Comparative Study on Endoscopic Treatments for Hemorrhoids (METHOD): a Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Total effective rate
研究概览
简要总结
Hemorrhoids is one of the most common anorectal diseases, can occur at any age and gender. Hemorrhoids generally do not have very serious clinical manifestations, but often bring huge life pressure and psychological burden to patients, so effective treatment is necessary. Traditional surgical treatment techniques, such as hemorrhoidectomy, may have defects such as anal pain and long recovery time. Recently, endoscopic hemorrhoid treatment has become a safe, effective and rapid rehabilitation treatment. Treatment of hemorrhoids treatment including endoscopic sclerotherapy, endoscopic rubber band ligation, endoscopic sclerotherapy combined with rubber band ligation, the three kinds of treatment methods have their own advantages, but existing research at home and abroad is still less and the comparison of various treatment methods lack of consensus. Our study is to compare the three kinds of treatment methods.
详细描述
In this trial, investigators plan to conduct a multicenter, randomized controlled clinical trial. The leader of the sponsoring organization strictly implements oversight of the protocol. Investigators intend to compare the total efficiency of the endoscopic sclerotherapy group, the endoscopic rubber band ligation group, and the endoscopic sclerotherapy combined with rubber band ligation group for the treatment of hemorrhoids. The Department of Gastroenterology at Jinling Hospital will take full charge of this trial, including recruitment of patients, endoscopic treatment, in-hospital nursing, follow-up work, etc. Informed consent forms from every patient will be signed before enrollment, and approval from the Ethical Committees of Jinling Hospital has been obtained.
After patients will be admitted to the hospital and sign informed consent, they will be randomly assigned to the endoscopic sclerotherapy group, the endoscopic rubber band ligation group, and the endoscopic sclerotherapy combined with rubber band ligation group in a 1:1:1 ratio of 130 patients in each group, and the assignment will be done by a mobile client randomization tool. Patients in each group completed bowel preparation according to the same requirements and performed the appropriate endoscopic treatment. The sclerosing agent is polydocanol and the ligature model is MBL-6-F.
Our main observation is the overall effectiveness rate (the ratio of the number of people whose symptoms improved and the number of people whose symptoms completely disappeared to the total number of people). Our secondary observation indicators are the incidence of complications (such as urinary retention, prostatic abscess, fecal incontinence, rectal stricture, infection, bacteraemia, etc.) within 1 year after hemorrhoid treatment, the presence of new symptoms within 1 year after treatment, the recurrence rate after treatment, patient satisfaction, endoscopic performance of hemorrhoids, intraoperative conditions, hospital days, hospital costs, the need for retreatment due to recurrence or worsening of symptoms, blood routine, urine routine, fecal routine, coagulation function, blood biochemistry, etc.
Investigators will observe the status of patients 48 hours after treatment, 3 month after treatment, 6 months after treatment, 9 months after treatment, and 1 year after treatment. Follow-up will be conducted through online questionnaires or telephone callbacks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign a written informed consent form.
- •Age 18-80 years with clinical symptoms of hemorrhoids.
- •Subjects able to follow the follow-up schedule, able to describe symptoms objectively and able to cooperate in completing the scale.
- •non-breastfeeding pregnant women and those with no pregnancy planned during the trial
- •not participating in various clinical trials in the 3 months prior to and during the trial
- •Not taking long-term anticoagulant drugs (e.g., clopidogrel, aspirin, triptans, etc.) or have stopped taking them for 5-7 days.
排除标准
- •those with severe organ insufficiency of the heart, brain, lungs and kidneys
- •those who cannot tolerate endoscopic treatment
- •those with severe coagulation disorders
- •men with a history of severe prostate enlargement
- •with severe intestinal diseases: colon malignancy, ulcerative colitis, Crohn's disease, anal fistula, anal fissure, acute thrombosed internal hemorrhoids
- •those who are allergic to sclerosing agents
- •Those who, in the opinion of the investigator, cannot be enrolled for any reason.
结局指标
主要结局
Total effective rate
时间窗: one year
Total effective rate includes effective rate and cure rate. Effective rate means that symptoms are better than before treatment；Cure rate refers to the percentage of symptoms that completely disappear.
次要结局
- Endoscopic presentation of hemorrhoids(1 year)
- Incidence of complications(1 year)
- Number of days in hospital(1 year)
- Hospitalization Costs(1 year)
- Incidence of needing re-treatment(1 year)
- Recurrence rate after treatment(1 year)
- Incidence of new symptoms(1 year)
- Patient satisfaction(1 year)
- Intraoperative situation(1 year)
研究者
Fangyu Wang
Professor Wang
Jinling Hospital, China