Prospective Randomized Multi-centre Trial Comparing the Clinical Efficacy, Safety and Patient Acceptability of Circular Stapled Anopexy With Closed Diathermy Haemorrhoidectomy for Haemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- global haemorrhoidal symptom control
研究概览
简要总结
The aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment, which is excisional haemorrhoidectomy.
详细描述
The current gold standard treatment of haemorrhoids namely, excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period. Methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique. Alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain. However, with the wound in the sensitive anoderm following excisional haemorrhoidectomy, pain continues to be a major problem irrespective of the method of excision or of the instrument employed.
The new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids. The prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound. This should result in reduction of the postoperative pain and subsequently should improve the recovery time. Further potential advantages of the technique should include a more physiological approach to the treatment of the disease.
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
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult human subjects (age >=16 years) with symptomatic haemorrhoids (Primary or recurrent)
- •symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment
排除标准
- •concurrent untreated or recurrent colorectal cancer
- •Active inflammatory bowel disease
- •Previous major anorectal surgery
- •On anticoagulant medications
- •Non-consenting patients
- •Unwilling for randomisation
研究组 & 干预措施
Stapled Anopexy
Circular stapled anopexy
干预措施: Circular stapled anopexy (Procedure)
Conventional Haemorrhoidectomy
Closed diathermy haemorrhoidectomy
干预措施: Closed diathermy haemorrhoidectomy (Procedure)
结局指标
主要结局
global haemorrhoidal symptom control
complication rates
Postoperative pain
次要结局
- Time to recovery
- Patient satisfaction
- Time to return to work
- Re-treatment rates
- Quality of life changes
- Cost effectiveness
- Day case surgeries
