Local vs General Anaesthesia in Stapled Hemorrhoidectomy: A Multicentric Controlled Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine whether local or general anaesthesia in stapled hemorrhoidectomy leads to a shorter operation time with a better patient comfort.
详细描述
Hemorrhoids are a frequent disease with the need of surgical intervention in 10-20% of the patients. The stapled hemorrhoidectomy according to Longo under general anesthesia (or spinal) is considered standard of care [1]. Cohort studies show that a pudendal bloc with local anesthesia is safe and efficient [2-4]. The majority of procedures are actually performed in private clinics or in an ambulatory setting underlining the importance of economic issues such as procedure time (anesthesia and operation time) and hospital stay.
We hypothesize that stapled hemorrhoidectomy under local anaesthesia shortens anaesthesia time and hospital stay and reduces costs with no disadvantages regarding pain, satisfaction and complication rate.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemorrhoids grade III suitable for elective stapled hemorrhoidectomy
排除标准
- •Age < 18 years
- •No informed consent
- •Emergency situation
- •Contraindication to either anaesthesia method
- •Patients not speaking french or german.
- •Additional anal pathology (fissure, tumour).
研究组 & 干预措施
A: general
general anesthesia: spinal and general
干预措施: general anesthesia (spinal and general) (Procedure)
B: pudendal
local anesthesia: pudendal block
干预措施: Local anesthesia (pudendal block) (Procedure)
研究者
Nicolas DEMARTINES
investigator
University of Lausanne Hospitals