Clinical trial NCT01774175: Comparison Between Coolprep and Picolyte for Bowel Cleansing
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stasis; Colon
Keywords: Bowel preparation
PEG with ascorbic acid
Picosulfate
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ottawa scale
timeFrame: Ottawa scale will be checked at the end of the colonoscopy. Participants won't be followed up because of this study.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Questionnaires related with satisfaction and side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
measure: Symptoms related with bowel preparation
timeFrame: Questionnaires related with side effects will be written just befor colonoscopy. Participants won't be followed up because of this study.
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical School
name: Jun Won Chung, Professor
role: STUDY_DIRECTOR
References: