Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial
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
- 否
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
Niels Qvist
Professor
Odense University Hospital
