NCT05228054Unknown不适用
Treatment of Hemorrhoid With 1940nm Laser Procedure
State Scientific Centre of Coloproctology, Russian Federation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reccurence rate
研究概览
简要总结
Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol
详细描述
Prospective randomized, control study. Patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. Patients will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol.
Follow up for one year. Primary end point - recurrence of hemorrhoids desease.
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
- Single (Investigator)
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
- •hemorrhoids 2-3st
排除标准
- •Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions
研究组 & 干预措施
Laser 1940nm
Experimental
Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm
干预措施: laser procedure (Procedure)
sclerotherapy
Active Comparator
Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy
干预措施: sclerotherapy (Procedure)
结局指标
主要结局
Reccurence rate
时间窗: 12 months
reccurence of hemorroids desease
次要结局
- Pain intensity(7 days)
- QoL(12 months)
研究者
研究点 (1)
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