BioHealx® Anal Fistula Device Post Market Surveillance Study

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

Non-Recurrence Incidence

Non-recurrence incidence determined by continued closure of the external fistula opening.

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.

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.

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)

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).

Device and Procedure Related Adverse Events

Measurement of device and/or procedure related adverse events will be recorded.

Adverse Event Comparison

Measurement of, incidence, severity and persistence of device and/or procedure related adverse events will be recorded and compared with previous BioHealx Anal Fistula Device clinical results and relevant comparator devices (e.g. cutting seton) and procedures (e.g., LIFT).

Occurrence of Fecal Incontinence

Fecal continence will be measured through combination of the patient reported Fecal Incontinence Quality of Life questionnaire (FIQL) and the Fecal Incontinence Severity Index questionnaire (FISI) scores at baseline and subsequent periods. 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. 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.

Rescue Analgesic and Therapeutic Antibiotic Comparison

Rescue analgesic and therapeutic antibiotic use will be recorded and compared with previous BioHealx Anal Fistula Device clinical results and other relevant fistula treatments.