Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000712404
Ethics application status
Approved
Date submitted
12/04/2016
Date registered
30/05/2016
Date last updated
9/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the quality of bowel preparation by addition of Movicol to standard bowel preparation regimen in patients undergoing routine colonoscopy: a randomized controlled trial
Scientific title
Assessing the quality of bowel preparation by addition of Movicol to standard bowel preparation regimen in patients undergoing routine colonoscopy: a randomized controlled trial
Secondary ID [1] 287961 0
Nil known
Universal Trial Number (UTN)
U1111-1179-0501
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal 296839 0
Condition category
Condition code
Cancer 297070 297070 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 298860 298860 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consenting patients who are to undergo routine colonoscopy will be randomised to receive the standard bowel preparation or Movicol (intervention) in addition to the standard bowel preparation.
Movicol is a combination product available in powder form. Each sachet of Movicol powder contains Macrogol-3350 13.125 g, Sodium chloride 350.7 mg, Sodium bicarbonate 178.5 mg, Potassium chloride 46.6 mg Lemon flavor and Potassium acesulfame as a sweetener.
Macrogol 3350 exerts an osmotic action in the gut, which induces a laxative effect.
Movicol is routinely used as laxative by increasing stool volume and is indicated in the treatment of chronic constipation.
Movicol is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum.
Each Movicol sachet should be dissolved in 125ml water and taken orally.
The usual adult dosage is 1 sachet daily. This may be increased to 2-3 sachets daily as required.
Participants in the intervention arm will receive 8 sachets of Movicol to be taken over the 5 days prior to the day of the procedure.
The first sachet is to be taken in the evening 5 days prior to the procedure. One sachet is taken at 7am and 7pm for the next 4 days. The eighth sachet is taken on the morning of the day prior to the procedure, ahead of commencing the standard bowel preparation of Prepkit C.
An instruction sheet and schedule for taking the Movicol sachets will be provided with the sachets. Participants will be asked to tick a box against each dose taken and return the form on the day of the procedure. This will enable researchers to monitor compliance with the intervention.
Intervention code [1] 293305 0
Treatment: Drugs
Comparator / control treatment
Control group/Arm 1 – Participants randomised to the control group will receive the standard bowel preparation of a low residue White Diet (for 2 days prior to the day of the procedure ) and Prepkit C (consisting of a first sachet of PICO PREP and one sachet of GLYCOPREP taken the day before the procedure, and a second sachet of PICO PREP the morning of the day of procedure, i.e., split doses overnight).
Control group
Active

Outcomes
Primary outcome [1] 296741 0
To determine whether the addition of Movicol prior to a standard bowel preparation improves the quality of bowel preparation in patients undergoing routine colonoscopy procedure.
Endoscopists will assess the quality of bowel preparation by use of the Ottawa Bowel Preparation Quality Scale. The scale comprises of 2 parts:
Part A of the scale where a score is applied to the degree of cleanliness of each colon segment (i.e. right colon, mid colon and rectosigmoid colon) before washing / suctioning of residual stool.
0 - indicates clearly visible mucosal detail +/- clear fluid with no stool residue
1 - refers to some turbid fluid or stool residue present but visible mucosal detail where washing and suctioning is not necessary
2 - indicates obscured mucosal detail by turbid fluid or stool residue where suctioning but not washing is necessary
3 - refers to stool obscuring mucosal detail where suctioning and washing is necessary to obtain a reasonable view
4 - indicates solid stool obscuring mucosal details despite aggressive washing and suctioning
Part B of the scale is the measure of fluid in the colon where 0 indicates small amount, 1 moderate amount and 2 large amount
Successful bowel preparation is defined by:
A score of 2 or lesser in each colonic segment in part A and a score of 2 or lesser for fluid in part B of the scale
Timepoint [1] 296741 0
Day of colonoscopy procedure
Secondary outcome [1] 320324 0
To examine patient compliance with a Movicol-augmented bowel preparation prior to colonoscopy. Compliance will be assessed by asking participants in the intervention group to record on the Movicol instruction and schedule sheet when each sachet dose is taken (by ticking boxes). The Movicol instruction/schedule sheet has been designed by the researchers specifically for the study.
Timepoint [1] 320324 0
Doses of Movicol are to be taken over the 5 days prior to day of the colonoscopy procedure. Participants are asked to record each Movicol sachet dose taken over the 5 day period.
Secondary outcome [2] 320325 0
To examine patient tolerance and acceptance with a Movicol-augmented bowel preparation compared with a standard bowel preparation prior to colonoscopy. A study questionnaire which has been designed by the researchers specifically for the study will ask participants to answer questions about their experience taking the bowel preparation they were allocated to..
Timepoint [2] 320325 0
Participants will be provided the Questionnaire by reception staff when they arrive on the day of their procedure. Completed questionnaires will be returned to reception staff for collection by the research nurse to ensure proceduralists remain blinded to the allocation.
Secondary outcome [3] 320326 0
To assess successful completion of colonoscopy between the control and intervention groups. Completion of colonoscopy is assessed by whether the caecum can be viewed by identification of the appendiceal orifice and triradiate fold. A photo is taken of this view as evidence of completion and as per standard practice..
Timepoint [3] 320326 0
Assessed during the colonoscopy procedure
Secondary outcome [4] 323879 0
To assess time taken to complete the procedure between the control and intervention groups. This is assessed by recording the time interval from the start of the procedure by insertion of the endoscope to the removal of the endoscope from the anus. The duration of the procedure is recorded as part of standard care, importantly withdrawal time is calculated once insertion is completed after reaching the caecum.
Timepoint [4] 323879 0
Assessed during the colonoscopy procedure and recorded on an endoscopist datasheet, designed by the researchers specifically for the study..
Secondary outcome [5] 323880 0
To assess polyp detection rates between the control and intervention groups. The number of polyps detected during the endoscopic insertion and withdrawal is recorded on the colonoscopy report as per standard care. For the purpose of this study, this data will be recorded on an endoscopist datasheet which has been designed by the researchers specifically for the study. The quality of bowel preparation will also be assessed by use of the validated Ottawa Bowel Preparation Quality Scale and recorded on the endoscopist datasheet at this time. This data will enable the researchers to determine whether quality of bowel preparation has an effect on polyp detection rate.
Timepoint [5] 323880 0
During the colonoscopy procedure polyps will be identified and resected. We will review histology reports to confirm tissue samples. Histology reports are usually available on the day of the procedure or day(s) following.

Eligibility
Key inclusion criteria
Consenting adult patients referred for outpatient colonoscopy procedure for clinically accepted indications (these generally include but are not restricted to iron deficiency anaemia, surveillance of bowel polyps, colorectal cancer screening, assessment of symptoms such as abdominal pain, diarrhoea and constipation, assessment or investigation of inflammatory bowel disease)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are as follows:
Conditions which are exclusions to colonoscopy in normal clinical practice (suspected bowel perforation, gastric outlet obstruction, toxic megacolon, severer colitis, pregnancy or lactation)
Significant renal failure (eGFR<30)
Significant heart failure (New York Heart Association Class III or IV)
Type 1 diabetes
Cystic fibrosis
Phenylketonuria (Prepkit C contraindicated)
Known hypersensitivity to a constituent of Picoprep, Glycoprep or Picosalax and Movicol
(Type 1 diabetics or Cystic Fibrosis patients are excluded as they follow specific guidelines for bowel preparation for colonoscopy at Alfred Hospital.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be screened for eligibility from their referrals to the endoscopy service and mailed the Participant Information and Consent Forms together with a letter of invitation an reply-paid envelope. Eligibility will confirmed by a member of the research team at a follow up phone call approximately one week after patients have received the PICF. Patients who are willing to participate will be asked to return the signed PICF. On receiving the signed consent form, the research nurse will randomise participants according to a computer-generated randomisation sequence. Participants in the control group will be notified by telephone call. Participants in the intervention group will be mailed the Movicol sachets and instruction sheet/schedule for taking each dose. Endscopists will remain blinded to the allocation,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer-generated sequence of randomisation with equal numbers of both study arms, hence equal chance of selecting either arm of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A total of 362 patients will be randomized. The sample size has been calculated assuming an 85% bowel preparation success rate for patients undergoing colonoscopy, based on prior bowel preparation audits at the Alfred, and a conjectured improvement in the success rate of 10% (e.g. from 85% to 95%) in the Movicol arm. Approximately 145 patients will be required in each treatment arm (two-sided alpha = 5% and power = 80%). Inflating this sample size requirement by up to 20% to account for dropouts, 181 patients will be randomized to each arm to test the primary outcome (i.e. Movicol arm vs. standard bowel preparation arm). Both intention-to-treat and per-protocol analyses will be performed to assess the primary outcome. The percentage of successful bowel preparations will be assessed in each treatment arm and a 95% confidence interval for the difference will be reported. A blinded interim analysis of the primary outcome will be performed after approximately 50% of the target for the number of randomized patients has been assessed for the primary endpoint (i.e. at least 72 assessed patients in each treatment arm). This interim analysis, in conjunction with any other relevant information, such as accrual rate and safety information, will be used by the Study Management Committee to guide a decision to continue randomizing patients to the study or terminate the study early for either an overwhelming difference in bowel preparation success rates or for futility.
Secondary endpoints will be compared using t-tests for continuous-scale and Likert-scale endpoints, and, binomial tests for binary endpoints.
In a supplementary analysis of the primary endpoint, a logistic regression analysis will be conducted to assess the impact of other factors on bowel preparation such as a history of constipation, regular laxative use, body mass index, use of opioid analgesia or type 2 diabetes mellitus, and to estimate the effect of Movicol on the achievement of successful bowel preparation, adjusted for these factors.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
As above. Movicol augmentation was not shown to improve bowel cleanliness for colonoscopy procedure.
Date of first participant enrolment
Anticipated
Actual
13/04/2016
Date of last participant enrolment
Anticipated
31/01/2017
Actual
9/08/2017
Date of last data collection
Anticipated
15/08/2017
Actual
15/08/2017
Sample size
Target
362
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292475 0
Self funded/Unfunded
Name [1] 292475 0
Country [1] 292475 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd, Melbourne Victoria, 3004
Country
Australia
Secondary sponsor category [1] 292437 0
None
Name [1] 292437 0
Address [1] 292437 0
Country [1] 292437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294756 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 294756 0
Ethics committee country [1] 294756 0
Australia
Date submitted for ethics approval [1] 294756 0
25/01/2016
Approval date [1] 294756 0
09/03/2016
Ethics approval number [1] 294756 0
Project Number 41/16

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

Contacts
Principal investigator
Name 61722 0
A/Prof Gregor Brown
Address 61722 0
Department of Gastroenterology
Alfred Hospital
55 Commercial Rd
Melbourne
Victoria, 3004
Country 61722 0
Australia
Phone 61722 0
+61 3 90768838
Fax 61722 0
+61 3 90762194
Email 61722 0
[email protected]
Contact person for public queries
Name 61723 0
Gregor Brown
Address 61723 0
Department of Gastroenterology
Alfred Hospital
55 Commercial Rd
Melbourne
Victoria, 3004
Country 61723 0
Australia
Phone 61723 0
+61 3 90768838
Fax 61723 0
+61 3 90762194
Email 61723 0
[email protected]
Contact person for scientific queries
Name 61724 0
Gregor Brown
Address 61724 0
Department of Gastroenterology
Alfred Hospital
55 Commercial Rd
Melbourne
Victoria, 3004
Country 61724 0
Australia
Phone 61724 0
+61 3 90768838
Fax 61724 0
+61 3 90762194
Email 61724 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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