Anal Fistula
Conditions
Keywords
Fistula-in-ano, Anal fistula, Perirectal fistula, Collagen plug, Surgisis, Seton
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.
Interventions
PROCEDURECollagen Plug Placement
PROCEDURESeton placement
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula healing | — |
| Treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to fistula healing | — |
| Time to treatment failure | — |
| Rates of postoperative fecal continence | — |
Countries
United States
Outcome results
None listed