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Specific Training After Stoma Surgery (STASS)

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Specific abdominal muscle training
Usual care
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer focused on measuring Hernia, Abdominal muscles, Stabilizing training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University HospitalRecruiting
  • Helsingborgs lasarettRecruiting
  • Skövde SjukhusRecruiting
  • Örebro UniversitetssjukhusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specific abdominal muscle training

Usual care treatment

Arm Description

Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery

No specific abdominal muscle training

Outcomes

Primary Outcome Measures

Parastomal hernia verified by computer tomography
Number of verified parastomal hernia by computer tomography

Secondary Outcome Measures

Manual evaluation of parastomal hernia
Visual evaluation of parastomal hernia assessed by Yes/No/Unsure
Measurement of parastomal hernia
Size of the hernia by caliper and app
Stomal function- symptoms
Questionnaire including stomal function, by Smietanski. 15 items answered by Likert scales from 0 (no symptoms) to 10 (worst imaginable symptoms)
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.
Generic Quality of life
EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.
Stoma specific Quality of Life
Stoma-QoL by Kald et al 2009. 20 questions with answers from 1 (always) to not at all (4).
Physical activity level
Grimby Scale, A scale from 1-6 where a higher score indicates higher level of physical activity
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.

Full Information

First Posted
January 4, 2021
Last Updated
February 24, 2023
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04701853
Brief Title
Specific Training After Stoma Surgery
Acronym
STASS
Official Title
Specific Training After Stoma Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Hernia, Abdominal muscles, Stabilizing training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Assessor will not be aware of which group the patients are included in.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Specific abdominal muscle training
Arm Type
Experimental
Arm Description
Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery
Arm Title
Usual care treatment
Arm Type
Active Comparator
Arm Description
No specific abdominal muscle training
Intervention Type
Other
Intervention Name(s)
Specific abdominal muscle training
Intervention Description
Specific abdominal muscle training
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Care according to each center.
Primary Outcome Measure Information:
Title
Parastomal hernia verified by computer tomography
Description
Number of verified parastomal hernia by computer tomography
Time Frame
6 to 36 months after surgery
Secondary Outcome Measure Information:
Title
Manual evaluation of parastomal hernia
Description
Visual evaluation of parastomal hernia assessed by Yes/No/Unsure
Time Frame
6 to 36 months after surgery
Title
Measurement of parastomal hernia
Description
Size of the hernia by caliper and app
Time Frame
6 to 36 months after surgery
Title
Stomal function- symptoms
Description
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
Title
Stomal function in daily life
Description
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
Title
Generic Quality of life
Description
EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.
Time Frame
6 to 36 months after surgery
Title
Stoma specific Quality of Life
Description
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
Title
Physical activity level
Description
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
Title
Back pain
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Fagevik Olsén, PhD
Phone
+46313421195
Email
monika.fagevik-olsen@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Fagev ik Olsén, PhD
Phone
+4631 342 1195
Email
monika.fagevik-olsen@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Phone
+46313421195
Email
monika.fagevik-olsen@vgregion.se
Facility Name
Helsingborgs lasarett
City
Helsingborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Bengtsson
Facility Name
Skövde Sjukhus
City
Skövde
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizelotte Kämpe
Facility Name
Örebro Universitetssjukhus
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Björklund

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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