NCT01615575已完成不适用
Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Recurrence
研究概览
简要总结
The aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV haemorrhoids with a long-term follow-up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •grade III and IV hemorrhoids requiring hemorrhoidectomy.
排除标准
- •first and second degree hemorrhoids
- •patients with firm and fibrotic external irreducible haemorrhoids
- •thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment
- •history of inflammatory bowel disease; history of colon, rectal or anal cancer
- •inability to give informed consent
- •age < 18 years
- •pregnant women.
结局指标
主要结局
Recurrence
时间窗: 42 months
A telephone interview with a structured questionnaire at a median follow-up of 42 months.
次要结局
- Postoperative pain(24 hr)
- Complications(One month)
研究者
Erasmo Spaziani
PhD
University of Roma La Sapienza
研究点 (2)
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