Actively Recruiting
Specific Training After Stoma Surgery
Led by Göteborg University · Updated on 2025-03-13
240
Participants Needed
4
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In Sweden, approximately 43,000 people have undergone surgery with ileo-, colo- or urostomy. The most common type of stomy is a sigmoidostomy. A large proportion, about 50%, of patients who receive a permanent sigmoidostomy develop a parastomal hernia which may have major impact. There are indications that specific abdominal exercise may reduce the risk of parastomal hernias, but randomized studies are lacking. The aims of the study are: 1. to evaluate the effect of specific exercise to counteract the development of parastomal hernia in sigmoidostomy and the hernia's impact on ostomy function, physical function and quality of life. 2. to examine patients' experience of living with parastomal hernia. The study plans to include 240 patients who on will undergo surgery and receive a sigmoidostomy. These will be randomized to receive only advice according to the usual routine to avoid the development of parastomal hernia or these advice with the addition of specific abdominal muscle training. The training is initiated before the operation and is then carried out during the first postoperative year. Follow-up will be done with a clinical assessment and with measurement of bulge and size of the parastomal hernia manually, with electronic measuring equipment and via computed tomography images. Patients will assess their stoma and stoma function and assess any discomfort and its consequences of hernia via a study-specific questionnaire. Type of ostomy bandage will also be registered. The evaluation will be carried out 6, 12 and 36 months postoperatively. Prior to the start of sub-study a, the planned measurement methods to assess whether a parastomal hernia is present will be tested for validity. In addition, a group of patients (≥15 people) with parastomal hernia will be included in a qualitative sub-study where they will be interviewed about their experiences of the hernia hernia and how it may affect daily life. The present study will be able to answer whether specific exercise can reduce the risk of parastomal hernia. Methods for clinically assessing and evaluating bulging and hernias will be tested and evaluated in relation to patient-reported symptoms. In addition, the study will provide information about the patient's experience of having a parastomal hernia and how it affects daily life and physical activity. The results will provide an increased understanding of parastomal hernias, which may change the follow-up of patients in the future.
CONDITIONS
Official Title
Specific Training After Stoma Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for permanent sigmoidostomy surgery
You will not qualify if you...
- Not Swedish speaking
- Impaired cognitive ability
- Physical disability limiting ability to do the exercises
- Lung disease including chronic cough
- Previous abdominal wall hernia
- Previous open abdominal surgery with scars 20 cm or larger
- Spread of malignant disease at inclusion
- Acute surgery
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
2
Helsingborgs lasarett
Helsingborg, Sweden
Actively Recruiting
3
Örebro Universitetssjukhus
Örebro, Sweden
Actively Recruiting
4
Skövde Sjukhus
Skövde, Sweden
Actively Recruiting
Research Team
M
Monika Fagevik Olsén, PhD
CONTACT
M
Monika Fagev ik Olsén, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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