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

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University Medical Center

Criteria

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