Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001175662p
Ethics application status
Submitted, not yet approved
Date submitted
20/10/2023
Date registered
14/11/2023
Date last updated
14/11/2023
Date data sharing statement initially provided
14/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing clinical effects and patient perspectives of a tailored parastomal ‘Hernia Halt’ in managing patient symptoms of parastomal hernias
Scientific title
Effects of a parastomal ‘Hernia Halt’ on patients’ lived experiences with a parastomal hernia
Secondary ID [1] 310828 0
nil known
Universal Trial Number (UTN)
U1111-1299-2942
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parastomal hernia 331827 0
Condition category
Condition code
Oral and Gastrointestinal 328568 328568 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to design and 3D print a stoma guard that is tailored to a patient's individual abdominal wall and stomal measurements, with the goal of improving their quality of life, reducing pain, and lowering the requirement of surgical parastomal hernia repair.
We will take detailed measurements of each patient's waist, abdominal wall and stoma to create a customised stoma guard design. We estimate this will take 45 minutes to complete, and will be undertaken by a medical student and research fellow working on this project. With these measurements, we will print using polylactic acid polymers and fit the customized stoma guards to the patients, ensuring proper comfort and functionality.
Patients will wear the guards for four weeks, and be encouraged to wear the guard while not sleeping/bathing, or emptying the stoma bag. Participants will be asked to clean the guard between each emptying of the bag with 70% alcohol wipes, which will be provided. A member of the research team will contact the participants each week to monitor use and receive feedback regarding the device.
Intervention code [1] 327240 0
Treatment: Devices
Comparator / control treatment
no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336374 0
Quality of life
Timepoint [1] 336374 0
At baseline prior to wearing the guard and after four weeks of wearing the guard
Primary outcome [2] 336375 0
Pain
Timepoint [2] 336375 0
At baseline prior to wearing the guard and after four weeks of wearing the guard
Secondary outcome [1] 428099 0
Leakage around the stoma
Timepoint [1] 428099 0
at baseline and after four weeks of wearing the guard
Secondary outcome [2] 428100 0
severity of episodes of bowel blockages related to the hernia
Timepoint [2] 428100 0
at baseline and after four weeks of wearing the guard
Secondary outcome [3] 428101 0
swelling of the stoma
Timepoint [3] 428101 0
at baseline and after four weeks of wearing the guard
Secondary outcome [4] 428102 0
Qualitative interview themes
Timepoint [4] 428102 0
after four weeks of wearing the guard
Secondary outcome [5] 428490 0
Feasibility of wearing the device
Timepoint [5] 428490 0
after four weeks of wearing the guard
Secondary outcome [6] 428491 0
Irritation of the stoma
Timepoint [6] 428491 0
at baseline and after four weeks of wearing the guard

Eligibility
Key inclusion criteria
1) Patients who have a parastomal hernia
2) Patients currently residing in the Te Whatu Ora Southern catchment
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to provide consent
2) Inability to converse in English
3) Patients who have an asymptomatic parastomal hernia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Safety/efficacy
Statistical methods / analysis
This is a pilot study in which the primary objective is to determine the feasibility and process for developing a tailored hernia guard. As such, we will recruit a convenience sample of 15 participants. This will also allow us to address the secondary objective of identifying themes of the patient experience with the parastomal hernia halt is expected to enable us to reach saturation of themes and breadth (meaning of messages).

Patient demographics will be described using appropriate descriptive statistics (mean and standard deviation for normally distributed continuous variables, median and inter-quartile range for other continuous variables, count and percentage for categorical variables).

Qualitative data will be summarized into themes. This is a novel qualitative study exploring patient perceptions of this device. For comparison of categorical data the Chi-square test or Fischer’s exact test will be used where appropriate. Continuous data, such as before and after SF-36 and pain VAS scores will be analysed using the independent samples t-test (reporting mean and standard deviation) and Wilcoxon Rank Sum (reporting median and interquartile range) test for normally and non-normally distributed data, respectively. The Shapiro-Wilk test will be used to assess the distribution of the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/02/2024
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 25915 0
New Zealand
State/province [1] 25915 0
Otago

Funding & Sponsors
Funding source category [1] 315076 0
University
Name [1] 315076 0
University of Otago
Country [1] 315076 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
201 Great King St Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317094 0
Hospital
Name [1] 317094 0
Dunedin Hospital
Address [1] 317094 0
201 Great King St, Dunedin 9016
Country [1] 317094 0
New Zealand
Other collaborator category [1] 282853 0
University
Name [1] 282853 0
Otago Polytech
Address [1] 282853 0
Forth St, Dunedin North, Dunedin 9016
Country [1] 282853 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314023 0
University of Otago Health Ethics Committee
Ethics committee address [1] 314023 0
362 Leith Street, Dunedin North, Dunedin 9016
Ethics committee country [1] 314023 0
New Zealand
Date submitted for ethics approval [1] 314023 0
09/09/2023
Approval date [1] 314023 0
Ethics approval number [1] 314023 0

Summary
Brief summary
Parastomal hernias are common complications following bowel cancer surgery with the formation of a stoma. These occur when abdominal contents protrude through the abdominal wall at the stoma site. Hernia symptoms can include pain, bulging, leakage, skin irritation, difficulty fitting the stoma, and occasionally life-threatening complications. The main treatment is surgical repair – but unfortunately the rate of hernia recurrence is high. Stoma guards and supportive devices can provide support to the abdominal wall around the stoma site, reducing symptoms associated with hernias, and possibly the need for surgery. The aim of this project is to 3D print a tailored stomal guard to improve quality of life, reduce pain, and the risk of surgical intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130154 0
Dr Kari Clifford
Address 130154 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago PO Box 56, Dunedin 9054
Country 130154 0
New Zealand
Phone 130154 0
+64 210668369
Fax 130154 0
Email 130154 0
kari.clifford@otago.ac.nz
Contact person for public queries
Name 130155 0
Dr Kari Clifford
Address 130155 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago PO Box 56, Dunedin 9054
Country 130155 0
New Zealand
Phone 130155 0
+64 210668369
Fax 130155 0
Email 130155 0
kari.clifford@otago.ac.nz
Contact person for scientific queries
Name 130156 0
Dr Kari Clifford
Address 130156 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago PO Box 56, Dunedin
Country 130156 0
New Zealand
Phone 130156 0
+64 210668369
Fax 130156 0
Email 130156 0
kari.clifford@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
anonymised data from the questionnaires
When will data be available (start and end dates)?
after publication and for ten years following
Available to whom?
researchers upon reasonable request.
Available for what types of analyses?
meta analyses and systematic reviews
How or where can data be obtained?
by contacting the principal investigator, kari.clifford@otago.ac.nz.


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.