The anal fistula claw: the OTSC clip for anal fistula closure.

AIM: Surgical closure of high or complex anal fistulae is often a difficult challenge. A special Nitinol clip, the OTSC clip (Ovesco AG), was evaluated for fistula closure in a porcine model.

METHOD: A total of 20 fistulae were created in 10 animals by seton insertion. Four weeks after fistula induction the setons were removed: one internal fistula opening per animal was left untreated as control whereas the other opening was closed by the OTSC clip using a specially developed transanal clip applicator. The safety and technical feasibility of the clip application were tested. Another 4 weeks later, fistulae were macroscopically assessed for closure. For histological examination, the anorectum including the fistula tract was excised en bloc.

RESULTS

Four weeks after clip placement, all external and internal fistula openings were macroscopically closed. The clip application site presented with an increased scarring. Microscopically, 40% of residual tracts and a more intense chronic inflammation were seen in the untreated control fistulae. After clip placement, 10% of the fistulae persisted associated with a higher density of collagen fibres indicating a better fistula scarring and healing. No unexpected side-effects or complications caused by the clip were observed.

CONCLUSION

Fistula closure using the OTSC clip represents a promising sphincter-preserving minimally invasive procedure. This study demonstrated the safety and feasibility of the 'anal fistula claw' for fistula closure. In spite of limitations of the porcine model the results justify clinical applications and further investigations.