Efficacy and Fafety of Low-volume Preparation in the Elderly: (EASY PREP) study
- Conditions
- Not Applicable
- Registration Number
- KCT0004539
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
Background and study aims: 1L-polyethylene glycol (PEG)/Ascorbic acid (Asc) was developed and intended to increase osmotic load by containing a greater quantity of ascorbate components and to be less volume requesting to drink. We aimed to compare the efficacy, tolerability and safety of 1LPEG/Asc versus 2L-PEG/Asc with a split-dosing regimen in elderly patients undergoing scheduled colonoscopy. Patients and methods: This was a prospective, non-inferiority, randomized, investigator-blinded, and multicenter study conducted in Korea between July 2019 and December 2020. Patients aged between 65 and 85 years were randomized to either 1L-PEG/Asc or 2L-PEG/Asc with split dose regimen at a 1:1 ratio. The efficacy of bowel preparation was evaluated using the Harefield Cleansing Scale (HCS) and the Boston Bowel Preparation Scale (BBPS). Results: A total of 202 patients were analyzed. Successful overall bowel preparation is similar between 1L-PEG/Asc and 2L-PEG/Asc based on HCS (95.1% vs 93.1%, P = 0.528) and BBPS (93.1% vs 90.0%, P = 0.422). The perfect overall bowel preparation in 1L-PEG/Asc was higher than that in 2L-PEG/Asc with HCS (40.2% vs 25.0%, P = 0.021) and BBPS (80.4% vs 68.0%, P = 0.044). 1L-PEG/Asc demonstrated superior high-quality preparation in right colon (46.1% vs 30.0% on HCS; P = 0.019, 83.3% vs 70.0% on BBPS; P = 0.025). Adenoma detection rate (47.1% vs 49.0%, P = 0.782), occurrence of adverse events (25.5% vs 23.0%, P = 0.680), laboratory shifts, and tolerability were comparable between two groups. Conclusions: 1L-PEG/Asc was overall as effective, safe, and tolerable as 2L-PEG/Asc in elderly patients with comorbidities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 202
Patients undergoing colonoscopy aged 65-84 who agreed to participate in the study.
? People who have had a colon resection
? Patients with congestive heart failure, acute myocardial infarction within 6 months
? American Society of Anesthesiology class III or above
? If you have a history of cirrhosis, ascites, chronic kidney disease, inflammatory growth disease, serious inflammatory diseases
? Those who complain of severe constipation (less than 3 times a week, those taking regular laxatives)
? Disabled people (cognitive and intellectual disabilities), pregnant women
? Paralysis, intestinal obstruction, toxic giant colon
? Patient who refused to sign the consent form
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adequate bowel preparation rate using Boston bowel preparation scale(BBPS)
- Secondary Outcome Measures
Name Time Method adequate bowel preparation rate using Harefield cleansing scale (HCS);compliance;easiness;safety;adenoma detection rate;polyp detection rate