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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
144
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.
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.
Tongliao City Hospital
Tongliao, Neimenggu, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Endoscopic diagnosis rate
Including the definite diagnosis and presumptive diagnosis
Time frame: During the colonoscopy (up to 48 hours from admission)
Cecal intubation time
The duration from the insertion of the colonoscope through the anus to reaching the cecum.
Time frame: During the colonoscopy (up to 48 hours from admission)
Lesion detection time
The duration from the insertion of the colonoscope through the anus to the initial identification of lesions.
Time frame: During the colonoscopy (up to 48 hours from admission)
Total procedure time
The duration from the insertion of the colonoscope through the anus to the withdrawal from the anus.
Time frame: During the colonoscopy (up to 48 hours from admission)
Cecal intubation rate
The proportion of patients in the study group in whom successful cecal intubation was achieved, relative to the total number of patients in the group.
Time frame: During the colonoscopy (up to 48 hours from admission)
Rate of bowel preparation related adverse events
Bowel preparation related adverse events included nausea, vomiting, bloating, hypotension, heart failure, electrolyte imbalance, aspiration pneumonia, etc.
Time frame: From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)
Rate of colonoscopy related adverse events
Colonoscopy related adverse events included perforation, recurrent bleeding, post-operational infection and death.
Time frame: From the start of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Rate of patients who sufferred from exacerbation of ALGIB
Exacerbation of ALGIB was defined as patients' subjective bleeding symptoms were worse than before the start of bowel preparation, or patients had a decrease in hemoglobin of more than 2g/L before and after bowel preparation.
Time frame: From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)
Bowel preparation satisfaction score
The satisfaction score of bowel preparation was evaluated from three dimensions: mood, discomfort symptoms, and general feeling, with each dimension ranging from 0 to 5 indicating from the worst to the best.
Time frame: At the end of bowel preparation (assessed up to 48 hours from admission)
Boston bowel preparation score
A score of 0 to 9 on the Boston Bowel Preparation scale indicates worst to best.
Time frame: During the colonoscopy (up to 48 hours from admission)
Endoscopic hemostasis rate
The rate of performance of endoscopic hemostasis.
Time frame: During the colonoscopy (up to 48 hours from admission)
Intervention or surgery rate
The rate of patients who underwent angiographic therapy or surgery after the primary colonoscopy.
Time frame: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Repeated endoscopy rate
The rate of patients who received a second-look of colonoscopy after the primary colonoscopy.
Time frame: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Transfusion rate
The rate of patients who need red blood cell transfusion after the primary colonoscopy.
Time frame: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.