Colon CancerSTASSNCT04701853
Specific Training After Stoma Surgery
A study testing Specific abdominal muscle training in people with Colon Cancer, run by Göteborg University at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Specific abdominal muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesSweden
- Study dates
- 1 May 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A consecutive series of patients who are scheduled to have a permanent sigmoidostomy
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
Monika Fagevik Olsén, PhD, +46313421195, monika.fagevik-olsen@vgregion.se
- Recruiting
Helsingborgs lasarett
Helsingborg
Eva Bengtsson
- Recruiting
Örebro Universitetssjukhus
Örebro
Camilla Björklund
- Recruiting
Skövde Sjukhus
Skövde
Lizelotte Kämpe
About this study
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.
Read more
The aims of the study are:
- 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.
- 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.
- Conditions
- Colon Cancer
- Being tested
- Specific abdominal muscle training, Usual care
- Keywords
- Hernia, Abdominal muscles, Stabilizing training
- Medical subject headings
- Colonic Neoplasms, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific abdominal muscle trainingOther
Specific abdominal muscle training
Usual careOther
Care according to each center.
| Study group | Role | What they receive |
|---|---|---|
| Specific abdominal muscle training | Experimental | Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery Receives: Other: Specific abdominal muscle training |
| Usual care treatment | Active comparator | No specific abdominal muscle training Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parastomal hernia verified by computer tomography
Number of verified parastomal hernia by computer tomography
Measured: 6 to 36 months after surgery
Secondary outcomes (8)
Manual evaluation of parastomal hernia
Visual evaluation of parastomal hernia assessed by Yes/No/Unsure
Measured: 6 to 36 months after surgery
Measurement of parastomal hernia
Size of the hernia by caliper and app
Measured: 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)
Measured: 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.
Measured: 6 to 36 months after surgery
Generic Quality of life
EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Preoperatively to 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 May 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Fagevik Olsén, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701853
- Sponsor's protocol ID
- FoU in VGR: 275326
- Acronym
- STASS
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Training After Stoma Surgery
- ClinicalTrials.gov ID
- NCT04701853
- Acronym / sponsor ID
- STASS / FoU in VGR: 275326
- Conditions
- Colon Cancer
- Keywords
- Hernia, Abdominal muscles, Stabilizing training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Specific abdominal muscle training | Experimental | Other: Specific abdominal muscle trainingSpecific abdominal muscle training which is introduced preoperatively and performed the first year after surgery |
| Usual care treatment | Active comparator | Other: Usual careNo specific abdominal muscle training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A consecutive series of patients who are scheduled to have a permanent sigmoidostomy
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific abdominal muscle trainingSpecific abdominal muscle training | Other | Specific abdominal muscle training |
| Usual careCare according to each center. | Other | Usual care treatment |
Primary outcome
Parastomal hernia verified by computer tomography
Time frame: 6 to 36 months after surgery
Number of verified parastomal hernia by computer tomography
8 secondary outcomes
Manual evaluation of parastomal hernia
Time frame: 6 to 36 months after surgery
Measurement of parastomal hernia
Time frame: 6 to 36 months after surgery
Stomal function- symptoms
Time frame: 6 to 36 months after surgery
Stomal function in daily life
Time frame: 6 to 36 months after surgery
Generic Quality of life
Time frame: 6 to 36 months after surgery
Stoma specific Quality of Life
Time frame: 6 to 36 months after surgery
Physical activity level
Time frame: Preoperatively to 36 months after surgery
Back pain
Time frame: Preoperatively to 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monika Fagevik Olsén, PhD principal investigator
Sahlgrenska University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific abdominal muscle training in people with Colon Cancer, run by Göteborg University at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Fagevik Olsén, PhD (+46313421195, monika.fagevik-olsen@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parastomal hernia verified by computer tomography (time frame: 6 to 36 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.