Efficacy and Safety of Split-dose Citrafleet Administered From 2 to 6 Hours Before Morning Colonoscopies
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy.
Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged
procedure duration and repeated procedures at earlier intervals. Emerging solid evidence is
pointing out the need of switching from preparation the day before to regimens in which half
or even more of the preparation is administered the same day of the procedure, which have
extensively demonstrated to provide a significantly better cleansing, being well tolerated.
Preparation can be fully administered the same day for afternoon procedures, whereas
split-dose regimens fit better with morning colonoscopies. However, the ideal regimen for
early morning colonoscopies is still to be elucidated. The second part of the preparation for
these patients is usually recommended to be taken during sleeping time (2-3 am) on the belief
that intake of fluids should be completely halted at least four hours prior to the
colonoscopy procedure Sodium picosulphate is a unique orange-flavoured cleansing agent dosed
as two powder sachets. Mayor advantages in comparison with current alternatives are
relatively small volumes (each sachet is mixed with only 150-250 mL of water) and a more
pleasant taste. It provides similar bowel cleansing than sodium phosphate and polyethylene
glycol solutions administered the day before. Nonetheless, focus on split-dose regimens has
been set on several polyethylene glycol (either high-volume or low-volume) regimens, but no
data are available for split-dose sodium-picosulphate regarding colonoscopy in adults.
The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate
low-volume split-dose regimen, in which the second-half of the preparation and fluids intake
are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning
colonoscopies, comparing this split-dose regimen with standard cleansing the day before with
sodium picosulphate/magnesium citrate.