Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Use of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water.
THe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid.
Ospedale Valduce, Gastroenterologia
Como, Italy
Ospedale S. Paolo
Milan, Italy
Ospedale L. Sacco, Endoscopic Unit
Milan, Italy
Efficacy of bowel cleansing
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
Time frame: Within 24 hrs
Safety
Occurrence of complications related to the intake or the two study products
Time frame: In the 24 hours within assumption of study products
Tolerability
Acceptability of the two study products in term of palatability and ease to take the products
Time frame: Within 12 hrs
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