Comparison of Oral Polyethylene Glycol and Enema for Diagnostic Efficacy in Urgent Colonoscopy for Acute Lower Gastrointestinal Bleeding: a Multicenter, Randomized, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Endoscopic diagnosis rate
研究概览
简要总结
The main goal of this study is to assess whether the diagnostic efficacy of enema is non-inferior to that of oral polyethylene glycol (PEG) in acute lower gastrointestinal bleeding (ALGIB) patients requiring urgent colonoscopy. The secondary objectives include: 1) evaluating potential differences between the enema and oral PEG groups in terms of the difficulty and safety of colonoscopy, as well as exacerbation of bleeding; 2) conducting subgroup analyses to compare the effectiveness of the two bowel preparation methods in specific populations, exploring potential candidate groups for different bowel preparation strategies, and promoting individualized diagnosis and treatment for ALGIB.
详细描述
This is a multicenter, prospective, single-blind, randomized controlled, non-inferiority study. The study includes the following steps:
Step 1: Participants will be enrolled based on predefined criteria, and demographic data, fasting water duration, accompanying symptoms, smoking history, alcohol consumption history, antithrombotic drug usage, previous history of lower gastrointestinal bleeding, Charlson comorbidity index, vital signs at admission, and laboratory results at admission will be collected.
Step 2: All participants will undergo stratified block randomization, and based on the randomization results, participants will receive bowel preparation using either PEG or enema. Subsequently, all participants will undergo urgent colonoscopy within 48 hours from admission.
Step 3: Follow-up records will be conducted at the following time points:
- Before colonoscopy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with hematochezia who were admitted to our hospitals were eligible for the study. Patients were included if they met the following criteria:
- •Had the last bloody bowel movement within 24 hours of presentation;
- •Aged 18 years or over
- •Had indications for clinical colonoscopy
排除标准
- •Known or suspected upper gastrointestinal bleeding meeting any of the following criteria:
- •A. Presence of hematemesis or black vomiting. B. Bloody or coffee nasogastric aspirate. C. Endoscopic evidence of acute upper gastrointestinal bleeding, such as gastric or duodenal ulcer bleeding, esophagogastric variceal bleeding, etc.
- •Previous colonoscopy has been performed at an external institution with a confirmed diagnosis.
- •Presence of primary or secondary coagulation disorders.
- •History of bowel diversion surgery (including partial colon resection).
- •Hemodynamic instability persists after fluid resuscitation (shock index greater than 1).
- •Interventional treatment has been performed and hemostasis has been successfully achieved.
- •Requires transfer to an intensive care unit due to the severity of the condition.
- •Unable to comply with oral polyethylene glycol administration or enema procedures.
- •Known or suspected relative contraindications to colonoscopy, such as toxic megacolon, acute intestinal obstruction, acute myocardial infarction, heart failure, severe liver failure, and end-stage renal disease.
- •Pregnant or lactating women.
结局指标
主要结局
Endoscopic diagnosis rate
时间窗: During the colonoscopy (up to 48 hours from admission)
Including the definite diagnosis and presumptive diagnosis
次要结局
- Transfusion rate(From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission))
- Rate of bowel preparation related adverse events(From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission))
- Intervention or surgery rate(From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission))
- Lesion detection time(During the colonoscopy (up to 48 hours from admission))
- Repeated endoscopy rate(From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission))
- Cecal intubation time(During the colonoscopy (up to 48 hours from admission))
- Cecal intubation rate(During the colonoscopy (up to 48 hours from admission))
- Rate of colonoscopy related adverse events(From the start of colonoscopy to the time of discharge (assessed up to 72 hours from admission))
- Boston bowel preparation score(During the colonoscopy (up to 48 hours from admission))
- Total procedure time(During the colonoscopy (up to 48 hours from admission))
- Endoscopic hemostasis rate(During the colonoscopy (up to 48 hours from admission))
- Rate of patients who sufferred from exacerbation of ALGIB(From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission))
- Bowel preparation satisfaction score(At the end of bowel preparation (assessed up to 48 hours from admission))
研究者
Min Li
Deputy Director of Science and Technology Department
Beijing Friendship Hospital