Comparison Between Coolprep and Picolyte for Bowel Cleansing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01774175|
Recruitment Status : Unknown
Verified January 2013 by Chung Jun Won, Gachon University Gil Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : January 23, 2013
Last Update Posted : January 25, 2013
|Condition or disease|
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|
|Estimated Enrollment :||250 participants|
|Observational Model:||Case Control|
|Official Title:||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|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||March 2014|
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
Sodium picosulfate 30.0mg Magnesium citrate 10.5g + 36.0g
- Ottawa scale [ Time Frame: 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
- Patient satisfaction [ Time Frame: 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
- Symptoms related with bowel preparation [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774175
|Study Director:||Jun Won Chung, Professor||Gachon University Gil Medical School|