Long-term efficacy and safety of a nitinol closure clip system for anal fistula treatment.
BACKGROUND
Treatment failure of anal fistula results in high re-occurrence rate.


METHODS
Efficacy and safety of a nitinol closure clip system (bear-claw clip) were evaluated for anal fistulae treatment in a 36-month long-term follow-up study.


RESULTS
Twenty-two patients were included. No patient had been treated with a bear-claw clip system before. All patients were fully continent before treatment. Follow-up time was 36 months (range 19-48 months). We observed a re-occurrence rate of 41% (nine patients) with presence of an active fistula. Time to recurrence was on average 6.9 months (range 3-11 months). Thirteen patients (59%) showed a complete healing of the fistula. Placed clip was removed in all patients on average after almost 5.8 months (3-12 months), in three cases the clip was left in situ. We did not observe any incontinence; one patient reported recurrent burning after defecation once the clip system was removed.


CONCLUSIONS
Clip placement is a minimally invasive sphincter-preserving procedure with minimal complications and with an acceptable recurrence rate in the long term. However, bear-claw clip placement should probably be offered patients as a treatment option before more invasive procedures with higher perioperative morbidity are taken into consideration.
a Clinic for General- and Visceral Surgery , Rotes Kreuz Krankenhaus Kassel , Kassel , Germany.|b Department of General, Visceral and Pediatric Surgery , University Medical Center Goettingen , Goettingen , Germany.
Sebastian
S
Dango
a Clinic for General- and Visceral Surgery , Rotes Kreuz Krankenhaus Kassel , Kassel , Germany.
Fillimon
F
Antonakis
a Clinic for General- and Visceral Surgery , Rotes Kreuz Krankenhaus Kassel , Kassel , Germany.
Dirk
D
Schrader
a Clinic for General- and Visceral Surgery , Rotes Kreuz Krankenhaus Kassel , Kassel , Germany.
Arkadiy
A
Radzikhovskiy
b Department of General, Visceral and Pediatric Surgery , University Medical Center Goettingen , Goettingen , Germany.
Michael B
MB
Ghadimi
a Clinic for General- and Visceral Surgery , Rotes Kreuz Krankenhaus Kassel , Kassel , Germany.
Rudolf
R
Hesterberg
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D019990:Perioperative Care; D012003:Rectal Fistula / Q000601:surgery*; D012008:Recurrence; D012189:Retrospective Studies; D013525:Surgical Instruments; D013997:Time Factors
D000497:Alloys; C013616:nitinol
Nitinol; anal fistula; anorectal disease; bear-claw clip; long-term follow up; minimally invasive surgery; outcome