Multicenter Randomized Controlled Trial of Doppler Guided Hemorrhoid Artery Ligation (DGHAL) and Mucopexy Versus Mucopexy Alone in the Treatment of Grade III Hemorrhoids
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- percentage of recurrences of hemorrhoidal prolapse
研究概览
简要总结
Hemorrhoidal disease is one of the most common proctological disease affecting the general population from the mid-teens onward with considerable implications for the National Health Service (NHS) both from an economic point of view and from surgeon's workload.Improved understanding of the pathogenesis of hemorrhoids and of the complications associated with excisional hemorrhoidectomy led to the invention of newer surgical procedures, including Doppler guided hemorrhoidal artery ligation (DGHAL).
This technique was introduced in 1995 by Morinaga et al. and consists in the use of a proctoscope with a Doppler transducer that detect the arterial structures.
Since DGHAL does not involve tissue excision, it is expected to be associated with reduced postoperative pain if compared with hemorrhoidectomy.
In the last decade several devices (THD and AMI/ HAL-RAR - Hemorrhoidal Artery Ligation and Recto Anal Repair) have been developed in order to improve and facilitate the execution of the technique, making easier the procedure.
The hypothesis of the study is that a simple mucopexy procedure by suture-fixation of anal cushion without the aim of a Doppler device, could be as effective as DGHAL and mucopexy to manage prolapsing grade III hemorrhoids.
详细描述
Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.
Primary aim of the Hamlet trial is to demonstrate that mucopexy without DGHAL for grade III haemorrhoids have equivalent recurrence rate at 1 year follow up of DGHAL with mucopexy procedure
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
- Single (Outcomes Assessor)
盲法说明
long term outcome will be evaluated by a third observer unaware of the type of surgery performed
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic grade III hemorrhoids according to Goligher
- •No other source of anal bleeding than hemorrhoids
- •Written informed consent
排除标准
- •Any previous hemorrhoid surgery
- •Participants expressing clear preference for one of the interventions
- •Pregnancy
- •Inability to understand the informed consent
- •Oral anticoagulants of congenital defects of the coagulation
- •Patients with immunodepression (i.e. HIV)
- •Other proctological diseases (fissures, fistulas, condyloma, etc)
- •IBD involving the anus ore the rectum
结局指标
主要结局
percentage of recurrences of hemorrhoidal prolapse
时间窗: 1 year follow up
Recurrence is defined as persistent or recurrent hemorrhoidal prolapse and graded according to Goligher in 4 degrees
次要结局
未报告次要终点