A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy
1. Study design: endoscopist-blinded, prospective, randomized controlled trial
2. Subjects
1. Entry criteria: Male or female patients, aged between18 and 75 years undergoing
elective outpatient colonoscopy were eligible for the study.
2. Exclusion criteria:
gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled
inflammatory bowel disease, previous colorectal resection, congestive heart failure,
recent acute myocardial infarction or unstable angina, uncontrolled arterial
hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73
m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity
to any bowel cleansing agents.
3. Sampling design: Consecutive recruitment of consenting patients
4. Variables Predictor
1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day
of the colonoscopy
2. group 2 (split PEG) received 2 L of PEG at 6:00 p.m the evening before colonoscopy
and 2 L of PEG at 4-6 hours before procedure
3. group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before
colonoscopy and another sachet of SPMC at 4-6 hours before procedure;
4. group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9
p.m the evening before colonoscopy and another sachet at 4-6 hours before
procedure.
5. Primary Outcome: Quality of bowel preparation (Ottawa scale)
6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)
Immediately following the colonoscopy, the endoscopist who were unaware of the preparation regimen scored the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS).
20 minutes
No
Yoon Tae Jeen
Study Director
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Korea: Ministry for Health, Welfare and Family Affairs
Korea University
NCT01778192
July 2012
December 2012
Name | Location |
---|