Comparison Between Coolprep and Picolyte for Bowel Cleansing

• Conditions: Stasis; Colon

• Registration Number: NCT01774175
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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.

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 Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-20
• Study First Posted: 2013-01-23
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-25
• Primary Completion: 2013-06
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ottawa scale	Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study.	\* 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

Secondary Outcome Measures

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