Specific abdominal muscle training
OtherSpecific abdominal muscle training
NCT Number: NCT04701853
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.
Interested in participating?
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Interventional
Not applicable
Sahlgrenska University Hospital, Gothenburg, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific abdominal muscle training
Care according to each center.
Time frame: 6 to 36 months after surgery
Number of verified parastomal hernia by computer tomography
Time frame: 6 to 36 months after surgery
Visual evaluation of parastomal hernia assessed by Yes/No/Unsure
Time frame: 6 to 36 months after surgery
Size of the hernia by caliper and app
Time frame: 6 to 36 months after surgery
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
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
EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.
Time frame: 6 to 36 months after surgery
Stoma-QoL by Kald et al 2009. 20 questions with answers from 1 (always) to not at all (4).
Time frame: Preoperatively to 36 months after surgery
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 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.
Contact information is provided by the study sponsor or research team.
Monika Fagev ik Olsén, PhD
CONTACT
Monika Fagevik Olsén, PhD
CONTACT
Göteborg University
Other
Acronym: STASS
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