Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease. A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evaluation of pain
研究概览
简要总结
The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.
详细描述
An estimated 4% of the adult population suffers from haemorrhoidal disease. In 1937 E. T. Milligan and C. N. Morgan described a method for operating piles that still is regarded "the gold standard" in the treatment of severe haemorrhoidal disease. This procedure is followed by a prolonged and painful recovery. To overcome the long recovery often combined with long sick leaves, less invasive methods for treating piles have been introduced during the last decade. However, few studies have compared patient benefits and the long term outcome of these techniques, and the choice of treatment is often based on the skills and experience of the individual surgeon. A new and promising mini invasive approach utilizes doppler-guided ligation of the haemorrhoidal arteries. All haemorrhoidal arteries are identified and then ligated approximately 2 cm above the anal canal. Thereafter the rectal mucosa with the piles is repositioned and fixed in the rectum with running sutures. This procedure is termed Recto Anal Repair (RAR) and leads to shrinking of the piles and restored anatomy of the anus and the rectum. The investigators want to execute a randomized, consecutive, prospective, controlled study with long term follow up to compare the RAR procedure to Milligans operation for the treatment of severe haemorrhoidal disease.
The primary goals are evaluation of pain and sick leave 7, 14 and 21 days after surgery and reported reduction of pile symptoms after 3, 6 and 12 months. In addition the investigators want to compare the overall satisfaction with the two procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic grade 3 and 4 haemorrhoidal disease
- •Age 18-80
- •Patients who are fitted for local and general anaesthesia
- •Patients who are able to understand the information given and are willing to give a written consent
排除标准
- •Previous operated for piles
- •Previous operated in the anal canal
- •Faecal incontinence
- •Inflammatory bowel disease with affection of the anal canal
- •Chronic diarrhea
- •Fissura ani
- •Fistula in ano
- •Chronic anal pain
- •Neurological illness with affection of anal sensation
- •Patients not able to follow the study protocol
- •Patients taking immunosuppressant medication
- •Pregnancy
- •Disability
- •Anal polyps
- •Medication affecting the coagulation system
- •Circular anal prolapse
研究组 & 干预措施
Milligan Morgan
干预措施: Surgery for advanced haemorrhoidal disease (Procedure)
Recto Anal Repair
干预措施: Surgery for advanced haemorrhoidal disease (Procedure)
结局指标
主要结局
Evaluation of pain
时间窗: up to 21 days
次要结局
- Evaluation of sick leave(up to 21 days)
