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Injectable silicone biomaterial for faecal incontinence due to internal anal sphincter dysfunction

机译:可注射有机硅生物材料用于因肛门内括约肌功能障碍而导致的大便失禁

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摘要

>Background: A weak or disrupted internal anal sphincter can cause passive faecal incontinence. Conservative measures may help some patients but there is no simple surgical solution for those who fail conservative treatment. A successful technique using trans-sphincteric injection of a bulking agent to augment the internal anal sphincter was developed in a previous pilot study.>Aim: To determine the clinical results and underlying physiological effects of biomaterial injection.>Patients: Six patients (four males, median age 53 years (range 36–65)) with faecal incontinence to solid or liquid stool related to poor internal anal sphincter function, of varied aetiology, were recruited.>Methods: Silicone based biomaterial injections were performed, under local anaesthesia, with antibiotic cover. Three injections were placed circumferentially, trans-sphincterically, entering away from the anal margin and injecting at or just above the dentate line. Anorectal physiological studies, endoanal ultrasound, a bowel symptom diary, a validated incontinence score, and quality of life questionnaires were completed before treatment and on completion of follow up.>Results: At a median follow up of 18 months (range 15–19), five of six patients had marked symptom improvement. Faecal incontinence scores improved from a median of 14/24 (range 11–20) before to 8/24 (6–15) after injection. Short form-36 quality of life physical and social function scores improved from a median of 26/100 (5–33) to 79/100 (25–100) and from 10/100 (5–37) to 100/100 (50–100), respectively. There was a corresponding physiological increase in maximum anal resting and squeeze pressures. Ultrasound showed the Bioplastique to be retained in the correct position in the improved patients without migration. There were no complications.>Conclusion: Trans-sphincteric injection of silicone biomaterial can provide a marked improvement in faecal incontinence related to a weak or disrupted internal anal sphincter. This is associated with improved sphincter function and quality of life.
机译:>背景:肛门内括约肌无力或破裂会导致被动性大便失禁。保守措施可能对某些患者有帮助,但对于保守治疗失败的患者,没有简单的手术解决方案。 >目的:确定生物材料注射剂的临床结果和潜在的生理效应。>目的是确定使用跨膜括约肌注射填充剂来增强肛门内括约肌的成功技术。 >患者:招募了6例患者(四名男性,中位年龄53岁(范围36-65)),其粪便大小便失禁与内部肛门括约肌功能差相关,病因各异。>方法:在局部麻醉下,以硅胶为基础的生物材料注射,并覆盖抗生素。将三个注射剂沿周向,经括约肌放置,远离肛门边缘进入,并在齿状线处或刚好高于齿状线进行注射。在治疗前和随访完成时,完成了肛门直肠生理学研究,肛门内超声,肠症状日记,失禁评分确认书以及生活质量问卷。>结果:中位随访时间为18个月(范围15-19),六名患者中有五名症状明显改善。排便失禁评分从注射前的中位数14/24(11-20)提高到注射后的中位数8/24(6-15)。简短的36岁生活质量的身体和社交功能得分从中位数26/100(5-33)提高到79/100(25-100),从10/100(5-37)提高到100/100(50 –100)。最大的肛门静息和挤压压力相应地增加了生理。超声检查显示,Bioplastique可在改善的患者中保持正确的位置,而无需迁移。没有并发症。>结论:经肛门括约肌注射有机硅生物材料可以显着改善肛门内括约肌无力或破裂引起的大便失禁。这与括约肌功能的改善和生活质量有关。

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