Anal Fistula, Fistula in Ano, Rectal Fistula, Transsphincteric Fistula
Conditions
Brief summary
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
Detailed 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.
Interventions
DEVICEStrattice-LIFT
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.
Sponsors
Rush University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of the anal fistula | 6 months | Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing of the anal fistula | 1 year | Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening |
| Postoperative Pain | 1 year | Postoperative pain will be assessed at each postoperative visit with a visual analog scale |
| Complications | 1 year | Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence |
Countries
United States
Outcome results
None listed