Long-term efficacy and safety of a nitinol closure clip system for anal fistula treatment

Abstract

Introduction: Treatment failure of anal fistula results in high re-occurrence rate.

Material and 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.

Discussions: 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.

Keywords:

• Nitinol
• minimally invasive surgery
• anorectal disease
• bear-claw clip
• anal fistula
• outcome
• long-term follow up

Acknowledgments

We would like to thank PD Dr. R. Prosst for support and feedback on the study.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.