Colon Cleansing Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study
This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy
Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume
preparation for colon cleansing. This study evaluates whether split dosing is associated to
a further increase in efficacy and acceptability in comparison to the standard dose regimen.
This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in
Italy.
Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either
in the standard dosing (group A, two sachets the day before endoscopy), or in the split
dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be
assessed using the Boston Scale (BBPS) and rated as adequate if >2 in each segment. Patient
acceptance, satisfaction, and related symptoms will be also recorded.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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