A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
试验速览
- 阶段
- 4 期
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.
研究概览
简要总结
"Internal hemorrhoid" affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People are willing to sign the informed consent form of this trial.
- •People(aged 18 to 70 years) with clinical symptoms such as bleedingprolapse and so on have been diagnosed with grade I, grade II and grade III internal hemorrhoids by colonic epdoscopy;
- •People can follow short-term (3 month) and long-term (12 month) visit plans;
- •Describe symptoms objectively and actively complete the evaluation scale;
- •No allergic diseases and allergy to sclerosing drugs;
- •Non-lactating and pregnant women: patients without pregnancy plan (including the men) in 1 month after the test;
- •Did not participate in any drug trials (including this trial drug) within 3 months before the trial;
- •People with long-term use of anticoagulant drugs (such as aspirin, clopidogrel, etc.) need to be stopped for 5-7 day
排除标准
- •People with severe insufficiency of heart, brain, lung and other organs, leading to inability to tolerate endoscopic treatment;
- •People with drug allergies or abnormal blood coagulation function;
- •People suffering from or combined with digestive tract diseases,such as the colon malignancyulcerative colitis or Crohn's diseaseacute diarrheaacute thrombotic internal hemorrhoids with painanal fistulaanal fissurefecal incontinence
- •Men with history of severe prostate hypertrop;
- •People with any reasons that the researchers believe can not be selected
研究组 & 干预措施
Foam sclerotherapy,FS
Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.
干预措施: Sclerosing foam of Lauromacrogol (Drug)
Liquid sclerotherapy,Ls
Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.
干预措施: Sclersing liqiud of Lauromacrogol (Drug)
结局指标
主要结局
the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.
时间窗: 12 months
after 12 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy.
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
时间窗: 12 months
After 12 months,all the participants will receive the telephone follow-up to record their self-assessment.
次要结局
- the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.(3 months)
- the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.(1 week)
- the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.(3 months)