Electrolyte Beverage Combined With Polyethylene Glycol for Colonoscopy Bowel Preparation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University
About this trial
This randomized controlled trial aims to evaluate the effects of different ratios of electrolyte beverage and water combined with polyethylene glycol (PEG) on bowel preparation quality before colonoscopy. Participants undergoing elective colonoscopy will be randomly assigned to one of three bowel preparation regimens: PEG prepared with water only, PEG prepared with a low ratio of electrolyte beverage and water, or PEG prepared with a medium ratio of electrolyte beverage and water. The primary outcome is adequate bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS). Secondary outcomes include bowel preparation completion rate, tolerability, adverse events, repeat colonoscopy rate, adenoma detection rate, and ingestion rhythm characteristics during bowel preparation. This study also aims to explore whether electrolyte beverage-assisted bowel preparation may improve bowel cleansing quality by influencing participants' ingestion rhythm and adherence during PEG intake.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18-75 years scheduled to undergo elective colonoscopy
Meet the standard clinical indications for colonoscopy;
Able to understand and comply with the bowel preparation procedure and complete oral polyethylene glycol (PEG) intake as required;
Able to comply with study-related data collection and follow-up;
Disqualifiers
Previously diagnosed colorectal cancer, intestinal obstruction, or suspected intestinal obstruction;
Active gastrointestinal bleeding or a definite history of gastrointestinal bleeding within the past 4 weeks (including melena, hematochezia, or hematemesis);
Severe renal insufficiency, decompensated heart failure, significant electrolyte imbalance, or other conditions unsuitable for PEG bowel preparation;
Known allergy to polyethylene glycol or components of the electrolyte beverage used in the study;
Trial design
Design model
Parallel
Treatments tested in this trial
PEG With Water
Other interventionPolyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.
PEG With Low-dose Electrolyte Beverage
Other interventionPolyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.
PEG With Medium-dose Electrolyte Beverage
Other interventionPolyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.
Treatment groups
405 Participants
are divided into 3 treatment groupsGroup A: Water GroupActive comparator 1 intervention
Group B: Low-dose Electrolyte Beverage GroupExperimental treatment 1 intervention
Group C: Medium-dose Electrolyte Beverage GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adequate Bowel Preparation Rate
Adequate bowel preparation is defined as a total Boston Bowel Preparation Scale (BBPS) score ≥6 with each colonic segment score ≥2 during colonoscopy.
Time frame
At the time of colonoscopy on Day 1Secondary outcomes
1
Total Boston Bowel Preparation Scale Score
Total Boston Bowel Preparation Scale (BBPS) score assessed during colonoscopy.
Time frame
At the time of colonoscopy on Day 12
Bowel Preparation Completion Rate
Proportion of participants who complete the planned polyethylene glycol bowel preparation within 60 minutes.
Time frame
During bowel preparation within 1 hour before colonoscopy on Day 13
Adverse Event Rate
Incidence of adverse events during bowel preparation, including nausea, vomiting, abdominal distension, abdominal pain, dizziness, and fatigue.
Time frame
During bowel preparation within 1 hour before colonoscopy on Day 1Sponsors and contacts
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Source ClinicalTrials.gov