Bowel Preparation Clinical Trial
Official title:
A Randomized Controlled Trial of Four Different Bowel Cleansing Regimens Prior to Colonoscopy: Efficacy, Patient Tolerability and Safety
To compare 4 commonly used bowel preparations in terms of efficacy, patient tolerability and safety. All these 4 bowel preparations are likely to be efficacious and safe. However, those with lower volume are likely to be better tolerated and completed by patients.
Adequate bowel preparation is imperative for diagnostic accuracy and therapeutic safety.
Several bowel cleansing preparations have been approved by Health Canada and are commonly
used prior to colonoscopy. Polyethylene glycol (PEG) has been considered to be the "gold
standard" for bowel preparation. It is a nonabsorbable solution which passes through the
bowel without net absorption or secretion. Significant fluid and electrolyte shifts are
therefore avoided. However, the large volume (4 liters), the salty taste and the sulphur
smell frequently lead to poor tolerability and compliance, sometimes resulting in inadequate
bowel preparation. Several other bowel cleansing preparations have been developed and
include sodium phosphate (NaP), magnesium citrate, and sodium picosulphate plus magnesium
oxide (PSMC)-containing preparations. NaP is a low volume hyperosmotic solution which draws
plasma water into the bowel lumen to promote colonic cleansing. As a result, significant
fluid and electrolyte shifts can occur. The advantage of the low volume is better patient
tolerance compared to PEG. However, even in healthy individuals severe electrolyte
disturbances have been reported when the 2 required doses are taken 12 hours apart.
Therefore Health Canada has recommended that 2 doses of NaP be taken 24 hours apart.
Patients with renal failure, congestive heart failure and liver failure should avoid this
preparation (Grade I A). PSMC is a hyperosmotic saline laxative which increases intraluminal
volume resulting in increased intestinal motility. Magnesium, a constituent of PSMC,
stimulates the release of cholecystokinin which also stimulates intestinal motility. Since
magnesium is eliminated by the kidney, patients with renal insufficiency or failure should
also avoid this preparation.
Many randomized controlled trials have compared the efficacy and tolerability of various
bowel cleansing regimens. Studies comparing full-volume (4 liters) PEG with low-volume (2
liters) PEG combined with magnesium citrate or bisacodyl have demonstrated equal efficacy of
colonic cleansing but with improved patient tolerance. However, there is little data on how
low volume PEG compares with NaP. The only meta-analysis of twenty nine trials on optimal
bowel preparation concluded that NaP was more effective in bowel cleansing than 4-liter PEG
or PSMC. However, there were only three trials comparing NaP to PSMC that met inclusion and
exclusion criteria in this meta-analysis and the results have been conflicting. Also there
were only three trials comparing PEG to PSMC in this meta-analysis with inconclusive data.
Moreover, the mean number of patients per trial was small at 223, with the highest number of
patients in a trial at 500.
A consensus document prepared by three leading American gastrointestinal societies (American
Society of Gastrointestinal Endoscopy, American Society of Colon and Rectal Surgeons and
Society of American Gastrointestinal and Endoscopic Surgeons) as well as a position paper by
the Canadian Association of Gastroenterology identified the lack of an ideal bowel
preparation which meets all these criteria. Furthermore, the need for further studies was
identified in the following areas:
1. Two-liter PEG vs NaP
2. PSMC vs NaP
Outpatients who need to undergo routine colonoscopy will be recruited. Each patient will be
randomly assigned to one of the four bowel preparations after they have given consent to
participate in the study:
1. Group 1. 4L PEG.
2. Group 2. 2L PEG plus 4 tablets of bisacodyl.
3. Group 3. 90 cc NaP.
4. Group 4. PSMC plus 1 bottle of Mg-citrate (300 cc).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
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