.1007/s00384-008-0567-0. Epub 2008 Aug 22.'}, {'pmid': '19039596', 'type': 'RESULT', 'citation': 'Farid M, Youssef T, Mahdy T, Omar W, Moneim HA, El Nakeeb A, Youssef M. Comparative study between botulinum toxin injection and partial division of puborectalis for treating anismus. Int J Colorectal Dis. 2009 Mar;24(3):327-34. doi: 10.1007/s00384-008-0609-7. Epub 2008 Nov 29.'}, {'pmid': '10733120', 'type': 'RESULT', 'citation': 'Maria G, Brisinda G, Bentivoglio AR, Cassetta E, Albanese A. Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome. Dis Colon Rectum. 2000 Mar;43(3):376-80. doi: 10.1007/BF02258305.'}, {'pmid': '3416122', 'type': 'RESULT', 'citation': 'Kamm MA, Hawley PR, Lennard-Jones JE. Lateral division of the puborectalis muscle in the management of severe constipation. Br J Surg. 1988 Jul;75(7):661-3. doi: 10.1002/bjs.1800750713.'}, {'pmid': '8674369', 'type': 'RESULT', 'citation': 'Park UC, Choi SK, Piccirillo MF, Verzaro R, Wexner SD. Patterns of anismus and the relation to biofeedback therapy. Dis Colon Rectum. 1996 Jul;39(7):768-73. doi: 10.1007/BF02054442.'}]}, 'descriptionModule': {'briefSummary': 'Comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation.\n\nAnismus is a significant cause of chronic constipation. This study came to compare the results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients. Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional constipation were included in this study. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the EAS. All patients had non relaxing puborectalis muscle.. The patients were randomized into three groups. Group I patients received biofeedback therapy, two times per week for about 1 month. Group II patients were injected with BTX- A. Group 111 partial division of puborectalis was done. Follow up was conducted weekly in the first month then monthly for about 1 year.', 'detailedDescription': 'Key words:\n\nObstructed defecation, chronic constipation, puborectalis, pelvic floor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60patients fulfilled Rome II criteria for functional constipation\n* All patients were unresponsive to laxatives or enema use\n\nExclusion Criteria:\n\n* Pregnant patients\n* Patients with sphincteric defect\n* Any patient proved to have colonic inertia by colon transit time\n* Any patient with previous history of pelvic surgery e.g. mesh rectopexy\n* Duhamel operation were excluded'}, 'identificationModule': {'nctId': 'NCT00735605', 'briefTitle': 'Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation', 'orgStudyIdInfo': {'id': 'anismus surgical and non'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1:BFD', 'description': 'The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip', 'interventionNames': ['Other: BFD']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 BTX A', 'description': 'Injected with BTX-A in the left lateral position; anesthesia was not required', 'interventionNames': ['Other: BTX A']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3: PDPR', 'description': 'Inner half of puborectalis sling was divided on each side by using a scalpel NO', 'interventionNames': ['Procedure: PDPR']}], 'interventions': [{'name': 'BFD', 'type': 'OTHER', 'otherNames': ['BIOFEEDBACK RETRAINING'], 'description': 'The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip', 'armGroupLabels': ['1:BFD']}, {'name': 'PDPR', 'type': 'PROCEDURE', 'otherNames': ['PARTIAL DIVISION OF PUBORECTALIS'], 'description': 'A 2-3 cm curved incision is made on either side of the anal canal along its posterolateral aspect, each about 2.5 cm distance from the anal verge Fig(2). After that dissection in ischiorectal fossa was done till reaching the puborectalis sling from outside i.e. extrasphincteric approach . Using a right angle forceps the puborectalis sling is lifted up, guided by the contralateral index finger in the anal canal Fig(3). Nearly the inner half of puborectalis sling was divided on each side by using a scalpel NO. 11 Fig(4). Complete haemostasis was followed by skin closure without drain', 'armGroupLabels': ['3: PDPR']}, {'name': 'BTX A', 'type': 'OTHER', 'otherNames': ['BOTILINUM TOXIN'], 'description': 'A vial of Dysport, 500 u, (Dysport, Ipsen, United Kingdom) is dissolved in 2.5 ml isotonic saline Fig(1). A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient', 'armGroupLabels': ['2 BTX A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Ayman Elnakeeb', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'ayman elnakeeb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MANSUORA UNIVERSITY HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'ayman el nakeeb', 'oldOrganization': 'mansour universty hospital'}}}}