The main objectives of this study are:1. The effect of high (2L) vs low (1L) volume bowel preparation on the quality of life of patients undergoing colonoscopy. 2. The cost-effectiveness of low-volume bowel preparation versus high-volume preparation…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoints are BBPS result (total and per segment), and proportion of
adequately prepared patients per type of bowel preparation.
Secondary outcome
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.
Background 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 ultra-low
volume bowel preparation fluids have been developed. Little is known on the
impact of these ultra-low volume bowel preparation fluids (1L), compared to
high-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.
Study objective
The main objectives of this study are:
1. The effect of high (2L) vs low (1L) volume bowel preparation on the quality
of life of patients undergoing colonoscopy.
2. The cost-effectiveness of low-volume bowel preparation versus high-volume
preparation.
Secondary study aims are to compare:
1. The Boston Bowel Preparation Score (BBPS) between low- versus high-volume
preparation
2. Subgroup differences for the following predefined subgroups: prior
experience with bowel preparation, and colonoscopy indication.
3. Measured change in QoL effect of bowel preparations in general using both
treatment groups
4. Correlation of patient reported QoL with clinical parameters and reported
bowel preparation tolerability
Study design
This multicenter randomized controlled trial (RCT) will be conducted in four
hospitals in the Netherlands. We will use secure web-based questionnaires and
invite patients to fill in the questionnaire 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. Data on colonoscopy findings and complications
will be retrieved from the patients* medical record.
Intervention
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 (Moviprep), which are both
currently used as bowel preparation for colonoscopy in the Netherlands.
Study burden and risks
There is no direct benefit for patients participating in this study. Risk
associated with participation are considered minimal, and are limited to the
possibility privacy related issues. Nonetheless, this is considered to be
minimal because of the use of pseudonymized data and GDPR compliant databases.
In the future, results from this study could possibly benefit many patients
undergoing colonoscopy, with the possibility of reducing the need for repeat
colonoscopies and improving patient experience of colonoscopies.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
• Age > 18 years
• Planned elective colonoscopy for screening 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:
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 < 30mL/min)
o Congestive heart failure (NYHA III or IV)
o Phenylketonuria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-004885-36-NL |
| CCMO | NL79014.091.21 |