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Search / Trial NCT04701853

Specific Training After Stoma Surgery

Launched by GÖTEBORG UNIVERSITY · Jan 7, 2021

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Hernia Abdominal Muscles Stabilizing Training

ClinConnect Summary

This clinical trial is studying whether specific abdominal exercises can help prevent a common problem called a parastomal hernia in patients who have undergone a type of surgery known as sigmoidostomy, often done for colon cancer. A parastomal hernia occurs when tissue pushes through the abdominal wall near the stoma (the opening created during surgery), and about 50% of patients with a permanent sigmoidostomy may develop this issue. The trial will involve 240 patients who will be randomly assigned to either receive standard advice on how to avoid hernias or to also participate in a special exercise program that begins before their surgery and continues for the first year after.

To be eligible for this study, patients need to be scheduled for a permanent sigmoidostomy and must be able to speak Swedish. Those with certain conditions, such as cognitive impairments or previous abdominal surgeries, will not be included. Participants can expect to be followed for up to three years, during which their hernia risk, stoma function, and overall quality of life will be assessed through various methods, including questionnaires and physical measurements. This trial aims to improve understanding of parastomal hernias and may lead to better care and support for patients in the future.

Gender

ALL

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

About Göteborg University

Göteborg University, a leading academic institution in Sweden, is committed to advancing healthcare through innovative research and clinical trials. With a strong focus on interdisciplinary collaboration, the university leverages its extensive expertise in various fields, including medicine, pharmacology, and social sciences, to address pressing health challenges. By sponsoring clinical trials, Göteborg University aims to contribute to the development of new therapies and improve patient outcomes, while adhering to the highest ethical standards and regulatory requirements. Their dedication to rigorous scientific inquiry and community engagement positions them as a pivotal player in the global health research landscape.

Locations

Gothenburg, , Sweden

Helsingborg, , Sweden

örebro, , Sweden

Skövde, , Sweden

Patients applied

0 patients applied

Trial Officials

Monika Fagevik Olsén, PhD

Principal Investigator

Sahlgrenska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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