Comparison Between Coolprep and Picolyte for Bowel Cleansing

A Randomised Controlled Trial of a 2 Litre Polyethylene Glycol Solution + Ascorbic Acid Versus Sodium Picosulphate + Magnesium Citrate Solution for Bowel Cleansing Prior to Colonoscopy

The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.

Study Overview

• Status: Unknown
• Conditions: Stasis; Colon

Detailed Description

The investigators can find easily colon cancer and poly by colonoscopy, but bowel preparation is very important to find the lesion. Desirable bowel preparation drug must be clearly removed stool, effective on colonoscopic finding and pathologic finding, quickly administrated agent and eliminated stool, comfort for patient, and less side effects.

PEG is very safe osmotic laxative. New agent(coolprep) which add ascorbic acid is less salty and less volume. Picosulfate+magnesium citrate(picolyte) taste orange, can be easily prepared bowel for colonoscopy by good taste and small volume. Magnesium with citrate acts like osmotic agent, picosulfate acts irritant agent.

The investigators will compare with PEG+ascorbic acid and picosulfate+magnesium citrate about bowel preparation, patient's satisfaction, side effects to identify effectiveness of new bowel preparation drug.

• Study Type: Observational
• Enrollment (Anticipated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will include a total of 250 patients. All patient randomized PEG+ascorbica acid(coolprep) and picosulfate magnesium citrate(picolyte), each group will include 125 patients.

The investigators decided sample size to 200 patients after comparing Ottawa scale. The investigators assumed there would be defference about 20 percent of bowel preparation between them. Recently, Ottawa scale of bowel preparation reported about 5 points. The investigators assumed that there could be differences between them about 1 point. The investigators decided each groups per 100 patients, if significance level was 0.05 and test power is 80 percent. The investigators start this study with a total of 220 patients because 10 percent of 200 patients could be drop out. The investigators readjust about 30 patients after interim analysis.

Description

Inclusion Criteria:

• Age : over 19 years
• Who will be done colonoscopy
• Who accepted informed consent

Exclusion Criteria:

• Age : over 80 years
• Electrolyte imbalance
• Liver function test abnormality, ascites(over 2 times, >Child class B)
• ARF or CRF(GFS<30)
• Recent MI(< 6months) or Unstable angina pectoris
• Congestive heart failure(NYHA > 2)
• Inflammatory bowel disease
• Abdominal minor surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Coolprep; A total of 2L A : NaCl 5.382g KCl 2.03g Sodium sulfate 15g Polyethylene glycol 3350 200.0g B : Ascorbic acid 9.4g Sodium ascorbate 11.8g
Picolyte; Sodium picosulfate 30.0mg Magnesium citrate 10.5g + 36.0g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ottawa scale	* Ottawa scale Individual evaluation of right, mid, and left colon: No liquid - 0 Minimal liquid, no suctioning required - 1 Suction required to see mucosa - 2 Wash and suction - 3 Solid stool,not washable - 4 Evaluation of the entire colon: Overall quantity of fluid 0-2 minimal -0 moderate - 1 Large - 2 * Aronchick score scale Minimal liquid, visible more than 95% of colon mucosa - excellent Clear liquid covered 5~25% of mucosa, visible more than 90% of colon mucosa - good Solid stool, washable, visible more than 90% of colon mucosa - Fair Solid stool, not washable, visible less than 90% of colon mucosa not washable - Poor Bowel preparation is needed - Inadequate	Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Taste, Comfort	Questionnaires related with satisfaction and side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
Symptoms related with bowel preparation	Nausea, Vomiting, Abdominal discomfort, Abdominal distension, Headache, Dizziness, Numbness	Questionnaires related with side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Investigators: Study Director: Jun Won Chung, Professor, Gachon University Gil Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 20, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Bowel preparation; PEG with ascorbic acid; Picosulfate
• Other Study ID Numbers: COOLPREPICOLYTE