Zurich Fistula Cohort Study
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|ClinicalTrials.gov Identifier: NCT03003351|
Recruitment Status : Unknown
Verified December 2016 by Benjamin Misselwitz, University of Zurich.
Recruitment status was: Not yet recruiting
First Posted : December 28, 2016
Last Update Posted : December 28, 2016
|Condition or disease|
|Fistula;Rectal Fistula; Rectouterine Fistula; Rectovesical Fistulas Recto Vaginal Crohn Disease|
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 . 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  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 .
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 . 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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
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
- Change in Perianal disease activity index (PDAI) [ Time Frame: 6 months after intervention ]
- Change in Fistula Drainage assessment [ Time Frame: 3, 6 & 12months after intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003351
|Contact: Benjamin Misselwitz, MDemail@example.com|
|Contact: Gerhard Rogler, MD PhD||++41 44 255 firstname.lastname@example.org|
|Division of Gastroenterology, University Hospital Zurich|
|Zurich, Switzerland, 8091|