Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation

National Cancer Center (NCC)

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: SUCLEAR®; Drug: HAPREP®

Study type: Interventional

Funder types: Other

Identifiers

NCT02551198

NCC2015-0210

Details and patient eligibility

About

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

Full description

For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation

Enrollment: 184 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

HAPREP® (PEG-Asc)

Active Comparator group

Description:

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)\[AM 5-7, the day of colonoscopy\]

Treatment:

Drug: HAPREP®

SUCLEAR® (OSS)

Experimental group

Description:

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)\[AM 5-7, the day of colonoscopy\]

Treatment:

Drug: SUCLEAR®