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临床试验/NCT05089500
NCT05089500Unknown不适用

A Prospective Multicenter Clinical Study of a Soft Endoscopic Treatment Protocol for Internal Hemorrhoid at Degree I-Ⅲ.

Renmin Hospital of Wuhan University2 个研究点 分布在 1 个国家目标入组 984 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
984
试验地点
2
主要终点
recurernce rate

研究概览

简要总结

This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores

详细描述

From November 2021 to July 2022, patients with internal hemorrhoids seeking treatment were enrolled according to the following criteria:

  1. Age 18 to 75, men and women;
  2. Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy;
  3. The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.

Exclusion criteria are as follows:

  1. age <18 or> 75;
  2. External hemorrhoids or mixed hemorrhoids;
  3. Ⅳ degree of hemorrhoid
  4. Unsymptomatic internal hemorrhoids;
  5. Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection;
  6. Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;
  7. There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.;
  8. Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;
  9. Women in pregnancy or puerperium;
  10. Sclerotic with allergy patient , such as polycininol, etc;
  11. Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;
  12. The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 to 75, men and women;
  • •Patients with clinical symptoms of degree I-Ⅲ internal hemorrhoids confirmed after medical history collection, clinical examination or colonoscopy;
  • •The patient was willing to receive minimally invasive treatment for internal hemorrhoids and sign informed consent by himself or his legal agent.

排除标准

  • •Age <18 or age> 75;
  • •External hemorrhoids or mixed hemorrhoids;
  • •degree Ⅳ internal hemorrhoids
  • •Unsymptomatic internal hemorrhoids
  • •Internal hemorrhoids were combined with complications such as chimerism, thrombosis, ulceration, or infection;
  • •Poor basic conditions can not tolerate endoscopic treatment, such as serious cardiovascular and cerebrovascular diseases, respiratory dysfunction, liver and kidney failure, mental disorders, etc.;
  • •There are other serious diseases involving the rectum and anus, such as anal fistula, perianal infection, anal stenosis, inflammatory bowel disease activity period, colorectal tumors, etc.;
  • •Patients with severe coagulation dysfunction or long-term oral anticoagulant drugs or antiplatelet aggregation drugs without withdrawal;
  • •Women in pregnancy or puerperium;
  • •Hardening agent allergy patients, such as polycininol, etc;
  • •Previous history of endoscopic treatment of hemorrhoid disease, surgical history or other low rectal and anal surgery history;
  • •The patient was unwilling to receive endoscopic treatment for internal hemorrhoids, and himself or his legal agent refused to sign the informed consent form.

研究组 & 干预措施

Endoscopic injection sclerotherapy

Experimental

干预措施: Endoscopic injection sclerotherapy (Other)

Endoscopic Band Ligation

Experimental

干预措施: Endoscopic Band Ligation (Other)

结局指标

主要结局

recurernce rate

时间窗: 12 months

After treatment, the recurrence of internal hemorrhoids symptoms (based on Goligher score and HDSS symptom score)

次要结局

  • Patient satisfaction survey(12 months)
  • Postoperative complications and adverse events(12 months)
  • Surgical costs(12 months)
  • Health-related QIL score(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ChenMingkai

Professor

Renmin Hospital of Wuhan University

研究点 (2)

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