Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Pain POD1
研究概览
简要总结
Background:
Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain.
Hypothesis and aim:
The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.
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 (Participant)
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
- •hemorrhoids grade 3
- •no active anti-coagulation treatment
- •no hemorrhoidal recurrence
- •no previous surgery on rectum or anus
- •no previous local radiotherapy
- •no mental incapacities, good study compliance can be expected
- •no severe incontinence (Wexner score > 12)
- •no severe comorbidities
- •no inflammatory anal diseases (abscesses, fistulas)
- •informed consent
排除标准
- •patient wish
- •inoperability with the assigned intervention, switching to other treatment method
结局指标
主要结局
Pain POD1
时间窗: between 6:00 am and 8:00 am the day after surgery
Visual analogue scale (VAS). Additionally recording of the pain medication used.
次要结局
- Pain 30d(30 days after surgery)
- Pain 1y(1 year after surgery)
- post operative surgical complications(within 30 post operative days)
- Continence 30d(30 days after surgery)
- Continence 1y(1 year after surgery)
- Pain after 8h(8 hours after surgery)
- Continence 2y(2 years after surgery)
- duration of medical leave(up to 3 months after surgery)
- Pain 2y(2 years after surgery)
研究者
Lukas Marti
Leitender Arzt (attending surgeon)
Cantonal Hospital of St. Gallen