Efficacy, Safety and Tolerability of Split-dose of PEG Compared With NaP Solution for Colonoscopy Preparation: A Randomized, Controlled Trial

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

: In several studies comparing of sodium phosphate solutions versus PEG, both regimen had similar efficacy of bowel cleansing and sodium phosphate solutions are more acceptable to patients because patient are required to consume smaller volume. But sodium phosphate solutions are associated with fluid and electrolyte disturbances, so use of sodium phosphate solution in routine medical check-up of outpatients is problematic. PEG can provide a rapid peroral approach to colon lavage without causing fluid and electrolyte disturbance. However, the need to ingest a large volume of fluid reduces patient compliance, and results in suboptimal bowel preparation. In order to overcome this disadvantage, several studies proved that split dose of PEG regimens were better quality preparation and more acceptable than single dose regimens. In Korea, need for outpatient or screening colonoscopy without laboratory test is increasing and split dose of PEG is used more frequently than other country in bowel preparation because of safety. But, superiority of split dose of PEG to sodium phosphate solution has not been demonstrated. The study was not yet existed about comparison of split dose PEG solution with sodium phosphate solution for bowel cleansing and tolerability in colonoscopy preparation. To use split dose of PEG in bowel preparation with medical evidence, we want to demonstrate split dose bowel preparation with PEG compared to sodium phosphate solutions provide a better colon cleansing efficacy and similar tolerability.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inje University
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Adult outpatients(at least 18 years of age, under 65 years) who undergo scheduled colonoscopy for screening, cancer surveillance or want procedure with/without non-specific gastrointestinal symptoms

Exclusion Criteria:

• age under 18 years, elderly patients(>,=65 yrs), pregnancy, breast feeding, patient with bowel obstruction, and other structural intestinal disorders, gut hypomotility(chronic constipation(< 2 bowel movement/week for 1yr), hypomotility syndrome, megacolon, idiopathic pseudoobstruction), renal failure, congestive heart failure, liver failure, pre-existing electrolyte disturbance(hypercalcemia, hyperphosphatemia); refusal of consent to participate in the study.