NCT00630669已完成不适用
Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- treatment success rate
研究概览
简要总结
The purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids.
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
- •Grade II or III internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy.
- •Age over 18 years
- •A life expectancy of at least 24 months
- •A signed written informed consent
排除标准
- •The patient was uncooperative or could not return for routine outpatient follow-up
- •Severe or end-stage co-morbid illness
- •Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months
- •Ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents
- •Presence of severe rectal pain
- •Recently thrombosed internal or external hemorrhoids
- •Anal stricture,fissure, fistula,or abscess
- •Rectal carcinoma or bleeding distal colonic polyp
- •Rectal varices
- •Acute or chronic colitis
- •Rectal prolapse
- •Radiation telangiectasia of the rectum
- •Prothrombin time >3 seconds over control
- •Platelet count <75,000
研究组 & 干预措施
1
Active Comparator
Rubber band ligation
干预措施: Rubber band ligation (Procedure)
2
Active Comparator
Bipolar coagulation
干预措施: Bipolar coagulation (Procedure)
结局指标
主要结局
treatment success rate
时间窗: one year
次要结局
- treatment complication rate(one year)
研究者
研究点 (1)
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