Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000617268p
Ethics application status
Not yet submitted
Date submitted
6/03/2018
Date registered
20/04/2018
Date last updated
20/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel Preparation Assessment Using Ultrasound Examination II
Scientific title
The use and efficacy of transabdominal ultrasound to assess bowel preparation prior to colonoscopy to avoid unnecessary repeat colonoscopies.
Secondary ID [1] 294262 0
None
Universal Trial Number (UTN)
Trial acronym
PAUSE2
Linked study record
ACTRN12618000507280 trial, will be the trial preceeding this trial to create study specific scoring systems (ultrasound and patient scoring).

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 306941 0
Ulcerative Colitis 306942 0
Colonoscopy preparation 306943 0
Inflammatory bowel disease 306944 0
bowel preparation 306945 0
Condition category
Condition code
Oral and Gastrointestinal 306041 306041 0 0
Crohn's disease
Oral and Gastrointestinal 306042 306042 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whether transabdominal ultrasound can accurately assess bowel preparation quality will be determined with our other observational trial (PAUSE). This part of the trial (RCT) will have two groups of patients scheduled for colonoscopies (who have followed their written and verbal standard bowel preparation instructions): 1)those that will go ahead with their colonoscopies without ultrasound assessment (control) and 2) those that will have transabdominal ultrasound assessment (30minutes prior to their colonoscopy, a focused transabdominal ultrasound to assess bowel preparation quality will be performed) and If needed (poor or inadequate bowel preparation as per their ultrasound score- score 0, 1 or 2 - similar to Boston Bowel prep lower scores are worse prep) one extra bowel cleanse (small volume oral bowel cleanse (as per treating clinician discretion) such as Picoprep: Sodium picosulfate; Magnesium oxide; Citric acid) will be had right away and 4 hours later the colonoscopy (intervention).
Intervention code [1] 300552 0
Prevention
Intervention code [2] 300553 0
Diagnosis / Prognosis
Comparator / control treatment
Control group: the group of patients not assessed by ultrasound and go ahead with their scheduled colonoscopy.

(Please note, if a patient states they have poor or inadequate bowel prep they will be excluded from the study as there is no point in randomising and doing an ultrasound on someone who has poor prep as then the non-ultrasound group will all have poor prep as compared to the ultrasound group who will get extra bowel cleansing. This is based on the fact that self reported bowel prep quality is not accurate as shown by other researchers - ie a high proportion of self reported adequate bowel preparation quality is actually poor quality).
Control group
Active

Outcomes
Primary outcome [1] 305066 0
To determine if ultrasound assessment prior to colonoscopy and if needed extra cleansing will improve colonoscopy bowel preparation quality as compared to the control group without any ultrasound assessment.
Timepoint [1] 305066 0
Ultrasound examinations will be performed within 30 minutes of the colonoscopy, The colonoscopy actual bowel preparation will be measured by the Boston Bowel Prep score (already validated) by the physician performing the colonoscopy.
Secondary outcome [1] 344075 0
To determine the duration required to perform the ultrasound examination. The time taken to perform the ultrasounds is recorded at the time of the transabdominal ultrasound examinations by the physician performing the ultrasound. This "duration" data will then be assessed at the end of the trial for all cases to determine the likely mean time for a complete rapid transabdominal ultrasound assessment.
Timepoint [1] 344075 0
Ultrasound examinations will be performed within 30 minutes of the colonoscopy and the duration of the ultrasound examination will be recorded.

Eligibility
Key inclusion criteria
English speaking,
Have followed the standard bowel cleansing instructions prior to their colonoscopy,
Have inflammatory Bowel Disease (such as Crohn's disease or ulcerative colitis).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cannot understand or give informed consent.
Self reported bowel preparation quality is poor.

Study design
Purpose of the study
Prevention
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)
Coin Toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size will be determined after PAUSE trial (pilot study) with the help of a statistician and SPSS program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
22/04/2019
Actual
Date of last data collection
Anticipated
30/04/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10317 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 21985 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 298899 0
Hospital
Name [1] 298899 0
Concord Hospital Gastroenterology Department
Country [1] 298899 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] 298113 0
None
Name [1] 298113 0
none
Address [1] 298113 0
N/A
Country [1] 298113 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299842 0
SLDH -Concord- Human Research Ethics Committee
Ethics committee address [1] 299842 0
Ground Floor - Building 20, Concord Repatriation General Hospital,
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 299842 0
Australia
Date submitted for ethics approval [1] 299842 0
30/04/2018
Approval date [1] 299842 0
Ethics approval number [1] 299842 0

Summary
Brief summary
Poor bowel preparation is common in inflammatory bowel disease (IBD) 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.

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 show that randomisation to the rapid ultrasound assessment (no radiation and no risks to the patient) that focuses on a few specific areas of the bowel to assess bowel preparation quality and allow for intervention (extra bowel prep) if required will be superior to the current standards (no ultrasound assessment) and can avoid the detrimental effects of poor bowel prep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81738 0
Dr Brandon Baraty
Address 81738 0
ACE Unit- Level 1 West
Concord Repatriation Hospital
Hospital Road, Concord, NSW, 2139
Country 81738 0
Australia
Phone 81738 0
+61410112026
Fax 81738 0
+61297676767
Email 81738 0
drbaraty@ibdultrasound.com
Contact person for public queries
Name 81739 0
Dr Brandon Baraty
Address 81739 0
ACE Unit- Level 1 West
Concord Repatriation Hospital
Hospital Road, Concord, NSW, 2139
Country 81739 0
Australia
Phone 81739 0
+61410112026
Fax 81739 0
+61297676767
Email 81739 0
drbaraty@ibdultrasound.com
Contact person for scientific queries
Name 81740 0
Dr Brandon Baraty
Address 81740 0
ACE Unit- Level 1 West
Concord Repatriation Hospital
Hospital Road, Concord, NSW, 2139
Country 81740 0
Australia
Phone 81740 0
+61410112026
Fax 81740 0
+61297676767
Email 81740 0
drbaraty@ibdultrasound.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23608Ethical approval-999999  

Results publications and other study-related documents

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