Healthy
Conditions
Keywords
polyethylene glycol with ascorbic acid, oral sulfate solution, bowel preparation
Brief summary
Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation. For bowel preparation, effective, well-tolerated and safe methods should be applied. Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation
Detailed description
For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation
Interventions
DRUGHAPREP®
Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc) : : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]
DRUGSUCLEAR®
Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]
Sponsors
Daehang Hospital
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age, between 20 and 75 2. Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy
Exclusion criteria
* Gastrointestinal obstruction * Bowel perforation * Gastric retention * Ileus * Toxic colitis or toxic megacolon * Known allergies to components of the OSS and PEG-Asc * History of colorectal resection * History of abdominopelvic surgery within 6 months * uncontrolled electrolyte imbalance * hereditary Phenylketonuria * Severe dehydration status * seizure * coma * Glucose-6-phosphate dehydrogenase deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequacy of bowel preparation | on the day of colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-point scale symptom questionnaire for drug tolerability | on the day of colonoscopy | 4(distressing) or 5(severely distressing) point would be untolerable |
| Number of Participants with Adverse Events | on the day of colonoscopy | — |
| colonoscopy insertion time | on the day of colonoscopy | — |
| adenoma detection rate | whithin 3 weeks from the day of colonoscopy | — |
Countries
South Korea
Outcome results
None listed