LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Assessment of postoperative pain
研究概览
简要总结
This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.
详细描述
The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Adult (above 18 years)
- •With prolapsed hemorrhoids (grades III or IV)
排除标准
- •Complicated hemorrhoid
- •Coexisting perianal disease
- •Previous perianal surgery
- •Unfit for general anesthesia
- •Pregnancy
- •History of bleeding tendency
结局指标
主要结局
Assessment of postoperative pain
时间窗: 12 months
Postoperative pain was assessed using the visual analogue scale (VAS)
次要结局
- Assessment of postoperative complications(12 months)