改良挂线法治疗高位肛瘘的多中心随机单盲临床观察

Clinical study of modified seton treatment on high anal fistulas by multicenter, randomized, single blind method

目的客观评价量化操作的挂线方法配合对口引流的改良手术方式治疗高位肛瘘的有效性和安全性。方法将120例高位肛瘘（单纯和复杂）患者以密闭信封随机分层法分为两组各60例。采用SPSS16．0统计分析两组实际入选患者、脱落及剔除的患者，进行人口统计学、病例分布及基线资料比较，判定疗效和安全性。试验组采用改良挂线配合对口引流法，对照组采用传统低位切开高位挂线法。观察并比较两组患者的愈合时间、挂线脱落时间、术后疼痛、肛门压力测定，客观评价优化改良手术方案的疗效及安全性。结果120例患者，最终有效118例，剔除脱落2例。试验组创面愈合时间（29．87±3．93）d短于对照组（35．32±8．61）d，p〈0．05）；试验组挂线脱落时间为（13．73±3．15）d，短于对照组（14．98±6．84）d，（P〈0．05）；试验组术后疼痛分数虽低于对照组，但无统计学意义，肛门压力测定均在正常范围内，肛门功能均未受影响。结论量化挂线配合对口引流的改良手术方法治疗高位肛瘘安全、有效。

Objective To evaluate the efficacy and safety of standardized seton therapy combined with the counterparts drainage improved surgical approach on the treatment of high anal fistula, and to form the technical specifications and application programsl Methods 120 patients of high anal fistula （simple and complex） from three centers were randomly divided into a treatment group and a control group, 60 cases in each group. SPSS16.0 was used to make a statistical analysis on actual enrolled patients, fall oft and excluded patients. Demographics, distribution of cases and baseline data were also compared between the two groups to determine the efficacy and safety. The treatment group was treated with a modified hanging line with their counterpart drainage; while the control group was treated with traditional low cut high hanging line method. The length of healing time, hung ofttimes, healing time, postoperative pain, anal and manometry were observed in both groups. Results Among 120 cases, 118 cases were effective and 2 cases excluded off Healing time of the treatment group （29.87±3.93）d was less than the control group（35.32±8.61）d, P〈0.05. Hang off time of the treatment group （13.73±3.15）d was less than the control group （14.98±6.84）d, P〈0.05. Although the postoperative pain scores of the treatment group was lower than the control group, but with not statistical significance. Anal manometry was within the normal range, and anal function was not affected. Conclusion The quantitative hung up with the improved counterparts drainage surgical methods were safe and effective in the treatment of high anal fistula.