Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-18 @ 3:51 PM
Study NCT ID:
NCT00830661
Status:
UNKNOWN
Last Update Posted:
2009-05-29
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure of this study will be to compare the rate of fistula closure between the ligation of the intersphincteric fistula track (LIFT) procedure and the use of a porcine bioabsorbable anal fistula plug', 'timeFrame': '1month, 3 month, 6 month, 12 month postoperatively'}], 'secondaryOutcomes': [{'measure': 'Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation', 'timeFrame': '1 month, 3 month, 6 month, 12 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transsphincteric anal fistula', 'cryptoglandular origin', 'anal fistula repair', 'Ligation of Intersphincteric Fistula Track (LIFT) procedure', 'anal fistula plug (Plug)', 'surgical repair'], 'conditions': ['Anal Fistula']}, 'descriptionModule': {'briefSummary': 'Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects 18 years of age or older.\n* Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.\n* Has a documented diagnosis, confirmed by physical exam and/or endorectal ultrasound (if available), of a trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).\n\nExclusion Criteria:\n\n* History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).\n* History of connective tissue disease.\n* Rectovaginal fistula.\n* Presence of horseshoe fistula.\n* History of immunosuppression therapy/treatment within previous six months.\n* Presents of a proximal diversion and refractory fistula.\n* Any physical conditions, disease, or disorder that would exclude subject from being a candidate for elective surgery.\n* Known history of allergy to pork or pork products."}, 'identificationModule': {'nctId': 'NCT00830661', 'acronym': 'LIFT vs PLUG', 'briefTitle': 'Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair', 'organization': {'class': 'OTHER', 'fullName': 'Colon and Rectal Surgery Associates, Ltd.'}, 'officialTitle': 'A Randomized, Prospective, Multi-Centered Study Comparing Clinical Outcomes of the Ligation of Intersphincteric Fistula Tract (LIFT)Procedure Versus Use of Anal Fistula Plug (AFP)in the Surgical Repair of Trans-Sphincteric Anal Fistulae of Cryptoglandular Origin', 'orgStudyIdInfo': {'id': 'SMG1108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LIFT', 'description': 'those subjects receiving the Ligation of Intersphincteric Fistula Track procedure', 'interventionNames': ['Procedure: Ligation of intersphincteric fistula track procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plug', 'description': 'those subjects randomized to the receive the placement of the porcine anal fistula plug', 'interventionNames': ['Procedure: anal fistula plug']}], 'interventions': [{'name': 'Ligation of intersphincteric fistula track procedure', 'type': 'PROCEDURE', 'description': 'Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure.', 'armGroupLabels': ['LIFT']}, {'name': 'anal fistula plug', 'type': 'PROCEDURE', 'description': 'placement of the porcine anal fistula plug as per the instructions for use in product packaging', 'armGroupLabels': ['Plug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Liliana Bordeianou, MD', 'role': 'CONTACT', 'phone': '617-643-0541'}, {'name': 'Liliana Bordeianou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deb Jones, BS', 'role': 'CONTACT', 'email': 'djones@crsal.org', 'phone': '651-225-7830'}, {'name': 'Rachael Peterson, BS', 'role': 'CONTACT', 'email': 'rpeterson@crsal.org', 'phone': '651-225-7817'}, {'name': 'Heather Rossi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Colon and Rectal Surgery Associates, Ltd', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Bleier, MD', 'role': 'CONTACT', 'email': 'Joshua.Bleier@uphs.upenn.edu'}, {'name': 'Joshua Bleier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'K1N6N5', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Husein Moloo, MD', 'role': 'CONTACT', 'email': 'hmoloo@ottawahospital.on.ca'}, {'name': 'Jonathon Cook, PhD', 'role': 'CONTACT', 'email': 'jcook@ohri.ca'}, {'name': 'Husein Moloo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jonathon Cook, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Deb J Jones, BS', 'role': 'CONTACT', 'email': 'djones@crsal.org', 'phone': '651-225-7830'}, {'name': 'Rachael Peterson, BS', 'role': 'CONTACT', 'email': 'rpeterson@crsal.org', 'phone': '651-225-7817'}], 'overallOfficials': [{'name': 'Heather L Rossi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota/Colon and Rectal Surgery Associates, Ltd.'}, {'name': 'Husein Moloo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}, {'name': 'Joshua Bleier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania Health System'}, {'name': 'Liliana Bordeianou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colon and Rectal Surgery Associates, Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'University of Ottawa', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Stanley M. Goldberg, MD Study Director', 'oldOrganization': 'University of Minnesota/Colon and Rectal Surgery Associates. Ltd'}}}}