Abstract
Purpose: While split-dose bowel preparation has gained acceptance as the most effective cleansing administration for colonoscopy, evening only regimens continue to be utilized. This study compares the efficacy of an oral sulfate (OS) preparation given as both evening and split administrations to 4L PEG-ELS given in its approved evening regimen. Methods: Adult outpatients scheduled for colonoscopy were enrolled into this single-blind, multi-center study and were administered either an OS preparation (SUPREP®) or 4L PEG-ELS (GoLYTELY®). Patients were equally randomized to either OS (split or PM only) or 4L PEG-ELS (PM only). Colonoscopies were performed by investigators blinded to treatment assignment. Cleansing was graded using a 4 point scale (Excellent: no more than small bits of adherent feces/fluid, Good: small amounts of feces or fluid not interfering with exam, Fair: enough feces or fluid to prevent a completely reliable exam, Poor: large amounts of fecal residue, additional cleansing required), where scores of Good or Excellent were considered “successful”. Each colon segment was also rated for the quantity of residual stool and fluid. The volume of irrigation water used during examination was also recorded. Results: Ninety-five percent of patients had successful cleansing with OS-Split, compared to 77% of PEG-ELS patients (p<0.001). With 74% successful preparations, OS-PM was non-inferior to PEG-ELS (p<0.001). OS-Split had more than twice as many excellent preparations as PEG-ELS or OS-PM (p < 0.001), and was superior to both in cleaning stool in all segments, including the ascending colon (p<0.001). The volume of water used to irrigate the colon during the procedure was about 50% less for OS-Split (74 ml) than for the PM only regimens (150-160 ml, p<0.01). Conclusion: Oral sulfate solution given in a split-dose regimen provides superior bowel cleansing compared to 4L PEG-ELS and evening only sulfate solution. This result was seen both overall and segmentally, and supports continued emphasis of split-dosing bowel preparations. Differences in utilization of irrigation water confirm the better efficacy associated with the split dose regimen. Comparing the efficacy of evening only preparations, there was no significant difference between OS-PM and PEG-ELS. Disclosure - Mr. McGowan - Employee: Braintree Laboratories; Dr. Cleveland - Employee: Braintree Laboratories; Dr. Rex - Speaker's Bureau: Ferring Laboratories, Speaker's Bureau: Braintree Laboratories; Dr. DiPalma - Speaker's Bureau: Braintree Laboratories, Other: Medical Director, Braintree Laboratories.Table: Table. Bowel preparation cleansing efficacy
Published Version
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