A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula

The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly
effective, but carries a significant risk of postoperative incontinence. A variety of
surgical procedures that do not divide the sphincter muscle may be offered to patients,
however none of them are as effective as fistulotomy.

The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the
treatment of transsphincteric fistulas. Initial results have been promising. However, some
fistulas recur after the LIFT procedure because the divided ends of the fistula tract
recanalize. Insertion of a barrier into the intersphincteric space may prevent this process.
Strattice is acellular porcine dermis, will be used for this purpose.

This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure
for the treatment of transsphincteric anal fistulas.

Inclusion Criteria:

1. Subject is 22 years of age or older

2. Subject is willing to comply with study related procedures

3. Subject is not pregnant

4. Subject has a transsphincteric fistula

5. Subject is medically fit to undergo LIFT

6. Subject has a draining seton for a minimum of 6 weeks

Exclusion Criteria:

1. Crohn's disease

2. Pelvic radiation treatment

3. Known or suspected HIV/AIDS

4. Known sensitivity to pork products

5. Abscess or fistula etiology other than cryptoglandular

6. Abdominal malignancies

7. Patients with <1 year life expectancy

8. History of smoking

9. Known anorectal dysfunction (fecal incontinence)

10. Chronic use of steroids or other agents which may affect wound healing

11. ASA ≥ 2

12. Unable to consent to study

13. Unable to complete 1 year follow up