Study design and oversight
high-dose bowel, P., NCT02661750
RECRUITMENT
The protocol was approved by the AMITA Institutional Review Board (AMITA 2015-0004-02, ClinicalTrials.gov NCT02661750 first registered January 22, 2016). The trial was designed by the authors with no outside input. All authors contributed to the study conception and design, material preparation, data collection and analysis. The first draft of the manuscript was written by David P. Gerard and all authors commented on each version of the manuscript. All authors read and approved the final manuscript. AMITA waived the fee for the Institutional Review Board. All other expenses associated with this study were paid for by the authors. Subjects received no financial reward and paid for their own preparations.The study was prospective and non-blinded. All patients in our clinic who previously had an inadequate colonoscopy preparation with less than 90% of the mucosa seen and scheduled a subsequent colonoscopy between January 2016 and December 2020 where invited to participate. All colonoscopies were performed by one of 2 gastroenterologists (DPG, MWR) between 8 a.m. to noon in the endoscopy labs at our office or two community hospitals.Subjects were outpatients undergoing elective colonoscopy, at least 18 years of age and not pregnant. Each subject signed an informed consent document.Subjects were assigned to receive a high-dose (459 g or 612 g) PEG and Gatorade bowel preparation solution dosed as shown in the upper half of Table Three-step high-dose bowel preparation protocol (top) with the contents of the bowel preparations obtained from the package inserts (below) compared to 4 L SF PEG-ELS (NuLYTELY) and our standard preparation of 306 g PEG in 64 oz of GatoradePoorly Absorbed mOsm is estimated by adding the number of mOsms of Phosphate plus 2.2 multiplied by the mOsm of PEG [L indicates liters; mOsm, milliosmoles. SF, sulfate free; ELS, electrolyte solution; PEG, polyethylene glycol-3350All patients were instructed to omit fruits and vegetables with seeds or foods that are high in fiber from their diet for 3 days-prior to their colonoscopy and to consume a clear liquid diet starting the day-prior (our standard dietary instructions for all patients undergoing colonoscopy). The patient instructions for the bowel preparations are provided in Additional file The study was designed to include a total of up to 100 subjects, but recruitment would terminate after 5 years if at least 50 subjects had enrolled. A subject was allowed to withdraw from the study until the day-prior to their colonoscopy. Beginning the day-prior to the colonoscopy, all subjects were evaluated on an intention-to-treat basis no matter what bowel preparation they actually used. Subjects could be switched to another bowel cleaning regimen chosen by the physician on-call if they could not tolerate the one assigned to them.
A physician (DPG) was responsible for monitoring the data for any adverse outcomes.