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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Rush University Medical Center

Current Primary Outcome: Healing of the anal fistula [ Time Frame: 6 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Healing of the anal fistula [ Time Frame: 1 year ]
    Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
  • Postoperative Pain [ Time Frame: 1 year ]
    Postoperative pain will be assessed at each postoperative visit with a visual analog scale
  • Complications [ Time Frame: 1 year ]
    Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence


Original Secondary Outcome: Same as current

Information By: Rush University Medical Center

Dates:
Date Received: April 17, 2015
Date Started: March 2015
Date Completion:
Last Updated: April 8, 2016
Last Verified: April 2016