An interventional study of Specific abdominal muscle training and Usual care in Colon Cancer, sponsored by Göteborg University. Recruiting at 4 sites in Sweden. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Göteborg University · Not applicable, Interventional, and Prevention
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 240 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery
Other: Specific abdominal muscle training
No specific abdominal muscle training
Other: Usual care
Specific abdominal muscle training
Care according to each center.
Parastomal hernia verified by computer tomography
Number of verified parastomal hernia by computer tomography
Time frame: 6 to 36 months after surgery
Manual evaluation of parastomal hernia
Visual evaluation of parastomal hernia assessed by Yes/No/Unsure
Time frame: 6 to 36 months after surgery
Measurement of parastomal hernia
Size of the hernia by caliper and app
Time frame: 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)
Time frame: 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.
Time frame: 6 to 36 months after surgery
Generic Quality of life
EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: Preoperatively to 36 months after surgery
Plan to share: Undecided
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