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NCT Number: NCT04701853

Specific Training After Stoma Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific abdominal muscle training

Other

Specific abdominal muscle training

Usual Care

Other

Care according to each center.

Primary outcomes

  1. Parastomal hernia verified by computer tomography

    Time frame: 6 to 36 months after surgery

    Number of verified parastomal hernia by computer tomography

Secondary outcomes

  1. Manual evaluation of parastomal hernia

    Time frame: 6 to 36 months after surgery

    Visual evaluation of parastomal hernia assessed by Yes/No/Unsure

  2. Measurement of parastomal hernia

    Time frame: 6 to 36 months after surgery

    Size of the hernia by caliper and app

  3. Stomal function- symptoms

    Time frame: 6 to 36 months after surgery

    Questionnaire including stomal function, by Smietanski. 15 items answered by Likert scales from 0 (no symptoms) to 10 (worst imaginable symptoms)

  4. Stomal function in daily life

    Time frame: 6 to 36 months after surgery

    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.

  5. Generic Quality of life

    Time frame: 6 to 36 months after surgery

    EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.

  6. Stoma specific Quality of Life

    Time frame: 6 to 36 months after surgery

    Stoma-QoL by Kald et al 2009. 20 questions with answers from 1 (always) to not at all (4).

  7. Physical activity level

    Time frame: Preoperatively to 36 months after surgery

    Grimby Scale, A scale from 1-6 where a higher score indicates higher level of physical activity

  8. Back pain

    Time frame: Preoperatively to 36 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Monika Fagev ik Olsén, PhD

CONTACT

[email protected]

+4631 342 1195

Monika Fagevik Olsén, PhD

CONTACT

[email protected]

+46313421195

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Acronym: STASS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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