• Zhonghua yi xue za zhi · Nov 2015

    Randomized Controlled Trial Multicenter Study

    [A multicenter randomized controlled clinical trial of Ligation of the Intersphincteric Fistula Tract Plus Bioprosthetic Anal Fistula Plug in the treatment of chronic anal fistula].

    • Yi Zheng, Zhenjun Wang, Xinqing Yang, Jinjie Cui, Chaowen Chen, Xuebin Zhang, Xiaoqiang Wang, Xiling Zhang, Xiangming Che, Jincai Chen, Feibo Cui, Weiliang Song, and Yuzhuo Chen.
    • Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
    • Zhonghua Yi Xue Za Zhi. 2015 Nov 10; 95 (42): 3454-7.

    ObjectiveTo evaluate the effectiveness and safety of Ligation of the Intersphincteric Fistula Tract Plus Bioprosthetic Anal Fistula Plug (LIFT-plug) in the treatment of chronic anal fistula.MethodsA total of 239 patients (199 males, 40 females) with chronic anal fistula were recruited from 5 hospitals between March 2011 and April 2013. These patients were randomly assigned to the experimental group (n=119) treated with LIFT-plug or the control group (n=120) treated with LIFT. The follow-up period was 180 days. The collected data included healing rate, the median healing time, the recurrence rate, the Visual Analogue Scale (VAS), the incontinence rate, and the safety indicators associated with the anal fistula plug.ResultsThe healing rate of the experimental group was better than the control group (96.5% vs 83.7%, P<0.05). The median healing time of the experimental group was 22 days and the latter was 30 days (P<0.05). By the end of the follow-up period, there was no recurrence found in the two groups. The VAS and the incontinence rate had no statistically significant difference between the two groups. There were no adverse events associated with the anal fistula plug in the experimental group.ConclusionLIFT-plug is simple, less invasive, and with shorter healing time and more satisfactory healing rate in treating chronic anal fistula compared with LIFT.

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