Training to prevent hernias after stoma surgery
Specific Training After Stoma Surgery
This study tests whether special abdominal exercises can help prevent hernias in patients who have had stoma surgery for colon cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Sex | All |
| Sponsor | Göteborg University Academic / other |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT04701853 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for permanent sigmoidostomy who can participate in the exercise intervention.
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.
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 performed: While there is a lack of randomized studies specifically addressing this intervention, there are indications that similar approaches may be beneficial.
Eligibility criteria
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 this trial is running
Gothenburg and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.