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临床试验/NCT00841620
NCT00841620已完成4 期

Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 1999年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
207
试验地点
2
主要终点
Self-reported frequency of symptoms

研究概览

简要总结

Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.

Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Grades III and IV haemorrhoids

排除标准

  • Previous operation for high anal fistula or injury to the anal sphincteres

结局指标

主要结局

Self-reported frequency of symptoms

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Niels Qvist

Professor

Odense University Hospital

研究点 (2)

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