Acute Lower Gastrointestinal Bleeding Clinical Trial
Official title:
Comparison of Oral Polyethylene Glycol and Enema for Diagnostic Efficacy in Urgent Colonoscopy for Acute Lower Gastrointestinal Bleeding: a Multicenter, Randomized, Non-inferiority Trial
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.
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: 1. Before colonoscopy: - Record the specific method and dosage of actual bowel preparation. - Record changes in vital signs, symptoms, and signs before and after bowel preparation, as well as occurrences of adverse events. - Conduct a satisfaction survey of bowel preparation. 2. During colonoscopy: - Record patient pain scores, Boston bowel preparation scores, cecal intubation time, lesion detection time, total procedure time, maximum insertion depth, observation of active bleeding, endoscopic diagnosis, endoscopic hemostasis, and perforation. 3. After colonoscopy: - Record postoperative adverse events, need for repeat endoscopy, transfusion, intervention or surgery, and final discharge diagnosis. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03098173 -
Comparing Early Versus Elective Colonoscopy
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N/A |