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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
240
Specific abdominal muscle training
Care according to each center.
Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGHelsingborgs lasarett
Helsingborg, Sweden
RECRUITINGÖrebro Universitetssjukhus
Örebro, Sweden
RECRUITINGSkövde Sjukhus
Skövde, Sweden
RECRUITINGParastomal 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
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