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Assessing clinical effects and patient perspectives of a tailored parastomal ‘Hernia Halt’ in managing patient symptoms of parastomal hernias

Effects of a parastomal ‘Hernia Halt’ on patients’ lived experiences with a parastomal hernia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001175662
Enrollment
15
Registered
2023-11-14
Start date
2023-12-01
Completion date
2024-02-01
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 stude

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.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1) Patients who have a parastomal hernia 2) Patients currently residing in the Te Whatu Ora Southern catchment

Exclusion criteria

1) Inability to provide consent 2) Inability to converse in English 3) Patients who have an asymptomatic parastomal hernia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026