The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep. Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy. * Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water. * Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
57
Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.
Central Virginia VA Health Care System
Richmond, Virginia, United States
Patient acceptance/satisfaction
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
Time frame: Periprocedural
Quality of bowel preparation
Measure: Boston Bowel Preparation Scale (BBPS) score in right, transverse, and left colon; total score 0-9. Adequate bowel preparation defined as total BBPS ≥ 6 with each segment score ≥ 2; proportion of patients achieving adequate prep compared between groups.
Time frame: During colonoscopy (single procedure)
Patient-reported symptoms during bowel preparation
Patient-reported symptoms (abdominal pain, cramping, bloating, nausea, vomiting, headaches, weakness, hunger, sleep difficulties) scored on a 5-point Likert scale (1 = none to 5 = severely distressing).
Time frame: Periprocedural
Adverse events during bowel preparation
Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
Time frame: Periprocedural
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