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

Early Phase 1TerminatedNCT02423330

Rush University Medical Center1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anal Fistula Rectal Fistula Fistula in Ano Transsphincteric Fistula

Interventions

Strattice-LIFTDEVICE

Patients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Healing of the anal fistula

Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening

Time frame: 6 months

Secondary Outcomes

Healing of the anal fistula

Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening

Time frame: 1 year

Postoperative Pain

Postoperative pain will be assessed at each postoperative visit with a visual analog scale

Time frame: 1 year

Complications

Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence

Time frame: 1 year

Data from ClinicalTrials.gov

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