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Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

Primary Purpose

Anal Fistula

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Collagen Plug Placement
Seton placement
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring Fistula-in-ano, Anal fistula, Perirectal fistula, Collagen plug, Surgisis, Seton

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group
  2. Patients that are older than 18 years of age and are able to understand and sign consent
  3. Patients that are suitable candidates for either seton or collagen plug placement

Exclusion Criteria:

  1. Preoperative patient exclusion factors:

    • Pregnant patients
    • Patients with a tumor-related fistula
    • Patients with known allergies to porcine products
    • Patients with known Crohn's disease

  2. Intraoperative patient exclusion factors:

    • Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery
    • Patients with a large diameter fistula (>3mm)
    • Patients with a superficial fistula
    • Patients with a short fistula (<1 cm in length)

Sites / Locations

  • H.Claude Hudson Comprehensive Health Center
  • Los Angeles County-USC Medical Center
  • USC Norris Cancer Center
  • USC/University Hospital

Outcomes

Primary Outcome Measures

Fistula healing
Treatment failure

Secondary Outcome Measures

Time to fistula healing
Time to treatment failure
Rates of postoperative fecal continence

Full Information

First Posted
March 20, 2007
Last Updated
March 15, 2017
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00450671
Brief Title
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
Official Title
Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 9, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.
Detailed Description
Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue). Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method. The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.

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, Perirectal fistula, Collagen plug, Surgisis, Seton

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Collagen Plug Placement
Intervention Type
Procedure
Intervention Name(s)
Seton placement
Primary Outcome Measure Information:
Title
Fistula healing
Title
Treatment failure
Secondary Outcome Measure Information:
Title
Time to fistula healing
Title
Time to treatment failure
Title
Rates of postoperative fecal continence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group Patients that are older than 18 years of age and are able to understand and sign consent Patients that are suitable candidates for either seton or collagen plug placement Exclusion Criteria: Preoperative patient exclusion factors: Pregnant patients Patients with a tumor-related fistula Patients with known allergies to porcine products Patients with known Crohn's disease Intraoperative patient exclusion factors: Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery Patients with a large diameter fistula (>3mm) Patients with a superficial fistula Patients with a short fistula (<1 cm in length)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas M Kaiser, MD
Organizational Affiliation
University of Southern California Department of Colorectal Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
H.Claude Hudson Comprehensive Health Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16258708
Citation
Zmora O, Neufeld D, Ziv Y, Tulchinsky H, Scott D, Khaikin M, Stepansky A, Rabau M, Koller M. Prospective, multicenter evaluation of highly concentrated fibrin glue in the treatment of complex cryptogenic perianal fistulas. Dis Colon Rectum. 2005 Dec;48(12):2167-72. doi: 10.1007/s10350-005-0199-1.
Results Reference
background
PubMed Identifier
17082891
Citation
Champagne BJ, O'Connor LM, Ferguson M, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum. 2006 Dec;49(12):1817-21. doi: 10.1007/s10350-006-0755-3.
Results Reference
background
PubMed Identifier
16421664
Citation
Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. doi: 10.1007/s10350-005-0288-1.
Results Reference
background

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Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

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