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Comparison Between Coolprep and Picolyte for Bowel Cleansing

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Chung Jun Won, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01774175
First received: January 17, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition
Stasis; Colon

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    * 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:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Nausea, Vomiting, Abdominal discomfort, Abdominal distension, Headache, Dizziness, Numbness


Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774175

Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Study Director: Jun Won Chung, Professor Gachon University Gil Medical School
  More Information

No publications provided

Responsible Party: Chung Jun Won, Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01774175     History of Changes
Other Study ID Numbers: COOLPREPICOLYTE
Study First Received: January 17, 2013
Last Updated: January 23, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Gachon University Gil Medical Center:
Bowel preparation
PEG with ascorbic acid
Picosulfate

Additional relevant MeSH terms:
Ascorbic Acid
Magnesium citrate
Picosulfate sodium
Antioxidants
Cathartics
Gastrointestinal Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014