Department of Surgery, Pelvic Floor Centre, Skåne University Hospital - Malmö, Lund University, Malmö, Sweden.
Colorectal Dis. 2021 Jan;23(1):178-185. doi: 10.1111/codi.15429. Epub 2020 Dec 26.
To evaluate the long-term success rate of treatment with the Surgisis (Biodesign ) anal fistula plug for complex anal fistulas, assess fistula plug failure over time and compare success rates for fistula plug between a group of patients with cryptoglandular fistula and another group with Crohn's fistula.
This is a single-centre study of consecutive patients treated with the Surgisis (Biodesign ) anal fistula plug between May 2006 and October 2009. All patients had complex anal fistulas in need of surgical treatment. The patients were assessed preoperatively by physical examination and three-dimensional (3D) endoanal ultrasound, and treated with a loose seton. Postoperative assessment by clinical examination and 3D endoanal ultrasound was performed at 2 weeks, 3 months and 6-12 months. Long-term follow-up was carried out in 2017 using a questionnaire, and clinical examination combined with 3D endoanal ultrasound was performed if the questionnaire indicated any signs of fistula recurrence.
A total of 95 patients were included; 30 had quiescent Crohn's disease. Overall, 151 plug procedures were performed. Long-term follow-up was undertaken in 90 (95%) patients; the results showed that after a median period of 110 months, the overall healing rate after one to five plug procedures was 38%. No statistically significant difference in success rate was found between the cryptoglandular fistula group and the Crohn's fistula group (P = 0.37). No further healing was observed after the use of three plugs.
Considering its low morbidity in a complex disease with high recurrence rates over time, the anal fistula plug may still be considered as one of the first-line treatments for patients with complex anal fistulas.
评估 Surgisis（Biodesign）肛门瘘管塞治疗复杂肛门瘘的长期成功率，评估瘘管塞随时间的失败率，并比较一组肛隐窝瘘患者和另一组克罗恩病瘘患者的瘘管塞成功率。
这是一项对 2006 年 5 月至 2009 年 10 月间连续接受 Surgisis（Biodesign）肛门瘘管塞治疗的患者进行的单中心研究。所有患者均患有需要手术治疗的复杂肛门瘘。患者术前通过体格检查和三维（3D）腔内超声进行评估，并采用松动挂线治疗。术后 2 周、3 个月和 6-12 个月进行临床检查和 3D 腔内超声评估。2017 年通过问卷调查进行长期随访，如果问卷调查显示有瘘复发迹象，则进行临床检查和 3D 腔内超声检查。
共纳入 95 例患者，其中 30 例为静止期克罗恩病患者。总共进行了 151 次塞栓治疗。90 例（95%）患者接受了长期随访；结果显示，在中位数为 110 个月的随访期后，一次至五次塞栓治疗后的总体愈合率为 38%。肛隐窝瘘组和克罗恩病瘘组的成功率无统计学差异（P=0.37）。使用三个塞栓后未观察到进一步愈合。
考虑到其在高复发率的复杂疾病中的低发病率，肛门瘘管塞仍可被视为治疗复杂肛门瘘的一线治疗方法之一。
