Zurich Fistula Cohort Study
Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedDecember 28, 2016
December 1, 2016
2 years
December 19, 2016
December 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Perianal disease activity index (PDAI)
6 months after intervention
Secondary Outcomes (1)
Change in Fistula Drainage assessment
3, 6 & 12months after intervention
Study Arms (2)
Fistula
Patients with Fistulaê that are not caused by Crohn's disease
Fistula and Crohn's disease
Patients with Fistulae that are caused by underlying Crohn's disease
Eligibility Criteria
Patients with fistulae
You may qualify if:
- Fistula
- written informed consent
You may not qualify if:
- age under 18
- retrospective analysis: documented rejection of clinical research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology, University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (20)
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: 7429313BACKGROUNDMichelassi 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: 8239781BACKGROUNDSolomon MJ. Fistulae and abscesses in symptomatic perianal Crohn's disease. Int J Colorectal Dis. 1996;11(5):222-6. doi: 10.1007/s003840050051.
PMID: 8951512BACKGROUNDAllan 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: 3293326BACKGROUNDBell 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: 12752351BACKGROUNDLoftus 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: 11856078BACKGROUNDLoftus 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: 9609752BACKGROUNDGivel 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: 6886354BACKGROUNDBell 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: 10792111BACKGROUNDPresent 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: 10228190BACKGROUNDSchwartz 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: 11910338BACKGROUNDHyder 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: 17041753BACKGROUNDGaertner 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: 17899271BACKGROUNDTopstad 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: 12792431BACKGROUNDRegueiro 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: 12769443BACKGROUNDMarzo 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: 25663759BACKGROUNDIrvine 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: 7884173BACKGROUNDSostegni 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: 12786607BACKGROUNDVaizey 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: 9862829BACKGROUNDHarvey 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.
PMID: 6102236BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 19, 2016
First Posted
December 28, 2016
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
December 28, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share