Background: A new prosthetic device, the ActiconTM artificial anal sphincter, has recently been introduced for treating severe faecal incontinence. The results of this procedure in 28 patients are presented. Methods: The patients underwent operation for severe faecal incontinence in four Italian university hospitals and patients were reviewed after a median follow-up of 19 (range 7-41) months. Results: Early infections occurred in four patients, requiring removal of the device in three. Dehiscence of the perineal wound occurred in nine patients. After activation of the device, the cuff had to be removed in a further four patients (for rectal erosion in two, anal pain in one and late infection in one). The cuff was accidentally broken in one patient. A new anal cuff was repositioned successfully in two patients. Overall, five patients had complete removal of the device and two removal of the cuff only. Twenty-one patients available for long-term evaluation had a major improvement in faecal continence. Median resting anal pressure increased from 27 mmHg before surgery to 32 mmHg after operation. Preoperative squeeze pressure was 42 mmHg while maximum postoperative anal pressure with the activated device was 67 mmHg. The median American Medical System incontinence score decreased significantly from 98.5 to 5.5 (P <0.001). Similar figures were observed using the Continence Grading Scale (from 14.9 to 2.6; P <0.001). Twelve patients developed symptoms of obstructed defaecation while two patients complained of anal pain. Conclusion: Improved continence was achieved after neosphincter implantation in three-quarters of the patients. Early infection and rectal erosion, together with difficulty in evacuating, are still major concerns with this technique.
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