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
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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