Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001424190
Ethics application status
Approved
Date submitted
7/10/2019
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Moviprep and Prepkit C Bowel preparation in inflammatory bowel disease patients and in the general population
Scientific title
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
Secondary ID [1] 299306 0
None
Universal Trial Number (UTN)
U1111-1240-3591
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 314434 0
Colon cancer 314731 0
Condition category
Condition code
Inflammatory and Immune System 312777 312777 0 0
Other inflammatory or immune system disorders
Cancer 313064 313064 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315575 0
Treatment: Other
Comparator / control treatment
Arm 2: Prep Kit C
Prep Kit C is the standard bowel preparation kit prescribed by our unit prior to colonoscopies.
Prep Kit C includes two sachets of Picoprep and one sachet of Glycoprep. The Picopreps are dissolved in one glass of warm water, and the Glycoprep is dissolved in one litre of warm water. The two Picoprep solutions are taken the evening before the procedure, spaced at least 4 hours apart. The Glycoprep is then taken in the early morning on the day of the colonoscopy.
Control group
Active

Outcomes
Primary outcome [1] 321484 0
Bowel preparation tolerability as determined by a Tolerability Questionnaire
Timepoint [1] 321484 0
On day of completion of bowel preparation
Secondary outcome [1] 375084 0
Tolerability of bowel preparation in IBD patients vs non-IBD patients.
A numerically higher score indicates a better tolerance. The questionnaire includes a five point Likert scale to assess tolerability (ranging from 0 to 5; very hard to very easy) and palatability (ranging from 0 to 5: very bad to very good) of the preparation. Common side effects (abdominal discomfort, abdominal pain, nausea, vomiting, abdominal distension, dizziness and shortness of breath) were also measure on a five point Likert scale (ranging from 0 to 5: severe degree of complaints to no complaints).
Timepoint [1] 375084 0
On day of completion of bowel preparation
Secondary outcome [2] 375085 0
Efficacy of bowel preparation; and efficacy in IBD vs non-IBD cohort
Efficacy of colon cleansing was assessed using the validated Ottawa Bowel Preparation Score. This grades the quality of bowel preparation from 0 to 4 (with 0 being no fluid and 4 pertaining to fluid/faecal material unable to be cleared) in three colonic segments (right, left and rectosigmoid) to reach a total score out of 14. All endoscopists attended calibrating sessions prior to study commencement. Two endoscopists assessed the efficacy of bowel cleansing regime independently at the time of the procedure. An average score was then calculated. Inadequate bowel preparation is defined as an Ottawa Bowel Preparation Score equal to or greater than 8.
Timepoint [2] 375085 0
At colonoscopy, which would be performed on day of completion of bowel preparation
Secondary outcome [3] 375086 0
Safety of bowel preparation; and safety in IBD vs non-IBD cohort
Blood tests were collected within one week before commencing bowel preparation, and on the day of the colonoscopy prior to the procedure for serum electrolyte determination in all participants. Changes in serum sodium, chloride, potassium, bicarbonate, urea, creatinine, magnesium, calcium and phosphate were measure.
Timepoint [3] 375086 0
Determined by analysis of electrolytes and renal function one week prior to commencement of bowel preparation, and on day of completion of bowel preparation
Secondary outcome [4] 375087 0
Effect of bowel preparation on disease activity in IBD patients; assessed by using the Simple Clinical Colitis Activity Index (SCCAI) and Simplified Crohn's Disease Activity Index (SCDAI)
Timepoint [4] 375087 0
Assessed at three different time points - one week prior to colonoscopy (baseline), and at one and four weeks following the colonoscopy

Eligibility
Key inclusion criteria
Patients undergoing outpatient colonoscopy
For IBD cohort - endoscopic and histological evidence of Crohn's disease or ulcerative colitis on a previous colonoscopy
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were stratified into two groups: IBD and non-IBD then randomised using a computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables were reported as mean (SD ). Two sample t-test was used to compare mean values of tolerability scores between bowel preparations (Mp vs Pc) and also between IBD and non-IBD groups. Statistical Analyses including the interquartile range were performed using SAS program version 9.4 (SAS institute. Inc. Cary.NC.USA) and p-value < 0.05 was considered statistically significant.
An estimated sample size of 120 per group was calculated to detect a 20% difference in the bowel preparation quality scores between Mp and Pc with 95% confidence and 90% power. Assuming a completion rate of 95%, a target of 250 participants for recruitment was sought.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
250
Accrual to date
Final
338
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14849 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 28108 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 303827 0
Hospital
Name [1] 303827 0
Gastroenterology & Hepatology Department Liverpool Hospital
Country [1] 303827 0
Australia
Primary sponsor type
Individual
Name
Susan Connor
Address
Liverpool Hospital, Elizabeth & Goulburn St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 304156 0
Individual
Name [1] 304156 0
Linda Zhang
Address [1] 304156 0
Liverpool Hospital, Elizabeth & Goulburn St, Liverpool NSW 2170
Country [1] 304156 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304341 0
SWSLHD Research and Ethics Office
Ethics committee address [1] 304341 0
Ethics committee country [1] 304341 0
Australia
Date submitted for ethics approval [1] 304341 0
26/04/2012
Approval date [1] 304341 0
24/05/2012
Ethics approval number [1] 304341 0
12/0068

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96610 0
A/Prof Susan Connor
Address 96610 0
Liverpool Hospital, Elizabeth & Goulburn St, Liverpool NSW 2170
Country 96610 0
Australia
Phone 96610 0
+61 2 87384085
Fax 96610 0
Email 96610 0
[email protected]
Contact person for public queries
Name 96611 0
Susan Connor
Address 96611 0
Liverpool Hospital, Elizabeth & Goulburn St, Liverpool NSW 2170
Country 96611 0
Australia
Phone 96611 0
+61 2 87384085
Fax 96611 0
Email 96611 0
[email protected]
Contact person for scientific queries
Name 96612 0
Susan Connor
Address 96612 0
Liverpool Hospital, Elizabeth & Goulburn St, Liverpool NSW 2170
Country 96612 0
Australia
Phone 96612 0
+61 2 87384085
Fax 96612 0
Email 96612 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.