Effect of Low-volume (1L) vs Intermediate-volume (2L) Bowel Preparation on Cost-effectiveness and Quality of Life (RESULT)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colonic Polyp
• Intervention / Treatment: Drug: Plenvu; Drug: Moviprep

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 Type: Interventional
• Enrollment (Actual): 509
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pleinvue; 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)	Drug: Plenvu; 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.; Other Names: Pleinvue
Active Comparator: Moviprep; a 2L PEG solution with added ascorbate (Moviprep, Norgine, active ingredients Macrogol 3350, Sodium Sulphate Anhydrous, Sodium chloride, Potassium chloride, Ascorbic acid, Sodium ascorbate)	Drug: Moviprep; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; colonoscopy; bowel preparation; Costeffectiveness
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: NL79014.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset used during this study is available from the corresponding author upon reasonable request
• IPD Sharing Time Frame: 15y
• IPD Sharing Access Criteria: The dataset used during this study is available from the corresponding author upon reasonable request
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No