Hemorrhoidal Artery Ligation With Doppler Guidance vs Digital Guidance for Grade II-III Hemorrhoidal Disease Treatment: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- recurrence
研究概览
简要总结
Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.
The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.
In this ongoing randomized, controlled, single center clinical study 200 patients randomly divided into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity (VAS), treatment satisfaction (1 to 5 points) and need for the drug therapy in 30 days and 8 weeks after surgery.
Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.
详细描述
Hemorrhoidal disease (HD), in its different manifestations, is not only the most frequented grounds of referring for medical attention, but also one of the reasons for the modest deterioration in the quality of life that can possibly result in temporary or permanent reduction of work capacities. Today, the doppler-guided dearterialization of hemorrhoidal arteries and the following suture-fixation mucopexy in the anal canal (synonyms: mucopexy, hemorrhoids lifting, HAL-RAR) is one of the most popular and actively studied methods of the stage II - III hemorrhoidal disease surgical treatment. A number of publications raise an issue whether it is really necessary to use a doppler while the localization of the hemorrhoidal arteries is typical in the vast majority of the observations and can be easily determined on palpation.
The aim of the study is to compare the direct and long-term results of the II - III grade HD surgical treatment with the use of two techniques of the suture ligation of the hemorrhoidal arteries with mucopexy. One of these methods is classic and widely known HAL-RAR, the other one has a principal differ in no-using the doppler to find the arteries, the surgeon defines them on palpation.
The hypothesis of the study is that the digital detection of hemorrhoidal arteries pulsation followed by suture ligation and mucopexy may be no less effective in the treatment of grade II - III hemorrhoids than the use of a doppler guide.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic grade II and III hemorrhoids according to Golligher.
- •No other source of anal bleeding than hemorrhoids due to total colonoscopy
- •Written voluntary informed consent
排除标准
- •Any previous hemorrhoid surgery (including mini invasive procedures)
- •Anal fistula
- •Chronic anal fissure with severe spasm of anal sphincters
- •Any stage colorectal cancer
- •Oral anticoagulants for congenital disorders of the coagulation system
- •Pregnancy
结局指标
主要结局
recurrence
时间窗: 2 weeks - 1 year
The rate of recurrence of any of initial symptoms or appearance of any new symptom of hemorrhoidal disease: anal bleeding during defecation, prolapse of hemorrhoidal piles or both.
次要结局
- Pain score(2 weeks)
- Patients satisfaction level(6 month and 1 year)