Trial Review

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
ACTRN12618000507280p
Ethics application status
Submitted, not yet approved
Date submitted
17/02/2018
Date registered
9/04/2018
Date last updated
27/03/2019
Date data sharing statement initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel Preparation Assessment Using Ultrasound Examination
Scientific title
Bowel preparation assessment using ultrasound examination following standard bowel cleansing regime in patients prior to their colonoscopy.
Secondary ID [1] 294040 0
none
Universal Trial Number (UTN)
Trial acronym
PAUSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's 306580 0
Ulcerative Colitis 306581 0
Colonoscopy Preparation 306582 0
Inflammatory Bowel Disease 306583 0
Bowel Cancer Screening and Surveillance 306584 0
Condition category
Condition code
Inflammatory and Immune System 305675 305675 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 305676 305676 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 305677 305677 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Whether transadbominal ultrasound can accurately assess bowel preparation quality will be determined with observational comparisons with already scheduled colonoscopies and the Boston Bowel Prep Scale and patient reported bowel preparation quality. Both IBD patients and non IBD patients will be included in this study.
The transabdominal ultrasound will be performed within 30minutes prior to the scheduled colonoscopy (after they have completed their bowel cleansing). The patients at this point are already in a bed and in hospital gowns and being readied for their colonoscopy. With patient privacy in mind and their curtains closed, only their abdomen will be exposed and the rest covered with the bed sheets, towels and their gown as needed. Then ultrasound Jelly is applied to the abdomen and the ultrasound probes (curved and linear) will be used to obtain ultrasound images of the quality of the bowel prep. Then the jelly is simply wiped off and the patient is ready for their colonoscopy.
From previous non-trial ultrasounds for other indications, de-identified images of possible degrees of faeces in the bowel can be used and a numerical scoring system developed (ie from collapsed bowel, to liquid, to semi-solid, to solid/dense material).
Intervention code [1] 300315 0
Not applicable
Comparator / control treatment
The main comparator will be the already validated Boston Bowel Prep score (BBP) which will be determined and recorded during the patient's colonoscopy and the compared to the ultrasound findings.
However, using previous literature results and including developing a stool-in-toilet picture score, there will be a self reported bowel quality score collected from the patients prior to (within 60 minutes of their procedure) their colonoscopy in paper format. This score will also be compared to the ultrasound and BBP scores.
Control group
Active

Outcomes
Primary outcome [1] 304775 0
To determine if focused transabdominal ultrasound examination of patients prior to their colonoscopy can determine bowel preparation quality (a scoring system designed specifically for this study) as compared to their colonoscopy Boston Bowel Prep score (already validated).

As ultrasound does not have any radiation or risks, no adverse events expected.
Timepoint [1] 304775 0
Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy.
The Boston Bowel Prep score is part of the standard reporting structure of colonoscopies and will be obtained during the patients colonoscopy by their proceduralist (ie as per standard and without influence from researchers).
Primary outcome [2] 304777 0
To determine if focused transabdominal ultrasound examination of patients prior to their colonoscopy can determine bowel preparation quality (a scoring system designed specifically for this study) as compared to the patient's self reported bowel prep scores (survey and self taken bowel motion pictures-a scoring system designed specifically for this study) will be collected/assessed within 60minutes of their colonoscopy.
Timepoint [2] 304777 0
Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy, and patient's self reported bowel prep scores (survey and patient taken bowel motion pictures) will be collected/assessed within 60minutes prior to the colonoscopy. Bowel motion pictures will be photos taken by the patient of their last 2 bowel motions using their own phones (within the last 12 hours prior to their colonoscopy) and will be compared to a pre-set chart (to be created- similar to Bristol Stool Chart but for bowel prep).
Secondary outcome [1] 343145 0
Cost benefit analysis of using bowel prep assessment by rapid ultrasound prior to colonoscopies (and possible extra cleanse depending on results), versus the current standard of repeating the colonoscopy on a different date if there is unsatisfactory bowel prep will be performed.
Timepoint [1] 343145 0
As the study will not interfere with current colonoscopy scheduling guidelines, should a repeat colonoscopy be required, it is expected it will be done as per current guidelines, The time points will be calculated modelling from guidelines and not require a specific timepoint- though physician specified repeat procedure date will be collected as well). The analysis will be undertaken near the end of the trial.
Secondary outcome [2] 343146 0
To determine if patient self reported bowel preparation quality (including photo chart score) will be accurate as compared to their actual colonoscopy Boston Bowel Prep (validated) score. Assessment will be by correlation between the validated Boston Bowel prep score and the patient self reported scores.
Timepoint [2] 343146 0
The patient's self reported bowel prep scores (survey and self taken bowel motion pictures) will be collected/assessed within 60minutes prior to their colonoscopy.
Bowel motion pictures will be photos taken by the patient of their last 2 bowel motions using their own phones (within the last 12 hours prior to their colonoscopy).
The Boston Bowel Prep score is part of the standard reporting structure of colonoscopies and will be obtained during the patients colonoscopy by their proceduralist (ie as per standard and without influence from researchers).
Secondary outcome [3] 343147 0
To determine if patient self reported bowel preparation quality score (a scoring system designed specifically for this study) will be accurate as compared to their ultrasound assessment score (a scoring system designed specifically for this study) as assessed by correlation between the two scores.
Timepoint [3] 343147 0
Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy, and patient's self reported bowel prep scores (survey and patient taken bowel motion pictures) will be collected/assessed within 60minutes prior to the colonoscopy. Bowel motion pictures will be photos taken by the patient of their last 2 bowel motions using their own phones within the last 12 hours prior to their colonoscopy.

Eligibility
Key inclusion criteria
Consenting patients,
English speaking,
Have followed the standard bowel cleansing instructions prior to their colonoscopy,
Have a scheduled colonoscopy for any indication including inflammatory bowel disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking or not able to give consent,

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Pilot study at this point, Will use a statistician professionally to determine sample size calculations as required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10053 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 21570 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 21571 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 298665 0
Hospital
Name [1] 298665 0
Concord Hospital Gastroenterology Department
Country [1] 298665 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital Gastroenterology Department
Address
ACE UNIT - Level 1 West
Concord Hospital
Hospital Road, Concord, NSW,
2139
Country
Australia
Secondary sponsor category [1] 297888 0
None
Name [1] 297888 0
Address [1] 297888 0
Country [1] 297888 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299619 0
SLDH -Concord- Human Research Ethics Committee
Ethics committee address [1] 299619 0
Ground Floor - Building 20, Concord Repatriation General Hospital,
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 299619 0
Australia
Date submitted for ethics approval [1] 299619 0
27/03/2018
Approval date [1] 299619 0
Ethics approval number [1] 299619 0

Summary
Brief summary
Poor bowel preparation is common in inflammatory bowel disease (IBD) and non-IBD patients and can lead to incomplete colonoscopic assessments and missed pathology. As such the patients are required to undergo either a second colonoscopy or earlier surveillance colonoscopies. This creates cumulative risks of colonoscopies (double the anesthetic and procedural risks), increased burden to the health care system (extra resources and colonoscopy spots used that could be used by other patients) and the patient (more inconvenience of further bowel prep and missed work for the procedure) as well as financial costs both to the health care system as well as the patient in multiple ways.

Other research has found patient reported bowel preparation quality (no bowel motion pictures) is often not accurate,

Being able to assess the patient's bowel preparation before giving them anaesthetic and more importantly, being able to know their prep is poor and given them extra bowel prep and have their procedure delayed by a few hours (put at the end of the endoscopy list) would be of huge benefit for both the patient and the health care system.

Our aim is to create a rapid ultrasound assessment (no radiation and no risks to the patient) that focuses on a few specific areas of the bowel to create a bowel prep scoring system which matches current validated colonoscopy bowel preparation scoring systems. Furthermore to show that by using the ultrasound scoring system that the detrimental effects of poor bowel preparation (discussed above) can be avoided and to create a cost-benefit analysis as well.
Trial website
Trial related presentations / publications
Public notes
Though IBD patients will be a main reason for this study as they require frequent colonoscopies, for the purposes of this trial, non-IBD patients will also be assessed and the data will be important for non-IBD related colonoscopies as well.

Contacts
Principal investigator
Name 81054 0
Dr Brandon Baraty
Address 81054 0
ACE Unit- Level 1 West
Concord Repatriation Hospital
Hospital Road, Concord, NSW, 2139
Australia
Country 81054 0
Australia
Phone 81054 0
+61410112026
Fax 81054 0
+61297676767
Email 81054 0
[email protected]
Contact person for public queries
Name 81055 0
Dr Brandon Baraty
Address 81055 0
ACE Unit- Level 1 West
Concord Repatriation Hospital
Hospital Road, Concord, NSW, 2139
Australia
Country 81055 0
Australia
Phone 81055 0
+61410112026
Fax 81055 0
Email 81055 0
[email protected]
Contact person for scientific queries
Name 81056 0
Dr Brandon Baraty
Address 81056 0
ACE Unit- Level 1 West
Concord Repatriation Hospital
Hospital Road, Concord, NSW, 2139
Australia
Country 81056 0
Australia
Phone 81056 0
+61410112026
Fax 81056 0
Email 81056 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
Patient privacy.


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.