NCT01263431已完成4 期
Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy
Scientific Institute San Raffaele2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- postoperative pain
研究概览
简要总结
Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction
详细描述
Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids
排除标准
- •Previous anal surgery or pelvic radiotherapy
- •Fecal incontinence or obstructed defecation
结局指标
主要结局
postoperative pain
时间窗: 1 week
次要结局
- postoperative morbidity(30 days)
- Relapse(24 months)
- patient's satisfaction(30 days)
- resumption of working activity(30 days)
研究者
Paola De Nardi
MD
Scientific Institute San Raffaele
研究点 (2)
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