Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-01 @ 5:55 PM
Study NCT ID:
NCT01612195
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2012-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2012-06-02', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula healing', 'timeFrame': '6 months', 'description': 'Clinical healing of a complex anal fistula as assessed in the clinic at 6 weeks and 6 months after anal fistula plug surgery. Further assessment prn.'}, {'measure': 'Anal continence', 'timeFrame': '6 months', 'description': 'Evaluation of anal continence by means of a validated questionnaire, namely the Fecal Incontinence Severity Index, at 6 weeks and 6 months after anal fistula plug surgery.'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Evaluation of health-related quality of life by means of a validated questionnaire, namely the Short-Form 36 version 2, at 6 weeks and 6 months after anal fistula plug surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anal fistula', 'anal continence', 'health-related quality of life'], 'conditions': ['Complex Anal Fistula']}, 'descriptionModule': {'briefSummary': 'Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The course of abscess-fistula disease as well as its treatment modalities may affect anal continence. The present cohort study investigates the results of anal fistula plug surgery. In particular, this study focus on the impact of anal fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons.', 'detailedDescription': "Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The clinical course of abscess-fistula disease as well as its treatment modalities may affect anal continence. Anal fistula plug surgery is an Health Canada and FDA approved surgical treatment that has demonstrated promising results in terms of fistula healing and minimal patients' burden. The present cohort study prospectively investigates the results of anal fistula plug surgery performed in teaching hospitals affiliated to the University of Toronto. In particular, this study focus on the impact of anal fistula plug surgery on health-related quality of life, and its 2 major determinants anal continence and fistula healing. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons. Quality of life and anal continence will be measured with the validated Short Form-36 Health Survey (SF-36 v2) and Fecal Incontinence Score Index (FISI) questionnaires, respectively. It is expected that the present study will provide objective information on the results and generalizability of anal fistula surgery, as well as on its impact on health-related quality of life and anal continence."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nComplex anal fistula as defined by\n\n* high transsphincteric fistula\n* extrasphincteric fistula\n* suprasphincteric fistula\n* recurrent fistula\n* multiple fistula openings, including horseshoe fistula\n* imperfect continence- jeopardized anal continence (anterior transsphincteric fistula, prior anal surgery)\n\nExclusion Criteria:\n\n* Uncomplicated fistula curable by simple fistulotomy\n* History of inflammatory bowel disease\n* Chronic immunosuppressive treatment (ie, systemic steroids for \\>3 days)\n* Clinical heart failure as defined by a CCS angina severity class ≥ III\n* Untreated cancer or cancer diagnosed/treated (all modalities) within 6 months\n* Estimated life expectancy inferior to 6 months\n* Incompetent subject\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01612195', 'briefTitle': 'Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula', 'orgStudyIdInfo': {'id': 'AFP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anal fistula plug', 'interventionNames': ['Procedure: Anal fistula plug']}], 'interventions': [{'name': 'Anal fistula plug', 'type': 'PROCEDURE', 'otherNames': ['Anal fistula plug Surgisis®'], 'description': 'All patients have a draining seton for at least 6 weeks prior placement of the anal fistula plug. All patients are administered a general anesthetic and are operated in the lithotomy position. The seton is removed, but no curettage or irrigation of the fistula tract is performed. The plug is inserted through the internal opening, and pulled through the external opening until it fit snugly and its base is sutured to the internal sphincter with 2 interrupted 2-0 polyglactin 910 sutures. The tip of the plug is cut at skin level and not sutured. The external opening is left open to allow for drainage. The patient is instructed to restrict physical and sexual activity for 2 weeks postoperatively. Patients are seen in the post-operative clinic at 10 days, 6 weeks and 6 months as per protocol.', 'armGroupLabels': ['Anal fistula plug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031 & 9007', 'city': 'Basel & St.Gallen', 'country': 'Switzerland', 'facility': 'University of Basel & Kantonsspital St.Gallen'}], 'overallOfficials': [{'name': 'Michel Adamina, MD, PD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': "Women's College Hospital", 'class': 'OTHER'}, {'name': 'St. Claraspital AG', 'class': 'OTHER'}, {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Michel Adamina, MD, PD, MSc', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}