This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).
Study Type
OBSERVATIONAL
Enrollment
50
Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.
The Colorectal Institute
Fort Myers, Florida, United States
RECRUITINGWeill Cornell Medicine
New York, New York, United States
RECRUITINGNorthwell Health
Staten Island, New York, United States
Successful Closure Repair
Successful closure repair of the anal fistula as determined by complete healing, i.e., internal and external opening closed (no evidence of an external opening present) without drainage
Time frame: 12 Months
Non-Recurrence Incidence
Non-recurrence incidence determined by continued closure of the external fistula opening.
Time frame: 24 and 36 Months
Fecal Incontinence Quality of Life
Fecal incontinence Quality of Life (FIQL) score at each follow-up visit (baseline visit and from 6-month and at subsequent follow-up visit) The FIQL score includes 29 items which form four scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment. The FIQL scale range includes a range of response options across its items, from 1 to 4 for most items, 1 to 5 for one item, and 1 to 6 for another. Lower scores indicate lower quality of life.
Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Fecal Incontinence Severity Index (FISI)
Fecal Incontinence Severity Index (FISI) at each follow-up visit (baseline visit and from 6-month and at each subsequent follow-up visit). The Fecal Incontinence Severity Index (FISI) Scale typically ranges from 0 to a maximum value 61. Higher scores on the FISI scale indicate a worse outcome, reflecting greater severity of fecal incontinence symptoms.
Time frame: 6 Month, 9 Month, 12 Month, 24 Month, 36 Month
Health Related Quality of Life
SF-36 Quality of life data will be collected (baseline visit and from 6-month and at each subsequent follow-up visit). Short Form 36 (SF-36) is a generic self-reported outcome measure that quantifies the quality of life in relation to health status. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. The scores range from 0-100 (the worst possible to the most possible)
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Maininle Health Lankenau
Bryn Mawr, Pennsylvania, United States
RECRUITINGGeisinger
Danville, Pennsylvania, United States
RECRUITINGTime frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Pain Score
Wong-Baker FACES Pain scores will be recorded at each follow-up visit (baseline visit and from 6-month and at each subsequent follow-up visit). The FACES Pain Scale ranges from 0 (no pain) to 10 (the worst pain).
Time frame: 6 Months, 9 Months, 12 Months, 24 Months, 36 Months
Rescue Analgesic and Therapeutic Antibiotic Use
Occurrence of use of rescue analgesic and/or therapeutic antibiotics beyond post-operative Day 5 after the surgery and at each follow-up visit.
Time frame: 6 Weeks, 3 Months, 6 Months, 9 Months, 12 Months, 24 Months, 36 Months