Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000883617
Ethics application status
Approved
Date submitted
7/08/2014
Date registered
20/08/2014
Date last updated
23/11/2022
Date data sharing statement initially provided
8/01/2020
Date results provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Bowel Preparation Alter Diagnostic Yield in Capsule Endoscopy?
Scientific title
Does Bowel Preparation Alter Diagnostic Yield in Capsule Endoscopy?
Secondary ID [1] 285118 0
Nil
Universal Trial Number (UTN)
U1111-1159-8755
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obscure gastrointestinal bleeding 292677 0
Condition category
Condition code
Oral and Gastrointestinal 292989 292989 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Capsule endoscopy (CE) is a safe, proven, non-invasive method of small bowel visualisation whereby a pill-sized video capsule is swallowed and passes through the digestive tract, taking photo images of the bowel. The images are transmitted to a receiving device attached to the patient’s skin for the 8 to 9 hour duration of recording. The capsule is disposable and usually passed from the bowel within 24 to 48 hours. The recorded images are analysed by an expert reader, typically a gastroenterologist, to investigate the cause of obscure gastrointestinal bleeding (OGIB) and obtain a diagnosis where small bowel pathology is suspected.

The current standard of care prior to CE does not include use of a bowel cleansing preparation. The yield of CE for detection of sources of OGIB has been estimated to range between 60 and 80%. Given the potential for small bowel contents including food, bilious secretions and blood to obscure visualisation of the small bowel lining, we postulate that the yield for detection of sources may be higher if the bowel is prepared by use of a bowel cleansing preparation.

Polyethylene glycol based (PEG) solutions have been extensively used for bowel cleansing prior to colonoscopic procedures and shown to be safe and tolerable. Low volume PEG preparations have been developed with the aim to improve tolerability and have been shown to have equal efficacy to standard preparation regimes in colonoscopy. We have chosen to use half volumes of two types of PEG preparations, ColonLYTELY and Moviprep, to improve visualisation of the small bowel which is not subject to the level of obscuration as the large bowel, and to improve patient tolerability.

The difference in findings of CE will be compared between three groups of patients who are randomised to the following preparations for the procedure.

Prior to ingestion of the capsule, patients in each group will be required to maintain a clear fluid diet for 18 hours. All patients will receive a standard 200mg dose of simethicone in 150ml of water at the time of capsule ingestion. Simethicone acts as an anti-foaming agent to reduce bubbles in the stomach and thereby improve views of the bowel during the procedure. (Times specified assume procedural commencement time of 8am.)

Arm 1 – no bowel preparation used (current standard of practice)
Patients randomised to arm 1 will fast for 6 hours before the procedure.

Arm 2 – Patients randomised to arm 2 will commence drinking 2L (standard is 4L) of ColonLYTELY 15 hours prior to the procedure (to be completed within 3 hours).

Arm 3 –Patient randomised to arm 3 will commence drinking 1L (standard is 2L) of Moviprep 4 hours prior to the procedure (to be completed within 1 hour).
Intervention code [1] 289967 0
Diagnosis / Prognosis
Intervention code [2] 289968 0
Treatment: Drugs
Comparator / control treatment
Control treatment:
Arm 1 – no bowel preparation used (standard of practice)
Control group
Active

Outcomes
Primary outcome [1] 292851 0
1. To determine if preparation regimes alter detection rates of relevant abnormal findings as assessed by an expert reader of the CE imaging and analysis of the results for each patient per lesion.
(Examples of relevant abnormal findings include angioectasias/angiodysplasias, ulcerations, arteriovenous malformations, varices, presence of active bleeding, multiple (>3) erosions and diverticulae.)
Timepoint [1] 292851 0
At the time of CE reading/reporting ideally within 21 days of the procedure
Secondary outcome [1] 309802 0
1. To assess impact of intervention on mucosal image quality.
Secondary outcome 1 will be assessed by image quality and defined by cumulative scores as determined by the validated scoring system as described by Brotz et al. The quantitative index scoring system we have selected was found to provide the least inter-reader variability in comparison to other scoring systems tested. Data collection includes the quantitative index scoring system that aims to limit the inter-observer/rater variability that exists with current CE preparation reporting. We accept that some variability will still exist and that this is an inherent limitation of CE preparation reporting.
Timepoint [1] 309802 0
At the time of the CE reading/reporting ideally within 21 days of the procedure
Secondary outcome [2] 309803 0
2. To determine if preparation improves study completion rates and transit times
Study completion rates will be recorded as either complete or incomplete, and if complete the small bowel transit time will be calculated. These results can then be compared for the three arms.
Timepoint [2] 309803 0
At the time of the CE reading/reporting ideally within 21 days of the procedure
Secondary outcome [3] 309804 0
3. To assess patient tolerability of intervention.
Safety and tolerability will be assessed with a standardised questionnaire which has been specifically designed for the study and by standardised telephone follow up with the patient.
Timepoint [3] 309804 0
The study questionnaire is to be completed on the day of, and prior to the procedure, and the patient follow up is to be completed at 30 days after the procedure.

Eligibility
Key inclusion criteria
* All participants must be over 18 years of age
* Able to give informed consent to trial participation
* OGIB without a cause being found on gastroscopy and colonoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Medical contraindication to outpatient PEG-based preparation solution
* Chronic Kidney Disease Stage 5
* Heart failure – NYHA class 4
* Fluid restricted to <2L/day
* Currently pregnant or attempting pregnancy
* PEG Allergy

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)
Potential participants will be identified at outpatient review by the treating Gastroenterologist/Investigator or on the receipt of an outpatient CE referral. For patients who are referred for CE from an external centre, the Investigator’s centre (responsible for performing the CE) will organize an outpatient review or phone consultation to assess medical suitability for bowel preparation. These patients may be enrolled at the time of review/consultation.
Consent for the procedure will be obtained via phone consultation (by the investigator), with written material including the PICF to be sent to the patient, or at the time of initial review.
Allocation will be concealed by use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential outpatients attending for investigation of OGIB will be randomised, using a computer generated random number generator, to one of 3 arms:
1. No preparation
2. 2L of standard PEG (ColonLYTELY) completed 12hrs prior to capsule study
3. 1L of low-volume PEG (Moviprep) completed 3hrs prior to capsule study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation:
Sample size calculation has been based on statistical effect of intervention on our primary objective. Abnormal P2 findings have been demonstrated to be detected in approximately 60% of patients (analysis of number of lesions and detection rates per patient) in previous studies without preparation, which was used as our control rate for sample size calculation. We suggest a 10-15% improvement in detection of abnormal findings as being clinically significant and useful. To detect a 15% improvement with a level of significance of 0.05 and power of 0.8, we require 152 patients per arm (for a 2-sided test) or 120 patients per arm (for a 1-sided test). To detect a 10% improvement with a level of significance of 0.05 and power of 0.8, we require 356 patients per arm (for a 2-sided test) or 281 patients per arm (for a 1-sided test). Formal analysis will be performed once we reach 456 patient enrolled with an option to extend the study if required.
Statistical Analysis Plan:
Data will be analysed by the investigators and statisticians. Descriptive statistics of the patients will be presented as mean and standard error for continuous variables and percentages for categorical variables. Univariate analyses will be used to screen demographic variables for confounders using one-way ANOVAs for continuous and chi-square for categorical variables. Logistic regression and general liner models will be used to determine whether there is a significant relationship between bowel preparation and the primary (diagnostic yield) and secondary (transit time, mucosal image quality and patient tolerability) outcome variables accounting for confounders.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
19/04/2015
Date of last participant enrolment
Anticipated
30/04/2020
Actual
29/10/2019
Date of last data collection
Anticipated
29/05/2020
Actual
29/11/2019
Sample size
Target
300
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 2815 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 2816 0
The Alfred - Prahran
Recruitment hospital [3] 2817 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 2818 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 19799 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [6] 19800 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 8501 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 8503 0
3181 - Prahran
Recruitment postcode(s) [3] 8504 0
3084 - Heidelberg
Recruitment postcode(s) [4] 8505 0
5000 - Adelaide
Recruitment postcode(s) [5] 34447 0
3065 - Fitzroy
Recruitment postcode(s) [6] 34448 0
3011 - Footscray
Recruitment outside Australia
Country [1] 6283 0
New Zealand
State/province [1] 6283 0
Christchurch

Funding & Sponsors
Funding source category [1] 289727 0
Self funded/Unfunded
Name [1] 289727 0
Country [1] 289727 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston, Queensland, 4029
Country
Australia
Secondary sponsor category [1] 288422 0
None
Name [1] 288422 0
Address [1] 288422 0
Country [1] 288422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291464 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee (EC00172)
Ethics committee address [1] 291464 0
Ethics committee country [1] 291464 0
Australia
Date submitted for ethics approval [1] 291464 0
Approval date [1] 291464 0
23/05/2014
Ethics approval number [1] 291464 0
HREC/13/QRBW/397

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

Contacts
Principal investigator
Name 50514 0
Dr Mark Appleyard
Address 50514 0
Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029
Country 50514 0
Australia
Phone 50514 0
+61 7 36468111
Fax 50514 0
+61 7 36464627
Email 50514 0
[email protected]
Contact person for public queries
Name 50515 0
Mark Appleyard
Address 50515 0
Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029
Country 50515 0
Australia
Phone 50515 0
+61 7 36468111
Fax 50515 0
+61 7 36464627
Email 50515 0
[email protected]
Contact person for scientific queries
Name 50516 0
Mark Appleyard
Address 50516 0
Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029
Country 50516 0
Australia
Phone 50516 0
+61 7 36468111
Fax 50516 0
+61 7 36464627
Email 50516 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
The data utilised in this study cannot be made open access due to privacy regulations.


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
SourceTitleYear of PublicationDOI
EmbaseClinical utility of purgative bowel preparation before capsule endoscopy: a multicenter, blinded, randomized controlled trial.2022https://dx.doi.org/10.1016/j.gie.2022.07.010
N.B. These documents automatically identified may not have been verified by the study sponsor.