Clinical study of modified seton treatment on high anal fistulas by multicenter, randomized,single blind method / 国际中医中药杂志

ABSTRACT

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 programs.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.SPSS 16.0 was used to make a statistical analysis on actual enrolled patients,fall off 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 off times,healing time,postoperative pain,anal and manometry were observed in both groups.Results Among 120 cases,118 eases were effective and 2 eases 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.