A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 15
- 主要终点
- Stigmata of Recent Hemorrhage (SRH) Identification Rate
研究概览
简要总结
This multi-center, randomized controlled trial study is planned to include 162 outpatients with onset of acute lower gastrointestinal bleeding to compare the rate of identification of stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day rebleeding rate, between 'early' colonoscopy and 'elective' colonoscopy.
详细描述
All patients will receive early colonoscopy or elective colonoscopy, but they do so by different timing.
Early colonoscopy will be performed within 24 h of the initial visit. Elective colonoscopy will be performed between 24 and 96 h after the initial visit.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 20 years, presenting with moderate-to-severe hematochezia or melena within 24 h of arrival, defined as (i) more than three occurrences of hematochezia within 8 h, (ii) hemorrhagic shock, or (iii) requiring transfusion.
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Patients with hematemesis, black vomiting, or melena.
- •Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
- •Patients who have impossible consumed the oral bowel preparation solution.
- •Patients who have undergone computed tomography.
- •Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days.
- •Ulcerative colitis or Crohn's disease patients.
- •Patients who have undergone abdominal surgery within the previous 10 days.
- •Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days.
- •Patients with suspected perforation or peritonitis.
- •Patients with suspected intestinal obstruction.
- •Patients with hemorrhagic shock refractory to infusion or blood transfusion.
- •Patients who have undergone total colectomy.
- •Patients with suspected disseminated intravascular coagulation.
- •Patients with end-stage malignant disease.
- •Patients with severe cardiac failure.
- •Patients with active thrombosis.
- •Patients with severe respiratory failure.
- •Pregnant patients.
结局指标
主要结局
Stigmata of Recent Hemorrhage (SRH) Identification Rate
时间窗: 0-4 day
Stigmata of Recent Hemorrhage (SRH) based on colonoscopic visualization of lesions, such as diverticulosis, tumor, ulcer, hemorrhoid, angioectasia, and polyps exhibiting active bleeding, a visible vessel, or an adherent clot.
次要结局
- Need for Additional Endoscopic Examinations(0-34 day)
- Need for Surgery(0-34 day)
- Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment(0-4 day)
- Need for Transfusion During Hospitalization(During hospitalization)
- Number of Participants With Colonoscopy-related Adverse Events(0-4 day)
- Need for Interventional Radiology(0-34 day)
- Number of Participants With Thirty-day Death Events(30 day)
- Number of Participants With Preparation-related Adverse Events(0-4 day)
- Thirty-day Rebleeding Rates(30 day)
- Length of Stay(0-34 day)
- Number of Participants With Thirty-day Thrombosis Events(30 day)
研究者
Atsuo Yamada
Department of Gastroenterology
Tokyo University