Adana Ozel Ortadogu Hospital, Adana, Turkey.
Adv Ther. 2018 Aug;35(8):1232-1238. doi: 10.1007/s12325-018-0743-8. Epub 2018 Jul 2.
This study aimed to evaluate the applicability, safety, results, and functional performance of Permacol™ collagen paste injection in patients with an anal fistula.
Thirty-one patients with anal fistula underwent Permacol™ collagen paste injection between February 2015 and February 2017. The patients were followed up for a total of 12 months with recovery conditions monitored at intervals of 3, 6, and 12 months. Preoperative insertion of seton was performed in 15 patients for a period of 6-8 weeks and 2 patients for a period of 12 weeks.
A trans-sphincteric anal fistula was present in 20 patients and an intersphincteric fistula was present in 11 patients. There was a recurrence in 7 patients (22.5%): 1 patient (3.2%) after 1-month follow-up, 3 patients (9.7%) after 3-month follow-up, 2 patients (6.5%) after 6-month follow-up, and 1 patient (3.2%) after 12-month follow-up. A complete recovery was observed in 24 (77.5%) patients after a 12-month follow-up. The mean Fecal Incontinence Severity Index score was 0.29 ± 0.64 preoperatively and 0.55 ± 1.03 after 12 months.
In this study, we show that treatment of patients with an anal fistula by injection of Permacol™ is a safe and successful method that does not compromise continence.
本研究旨在评估 Permacol™ 胶原糊注射在肛瘘患者中的适用性、安全性、结果和功能表现。
2015 年 2 月至 2017 年 2 月期间，31 例肛瘘患者接受 Permacol™ 胶原糊注射治疗。对患者进行了为期 12 个月的随访，随访间隔为 3、6 和 12 个月，监测恢复情况。15 例患者术前留置挂线 6-8 周，2 例患者留置挂线 12 周。
20 例患者为经括约肌肛瘘，11 例患者为括约肌间肛瘘。7 例患者（22.5%）复发：1 例（3.2%）在 1 个月随访时，3 例（9.7%）在 3 个月随访时，2 例（6.5%）在 6 个月随访时，1 例（3.2%）在 12 个月随访时。12 个月随访时，24 例（77.5%）患者完全康复。术前粪便失禁严重程度指数评分均值为 0.29±0.64，术后 12 个月为 0.55±1.03。
本研究表明，Permacol™ 注射治疗肛瘘患者是一种安全有效的方法，不会影响肛门控便功能。
