Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

Cook Group Incorporated35 enrolled

Overview

The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.

Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anal Fistula

Interventions

Anal Fistula Plug (SurgiSIS AFP)DEVICE

Anal Fistula Plug

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old or older * Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric * Signed informed consent * Willing to return for follow-up visits Exclusion Criteria: * Crohn's Disease * Ulcerative Colitis * HIV Positive * Immune System Disorder * Collagen Disorder * Tuberculosis * History of radiation to anorectal region * Allergies to pig tissue * Religious or cultural objection to use of pig tissue in this surgical application * J-pouch fistulas * Previous Surgisis AFP Plug placement in target fistula tract * Tracts with acute abscess, infection or inflammation * Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy

Locations (1)

King Khalid University Hospital

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Healing Success

Time frame: 12 months

Secondary Outcomes

Change in Quality of Life Measures

Time frame: 3, 6, and 12 months

Data from ClinicalTrials.gov

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