ACTRN12611001167954招募中不适用
Randomised controlled trial comparing anal fistula closure rates between anal fistula plug insertion and ligation of intersphincteric fistula tract in patients with complex anal fistula of cryptoglandular origin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with complex transphincteric anal fistula of cryptoglandular origin determined by examination under anaesthesia and endoanal ultrasography will be eligible for the study following the insertion of a seton into the fistula tract for a minimum of 6 weeks.
排除标准
- •1) Active anorectal or perianal sepsis
- •2) Anovaginal or rectovaginal fistulas
- •3) Ileo-anal pouch vaginal fistulas
- •4) Allergy or intolerance to porcine products
- •5) Ulcerative colitis or Crohn’s disease
- •6) Previous anal fistula plug, LIFT procedure, fistulotomy, lateral anal sphincterotomy and anal sphincter repair
- •7) Pregnancy at recruitment or parturition during study follow-up period
- •8) Patients deemed unable to give informed consent on clinical grounds
研究者
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