Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Haemorrhoidal Symptoms
研究概览
简要总结
A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.
Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
- •The patient has a Haemorrhoidal Symptom Score of 4 or more
- •The patient has an American Society of Anaesthesiologists (ASA) score I-II
- •The patient's age is 18-85 years at inclusion
- •The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion
排除标准
- •The patient has had previous operation for haemorrhoids within the last 2 years
- •The patient has had previous operation for anal incontinence
- •The patient has an active anal fistula
- •The patient has an active anal fissure
- •The patient has anal incontinence for solid stools
研究组 & 干预措施
Transanal Haemorrhoidal Dearterialization
Patients randomised to Transanal Haemorrhoidal Dearterialization.
干预措施: Transanal Haemorrhoidal Dearterialization (Procedure)
Open Haemorrhoidectomy
Patients randomised to Open Haemorrhoidectomy
干预措施: Open Haemorrhoidectomy (Procedure)
结局指标
主要结局
Haemorrhoidal Symptoms
时间窗: 1-year and 5-years postoperatively
Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20. The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively.
次要结局
- Postoperative pain(14 days postoperatively)
- Complications(1-year and 5-years postoperatively)
- Anal continence(1-year and 5-years postoperatively)
- Quality of Life(1-year and 5-years postoperatively)
- Health cost analysis(1-year and 5-years postoperatively)
研究者
Per Olov Gunnar Olaison
MD, PhD
Holbaek Sygehus