Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000471684
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
9/05/2023
Date last updated
25/04/2024
Date data sharing statement initially provided
9/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy female volunteer study to examine the effect of different body positions and environment on defecation physiology
Scientific title
Healthy female volunteer study to examine the effect of different body positions and environment on defecation physiology
Secondary ID [1] 309180 0
Nil known
Universal Trial Number (UTN)
U1111-1289-6606
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation - Dyssynergic defecation 329316 0
Condition category
Condition code
Oral and Gastrointestinal 326261 326261 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Firstly, participants will undergo baseline assessment that includes anorectal ultrasound and anorectal manometry. Anorectal ultrasound involves examination of the anal sphincters using a transrectal ultrasound probe. Then participants will undergo anorectal manometry. Participants will have a flexible catheter inserted into rectum to measure the rectal and sphincter pressure during various manoeuvres including balloon expulsion. Rectal sensation will be measured by inflating rectal balloon.

Healthy volunteers will be asked to expel rectal balloon in different settings - Supine and 2 sitting positions. For sitting positions: Setting 1) In a conventional toilet in privacy Setting 2) On a commode chair behind the curtain (partial privacy). Order in which balloons are expelled will be randomised. All participants will also undergo anorectal manometry and anal ultrasound.

All procedures will be performed by either a doctor (gastroenterologist or advanced trainee for gastroenterology) or a specialist nurse. Participants will only need to attend one session lasting approximately 1-2 hours to complete the study.
Intervention code [1] 325628 0
Diagnosis / Prognosis
Comparator / control treatment
Balloon expulsion in private toilet (current standard of care for balloon expulsion in this unit)
Control group
Active

Outcomes
Primary outcome [1] 334325 0
Balloon expulsion time measured using stopwatch
Timepoint [1] 334325 0
At the time of intervention
Secondary outcome [1] 420249 0
Ease and comfort of balloon expulsion will be rated by participants on a ten point visual analogue scale. After each position/environments has been tested, participants will be asked to give score out of 10. Then this response will be recorded on the result sheet by the investigator.

After completing all three positions/environments have been tested, Participants will be asked to choose the position/environment that was the most easy and comfortable. Then this response will be recorded on the result sheet by the investigator.
Timepoint [1] 420249 0
At the time of intervention

Eligibility
Key inclusion criteria
1) Age 20 to 75
2) Females
3) English speakers
4) Patients who are eligible for Medicare benefit in Australia
5) Willingness to answer screening questionnaire
6) Willingness to give written informed consent
7) Willingness to comply with the study.
Minimum age
20 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Women breast feeding or pregnant.
2) Definable gastrointestinal disorder based on the ROME questionnaire : Disorders excluded: Irritable bowel syndrome, functional bloating, functional constipation or diarrhoea, abdominal pain and functional anorectal disorders.
3) Presence of overt organic anorectal disorder
4) Medications that alter motility of the GI tract, such as loperamide and opioids
5) History of anorectal or distal colon surgery.
6) History of complicated vaginal delivery
7) History of psychological illness or condition such as interfere with the patient’s ability to understand the requirements of the study. This will be assessed by: (a) hospital anxiety and depression score, (b) screening questionnaire questions about medical conditions and current medications, and (c) brief physician interview and discussion of patient information and consent form before patients consent.

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)
Randomised sequences of balloon expulsion order will be generated and put into a opaque envelope. Then this sequence will be randomly selected at the beginning of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequences will be generated by computer the ensure there are equal distribution of different balloon expulsion order sequences.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
T-test will be used to compare the mean balloon expulsion times and the rating of ease and comfort of balloon expulsion between different position & environment. Proportional analysis will also be used to determine which position & environment was perceived to have the easiest and the most comfortable balloon expulsion experience.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24441 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 40022 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 313378 0
Hospital
Name [1] 313378 0
Royal North Shore Hospital - Northern Sydney Local Health District
Country [1] 313378 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital - Northern Sydney Local Health District
Address
Reserve Road, St Leonards NSW 2065, Australia
Country
Australia
Secondary sponsor category [1] 315140 0
None
Name [1] 315140 0
Address [1] 315140 0
Country [1] 315140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312595 0
Northern Sydney Local Health District - Research Ethics Office
Ethics committee address [1] 312595 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 312595 0
Australia
Date submitted for ethics approval [1] 312595 0
04/07/2022
Approval date [1] 312595 0
07/12/2022
Ethics approval number [1] 312595 0
2022/ETH00660

Summary
Brief summary
This study is a healthy volunteer study assessing anorectal function during defecation. The balloon expulsion study is one of the diagnostic tests used to assess dyssynergic defecation - condition where there is a poor coordination of pelvic floor muscle resulting in impaired defecation.

In this study, participants will be asked to undergo anorectal ultrasound, anorectal manometry followed by rectal balloon expulsion tests in three different positions.

Balloon expulsion time and the ease and comfort of balloon expulsion will be compared between different positions and environments. Result from this tests will contribute to further refining the interpretation and performing balloon expulsion test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125226 0
A/Prof Allison Malcolm
Address 125226 0
Gastroenterology Department Level 4 Royal North Shore Hospital Reserve Road St Leonards NSW 2065
Country 125226 0
Australia
Phone 125226 0
+612 9463 2460
Fax 125226 0
Email 125226 0
allison.malcolm@sydney.edu.au
Contact person for public queries
Name 125227 0
Dr Calvin Park
Address 125227 0
Gastroenterology Department Level 4 Royal North Shore Hospital Reserve Road St Leonards NSW 2065
Country 125227 0
Australia
Phone 125227 0
+612 9463 2460
Fax 125227 0
Email 125227 0
NSLHD-ngresearch@health.nsw.gov.au
Contact person for scientific queries
Name 125228 0
A/Prof Allison Malcolm
Address 125228 0
Gastroenterology Department Level 4 Royal North Shore Hospital Reserve Road St Leonards NSW 2065
Country 125228 0
Australia
Phone 125228 0
+612 9463 2460
Fax 125228 0
Email 125228 0
NSLHD-ngresearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.