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

NCT05242562 | Completed

• 1 other identifier: NL79014.091.21
• Study Type: interventional
• Target: 509
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Colonic Polyp

Keywords

colonoscopy; bowel preparation; Quality of life; Costeffectiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• absolute score of SF-36 (short-form 36)

  within 1 week after colonoscopy, questionnaire 2/2

• absolute score EQ-5D-5L

  within 1 week after colonoscopy, questionnaire 2/2

• Correlation of clinical parameters and tolerability to Quality of life scores

  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

  questionnaire 2/2, within 1 week after colonoscopy

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

  questionnaire 2/2, within 1 week after colonoscopy

Study Arms (2)

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)

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)

Drug: Moviprep

Interventions

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.

Also known as: Pleinvue

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.

Moviprep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Planned elective colonoscopy for surveillance or diagnostic indications

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Interventions

Polyethylene Glycols; MoviPrep

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: February 16, 2022
• Study Start: May 16, 2022
• Primary Completion: February 27, 2023
• Study Completion: March 2, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: 15y
• Access Criteria: The dataset used during this study is available from the corresponding author upon reasonable request

Locations

NL (1)