Bowel Preparation, Efficacy, Tolerability, Safety, Bowel Preparation for Colonoscopy, Colon Cancer Screening
Conditions
Keywords
colonoscopy, bowel preparation
Brief summary
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.
Interventions
OTHERUse of a standardized meal content (food-kit) the day prior to colonoscopy
Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
DRUGPolyethylene glycol 3350 - electrolyte solution (GoLYTELY)
Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.
Sponsors
Joseph Spataro
Happy Colon Foods
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
single-blinded endoscopist
Intervention model description
Feasibility study comparing low-fiber vs clear-liquid diet before colonoscopy
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
\- Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)
Exclusion criteria
* Personal history of colorectal cancer * Inflammatory bowel disease * Prior colon resection * Antithrombotic therapy precluding polypectomy * Pregnancy * Hospitalization at the time of the scheduled procedure * Celiac disease (food kit contained gluten products) * Prior colonoscopy (cognitive bias) * Chronic kidney disease stage 3 or higher * Age 70 years or older.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient acceptance/satisfaction | Periprocedural | Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of bowel preparation | During colonoscopy (single procedure) | 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. |
| Patient-reported symptoms during bowel preparation | Periprocedural | 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). |
| Adverse events during bowel preparation | Periprocedural | Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale. |
Countries
United States
Outcome results
None listed