A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
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|ClinicalTrials.gov Identifier: NCT02423330|
Recruitment Status : Unknown
Verified April 2016 by Marc Singer, Rush University Medical Center.
Recruitment status was: Recruiting
First Posted : April 22, 2015
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anal Fistula Rectal Fistula Fistula in Ano Transsphincteric Fistula||Device: Strattice-LIFT||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||January 2017|
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423330
|Contact: Marc Singer, MDemail@example.com|
|Contact: Karen Ohara||(312) 942-3717||Karen_Ohara@Rush.edu|