Comparison of the Efficacy and Safety of Endoscopic Hemorrhoids Ligation: a Single-center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- complication
研究概览
简要总结
Endoscopic superior rectal mucosal ligation and hemorrhoids ligation are two types of endoscopic ligation, The aim of this study is to compare the clinical efficacy and safety of these two approaches.If you accept this study,you need to provide case information before the operation, complete the endoscopic treatment according to the routine colonoscopy procedure, and follow-up survey after the operation.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the Goligher classification in the Chinese guidelines for the diagnosis and treatment of hemorrhoids (2020) , patients who are diagnosed with grade II-III internal hemorrhoids .
- •Patients who voluntarily participate and sign the informed consent form.
排除标准
- •patients who had severe heart, liver, and kidney disease.
- •patients who had severe immune deficiency.
- •patient's general condition is too poor to tolerate endoscopic therapy.
- •patients had a history of pelvic chemoradiotherapy.
- •patients had severe infection or inflammatory lesion in the rectum or anal canal,or the rectum or anal canal had undergone surgery.
- •patient is a pregnant woman.
- •patients who disagree with endoscopic treatment and are concerned about the possible risks refused to sign the informed consent form.
- •the follow-up time is insufficient and the clinical data were incomplete.
结局指标
主要结局
complication
时间窗: 7 days after operation
Postoperative complications, such as dysuria, thrombotic external hemorrhoids, perianal abscess,and so on.
clinical efficacy
时间窗: 1 month after operation
Complete disappearance of postoperative symptoms is regarded as a cure, postoperative symptoms relief is regarded as partial cure, and symptoms as same as before are considered ineffective.
次要结局
未报告次要终点