Anal Fistula
Conditions
Keywords
Anal fistula, fistula in ano, anorectal fistula
Brief summary
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
Interventions
DEVICESurgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia.
DEVICEFlap
Advancement flap surgery is performed; no anal fistula plug is placed
Sponsors
Cook Biotech Incorporated
Cook Ireland, Ltd.
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over eighteen years old * Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature * Pre-placement of seton required for at least 6 weeks prior to surgical treatment * Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer
Exclusion criteria
* Recurrent fistula tracts * J-pouch fistulas * Superficial fistulas * Fistulas with active abscess, infection, or acute inflammation * History of Chron's Disease * History of Ulcerative Colitis * History of HIV or other immune system disease * History of collagen disease * History of radiation to the anorectal region * Allergies to pig tissue or pig products * Religious or cultural objection to the use of pig tissue
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Success | 12 months | Healing was defined as closure of external opening with absence of abscess, drainage and pain. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgisis® AFP Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia. | 43 |
| Flap Flap: Advancement flap surgery is performed; no anal fistula plug is placed | 39 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Fistula draining at 6 months | 2 | 4 |
| Overall Study | Lost to Follow-up | 9 | 5 |
| Overall Study | Patients were not treated | 1 | 3 |
| Overall Study | Persistence or recurrence of fistula | 5 | 2 |
| Overall Study | Technical failure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Surgisis® AFP | Flap | Total |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 13.2 | 49.4 years STANDARD_DEVIATION 13.1 | 47.2 years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Male | 33 Participants | 23 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 43 | 5 / 39 |
| serious Total, serious adverse events | 1 / 43 | 2 / 39 |
Outcome results
Primary
Healing Success
Healing was defined as closure of external opening with absence of abscess, drainage and pain.
Time frame: 12 months
Population: Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgisis® AFP | Healing Success | 22 participants |
| Flap | Healing Success | 25 participants |
p-value: 0.59Fisher Exact