Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy

• Conditions: Colonoscopy [E01.370.372.250.250.200]
• Interventions: Drug: polyethylene glycol, ascorbic acid

• Registration Number: NCT01740518
• Lead Sponsor: Dong Il Park, M.D, Ph.D.

Brief Summary

The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-patients

Detailed Description

Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Last Update Submitted: 2012-11-30
• Primary Completion: 2012-12
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Out-patients for colonoscopy

Exclusion Criteria

• age under 19 years or over 80 years
• Intestinal obstruction
• Women of pregnant, breastfeeding, or at risk of becoming pregnant
• major psychiatric illness
• known allergy to PEG
• serious condition- severe cardiac, renal, or metabolic diseases
• past history of colon resection
• current acute exacerbation of chronic inflammatory bowel disease
• functional constipation defined by Rome III diagnostic criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEG + ascorbic acid	polyethylene glycol, ascorbic acid	Those who taken PEG 2L + ascorbic acid

Primary Outcome Measures

Name	Time	Method
The efficacy of bowel preparation	one day (after colonoscopy)	three segmental preparation scoring (0\~4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid

Secondary Outcome Measures

Name	Time	Method
Patient's compliance and acceptability	one day (after injestion of preparation solution)	satisfaction (Visual Analogue Scale) amount of ingestion, frequency and amount of vomiting, tolerability, complication, taste

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of