Clinical trial NCT04701853: Specific Training After Stoma Surgery
Official title: Specific Training After Stoma Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: Hernia
Abdominal muscles
Stabilizing training
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

- A consecutive series of patients who are scheduled to have a permanent sigmoidostomy

Exclusion Criteria:

* Not Swedish speaking
* Impaired cognitive ability
* Physical disability that limits the possibility of carrying out the intervention.
* Lung disease including chronic cough.
* Previous hernia in the abdominal wall.
* Previous open abdominal surgery with scars ≥20 cm
* Spread malignant disease at inclusion
* Acute surgery

Primary outcomes:
measure: Parastomal hernia verified by computer tomography
timeFrame: 6 to 36 months after surgery
Secondary outcomes:
measure: Manual evaluation of parastomal hernia
timeFrame: 6 to 36 months after surgery
measure: Measurement of parastomal hernia
timeFrame: 6 to 36 months after surgery
measure: Stomal function- symptoms
timeFrame: 6 to 36 months after surgery
measure: Stomal function in daily life
timeFrame: 6 to 36 months after surgery
measure: Generic Quality of life
timeFrame: 6 to 36 months after surgery
measure: Stoma specific Quality of Life
timeFrame: 6 to 36 months after surgery
measure: Physical activity level
timeFrame: Preoperatively to 36 months after surgery
measure: Back pain
timeFrame: Preoperatively to 36 months after surgery
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Skövde
country: Sweden
facility: Skövde Sjukhus
city: Örebro
country: Sweden
facility: Örebro Universitetssjukhus
Study officials:
affiliation: Sahlgrenska University Hospital
name: Monika Fagevik Olsén, PhD
role: PRINCIPAL_INVESTIGATOR
References: