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Anal Fistula Plug Versus Endorectal Advancement Flap (AFPERAF)

Primary Purpose

Anal Fistula

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Anal Fistula Plug
Endorectal Advancement Flap
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring fistula in ano, anal fistula, recurrence, costs

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Recurrent anal fistula

No recurrence of anal fistula

Arm Description

Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap

Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap

Outcomes

Primary Outcome Measures

Anal fistula recurrence rate

Secondary Outcome Measures

Cost
In-hospital costs. Typically 1 to 3 days of hospitalization
Complication rate
Classified according to the Clavien-Dindo Classification of Surgical Complications.
Length of hospital stay
Typically 1 to 3 days of hospitalization.
Independent factors predicting fistula recurrence
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
Independent factors predicting higher costs
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.

Full Information

First Posted
August 5, 2013
Last Updated
August 22, 2013
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01931371
Brief Title
Anal Fistula Plug Versus Endorectal Advancement Flap
Acronym
AFPERAF
Official Title
An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
fistula in ano, anal fistula, recurrence, costs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recurrent anal fistula
Arm Type
Active Comparator
Arm Description
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Arm Title
No recurrence of anal fistula
Arm Type
Active Comparator
Arm Description
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Intervention Type
Procedure
Intervention Name(s)
Anal Fistula Plug
Other Intervention Name(s)
Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
Intervention Description
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
Intervention Type
Procedure
Intervention Name(s)
Endorectal Advancement Flap
Other Intervention Name(s)
Advancement Mucosa Flap
Intervention Description
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
Primary Outcome Measure Information:
Title
Anal fistula recurrence rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Cost
Description
In-hospital costs. Typically 1 to 3 days of hospitalization
Time Frame
3 days
Title
Complication rate
Description
Classified according to the Clavien-Dindo Classification of Surgical Complications.
Time Frame
3 days
Title
Length of hospital stay
Description
Typically 1 to 3 days of hospitalization.
Time Frame
3 days
Title
Independent factors predicting fistula recurrence
Description
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
Time Frame
One year
Title
Independent factors predicting higher costs
Description
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver M Fisher, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Nocito, MD
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19733880
Citation
Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6.
Results Reference
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PubMed Identifier
19638912
Citation
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Results Reference
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Anal Fistula Plug Versus Endorectal Advancement Flap

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