ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 information initially 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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Control treatment:
Arm 1 – no bowel preparation used (standard of practice)

Control group

Active

Outcomes

Primary outcome [1]

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]

At the time of CE reading/reporting ideally within 21 days of the procedure

Secondary outcome [1]

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]

At the time of the CE reading/reporting ideally within 21 days of the procedure

Secondary outcome [2]

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]

At the time of the CE reading/reporting ideally within 21 days of the procedure

Secondary outcome [3]

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]

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?

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]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

The Alfred - Prahran

Recruitment hospital [3]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [4]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [5]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [6]

Western Hospital - Footscray - Footscray

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Recruitment postcode(s) [2]

3181 - Prahran

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

5000 - Adelaide

Recruitment postcode(s) [5]

3065 - Fitzroy

Recruitment postcode(s) [6]

3011 - Footscray

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Royal Brisbane and Women's Hospital

Address

Butterfield St, Herston, Queensland, 4029

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane & Women’s Hospital Human Research Ethics Committee (EC00172)

Ethics committee address [1]

Level 7, Block 7
Royal Brisbane and Women's Hospital
Metro North Health Service District
Butterfield, Herston, Qld, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/05/2014

Ethics approval number [1]

HREC/13/QRBW/397

Summary

Brief summary

This prospective randomised trial will compare the diagnostic yield of capsule endoscopy (CE) findings between three patient groups undergoing CE to investigate obscure gastrointestinal bleeding (OGIB). A control group who will take no bowel preparation will be compared to two groups undergoing different bowel preparation regimens.

CE is a standard test for the investigation of OGIB. A video capsule device is swallowed by the patient and passes through the gastrointestinal tract taking 2-6 images per second. The examination is then reviewed for abnormalities that may represent a source of bleeding. The study is specifically aimed at examining the small bowel mucosa although abnormalities can be picked up in other areas.

The diagnostic utility of CE can be adversely impacted by small bowel residue obscuring mucosal views. Mucosal views in endoscopic examinations can be improved by pretest preparation regimens, such as bowel preparation in colonoscopy, or washing and suctioning during the procedure. The capsule device is unable to directly clean the mucosa hence prepration regimens are the only option to improve mucosal views by reducing the amount of residue present.

Currently there is limited data to recommend routine use of bowel preparation regimens for capsule endoscopy. Our hypothesis is that bowel preparation taken prior to capsule ingestion will improve small bowel mucosal visualisation thereby improving the diagnostic utility of the test.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mark Appleyard

Address

Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029

Country

Australia

Phone

+61 7 36468111

Fax

+61 7 36464627

[email protected]

Contact person for public queries

Name

Dr Mark Appleyard

Address

Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029

Country

Australia

Phone

+61 7 36468111

Fax

+61 7 36464627

[email protected]

Contact person for scientific queries

Name

Dr Mark Appleyard

Address

Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield St, Herston, Queensland, 4029

Country

Australia

Phone

+61 7 36468111

Fax

+61 7 36464627

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		https://doi.org/10.1016/j.gie.2022.07.010 Gastroi... [More Details]
Basic results	No			366864-(Uploaded-22-11-2022-16-27-29)-Basic results summary.docx

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Clinical utility of purgative bowel preparation before capsule endoscopy: a multicenter, blinded, randomized controlled trial.	2022	https://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.

Trial Review

Documents added manually

Documents added automatically