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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
Sponsor:
Information provided by (Responsible Party):
Benjamin Misselwitz, University of Zurich

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.

Condition or disease
Fistula;Rectal Fistula; Rectouterine Fistula; Rectovesical Fistulas Recto Vaginal Crohn Disease

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with fistulae
Criteria

Inclusion Criteria:

  • Fistula
  • written informed consent

Exclusion Criteria:

  • age under 18
  • retrospective analysis: documented rejection of clinical research

Information from the National Library of Medicine

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


Contacts
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Contact: Benjamin Misselwitz, MD ++41442552645 benjamin.misselwitz@usz.ch
Contact: Gerhard Rogler, MD PhD ++41 44 255 9519 gerhard.rogler@usz.ch

Locations
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Switzerland
Division of Gastroenterology, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Publications:

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Responsible Party: Benjamin Misselwitz, Principal Investigator, University of Zurich
ClinicalTrials.gov Identifier: NCT03003351    
Other Study ID Numbers: KEK-ZH-Nr. 2016-00367
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Benjamin Misselwitz, University of Zurich:
Fistula
Cohort Study
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Rectovaginal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases
Vaginal Fistula
Vaginal Diseases