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Anal Fistula Plug Versus Endorectal Advancement Flap (AFPERAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931371
Recruitment Status : Unknown
Verified August 2013 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

Condition or disease Intervention/treatment Phase
Anal Fistula Procedure: Anal Fistula Plug Procedure: Endorectal Advancement Flap Not Applicable

Detailed Description:
A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
Study Start Date : May 2007
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Active Comparator: Recurrent anal fistula
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Procedure: Anal Fistula Plug
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
Other Name: Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)

Procedure: Endorectal Advancement Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
Other Name: Advancement Mucosa Flap

Active Comparator: No recurrence of anal fistula
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Procedure: Anal Fistula Plug
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
Other Name: Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)

Procedure: Endorectal Advancement Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
Other Name: Advancement Mucosa Flap




Primary Outcome Measures :
  1. Anal fistula recurrence rate [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Cost [ Time Frame: 3 days ]
    In-hospital costs. Typically 1 to 3 days of hospitalization

  2. Complication rate [ Time Frame: 3 days ]
    Classified according to the Clavien-Dindo Classification of Surgical Complications.

  3. Length of hospital stay [ Time Frame: 3 days ]
    Typically 1 to 3 days of hospitalization.

  4. Independent factors predicting fistula recurrence [ Time Frame: One year ]
    Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.

  5. Independent factors predicting higher costs [ Time Frame: One year ]
    Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18 years of age or more)
  • Single anal fistula
  • Surgically treated with anal fistula plug or endorectal advancement flap

Exclusion Criteria:

  • Children or adolescents
  • Pregnancy
  • Patients treated with setons alone

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): NCT01931371


Locations
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Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Oliver M Fisher, MD University of Zurich
Study Chair: Antonio Nocito, MD University of Zurich
Publications:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01931371    
Other Study ID Numbers: AFPERAF
KEK-ZH-Nr. 2013-XYZ ( Other Identifier: Cantonal Ethical Committee Canton of Zurich )
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013
Keywords provided by University of Zurich:
fistula in ano
anal fistula
recurrence
costs
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases