Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT03003351
Status:
UNKNOWN
Last Update Posted:
2016-12-28
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zurich Fistula Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D012006', 'term': 'Rectovaginal Fistula'}, {'id': 'D003424', 'term': 'Crohn Disease'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014624', 'term': 'Vaginal Fistula'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perianal disease activity index (PDAI)', 'timeFrame': '6 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Change in Fistula Drainage assessment', 'timeFrame': '3, 6 & 12months after intervention'}]}, 'conditionsModule': {'keywords': ['Fistula', 'Cohort Study'], 'conditions': ['Fistula;Rectal', 'Fistula; Rectouterine', 'Fistula; Rectovesical', 'Fistulas Recto Vaginal', 'Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '7429313', 'type': 'BACKGROUND', 'citation': "Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525."}, {'pmid': '8239781', 'type': 'BACKGROUND', 'citation': "Michelassi F, Stella M, Balestracci T, Giuliante F, Marogna P, Block GE. Incidence, diagnosis, and treatment of enteric and colorectal fistulae in patients with Crohn's disease. Ann Surg. 1993 Nov;218(5):660-6. doi: 10.1097/00000658-199321850-00012."}, {'pmid': '8951512', 'type': 'BACKGROUND', 'citation': "Solomon MJ. Fistulae and abscesses in symptomatic perianal Crohn's disease. Int J Colorectal Dis. 1996;11(5):222-6. doi: 10.1007/s003840050051."}, {'pmid': '3293326', 'type': 'BACKGROUND', 'citation': "Allan A, Keighley MR. Management of perianal Crohn's disease. World J Surg. 1988 Apr;12(2):198-202. doi: 10.1007/BF01658054. No abstract available."}, {'pmid': '12752351', 'type': 'BACKGROUND', 'citation': "Bell SJ, Williams AB, Wiesel P, Wilkinson K, Cohen RC, Kamm MA. The clinical course of fistulating Crohn's disease. Aliment Pharmacol Ther. 2003 May 1;17(9):1145-51. doi: 10.1046/j.1365-2036.2003.01561.x."}, {'pmid': '11856078', 'type': 'BACKGROUND', 'citation': "Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x."}, {'pmid': '9609752', 'type': 'BACKGROUND', 'citation': "Loftus EV Jr, Silverstein MD, Sandborn WJ, Tremaine WJ, Harmsen WS, Zinsmeister AR. Crohn's disease in Olmsted County, Minnesota, 1940-1993: incidence, prevalence, and survival. Gastroenterology. 1998 Jun;114(6):1161-8. doi: 10.1016/s0016-5085(98)70421-4."}, {'pmid': '6886354', 'type': 'BACKGROUND', 'citation': "Givel JC, Hawker P, Allan R, Keighley MR, Alexander-Williams J. Entero-enteric fistula complicating Crohn's disease. J Clin Gastroenterol. 1983 Aug;5(4):321-3. doi: 10.1097/00004836-198308000-00007."}, {'pmid': '10792111', 'type': 'BACKGROUND', 'citation': "Bell SJ, Kamm MA. Review article: the clinical role of anti-TNFalpha antibody treatment in Crohn's disease. Aliment Pharmacol Ther. 2000 May;14(5):501-14. doi: 10.1046/j.1365-2036.2000.00777.x."}, {'pmid': '10228190', 'type': 'BACKGROUND', 'citation': "Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804."}, {'pmid': '11910338', 'type': 'BACKGROUND', 'citation': "Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362."}, {'pmid': '17041753', 'type': 'BACKGROUND', 'citation': "Hyder SA, Travis SP, Jewell DP, McC Mortensen NJ, George BD. Fistulating anal Crohn's disease: results of combined surgical and infliximab treatment. Dis Colon Rectum. 2006 Dec;49(12):1837-41. doi: 10.1007/s10350-006-0656-5."}, {'pmid': '17899271', 'type': 'BACKGROUND', 'citation': "Gaertner WB, Decanini A, Mellgren A, Lowry AC, Goldberg SM, Madoff RD, Spencer MP. Does infliximab infusion impact results of operative treatment for Crohn's perianal fistulas? Dis Colon Rectum. 2007 Nov;50(11):1754-60. doi: 10.1007/s10350-007-9077-3. Epub 2007 Sep 27."}, {'pmid': '12792431', 'type': 'BACKGROUND', 'citation': "Topstad DR, Panaccione R, Heine JA, Johnson DR, MacLean AR, Buie WD. Combined seton placement, infliximab infusion, and maintenance immunosuppressives improve healing rate in fistulizing anorectal Crohn's disease: a single center experience. Dis Colon Rectum. 2003 May;46(5):577-83. doi: 10.1007/s10350-004-6611-4."}, {'pmid': '12769443', 'type': 'BACKGROUND', 'citation': "Regueiro M, Mardini H. Treatment of perianal fistulizing Crohn's disease with infliximab alone or as an adjunct to exam under anesthesia with seton placement. Inflamm Bowel Dis. 2003 Mar;9(2):98-103. doi: 10.1097/00054725-200303000-00003."}, {'pmid': '25663759', 'type': 'BACKGROUND', 'citation': "Marzo M, Felice C, Pugliese D, Andrisani G, Mocci G, Armuzzi A, Guidi L. Management of perianal fistulas in Crohn's disease: an up-to-date review. World J Gastroenterol. 2015 Feb 7;21(5):1394-403. doi: 10.3748/wjg.v21.i5.1394."}, {'pmid': '7884173', 'type': 'BACKGROUND', 'citation': "Irvine EJ. Usual therapy improves perianal Crohn's disease as measured by a new disease activity index. McMaster IBD Study Group. J Clin Gastroenterol. 1995 Jan;20(1):27-32."}, {'pmid': '12786607', 'type': 'BACKGROUND', 'citation': "Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. doi: 10.1046/j.1365-2036.17.s2.17.x."}, {'pmid': '9862829', 'type': 'BACKGROUND', 'citation': 'Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.'}, {'pmid': '6102236', 'type': 'BACKGROUND', 'citation': "Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available."}]}, 'descriptionModule': {'briefSummary': "This is a pro- and retrospective cohort study to evaluate the natural history and outcome of various treatment options of patients with fistula. At each clinical visit parameters describing activity of a fistula, potential underlying Crohn's disease, investigations as well as the current treatment will be entered into a database. Selected patients can also be contacted by phone in the form of a structured interview. Data will be analyzed to determine treatment outcomes, characterize the natural history as well as risk factors for complications of treatment and an unfavorable disease course. The same data will be obtained and analyzed retrospectively from patients who visited the clinic prior to January 2017.", 'detailedDescription': 'Fistulizing disease remains a frequent and severe problem for patients with Crohn\'s disease (CD). Life-time prevalence of fistula for patients with CD has been estimated to be 17 - 50% \\[1-5\\] with a cumulative incidence of 33% and 50% after 10 years and 20 years disease duration, respectively. These numbers have been confirmed by population-based studies \\[6, 7\\].\n\nPatients with CD and fistula have a decreased quality of life. Reasons include perianal pain, discharge from the vagina, abdominal wall, perianal region and urinary tract infections. Fistula are frequently associated with abscess formation \\[8\\]. Unfortunately, surgical and medical treatment options for fistula for CD patients remain limited. Treatment with the tumor-necrosis factor (TNF) antibody infliximab remains the best medical treatment option available: At least temporary fistula closure is observed for 55% of treated fistula (compared to 12% for placebo). However, treatment success is frequently limited to a short time period of 3 month \\[9, 10\\]: 34% of all fistula patients experience recurrent fistula despite therapy \\[6\\] and successful treatment is limited to one third patients. For these reasons, up to 82% of all fistula need surgical treatment. Surgical options include non-cutting setons, application of fibrin glue as a "fistula plug", ligation of the intersphincteric fistula tract (LIFT) and reparative surgery including mucosal advancement flaps. However, surgical therapy for fistula patients can be complicated by slow wound healing, recurrent disease and additional problems \\[11\\].\n\nCombined medical and surgical treatment for patients with fistula and CD can significantly improve clinical outcomes \\[12-15\\]. However, the best combination of clinical and surgical methods has yet to be determined \\[16\\]. Open questions include timing of seton removal and outcomes of the various surgical procedures for different patient groups.\n\nAt the University Hospital Zurich (USZ) the investigators recently started a combined surgical and gastroenterological clinic for patients with fistula. In the new clinic patients are seen by gastroenterologists and surgeons and the investigators are aiming for joint treatment decisions. Due to this combination of expertise and improved access to gastroenterological and surgical resources the investigators are expecting better treatment results for the patients and improved satisfaction for patients and referring physicians.\n\nWith the current study the investigators want to achieve the following objectives:\n\n* Continuous monitoring of the quality of medical and surgical treatment\n* Determining the outcome of various fistula therapies and calculating risk factors for a favorable and unfavorable outcome\n* Understanding the natural history of perianal fistula and calculate risk factors for a favorable and unfavorable outcome.\n\nThe investigators are therefore proposing a pro- and retrospective database containing data regarding the clinical history, patient symptoms, examinations, lab values as well as other parameters. The database will be used for quality management regarding the daily work at USZ and to improve understanding regarding treatment options and the natural history of fistula. The investigators expect significant benefits for future patients from their analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with fistulae', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fistula\n* written informed consent\n\nExclusion Criteria:\n\n* age under 18\n* retrospective analysis: documented rejection of clinical research'}, 'identificationModule': {'nctId': 'NCT03003351', 'briefTitle': 'Zurich Fistula Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2016-00367'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fistula', 'description': "Patients with Fistulaê that are not caused by Crohn's disease"}, {'label': "Fistula and Crohn's disease", 'description': "Patients with Fistulae that are caused by underlying Crohn's disease"}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Division of Gastroenterology, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Benjamin Misselwitz, MD', 'role': 'CONTACT', 'email': 'benjamin.misselwitz@usz.ch', 'phone': '++41442552645'}, {'name': 'Gerhard Rogler, MD PhD', 'role': 'CONTACT', 'email': 'gerhard.rogler@usz.ch', 'phone': '++41 44 255 9519'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin Misselwitz', 'investigatorAffiliation': 'University of Zurich'}}}}