Training to prevent hernias after stoma surgery
Official title: Specific Training After Stoma Surgery
Run by Göteborg University · NCT04701853 · Data updated 2026-11-12
This study tests whether special abdominal exercises can help prevent hernias in patients who have had stoma surgery for colon cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Göteborg University Academic / other |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Status | Recruiting |
| Started | May 1, 2021 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 13, 2025 |
| Trial ID | NCT04701853 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients scheduled for permanent sigmoidostomy who can participate in the exercise intervention.
✕Probably not a fit
Patients who are not Swedish speaking, have cognitive impairments, or physical disabilities that limit their ability to perform the intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of specific abdominal muscle training in preventing parastomal hernias in patients undergoing permanent sigmoidostomy due to colon cancer. It aims to include 240 patients who will be randomized to receive either standard advice or standard advice plus the abdominal training intervention. The study will also assess the impact of hernias on ostomy function, physical function, and quality of life, as well as patients' experiences living with parastomal hernias.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of parastomal hernias and improve the quality of life for patients with sigmoidostomies.
How similar studies have gone: While there is a lack of randomized studies specifically addressing this intervention, there are indications that similar approaches may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- A consecutive series of patients who are scheduled to have a permanent sigmoidostomy Exclusion Criteria: * Not Swedish speaking * Impaired cognitive ability * Physical disability that limits the possibility of carrying out the intervention. * Lung disease including chronic cough. * Previous hernia in the abdominal wall. * Previous open abdominal surgery with scars ≥20 cm * Spread malignant disease at inclusion * Acute surgery
Where it's running
-
Sahlgrenska University Hospital
Gothenburg, Sweden Recruiting -
Helsingborgs lasarett
Helsingborg, Sweden Recruiting -
Örebro Universitetssjukhus
Örebro, Sweden Recruiting -
Skövde Sjukhus
Skövde, Sweden Recruiting
Study contacts
- Principal investigator: Monika Fagevik Olsén, PhD — Sahlgrenska University Hospital
- Study coordinator: Monika Fagevik Olsén, PhD
- Email: monika.fagevik-olsen@vgregion.se
- Phone: +46313421195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.