肛瘘微创平台用于治疗高位复杂性肛瘘的临床研究

Clinical study of minimally invasive anal fistula platform for the treatment of high complex anal fistula

目的观察肛瘘微创平台用于治疗高位复杂性肛瘘的效果,评价其临床疗效性及安全性。方法选取2016年10月至2018年5月在南京市中医院肛肠中心就诊且符合高位复杂性肛瘘诊断标准的106名患者,利用随机数字表将患者随机分为观察组和对照组,其中观察组采用肛瘘微创平台治疗,对照组采用传统低位切开高位挂线术进行手术治疗,术后采取电话或网络随访4~30(中位数10)个月。结果两组治愈率及安全性评价差异无统计学意义(χ^2=2.37,P>0.05),观察组及对照组愈合时间分别为(38.61±7.15)天和(51.72±9.25)天,差异有统计学意义(t=-8.02,P<0.01)。观察组术后肛管静息压及最大收缩压均大于对照组(t=5.71,7.83;P<0.05),Wexner评分优于对照组(t=-4.40,P<0.05)。结论肛瘘微创平台治疗高位复杂性肛瘘疗效确切,安全可靠。

Objective To observe the effect of minimally invasive platform for treatment of high complexity anal fistula,and to evaluate the clinical efficacy and safety.Methods 106 patients who met the diagnostic criteria of high complex anal fistula in Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine from October 2016 to May 2018 were divided into observation group and control group according to the principle of randomization.The observation group was treated with video-assisted fistula excision and suture,while the control group was treated with traditional low incision and high thread hanging operation.The patients were treated by telephone after operation or network follow-up for 4~30(median 10)months.Results There was no significant difference in the cure rate and safety evaluation between the two groups(χ^2=2.37,P>0.05).The healing time of the observation group and the control group were(38.61±7.15)days and(51.72±9.25)days respectively,the difference was statistically significant(t=-8.02,P<0.01).The resting pressure and the maximum systolic pressure of the anal canal in the observation group were higher than those in the control group(t=5.71,7.83;P<0.05),and the Wexner score was better than that in the control group(t=-4.40,P<0.05).Conclusion Video-assisted fistula planning with internal orifice resection and suture is effective,safe and reliable.