Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific abdominal muscle training | Experimental | Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery |
|
| Usual care treatment | Active Comparator | No specific abdominal muscle training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific abdominal muscle training | Other | Specific abdominal muscle training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parastomal hernia verified by computer tomography | Number of verified parastomal hernia by computer tomography | 6 to 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Manual evaluation of parastomal hernia | Visual evaluation of parastomal hernia assessed by Yes/No/Unsure | 6 to 36 months after surgery |
| Measurement of parastomal hernia | Size of the hernia by caliper and app |
Not provided
Inclusion Criteria:
- A consecutive series of patients who are scheduled to have a permanent sigmoidostomy
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monika Fagevik Olsén, PhD | Contact | +46313421195 | monika.fagevik-olsen@vgregion.se | |
| Monika Fagev ik Olsén, PhD | Contact | +4631 342 1195 | monika.fagevik-olsen@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Monika Fagevik Olsén, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 413 45 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
A single blind, randomized, controlled, intervention study. Evaluation of the addition of specific muscle training for patients undergoing intestine surgery including a sigmoidostomy compared to standard care
Not provided
Not provided
Assessor will not be aware of which group the patients are included in.
| Usual care | Other | Care according to each center. |
|
| 6 to 36 months after surgery |
| Stomal function- symptoms | Questionnaire including stomal function, by Smietanski. 15 items answered by Likert scales from 0 (no symptoms) to 10 (worst imaginable symptoms) | 6 to 36 months after surgery |
| Stomal function in daily life | Questionnaire including stomal function in normal life, by Hjortswang 2006. Four questions which are answered by 6-levels Lickert scales from no (0) tom maximal (5) symptoms. | 6 to 36 months after surgery |
| Generic Quality of life | EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life. | 6 to 36 months after surgery |
| Stoma specific Quality of Life | Stoma-QoL by Kald et al 2009. 20 questions with answers from 1 (always) to not at all (4). | 6 to 36 months after surgery |
| Physical activity level | Grimby Scale, A scale from 1-6 where a higher score indicates higher level of physical activity | Preoperatively to 36 months after surgery |
| Back pain | Back pain questionnaire by Granström et al 2020. Includes two visual analogue scales from 0 (no pain ) to 100 (Worst imaginable pain) mm and six questions which are answered on a Likert scale (4-5 levels) from no to maximal symptoms. | Preoperatively to 36 months after surgery |
| Helsingborgs lasarett | Recruiting | Helsingborg | Sweden |
|
| Örebro Universitetssjukhus | Recruiting | Örebro | Sweden |
|
| Skövde Sjukhus | Recruiting | Skövde | Sweden |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |