Colorectal Cancer Clinical Trial
— RESULTOfficial title:
Effect of Low-volume (1L) vs Intermediate-volume (2L) Bowel Preparation on Cost-effectiveness and Quality of Life (RESULT Study). A Multicenter Randomized Controlled Trial
Verified date | August 2022 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adequate bowel preparation for colonoscopy is paramount for optimal diagnostic accuracy and safety. However, the need for high volumes to clean the colon often makes it difficult for patients to adhere to. Therefore, new low volume bowel preparation fluids have been developed. Little is known on the impact of these low volume bowel preparation fluids (1L), compared to intermediate-volume (2L) laxatives on quality of life (QoL) and cost-effectiveness. This study aims to provide further evidence on the presumed positive effect of ultra-low volume bowel preparation on patients' QoL and cost-effectiveness, in addition to its already demonstrated positive effect on bowel cleansing for colonoscopy. This multicenter randomized controlled trial (RCT) will be conducted in four hospitals in the Netherlands. Secure web-based questionnaires will be used before starting bowel preparation (baseline, t=0) and within 1 week (t=1) after colonoscopy, to assess the impact of bowel preparation on QoL and explore costs and productivity loss for cost-effectiveness analysis.
Status | Completed |
Enrollment | 509 |
Est. completion date | March 1, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Planned elective colonoscopy for surveillance or diagnostic indications 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: - Glucose-6-phosphate-dehydrogenase (G6PD) deficiency - (sub)ileus - Bowel obstruction or perforation - Acute abdomen - Gastroparesis - intolerance for any of the formulation ingredients - Severe renal insufficiency (creatinine clearance < 30mL/min) - Congestive heart failure (NYHA III or IV) - Phenylketonuria |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boston Bowel preparation scale score (total and per segment) | Level of bowel cleanliness achieved with the bowel preparation used. Segmental scores range from 0 to 3, in which 0 is worst and 3 is best. A segmental score of 2 or more is considered adequate for colonoscopy. | during colonoscopy procedure | |
Primary | Proportion of adequately prepared patients per type of bowel preparation | Level of bowel cleanliness achieved with the bowel preparation used. Segmental boston bowel preparation scores range from 0 to 3, in which 0 is worst and 3 is best. A segmental score of 2 or more is considered adequate for colonoscopy. | during colonoscopy procedure | |
Secondary | absolute score of SF-36 (short-form 36) | Change in scoring on the short-form 36 questionnaire before and after bowel preparation. Higher scores indicate a higher quality of life. | within 1 week after colonoscopy, questionnaire 2/2 | |
Secondary | absolute score EQ-5D-5L | Change in scoring on EuroQol group 5Dimension-5Levels questionnaire before and after bowel preparation. Higher scores indicate a higher quality of life. | within 1 week after colonoscopy, questionnaire 2/2 | |
Secondary | Correlation of clinical parameters and tolerability to Quality of life scores | Correlation of answers to questionaire on tolerability and relation to bowel cleanliness to scoring on SF-36 (short form 36) and EQ-5D-5L (EuroQol group 5 dimensions 5 levels), higher scores indicate a higher quality of life. | questionnaire 2/2, within 1 week after colonoscopy | |
Secondary | Subgroup differences for absolute scores on SF-36 for colonoscopy indication and prior experience with bowel preparation | Change in QoL scores on SF-36 based on having prior experience with bowel preparation, and differences between colonoscopy indications. SF-36 (short form 36), higher scores indicate a higher quality of life. | questionnaire 2/2, within 1 week after colonoscopy | |
Secondary | Subgroup differences in costs for colonoscopy indication and prior experience with bowel preparation | Change in costs based on having prior experience with bowel preparation, and differences between colonoscopy indications. | questionnaire 2/2, within 1 week after colonoscopy | |
Secondary | Subgroup differences for absolute scores on EQ-5D-5L for colonoscopy indication and prior experience with bowel preparation | Change QoL scores on EQ-5D-5L based on having prior experience with bowel preparation, and differences between colonoscopy indications. EQ-5D-5L (EuroQol group 5 dimensions 5 levels), higher scores indicate a higher quality of life. | questionnaire 2/2, within 1 week after colonoscopy | |
Secondary | Total individual costs | Total costs made per individual for the bowel preparation process, including cost for being absent at work and caregiver costs. | questionnaire 2/2, within 1 week after colonoscopy | |
Secondary | Incremental cost-effectiveness ratio | Change in costs per quality adjusted life years between the low-volume arm and intermediate volume arm. | within 1 week after colonoscopy, questionnaire 2/2 | |
Secondary | treating physician advised surveillance interval per study arm | advised surveillance interval correlated to colonoscopy findings and BBPS (boston bowel preparation scale) score by the treating physician. Higher scores indicate higher bowel cleanliness | During colonoscopy procedure |
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