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NCT Number: NCT05242562

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Polyp Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plenvu

Drug

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

MoviPrep

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. absolute score of SF-36 (short-form 36)

    Time frame: within 1 week after colonoscopy, questionnaire 2/2

    Change in scoring on the short-form 36 questionnaire before and after bowel preparation. Higher scores indicate a higher quality of life.

  2. absolute score EQ-5D-5L

    Time frame: within 1 week after colonoscopy, questionnaire 2/2

    Change in scoring on EuroQol group 5Dimension-5Levels questionnaire before and after bowel preparation. Higher scores indicate a higher quality of life.

  3. Correlation of clinical parameters and tolerability to Quality of life scores

    Time frame: questionnaire 2/2, within 1 week after colonoscopy

    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.

  4. 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

    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.

  5. Subgroup differences in costs for colonoscopy indication and prior experience with bowel preparation

    Time frame: questionnaire 2/2, within 1 week after colonoscopy

    Change in costs based on having prior experience with bowel preparation, and differences between colonoscopy indications.

  6. 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

    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.

  7. Total individual costs

    Time frame: questionnaire 2/2, within 1 week after colonoscopy

    Total costs made per individual for the bowel preparation process, including cost for being absent at work and caregiver costs.

  8. Incremental cost-effectiveness ratio

    Time frame: within 1 week after colonoscopy, questionnaire 2/2

    Change in costs per quality adjusted life years between the low-volume arm and intermediate volume arm.

  9. treating physician advised surveillance interval per study arm

    Time frame: During colonoscopy procedure

    advised surveillance interval correlated to colonoscopy findings and BBPS (boston bowel preparation scale) score by the treating physician. Higher scores indicate higher bowel cleanliness

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study 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

Acronym: RESULT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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