Condition: Colon Cancer · Sponsor: Göteborg University
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 register…
This description comes directly from the study's public registry record.
Monika Fagevik Olsén, PhD · +46313421195 · monika.fagevik-olsen@vgregion.se
Monika Fagev ik Olsén, PhD · +4631 342 1195 · monika.fagevik-olsen@vgregion.se
Always discuss trial participation with your own doctor first.
| Sahlgrenska University Hospital | Gothenburg, Sweden | Recruiting |
| Helsingborgs lasarett | Helsingborg, Sweden | Recruiting |
| Örebro Universitetssjukhus | Örebro, Sweden | Recruiting |
| Skövde Sjukhus | Skövde, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04701853