<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003351</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2016-00367</org_study_id>
    <nct_id>NCT03003351</nct_id>
  </id_info>
  <brief_title>Zurich Fistula Cohort Study</brief_title>
  <official_title>Assessment of the Natural History and Treatment Outcomes for Patients With Fistula - a Pro- and Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <brief_summary>
    <textblock>
      This is a pro- and retrospective cohort study to evaluate the natural history and outcome of&#xD;
      various treatment options of patients with fistula. At each clinical visit parameters&#xD;
      describing activity of a fistula, potential underlying Crohn's disease, investigations as&#xD;
      well as the current treatment will be entered into a database. Selected patients can also be&#xD;
      contacted by phone in the form of a structured interview. Data will be analyzed to determine&#xD;
      treatment outcomes, characterize the natural history as well as risk factors for&#xD;
      complications of treatment and an unfavorable disease course. The same data will be obtained&#xD;
      and analyzed retrospectively from patients who visited the clinic prior to January 2017.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fistulizing disease remains a frequent and severe problem for patients with Crohn's disease&#xD;
      (CD). Life-time prevalence of fistula for patients with CD has been estimated to be 17 - 50%&#xD;
      [1-5] with a cumulative incidence of 33% and 50% after 10 years and 20 years disease&#xD;
      duration, respectively. These numbers have been confirmed by population-based studies [6, 7].&#xD;
&#xD;
      Patients with CD and fistula have a decreased quality of life. Reasons include perianal pain,&#xD;
      discharge from the vagina, abdominal wall, perianal region and urinary tract infections.&#xD;
      Fistula are frequently associated with abscess formation [8]. Unfortunately, surgical and&#xD;
      medical treatment options for fistula for CD patients remain limited. Treatment with the&#xD;
      tumor-necrosis factor (TNF) antibody infliximab remains the best medical treatment option&#xD;
      available: At least temporary fistula closure is observed for 55% of treated fistula&#xD;
      (compared to 12% for placebo). However, treatment success is frequently limited to a short&#xD;
      time period of 3 month [9, 10]: 34% of all fistula patients experience recurrent fistula&#xD;
      despite therapy [6] and successful treatment is limited to one third patients. For these&#xD;
      reasons, up to 82% of all fistula need surgical treatment. Surgical options include&#xD;
      non-cutting setons, application of fibrin glue as a &quot;fistula plug&quot;, ligation of the&#xD;
      intersphincteric fistula tract (LIFT) and reparative surgery including mucosal advancement&#xD;
      flaps. However, surgical therapy for fistula patients can be complicated by slow wound&#xD;
      healing, recurrent disease and additional problems [11].&#xD;
&#xD;
      Combined medical and surgical treatment for patients with fistula and CD can significantly&#xD;
      improve clinical outcomes [12-15]. However, the best combination of clinical and surgical&#xD;
      methods has yet to be determined [16]. Open questions include timing of seton removal and&#xD;
      outcomes of the various surgical procedures for different patient groups.&#xD;
&#xD;
      At the University Hospital Zurich (USZ) the investigators recently started a combined&#xD;
      surgical and gastroenterological clinic for patients with fistula. In the new clinic patients&#xD;
      are seen by gastroenterologists and surgeons and the investigators are aiming for joint&#xD;
      treatment decisions. Due to this combination of expertise and improved access to&#xD;
      gastroenterological and surgical resources the investigators are expecting better treatment&#xD;
      results for the patients and improved satisfaction for patients and referring physicians.&#xD;
&#xD;
      With the current study the investigators want to achieve the following objectives:&#xD;
&#xD;
        -  Continuous monitoring of the quality of medical and surgical treatment&#xD;
&#xD;
        -  Determining the outcome of various fistula therapies and calculating risk factors for a&#xD;
           favorable and unfavorable outcome&#xD;
&#xD;
        -  Understanding the natural history of perianal fistula and calculate risk factors for a&#xD;
           favorable and unfavorable outcome.&#xD;
&#xD;
      The investigators are therefore proposing a pro- and retrospective database containing data&#xD;
      regarding the clinical history, patient symptoms, examinations, lab values as well as other&#xD;
      parameters. The database will be used for quality management regarding the daily work at USZ&#xD;
      and to improve understanding regarding treatment options and the natural history of fistula.&#xD;
      The investigators expect significant benefits for future patients from their analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Perianal disease activity index (PDAI)</measure>
    <time_frame>6 months after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fistula Drainage assessment</measure>
    <time_frame>3, 6 &amp; 12months after intervention</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fistula;Rectal</condition>
  <condition>Fistula; Rectouterine</condition>
  <condition>Fistula; Rectovesical</condition>
  <condition>Fistulas Recto Vaginal</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Fistula</arm_group_label>
    <description>Patients with Fistulaê that are not caused by Crohn's disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fistula and Crohn's disease</arm_group_label>
    <description>Patients with Fistulae that are caused by underlying Crohn's disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with fistulae&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fistula&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18&#xD;
&#xD;
          -  retrospective analysis: documented rejection of clinical research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Benjamin Misselwitz, MD</last_name>
    <phone>++41442552645</phone>
    <email>benjamin.misselwitz@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gerhard Rogler, MD PhD</last_name>
    <phone>++41 44 255 9519</phone>
    <email>gerhard.rogler@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Gastroenterology, University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>7429313</PMID>
  </reference>
  <reference>
    <citation>Michelassi 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.</citation>
    <PMID>8239781</PMID>
  </reference>
  <reference>
    <citation>Solomon MJ. Fistulae and abscesses in symptomatic perianal Crohn's disease. Int J Colorectal Dis. 1996;11(5):222-6. doi: 10.1007/s003840050051.</citation>
    <PMID>8951512</PMID>
  </reference>
  <reference>
    <citation>Allan 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.</citation>
    <PMID>3293326</PMID>
  </reference>
  <reference>
    <citation>Bell 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.</citation>
    <PMID>12752351</PMID>
  </reference>
  <reference>
    <citation>Loftus 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.</citation>
    <PMID>11856078</PMID>
  </reference>
  <reference>
    <citation>Loftus 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. Erratum In: Gastroenterology 1999 Jun;116(6):1507.</citation>
    <PMID>9609752</PMID>
  </reference>
  <reference>
    <citation>Givel 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.</citation>
    <PMID>6886354</PMID>
  </reference>
  <reference>
    <citation>Bell 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.</citation>
    <PMID>10792111</PMID>
  </reference>
  <reference>
    <citation>Present 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.</citation>
    <PMID>10228190</PMID>
  </reference>
  <reference>
    <citation>Schwartz 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.</citation>
    <PMID>11910338</PMID>
  </reference>
  <reference>
    <citation>Hyder 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.</citation>
    <PMID>17041753</PMID>
  </reference>
  <reference>
    <citation>Gaertner 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.</citation>
    <PMID>17899271</PMID>
  </reference>
  <reference>
    <citation>Topstad 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.</citation>
    <PMID>12792431</PMID>
  </reference>
  <reference>
    <citation>Regueiro 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.</citation>
    <PMID>12769443</PMID>
  </reference>
  <reference>
    <citation>Marzo 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.</citation>
    <PMID>25663759</PMID>
  </reference>
  <reference>
    <citation>Irvine 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.</citation>
    <PMID>7884173</PMID>
  </reference>
  <reference>
    <citation>Sostegni 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.</citation>
    <PMID>12786607</PMID>
  </reference>
  <reference>
    <citation>Vaizey 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.</citation>
    <PMID>9862829</PMID>
  </reference>
  <reference>
    <citation>Harvey 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.</citation>
    <PMID>6102236</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Benjamin Misselwitz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fistula</keyword>
  <keyword>Cohort Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Rectal Fistula</mesh_term>
    <mesh_term>Rectovaginal Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003351
org study id: KEK-ZH-Nr. 2016-00367
nct id: NCT03003351
lead sponsor: 
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.
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.
observational model: Cohort
measure: Change in Perianal disease activity index (PDAI)
time frame: 6 months after intervention
measure: Change in Fistula Drainage assessment
time frame: 3, 6 & 12months after intervention
arm group label: Fistula
description: Patients with Fistulaê that are not caused by Crohn's disease
arm group label: Fistula and Crohn's disease
description: Patients with Fistulae that are caused by underlying Crohn's disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Misselwitz, MD
phone: ++41442552645
email: benjamin.misselwitz@usz.ch
last name: Gerhard Rogler, MD PhD
phone: ++41 44 255 9519
email: gerhard.rogler@usz.ch
facility: 
country: Switzerland
citation: 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: 7429313
citation: Michelassi 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: 8239781
citation: Solomon MJ. Fistulae and abscesses in symptomatic perianal Crohn's disease. Int J Colorectal Dis. 1996;11(5):222-6. doi: 10.1007/s003840050051.
PMID: 8951512
citation: Allan 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: 3293326
citation: Bell 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: 12752351
citation: Loftus 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: 11856078
citation: Loftus 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. Erratum In: Gastroenterology 1999 Jun;116(6):1507.
PMID: 9609752
citation: Givel 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: 6886354
citation: Bell 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: 10792111
citation: Present 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: 10228190
citation: Schwartz 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: 11910338
citation: Hyder 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: 17041753
citation: Gaertner 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: 17899271
citation: Topstad 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: 12792431
citation: Regueiro 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: 12769443
citation: Marzo 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: 25663759
citation: Irvine 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: 7884173
citation: Sostegni 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: 12786607
citation: Vaizey 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: 9862829
citation: Harvey 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: 6102236
responsible party type: Principal Investigator
investigator affiliation: University of Zurich
investigator full name: Benjamin Misselwitz
investigator title: Principal Investigator
mesh term: Crohn Disease
mesh term: Rectal Fistula
mesh term: Rectovaginal Fistula
mesh term: Fistula
sharing ipd: No