SIS Biomaterial Application in Treatment of Fecal Incontinence Caused by Anal Sphincter Injury- An Animal Study.
Abstracts
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Background: Surgical treatment of fecal incontinence (FI) includes various techniques. Each therapy option has specific indications and limitations, therefore none can be recommended as gold standard. Application of newly developed biomaterial: SIS ( Swine Intestine Submucosa), gives an opportunity of functionally specific tissue regrowth, using SIS as acellular, collagen matrix. That was confirmed in laboratory and preliminary animal studies. Aim of this study was to assess the regeneration of the anal sphincter muscles after artificial, surgical disruption (mimicking mechanism of fecal incontinence) and instant repair with SIS tape. Material and method: Local Bioethics Committee approval was obtained. Anal sphincter muscle was surgically disrupted in a group of 15 sheep. 5 sheep were a control group (A). At remaining 10 of them, SIS was then applied around external anal sphincter bridging the gap of the muscle continuity. Follow-up time was 3 to 6 weeks. Pelvic floor specimens, including anorectum, were obtained after 3 weeks ( group B) and after 6 weeks (group C). Serial histopathological examination of the specimens were performed. Results: FI was present in 5 animals during follow up time in the control A group. In group B and C, FI symptoms gradually disappeared in third follow-up week. Histopathological examination revealed significant angioneogenesis in 5 of 5 cases of group B, and in 4 of group C. The gap in the anal sphincter was totally filled by muscular tissue in all animals of groups B and C, and by fibrous tissue in group A. Conclusions: SIS tape application for anal sphincter repair results in good clinical and pathological effect. Surgical technique requires further investigation in a clinical trials. |