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

Early Phase 1

Terminated

• Conditions: Fistula in Ano; Anal Fistula; Rectal Fistula; Transsphincteric Fistula
• Interventions: Device: Strattice-LIFT

• Registration Number: NCT02423330
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-22
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Strattice-LIFT	Strattice-LIFT	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States