Comparison of Moviprep and Prepkit C Bowel preparation in inflammatory bowel disease patients and in the general population

A randomised controlled trial comparing tolerability, efficacy and safety of Moviprep and Prep Kit C for bowel preparation prior to colonoscopy in inflammatory bowel disease patients and the general population

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001424190

Enrollment

338

Registered

2019-10-15

Start date

2013-03-01

Completion date

2016-12-30

Last updated

2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are no prospective studies which examine tolerability and efficacy of Prep Kit C compared to Moviprep bowel preparations in both the IBD and the general non-IBD populations. Often, IBD patients tolerate bowel preparation poorly compared to the general population. Furthermore knowledge about the impact of Prep Kit C and Moviprep on IBD activity is limited. Accordingly, this study aimed to compare split protocols of Prep Kit C with Moviprep in patients with and without IBD. We hypothesised that Moviprep bowel preparation would be better tolerated and result in greater efficacy than Prep Kit C. We additionally hypothesised that IBD patients overall would tolerate bowel preparation more poorly than the general population.

Interventions

Randomised to two different types of bowel prep: Moviprep or Prep Kit C All patients were provided with the bowel preparation kits and written information explaining appropriate diet changes, instructions on how to prepare and timing of consumption. This information was additionally explained at a face-to-face review in the outpatient clinic up to four weeks before the colonoscopy by either a senior gastroenterologist or a gastroenterology advanced trainee. Arm 1: Moviprep Moviprep comes with two large sachets (sachet A) and two small sachets (sachet B). Each pair of sachets (A and B) is dissolved in one litre of water to make a solution. One litre is taken the evening before the procedure and the other in the early morning on the day of of the colonoscopy.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patients undergoing outpatient colonoscopy For IBD cohort - endoscopic and histological evidence of Crohn's disease or ulcerative colitis on a previous colonoscopy

Exclusion criteria

Non-English speaking Renal insufficiency (defined as estimated glomerular filtration rate of less than 50ml/min Cardiac failure (New York Heart Association Class greater than 2) Advanced liver disease (Child Pugh B or C) Poorly controlled diabetes mellitus Bowel obstruction or megacolon Total or limited colonic resection Dysphagia Pregnancy or plans to become pregnant during trial period

Outcome results