Cost Effectiveness of Local Anaesthetic Day Surgical Haemorrhoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Average pain and expectation score.
研究概览
简要总结
Background: Local anaesthetic day-care open haemorrhoidectomy (LH) is feasible, cheap and may be the cost-effective surgical approach to third degree haemorrhoids. This prospective randomised controlled trial compares patient's evaluation of LH with general anaesthetic day-care Park's modified Milligan-Morgan haemorrhoidectomy (GH).
Methods: 41 patients with third degree haemorrhoids were randomised to LH (19 cases) and GH (22 cases). Demographics were comparable. Independent assessment (by a research nurse) and clinical evaluation ran parallel for 6 months. Outcome measures were average and expected pain scores for 10 days; satisfaction scores at 10 days, 6 weeks and 6 months. Secondary outcomes were journey time and cost in day surgery.
详细描述
INTRODUCTION:
Open haemorrhoidectomy is a commonly performed painful operation. In 1998-99, 26514 haemorrhoidectomies were performed in the UK of which 14373 were day cases. A further 5342 could have been performed as day surgery1. Improvements in multimodal2 and pre-emptive analgesia3, introduction of stapled anopexy4 and improvements in patient counselling5 have led to increasing number of day surgical treatment of haemorrhoids. Technique of LH is described6-11 but with the paucity of randomised controlled trials this is rarely offered as a routine choice to patients with third degree haemorrhoids.
AIM:
This randomised controlled trial compares patient-evaluation of postoperative pain and expected pain scores for 10 days and satisfaction scores at 10 days, 6 weeks and 6 months between local and general anaesthetic day surgical open haemorrhoidectomy. Clinical outcomes (for 6 months), cost comparison and evaluation of total journey time in day surgical unit formed part of the study.
PATIENTS AND METHODS:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Third degree haemorrhoids
排除标准
- •Unfit for day-surgery or general anaesthesia.
结局指标
主要结局
Average pain and expectation score.
时间窗: 6 months
次要结局
- Journey time and cost analysis(6 months.)