bowel cancer Colorectal cancer
Conditions
Interventions
Patients will be randomized during the pre-colonoscopy hospital visit between a
specialized low-volume 1-liter bowel preparation fluid (Pleinvue) and an
high-volume 2-liter bowel preparation fluid (
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age > 18 years • Planned elective colonoscopy for screening or diagnostic indications
Exclusion criteria
Exclusion criteria: • Therapeutic colonoscopy (e.g. endoscopic mucosal resection (EMR) • History of (sub) total colectomy • Inflammatory bowel disease (IBD) • Inpatient status • Indication for an intensified bowel preparation regime • Emergency colonoscopy • Limited Dutch language skills • Dementia • Visual impairment • Commonly accepted contra-indications for non-iso osmotic bowel preparation and ascorbate: o Glucose-6-phosphate-dehydrogenase (G6PD) deficiency o (sub)ileus o Bowel obstruction or perforation o Acute abdomen o Gastroparesis o intolerance for any of the formulations ingredients o Severe renal insufficiency (creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoints are BBPS result (total and per segment), and proportion of adequately prepared patients per type of bowel preparation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: the absolute score SF-36 and EQ-5D-5L before and after bowel preparation, and incremental cost-effectiveness ratio (ICER), in terms of costs per QALYs, correlation of the clinical parameters and tolerability to QoL scores, total individual costs, treating physician advised surveillance interval per study arm, and subgroup differences for colonoscopy indication and prior experience with bowel preparation. | — |
Countries
Netherlands
Outcome results
None listed