Department of Colorectal Surgery, York Teaching Hospital, 1 Celtic Close, York, YO26 5QJ, UK.
Updates Surg. 2012 Dec;64(4):289-95. doi: 10.1007/s13304-012-0176-x. Epub 2012 Sep 5.
The aim of this study is to assess the safety and efficacy of Permacol(®) implant for the treatment of idiopathic faecal incontinence using a novel injection technique. Patients with idiopathic passive faecal incontinence were selected for trans-submucosal injection of Permacol(®) after assessment by anorectal physiology and endoanal ultrasonography. Clinical assessment and St. Mark's Incontinence Score were used to evaluate efficacy before and at two time points (1 and 2 years) after treatment. Rockwood Score were also used to determine quality of life before and after treatment. The Friedman and Chi-square tests were used to compare continuous and categorical data, respectively. A p value of <0.05 was deemed significant. Thirty-eight patients (24 female), median age 66 years, were recruited. At maximum clinical follow-up (median of 9 months), response to Permacol(®) injections was categorised as excellent, good, fair and poor in 12, 5, 4 and 17 patients, respectively. St. Mark's Score improved in 72 and 63 % of patients at 1 and 2 years, respectively. However, a smaller proportion of patients (39 and 27 %, respectively) achieved a 50 %, or more, improvement in Mark's Score. All four domains of Rockwood Quality of Life Score improved on first and second year follow-up, however, only two domains, coping and embarrassment, were statistically significant. Permacol(®) injection improved symptoms by >50 % in 39 and 27 % of patients on short and medium-term follow-ups, respectively. The trans-submucosal technique for injection of Permacol(®) in this study was safe with no significant adverse outcomes.
本研究旨在评估 Permacol(®)植入物用于治疗特发性粪便失禁的安全性和有效性,采用新型注射技术。选择特发性被动性粪便失禁患者,在经过直肠生理和内肛门超声评估后,进行 Permacol(®)黏膜下注射。采用临床评估和 St. Mark 失禁评分评估治疗前和治疗后两个时间点(1 年和 2 年)的疗效。还使用 Rockwood 评分来评估治疗前后的生活质量。采用 Friedman 和卡方检验分别比较连续和分类数据。p 值<0.05 被认为具有统计学意义。共招募了 38 名患者(24 名女性),中位年龄 66 岁。在最大临床随访(中位数为 9 个月)时,12 名、5 名、4 名和 17 名患者的 Permacol(®)注射反应分别被归类为极好、良好、一般和差。St. Mark 评分在 1 年和 2 年时分别改善了 72%和 63%的患者。然而,只有 39%和 27%的患者在 Mark 评分上取得了 50%或更多的改善。Rockwood 生活质量评分的所有四个领域在首次和第二年随访时均有所改善,但只有两个领域,应对和尴尬,具有统计学意义。Permacol(®)注射在短期和中期随访中分别使 39%和 27%的患者症状改善了>50%。本研究中 Permacol(®)黏膜下注射的经黏膜技术是安全的,没有显著的不良结果。