Bowel Preparation Clinical Trial
Official title:
A Head-to-head Comparison Study of Polyethylene Glycol, Polyethylene Glycol Plus Sodium Picosulfate, and Sodium Picosulfate
Sodium picosulfate/magnesium citrate (SPMC) is generally better tolerated than PEG, its
cleansing effect remains uncertain. While most studies showed SPMC was non-inferior to PEG,
some studies reported that SPMC was less effective than PEG. To improve the bowel cleansing
effect of SPMC, splitting the dose by using one sachet the evening before colonoscopy and the
other sachet 4 to 5 hours before colonoscopy in the morning, has been proposed.Adding
bisacodyl to the regimen also has been shown to be helpful. Some side effects, such as
hyponatremia, dehydration and sleep disturbance, were reported to be more commonly associated
with SPMC than with PEG.
To enhance the efficacy and reduce the side effects, two studies have evaluated the
combination of SPMC and PEG, with conflicting results.The effect of combining PEG and SPMC
should be best appreciated with head-to-head comparison with PEG and SPMC alone at the same
time.
Therefore we designed this head-to-head comparison study for 2 L PEG, 1L PEG plus one sachet
of SPMC and 2 sachet of SPMC, all with split-dose and the addition of 10 ml bisacodyl. Our
hypothesis is the bowel cleansing effect of the combination regimen was not inferior to PEG
alone. The tolerability, acceptability and side effects of the 3 regimen will also be
evaluated.
Patients will be randomly assigned to either PEG, PEG plus SPMC or SPMC group, in a 1:1:1
ratio using a computer-generated sequence. The treatment allocation will be concealed and
revealed by non-research medical personnel at the screening visit.
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