Department of General and Visceral Surgery, Friedrich-Alexander-University, Krankenhausstraße 12, 91054, Erlangen, Germany.
Department of General and Visceral Surgery, Hospital Hallerwiese, Nuremberg, Germany.
Tech Coloproctol. 2019 Feb;23(2):135-141. doi: 10.1007/s10151-019-01932-z. Epub 2019 Feb 13.
Permacol™ collagen paste, an acellular crosslinked porcine dermal collagen matrix suspension, is a new treatment option for anal fistula. Data remain limited, however, and as yet only the results of one case of Crohn's fistula treated with Permacol™ paste has been reported. The aim of this study was to assess the use of Permacol™ collagen paste in patients with cryptoglandular and Crohn's perianal fistulae.
A prospective study was conducted on patients with anal fistula, treated with Permacol™ paste. Patients were followed at 1 week, 6 and 12 months, and on demand thereafter. The main focus was on fistula healing and postoperative continence. The former was defined as the absence of signs of recurrence on clinical examination, proctoscopy and rigid rectoscopy. Fecal incontinence was assessed before surgery and at each follow-up.
Thirty patients (19 women, 11 men; mean age 46 years), 12 (40%) of whom had Crohn's disease were included. The average number of previous fistula operations was 6. All patients had ≥ 6 months of follow-up, and 24 patients (80%) had ≥ 12 months of follow-up. The healing rate in all patients was 57% (17 of 30 patients) at 6 months and 63% (15 of 24 patients) at 12 months. One patient reported a worsening of fecal incontinence at 12 months; 2 patients had adverse events (perianal pain: n = 1, fluid accumulation n = 1) requiring fistula drainage. Patient characteristics, healing, incontinence, and adverse events did not differ significantly between patients with and without Crohn's disease.
Our data indicate that Permacol™ paste is a safe and moderately effective treatment for cryptoglandular and Crohn's fistulae.
Permacol™胶原蛋白膏，一种去细胞交联猪真皮胶原基质悬浮液，是治疗肛瘘的一种新的治疗选择。然而，数据仍然有限，目前只有一例克罗恩病肛瘘患者接受 Permacol™膏治疗的结果报告。本研究旨在评估 Permacol™胶原蛋白膏在肛肠瘘患者中的应用。
对接受 Permacol™膏治疗的肛瘘患者进行前瞻性研究。患者在 1 周、6 个月和 12 个月进行随访，并在有需要时进行随访。主要关注的是瘘管愈合和术后控便能力。前者定义为临床检查、直肠镜和刚性直肠镜检查无复发迹象。术前和每次随访时评估粪便失禁。
30 例患者（19 名女性，11 名男性；平均年龄 46 岁），其中 12 例（40%）患有克罗恩病。平均既往瘘管手术次数为 6 次。所有患者均随访≥6 个月，24 例（80%）患者随访≥12 个月。所有患者的愈合率在 6 个月时为 57%（30 例患者中的 17 例），在 12 个月时为 63%（24 例患者中的 15 例）。1 例患者在 12 个月时报告粪便失禁恶化；2 例患者出现不良事件（肛周疼痛：n=1，液体积聚：n=1），需要引流瘘管。有无克罗恩病的患者在患者特征、愈合、失禁和不良事件方面无显著差异。
我们的数据表明，Permacol™膏是治疗肛肠瘘的一种安全且中等有效的治疗方法。
