Colorectal CancerRESULTNCT05242562
Effect of Low-volume (1L) vs Intermediate-volume (2L) Bowel Preparation on Cost-effectiveness and Quality of Life
A study testing Plenvu and Moviprep in people with Colorectal Cancer and Colonic Polyp, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colonic Polyp
- What is being tested?
- Plenvu and Moviprep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 May 2022to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Planned elective colonoscopy for surveillance or diagnostic indications
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Official 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
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.
Read the detailed description
Background and aims: 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.
Study design: 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. Data on colonoscopy findings and complications will be retrieved from the patients' medical record.
Study population: This multicenter study will include 470 patients from 4 hospitals.
Intervention: Patients will be randomized during the pre-colonoscopy hospital visit between a specialized low-volume 1-liter bowel preparation fluid (Pleinvue) or an intermediate-volume 2-liter bowel preparation fluid (Moviprep), which are already both routinely used as bowel preparation for colonoscopy in the Netherlands.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no direct benefit for patients participating in this study. Risk associated with participation are considered minimal, and are limited to the possibility of 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 patients undergoing colonoscopy, with the possibility of reducing the need for repeat colonoscopies and improving patient experience of colonoscopies.
- Conditions
- Colorectal Cancer, Colonic Polyp
- Being tested
- Plenvu, Moviprep
- Keywords
- colonoscopy, bowel preparation, Quality of life, Costeffectiveness
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlenvuDrug
Also called Pleinvue
a recently developed 1 liter bowel preparation fluid that is often used in clinical practice. Patients will receive a split dose protocol, low-residue diet 2 days before colonoscopy, and clear liquid diet 1 day before colonoscopy.
MoviprepDrug
a 2 liter widely established 2 liter bowel preparation fluid that is commonly used in clinical practice. Patients will receive a split dose protocol, low-residue diet 2 days before colonoscopy, and clear liquid diet 1 day before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Pleinvue | Experimental | a 1L poly ethylene glycol PEG solution with added ascorbate (Pleinvue, Norgine, active ingredients PEG 3350, Sodium ascorbate, Sodium sulfate, Ascorbic acid, Sodium chloride, Potassium chlorid) Receives: Drug: Plenvu |
| Moviprep | Active comparator | a 2L PEG solution with added ascorbate (Moviprep, Norgine, active ingredients Macrogol 3350, Sodium Sulphate Anhydrous, Sodium chloride, Potassium chloride, Ascorbic acid, Sodium ascorbate) Receives: Drug: Moviprep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during colonoscopy procedure
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.
Measured: during colonoscopy procedure
Secondary outcomes (9)
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.
Measured: within 1 week after colonoscopy, questionnaire 2/2
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.
Measured: within 1 week after colonoscopy, questionnaire 2/2
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.
Measured: questionnaire 2/2, within 1 week after colonoscopy
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.
Measured: questionnaire 2/2, within 1 week after colonoscopy
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.
Measured: questionnaire 2/2, within 1 week after colonoscopy
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.
Measured: questionnaire 2/2, within 1 week after colonoscopy
Total individual costs
Total costs made per individual for the bowel preparation process, including cost for being absent at work and caregiver costs.
Measured: questionnaire 2/2, within 1 week after colonoscopy
Incremental cost-effectiveness ratio
Change in costs per quality adjusted life years between the low-volume arm and intermediate volume arm.
Measured: within 1 week after colonoscopy, questionnaire 2/2
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
Measured: During colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start16 May 2022
- Primary completion27 Feb 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized during the pre-colonoscopy hospital visit between a specialized low-volume 1-liter bowel preparation fluid (Pleinvue) or an intermediate-volume 2-liter bowel preparation fluid (Moviprep)
- Masking
- None (open label)
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242562
- Sponsor's protocol ID
- NL79014.091.21
- Acronym
- RESULT
- Status last verified
- Nov 2024
- First submitted
- 30 Sep 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset used during this study is available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05242562
- Acronym / sponsor ID
- RESULT / NL79014.091.21
- Conditions
- Colorectal Cancer, Colonic Polyp
- Keywords
- colonoscopy, bowel preparation, Quality of life, Costeffectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and aims: 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.
Study design: 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. Data on colonoscopy findings and complications will be retrieved from the patients' medical record.
Study population: This multicenter study will include 470 patients from 4 hospitals.
Intervention: Patients will be randomized during the pre-colonoscopy hospital visit between a specialized low-volume 1-liter bowel preparation fluid (Pleinvue) or an intermediate-volume 2-liter bowel preparation fluid (Moviprep), which are already both routinely used as bowel preparation for colonoscopy in the Netherlands.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no direct benefit for patients participating in this study. Risk associated with participation are considered minimal, and are limited to the possibility of 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 patients undergoing colonoscopy, with the possibility of reducing the need for repeat colonoscopies and improving patient experience of colonoscopies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized during the pre-colonoscopy hospital visit between a specialized low-volume 1-liter bowel preparation fluid (Pleinvue) or an intermediate-volume 2-liter bowel preparation fluid (Moviprep)
| Arm | Type | Receives |
|---|---|---|
| Pleinvue | Experimental | Drug: Plenvua 1L poly ethylene glycol PEG solution with added ascorbate (Pleinvue, Norgine, active ingredients PEG 3350, Sodium ascorbate, Sodium sulfate, Ascorbic acid, Sodium chloride, Potassium chlorid) |
| Moviprep | Active comparator | Drug: Moviprepa 2L PEG solution with added ascorbate (Moviprep, Norgine, active ingredients Macrogol 3350, Sodium Sulphate Anhydrous, Sodium chloride, Potassium chloride, Ascorbic acid, Sodium ascorbate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Planned elective colonoscopy for surveillance or diagnostic indications
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlenvuAlso: Pleinvuea recently developed 1 liter bowel preparation fluid that is often used in clinical practice. Patients will receive a split dose protocol, low-residue diet 2 days before colonoscopy, and clear liquid diet 1 day before colonoscopy. | Drug | Pleinvue |
| Moviprepa 2 liter widely established 2 liter bowel preparation fluid that is commonly used in clinical practice. Patients will receive a split dose protocol, low-residue diet 2 days before colonoscopy, and clear liquid diet 1 day before colonoscopy. | Drug | Moviprep |
Primary outcome
Boston Bowel preparation scale score (total and per segment)
Time frame: during colonoscopy procedure
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.
Proportion of adequately prepared patients per type of bowel preparation
Time frame: during colonoscopy procedure
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.
9 secondary outcomes
absolute score of SF-36 (short-form 36)
Time frame: within 1 week after colonoscopy, questionnaire 2/2
absolute score EQ-5D-5L
Time frame: within 1 week after colonoscopy, questionnaire 2/2
Correlation of clinical parameters and tolerability to Quality of life scores
Time frame: questionnaire 2/2, within 1 week after colonoscopy
Subgroup differences for absolute scores on SF-36 for colonoscopy indication and prior experience with bowel preparation
Time frame: questionnaire 2/2, within 1 week after colonoscopy
Subgroup differences in costs for colonoscopy indication and prior experience with bowel preparation
Time frame: questionnaire 2/2, within 1 week after colonoscopy
Subgroup differences for absolute scores on EQ-5D-5L for colonoscopy indication and prior experience with bowel preparation
Time frame: questionnaire 2/2, within 1 week after colonoscopy
Total individual costs
Time frame: questionnaire 2/2, within 1 week after colonoscopy
Incremental cost-effectiveness ratio
Time frame: within 1 week after colonoscopy, questionnaire 2/2
treating physician advised surveillance interval per study arm
Time frame: During colonoscopy procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes. The dataset used during this study is available from the corresponding author upon reasonable request
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plenvu and Moviprep in people with Colorectal Cancer and Colonic Polyp, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel preparation scale score (total and per segment) (time frame: during colonoscopy procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.