Specific Training After Stoma Surgery (STASS)

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 Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Other: Specific abdominal muscle training; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monika Fagev ik Olsén, PhD; Phone Number: +4631 342 1195; Email: monika.fagevik-olsen@vgregion.se
• Study Contact Backup: Name: Monika Fagevik Olsén, PhD; Phone Number: +46313421195; Email: monika.fagevik-olsen@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Monika Fagevik Olsén, PhD; Phone Number: +46313421195; Email: monika.fagevik-olsen@vgregion.se
  • Helsingborg, Sweden
    • Recruiting
    • Helsingborgs Lasarett
    • Contact: Eva Bengtsson
  • Skövde, Sweden
    • Recruiting
    • Skövde Sjukhus
    • Contact: Lizelotte Kämpe
  • Örebro, Sweden
    • Recruiting
    • Orebro universitetssjukhus
    • Contact: Camilla Björklund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific abdominal muscle training; Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery	Other: Specific abdominal muscle training; Specific abdominal muscle training
Active Comparator: Usual care treatment; No specific abdominal muscle training	Other: Usual care; Care according to each center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parastomal hernia verified by computer tomography	Number of verified parastomal hernia by computer tomography	6 to 36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manual evaluation of parastomal hernia	Visual evaluation of parastomal hernia assessed by Yes/No/Unsure	6 to 36 months after surgery
Measurement of parastomal hernia	Size of the hernia by caliper and app	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)	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.	6 to 36 months after surgery
Generic Quality of life	EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.	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).	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	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.	Preoperatively to 36 months after surgery

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Monika Fagevik Olsén, PhD, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Hernia; Abdominal muscles; Stabilizing training
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID Numbers: FoU in VGR: 275326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No