Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia
Completed
- Conditions
- Anal Fistula
- Interventions
- Device: Anal Fistula Plug (SurgiSIS AFP)
- Registration Number
- NCT00703131
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Anal Fistula Plug (SurgiSIS AFP) Anal Fistula Plug
- Primary Outcome Measures
Name Time Method Healing Success 12 months
- Secondary Outcome Measures
Name Time Method Change in Quality of Life Measures 3, 6, and 12 months
Trial Locations
- Locations (1)
King Khalid University Hospital
🇸🇦Riyadh, Saudi Arabia