Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
Seton Placement vs. Surgisis Anal Fistula Plug Insertion for Perirectal Fistula: A Prospective Randomized Study
2 other identifiers
interventional
300
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2007
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 20, 2007
CompletedFirst Posted
Study publicly available on registry
March 22, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2013
CompletedMarch 17, 2017
March 1, 2017
March 20, 2007
March 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fistula healing
Treatment failure
Secondary Outcomes (3)
Time to fistula healing
Time to treatment failure
Rates of postoperative fecal continence
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant patients
- Patients with a tumor-related fistula
- Patients with known allergies to porcine products
- Patients with known Crohn's disease
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
H.Claude Hudson Comprehensive Health Center
Los Angeles, California, 90007, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
USC/University Hospital
Los Angeles, California, 90033, United States
Related Publications (3)
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.
PMID: 16258708BACKGROUNDChampagne 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.
PMID: 17082891BACKGROUNDJohnson 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.
PMID: 16421664BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas M Kaiser, MD
University of Southern California Department of Colorectal Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2007
First Posted
March 22, 2007
Study Start
February 1, 2007
Study Completion
May 9, 2013
Last Updated
March 17, 2017
Record last verified: 2017-03