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Trial registered on ANZCTR


Registration number
ACTRN12624000496516p
Ethics application status
Not yet submitted
Date submitted
16/02/2024
Date registered
23/04/2024
Date last updated
23/04/2024
Date data sharing statement initially provided
23/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Transabdominal and Transperineal Ultrasound in Proctitis Assessment
Scientific title
The accuracy and reliability of transabdominal and trans-perineal ultrasound in the assessment of the proctitis and impact of subcutaneous adipose tissue and bladder fullness
Secondary ID [1] 311557 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TRUST-PA - TRansabdominal and tranSperineal Ultrasound in proctiTis Assessment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proctitis 332920 0
Condition category
Condition code
Oral and Gastrointestinal 329633 329633 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Objective: To evaluate the accuracy and reliability of transabdominal and trans-perineal ultrasound in assessing the rectum, using colonoscopy or flexible sigmoidoscopy as the reference standard, and to explore the impact of subcutaneous adipose tissue(SAT) and bladder fullness on image quality and accuracy.

Design: Cross-sectional study

Recruitment:
Participants: Adults with known or suspected IBD involving the rectum undergoing colonoscopy or flexible sigmoidoscopy for any clinical indication and intestinal ultrasound (IUS) within 30 days.

Methods:
Undergo colonoscopy or flexible sigmoidoscopy, with endoscopists blinded to ultrasound findings.

Ultrasound:

Preparation – 2 hours not emptying ones bladder

First part - Transabdominal ultrasound (TAUS) - 10 minutes

Standard of care intestinal ultrasound, including assessing the rectum transabdominally in both the transverse and sagittal views.

Assessment of bladder fullness

Measurement of Subcutaneous Adipose Tissue (SAT):
a. Above the Umbilicus (for comparison):
Identify a point 1 cm above the umbilicus in the midline.
Using a high-frequency linear probe, obtain an image initially on transverse view and later in the longitudinal (or sagittal) axis.
Freeze the photo at the end of the expiration.
Measure the distance from the inner surface of the skin to the outer surface of the linea alba.
This distance represents the thickness of the SAT in the upper abdomen.
SAT will appear as a hypoechoic (darker) layer between the hyperechoic (brighter) skin and the hyperechoic linea alba
Take 2 sagittal and 2 transverse multiple and average them for added accuracy.

b. Suprapubic Area:
Applying a similar strategy but now placing the probe perpendicular to the skin in the midline, approximately 5-10 cm below the umbilicus.

Measure the thickness of the SAT from the inner surface of the skin to the outer surface of the linea alba.
Take 2 sagittal and 2 transverse multiple and average them for added accuracy.

Second part Transperineal ultrasound(TPUS) - 5 minutes
Use the micro-convex prob. Measure first in coronal and later in sagittal.
Consider having two sonographers measure the SAT and VAT independently in a subset of patients to determine inter-rater reliability

Both will be done on the same day, starting with transabdominal approach followed by the transperineal approach.
Intervention code [1] 328007 0
Not applicable
Comparator / control treatment
Standard of care flexible sigmoidoscopy or colonoscopy done within 30 days of the ultrasound.

All standard of care procedures are done by gastroenterologists using Olympus colonoscopes and include biopsies of all examined colonic segments.
Control group
Active

Outcomes
Primary outcome [1] 337417 0
Accuracy of bowel wall thickness measured via transabdominal and transperineal ultrasound in assessing the rectum for inflammation compared to colonoscopy or flexible sigmoidoscopy.
Timepoint [1] 337417 0
Ultrasound and colonoscopy or flexible sigmoidoscopy done within 30 days
Primary outcome [2] 337635 0
Accuracy of colour Doppler measured via transabdominal and transperineal ultrasound in assessing the rectum for inflammation compared to colonoscopy or flexible sigmoidoscopy.
Timepoint [2] 337635 0
Ultrasound and colonoscopy or flexible sigmoidoscopy done within 30 days
Primary outcome [3] 337636 0
The accuracy of a composite of bowel wall thickness and colour doppler signal via transabdominal and transperineal ultrasound in assessing the rectum for inflammation compared to colonoscopy or flexible sigmoidoscopy.
Timepoint [3] 337636 0
Ultrasound and colonoscopy or flexible sigmoidoscopy done within 30 days
Secondary outcome [1] 431796 0
Quality of ultrasound views
Timepoint [1] 431796 0
On the same day of ultrasound
Secondary outcome [2] 431797 0
SAT thickness
Timepoint [2] 431797 0
On the same day of ultrasound
Secondary outcome [3] 431798 0
Bladder fullness
Timepoint [3] 431798 0
On the same day of ultrasound
Secondary outcome [4] 432586 0
The reliability of bowel composite bowel wall thickness and colour doppler in assessing rectal inflammation
Timepoint [4] 432586 0
One the same day of ultrasound

Eligibility
Key inclusion criteria
Participants: Adults with known or suspected IBD involving the rectum undergoing colonoscopy or flexible sigmoidoscopy for any clinical indication and IUS within 30 days.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ileoanal pouch
Previous proctectomy
Diverted bowel

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The overall accuracy of the ultrasound methods TAUS and TPUS will be assessed using Receiver Operating Characteristic (ROC) curves. Their accuracy at assessing severity of ICI colitis will be assessed by correlating colonoscopy features and Mayo and UCEIS scores, using the Spearman’s rank order correlation. The reliability of TAUS and TPUS tools will be assessed a two-way random-effects intraclass coefficient (ICC) estimate

Regression analysis to determine the relationship between SAT thickness, bladder fullness, and ultrasound image quality or accuracy.

ROC curve to determine SAT thickness cut-off for optimal rectal visualization transabdominally.

Paired t-test or Wilcoxon signed-rank test (if the data is not normally distributed) to compare SAT measurements from the two sites. Pearson or spearmen rank can also be used to correlate the two.

McNemar's test to compare accuracy between transabdominal and transperineal methods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
28/12/2025
Actual
Date of last data collection
Anticipated
28/12/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26185 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42058 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315854 0
Hospital
Name [1] 315854 0
The Alfred
Country [1] 315854 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Country
Australia
Secondary sponsor category [1] 317989 0
None
Name [1] 317989 0
None
Address [1] 317989 0
Country [1] 317989 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314707 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314707 0
Ethics committee country [1] 314707 0
Australia
Date submitted for ethics approval [1] 314707 0
01/07/2024
Approval date [1] 314707 0
Ethics approval number [1] 314707 0

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

Contacts
Principal investigator
Name 132466 0
Dr Zaid Ardalan
Address 132466 0
The Alfred Hospital 99 commercial road, Melbourne, VIC, 3004
Country 132466 0
Australia
Phone 132466 0
+61 409730301
Fax 132466 0
Email 132466 0
z.ardalan@alfred.org.au
Contact person for public queries
Name 132467 0
Zaid Ardalan
Address 132467 0
The Alfred Hospital 99 commercial road, Melbourne, VIC, 3004
Country 132467 0
Australia
Phone 132467 0
+61 409730301
Fax 132467 0
Email 132467 0
z.ardalan@alfred.org.au
Contact person for scientific queries
Name 132468 0
Zaid Ardalan
Address 132468 0
The Alfred Hospital 99 commercial road, Melbourne, VIC, 3004
Country 132468 0
Australia
Phone 132468 0
+61 409730301
Fax 132468 0
Email 132468 0
z.ardalan@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified data of all outcomes
When will data be available (start and end dates)?
Once research is published data will be available with no end date
Available to whom?
Everyone who has access to the published article
Available for what types of analyses?
Any analysis as data will be raw
How or where can data be obtained?
The practice is for the journals to upload a link to the data along with the published article.


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.