Prospective Study About the Efficacy of the Longo's Intervention for the Treatment of Hemorrhoids and Rectal Mucosal Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Efficacy of the Longo's intervention (distance in the staple line till the dentate line of the anal canal in cm)
研究概览
简要总结
The aim of this study is to define the significance of the distance of the staple line to the dentate line of the anal canal in the efficacy of the Longo's intervention.
详细描述
Is going to be carried out with patients from 18 to 70 years old with hemorrhoids in a level III and IV in the Lord scale.
In the surgery Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Neither the evaluator of the research and the participant do not know the lenght of the Longo's intervention that is performed.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men from 18 to 70 years old
- •Hemorrhoids in level III and IV in the Lord scale
- •Surgery without income and conventional hospitalization
排除标准
- •Previous hemorrhoidal intervention
- •Actual anal pathology
研究组 & 干预措施
Group 1
Suture confection of theTobacco-pouch of 4.5cm from the anal margin.
干预措施: 4.5cm suture (Procedure)
Group 2
Suture confection of theTobacco-pouch of 6cm from the anal margin.
干预措施: 6cm suture (Procedure)
结局指标
主要结局
Efficacy of the Longo's intervention (distance in the staple line till the dentate line of the anal canal in cm)
时间窗: up to 6 months
The distance in the staple line till the dentate line of the anal canal will be measured.
次要结局
未报告次要终点
研究者
Luis Antonio Hidalgo Grau
MD, PhD
Hospital de Mataró