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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02423330
• Other study ID #: 14072904
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: September 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Fistula in Ano
• Rectal Fistula
• Transsphincteric Fistula

Intervention

Device:
• Strattice-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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	1 year
Secondary	Postoperative Pain	Postoperative pain will be assessed at each postoperative visit with a visual analog scale	1 year
Secondary	Complications	Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence	1 year