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Comparison Between Coolprep and Picolyte for Bowel Cleansing

G

Gachon University Gil Medical Center

Status

Unknown

Conditions

Stasis; Colon

Study type

Observational

Funder types

Other

Identifiers

NCT01774175
COOLPREPICOLYTE

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Coolprep
Description:
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
Description:
Sodium picosulfate 30.0mg Magnesium citrate 10.5g + 36.0g

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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