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

Rush

Status and phase: Terminated; Early Phase 1

Conditions: Rectal Fistula; Transsphincteric Fistula; Fistula in Ano; Anal Fistula

Treatments: Device: Strattice-LIFT

Study type: Interventional

Funder types: Other

Identifiers

NCT02423330

14072904

Details and patient eligibility

About

This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Strattice-LIFT

Experimental group

Treatment:

Device: Strattice-LIFT