Fistula;RectalNCT03003351
Zurich Fistula Cohort Study
An observational study of Fistula;Rectal and Fistula; Rectouterine, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula;Rectal, Fistula; Rectouterine, Fistula; Rectovesical
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with fistulae
Who may be able to join
- Fistula
- written informed consent
Who cannot join
- age under 18
- retrospective analysis: documented rejection of clinical research
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Gastroenterology, University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study
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.
Read the detailed description
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].
Patients 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].
Combined 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.
At 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.
With the current study the investigators want to achieve the following objectives:
- Continuous monitoring of the quality of medical and surgical treatment
- Determining the outcome of various fistula therapies and calculating risk factors for a favorable and unfavorable outcome
- Understanding the natural history of perianal fistula and calculate risk factors for a favorable and unfavorable outcome.
The 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.
- Conditions
- Fistula;Rectal, Fistula; Rectouterine, Fistula; Rectovesical, Fistulas Recto Vaginal, Crohn Disease
- Keywords
- Fistula, Cohort Study
- Medical subject headings
- Rectal Fistula, Fistula, Rectovaginal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perianal disease activity index (PDAI)
Measured: 6 months after intervention
Secondary outcomes (1)
Change in Fistula Drainage assessment
Measured: 3, 6 & 12months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Fistula;RectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Misselwitz, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003351
- Sponsor's protocol ID
- KEK-ZH-Nr. 2016-00367
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 7429313Michelassi 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.
PubMed 8239781Solomon MJ. Fistulae and abscesses in symptomatic perianal Crohn's disease. Int J Colorectal Dis. 1996;11(5):222-6. doi: 10.1007/s003840050051.
PubMed 8951512Allan 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.
PubMed 3293326Bell 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.
PubMed 12752351Loftus 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.
PubMed 11856078Loftus 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.
PubMed 9609752Givel 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.
PubMed 6886354Bell 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.
PubMed 10792111Present 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.
PubMed 10228190Schwartz 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.
PubMed 11910338Hyder 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.
PubMed 17041753Gaertner 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.
PubMed 17899271Topstad 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.
PubMed 12792431Regueiro 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.
PubMed 12769443
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03003351
- Acronym / sponsor ID
- KEK-ZH-Nr. 2016-00367
- Conditions
- Fistula;Rectal, Fistula; Rectouterine, Fistula; Rectovesical, Fistulas Recto Vaginal, Crohn Disease
- Keywords
- Fistula, Cohort Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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].
Patients 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].
Combined 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.
At 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.
With the current study the investigators want to achieve the following objectives:
- Continuous monitoring of the quality of medical and surgical treatment
- Determining the outcome of various fistula therapies and calculating risk factors for a favorable and unfavorable outcome
- Understanding the natural history of perianal fistula and calculate risk factors for a favorable and unfavorable outcome.
The 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.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fistulae
Key inclusion criteria (2 listed)
- Fistula
- written informed consent
Key exclusion criteria (2 listed)
- age under 18
- retrospective analysis: documented rejection of clinical research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Perianal disease activity index (PDAI)
Time frame: 6 months after intervention
1 secondary outcome
Change in Fistula Drainage assessment
Time frame: 3, 6 & 12months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Background: PubMed 7429313Hellers 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.
- Background: PubMed 8239781Michelassi 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.
- Background: PubMed 8951512Solomon MJ. Fistulae and abscesses in symptomatic perianal Crohn's disease. Int J Colorectal Dis. 1996;11(5):222-6. doi: 10.1007/s003840050051.
- Background: PubMed 3293326Allan 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.
- Background: PubMed 12752351Bell 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.
- Background: PubMed 11856078Loftus 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.
- Background: PubMed 9609752Loftus 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.
- Background: PubMed 6886354Givel 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.
- Background: PubMed 10792111Bell 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.
- Background: PubMed 10228190Present 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.
- Background: PubMed 11910338Schwartz 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.
- Background: PubMed 17041753Hyder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula;Rectal and Fistula; Rectouterine, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Misselwitz, MD (++41442552645, benjamin.misselwitz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perianal disease activity index (PDAI) (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003351, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.