NCT06254443

Oral PEG vs. Enema in Urgent Colonoscopy for ALGIB

Comparison of Oral Polyethylene Glycol and Enema for Diagnostic Efficacy in Urgent Colonoscopy for Acute Lower Gastrointestinal Bleeding: a Multicenter, Randomized, Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Lower Gastrointestinal Bleeding

Interventions

Type	Name	Description
OTHER	Enema Bowel preparation	Enema Group (Experimental Group): Enema is administered using either normal saline or 1% soapy water for cleansing until the effluent is clear of fecal debris, or until a total volume of 3000 ml of enema solution has been administered. The enema should be initiated 4-6 hours before colonoscopy, with the dosage and frequency of incremental enemas determined based on the patient's tolerance. The final enema administration should be completed no later than 10 minutes before the scheduled colonoscopy.
OTHER	PEG Bowel preparation	Oral PEG Group (Control Group): Following the administration protocol recommended by the Chinese expert consensus for PEG, a 3 L PEG regimen is employed. The regimen involves segmented intake, with 1 L taken 10-12 hours before the intestinal examination and an additional 2 L taken 4-6 hours before the examination on the day of the procedure.

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-02-12
• Last updated: 2025-01-22

Locations

3 sites across 1 country: China