Effect of Low-volume (1L) vs Intermediate-volume (2L) Bowel Preparation on Cost-effectiveness and… (NCT05242562) | Clinical Trial Compass
CompletedNot Applicable
Effect of Low-volume (1L) vs Intermediate-volume (2L) Bowel Preparation on Cost-effectiveness and Quality of Life
Netherlands509 participantsStarted 2022-05-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Boston Bowel preparation scale score (total and per segment)
Timeframe: during colonoscopy procedure
2
Proportion of adequately prepared patients per type of bowel preparation