Clinical Trial: Zurich Fistula Cohort Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study

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.

Detailed Summary:

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
Sponsor: University of Zurich

Current Primary Outcome: Change in Perianal disease activity index (PDAI) [ Time Frame: 6 months after intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in Fistula Drainage assessment [ Time Frame: 3, 6 & 12months after intervention ]

Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: December 19, 2016
Date Started: January 2017
Date Completion: January 2019
Last Updated: December 21, 2016
Last Verified: December 2016