Specific Training After Stoma Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Specific abdominal muscle training, Usual care.
- Who it may be relevant to
- Registry conditions: Colon Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Specific abdominal muscle training
Specific abdominal muscle training - Other Usual care
Care according to each center.
Primary outcome measures
- Parastomal hernia verified by computer tomography [Time frame: 6 to 36 months after surgery]
Secondary outcome measures (8)
- Manual evaluation of parastomal hernia [Time frame: 6 to 36 months after surgery]
- Measurement of parastomal hernia [Time frame: 6 to 36 months after surgery]
- Stomal function- symptoms [Time frame: 6 to 36 months after surgery]
- Stomal function in daily life [Time frame: 6 to 36 months after surgery]
- Generic Quality of life [Time frame: 6 to 36 months after surgery]
- Stoma specific Quality of Life [Time frame: 6 to 36 months after surgery]
- Physical activity level [Time frame: Preoperatively to 36 months after surgery]
- Back pain [Time frame: Preoperatively to 36 months after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Sweden · 4 centers
- Sahlgrenska University Hospital — Gothenburg
- Helsingborgs lasarett — Helsingborg
- Örebro Universitetssjukhus — Örebro
- Skövde Sjukhus — Skövde
Identifiers
NCT: NCT04701853 · FoU in VGR: 275326