A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL COMPARING ONE BOTTLE OF ORAL SODIUM PHOSPHATE AND STIMULANT LAXATIVES WITH LARGE VOLUME POLYETHYLENE GLYCOL SOLUTION FOR COLON CLEANSING

LC Hookey, WT Depew, S Vanner

GI Diseases Research Unit, Queen's University, Kingston, Ontario

INTRODUCTION: We examined an alternative to two bottles of oral sodium phosphate for colon cleansing prior to colonoscopy by comparing one bottle of oral sodium phosphate, four bisacodyl tablets, and one bisacodyl enema (Fleet Prep Kit #3; FPK#3) to polyethylene glycol (Colyte 4L; PEG).
METHODS: Patients undergoing outpatient colonoscopy were randomized to receive either FPK#3 (45 ml oral sodium phosphate at 7:00PM, 4 oral bisacodyl tablets at 9:30 PM, and a bisacodyl enema 2 hours before the procedure) or PEG (4L over 1 hour at 7:00PM the night before). Blood chemistry, weight, and postural vitals were obtained at baseline and one hour prior to the procedure. The subjects rated the tolerability of the preparations and their symptoms. Colonoscopists were blinded to the colonic cleansing preparation and graded the cleansing efficacy. We calculated that 80 patients were required in each arm to detect a 20% difference with FPK #3 in tolerability and efficacy compared to PEG. Exclusion criteria were renal insufficiency, congestive heart failure, large volume ascites, age >80, recent cardiac event, and/or fecal incontinence.
RESULTS: To date 75 patients have been enrolled in 6 weeks and 24 have completed their colonoscopy. One hundred percent of FPK#3 patients finished the entire preparation compared to 62%of PEG patients (P=0.01). Furthermore, 100% of FPK#3 patients rated the preparation as easy or tolerable compared to only 8% of the PEG patients (P<0.0001). Forty-one per cent of PEG patients reported nausea and/or vomiting compared to 20% of the FPK#3 patients. Colonoscopists rated the efficacy of the cleansing as excellent or good in 63% of FPK#3 and 66% of the PEG.
CONCLUSIONS: These preliminary data suggest that FPK#3 is much better tolerated than PEG and is at least as effective as PEG for colon cleansing.

This study is supported in part by an unrestricted educational grant from CB Fleet Co, Lynchburg, Virginia, USA.