van der Hagen, S.J. et al (2007). British Journal of Surgery, 94, 222-223.
INTRODUCTION: PTQ™ Implants may be used to correct the keyhole defect by restoring the symmetry of the anal canal. The aim of this prospective study was to evaluate the effectiveness of such implants in the treatment of faecal soiling after anal surgery.
PATIENTS AND METHODS: Patients with faecal soiling and a keyhole defect demonstrated by endoanal ultrasonography but otherwise normal anorectal function were treated with PTQ™ Implants (Uroplasty BV; Geleen, The Netherlands). Injections were performed on an outpatient basis under local anaesthesia with the patient in the supine position. Needle tips were positioned in the submucosal internal sphincter interface under the guidance of a palpating finger and a maximum of 7.5 ml was injected. Adverse effects were assessed after 2 weeks. If physical examination and ultrasonography revealed that bulking was insufficient, further implantation was carried out 4 weeks after the initial procedure, using a maximum of 7.5 ml. Patients completed a 2-week bowel habit diary and a quality of life questionnaire, and rated their satisfaction on a visual analogue scale before the procedure, and at 3 and 12 months after treatment. Quality of life score was assessed with a EuroQol-5D instrument that evaluates the existence of problems in five health domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression in relation to faecal incontinence. Comparisons were made between the outcome obtained before treatment and at 3 months and 12 months foIlow-up using the Wilcoxon test. Statistical significance was assigned at the P < 0.05 level.
RESULTS: Twenty-four consecutive patients (16 men) with a median age of 55 (range 33-79) years were included in the study. A mean volume of 6.7 (range 2.5-18.0) ml was injected in one or more sessions to bulk the keyhole defect. There were no adverse effects apart from one transient infection. Eight patients received a second PTQ™ Implant and two patients required a third procedure. The mean patient satisfaction score improved from 2.8 to 6.6 (P = 0.001).
The mean daily soiling frequency was 2.0 (range 1-5) before treatment, and 1.1 (range 0-3) (P = 0.001) and 1.5 (range 0-3) (P = 0.001) after 3 and 12 months respectiveIy. The mean Vaizey incontinence score was 4.2 (range 0-8) before treatment and 2.5 (range 0-6) (P < 0.001) and 2.1 (range 0-6) (P < 0.001) after 3 and 12 months respectively. The mean resting and squeeze anal canal pressures did not change after treatment. Faecal soiling resolved completely in five patients and a partial response was obtained in 11 patients.
DISCUSSION: In this study PTQ™ Implants were used to correct the asymmetry of the anal canal by specifically bulking the site of the keyhole defect. Vaizey incontinence score and soiling complaints decreased significantly in 16 patients. Responses to the quality of life questionnaire, developed especially for faecal incontinence rather than faecal soiling, did not show a significant improvement except in psychosocial functioning after this procedure. In this and other studies the PTQ™ Implants appeared to be safe and effective. Half of the patients had undergone low fistula surgery. At this time it is not possible to speculate on the risk of fistula recurrence at long-term follow-up. The present results indicate that use of PTQ Implants to bulk keyhole defects in the anal canal seems effective in the short term.
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