跳至主要内容
临床试验/ACTRN12624000557538
ACTRN12624000557538尚未招募Unknown

Healing without faecal incontinence - a comparison of cutting seton versus ligation of intersphincteric fistula tract (LIFT) for complex cryptoglandular fistula-in-ano: a prospective, multi-center, randomized trial

St George Hospital0 个研究点目标入组 200 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
Unknown
状态
尚未招募
入组人数
200

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

  • Adult patients (18 years and over) with complex cryptoglandular anal fistula requiring operative management
  • Complex fistulae are defined as high trans- sphincteric or supra-sphincteric fistulas, anteriorly situated fistulas in women, fistula disease in the presence of impaired continence, and any recurrent fistulas
  • Able to give valid consent
  • Current loose seton in situ for control of perianal sepsis
  • Deemed by treating surgeon based on imaging (endoanal ultrasound or MR) or examination under anaesthesia to be suitable for LIFT or cutting seton (based on anatomy of the tract)

排除标准

  • Fistula anatomy or patient deemed unsuitable by the treating surgeon for either cutting seton or LIFT
  • Inflammatory bowel disease – currently active or known history
  • Secondary/non-cryptoglandular aetiology (ie. radiation, trauma, malignancy)
  • Active immunosuppression (diabetes excepted)
  • Patients defunctioned with a stoma

研究者

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