Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)
Overview
- Phase
- Phase 3
- Intervention
- HAPREP®
- Conditions
- Healthy
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Adequacy of bowel preparation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Dae Kyung Sohn
M.D., PhD
National Cancer Center, Korea
Eligibility Criteria
Inclusion Criteria
- •Age, between 20 and 75
- •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
- •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
Arms & Interventions
HAPREP® (PEG-Asc)
subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]
Intervention: HAPREP®
SUCLEAR® (OSS)
subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation : OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]
Intervention: SUCLEAR®
Outcomes
Primary Outcomes
Adequacy of bowel preparation
Time Frame: on the day of colonoscopy
Secondary Outcomes
- adenoma detection rate(whithin 3 weeks from the day of colonoscopy)
- 5-point scale symptom questionnaire for drug tolerability(on the day of colonoscopy)
- Number of Participants with Adverse Events(on the day of colonoscopy)
- colonoscopy insertion time(on the day of colonoscopy)