Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Healthy Person; Bowel Preparation Before Colonoscopy

Treatments: Drug: 2L Coolprep®; Drug: 1L Coolprep® and Bisacodyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01745835

Coolprep study

Details and patient eligibility

About

comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.

Enrollment: 196 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• willing to consent/undergo necessary procedures
• between the age of 20 and 75 years
• healthy persons planning to have a colonoscopy

Exclusion criteria

• history of abdominal surgery except appendectomy
• inflammatory bowel disease
• clinically or laboratory-confirmed ileus (both functional and mechanical)
• malignancy
• clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
• dementia, cognitive impairment
• the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
• known sensitivity to the agents used
• Pregnancy, Lactating woman

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

2L Coolprep®

Active Comparator group

Treatment:

Drug: 2L Coolprep®

1L Coolprep® and Bisacodyl

Experimental group

Treatment:

Drug: 1L Coolprep® and Bisacodyl