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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Marc Singer, Rush University Medical Center

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

Condition or disease Intervention/treatment Phase
Anal Fistula Rectal Fistula Fistula in Ano Transsphincteric Fistula Device: Strattice-LIFT Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
Study Start Date : March 2015
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Strattice-LIFT 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Postoperative Pain [ Time Frame: 1 year ]
    Postoperative pain will be assessed at each postoperative visit with a visual analog scale

  3. Complications [ Time Frame: 1 year ]
    Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Marc Singer, MD 3129427088 marc_singer@rush.edu
Contact: Karen Ohara (312) 942-3717 Karen_Ohara@Rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Marc Singer, MD    312-942-7088    marc_singer@rush.edu   
Contact: Karen Ohara    312-942-3717    Karen_Ohara@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
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Responsible Party: Marc Singer, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02423330    
Other Study ID Numbers: 14072904
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases