Core muscle training to prevent hernias and pain after abdominal surgery
Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
This study is testing if doing core muscle exercises right after abdominal surgery can help prevent hernias and reduce pain afterwards for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 588 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 5 sites (Koblenz and 4 other locations) |
| Trial ID | NCT03808584 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of core muscle training on the incidence of incisional hernias and chronic postsurgical pain (CPSP) following abdominal surgery. Patients will be randomly assigned to either standard postoperative care or a regimen of core muscle exercises immediately after surgery. The study aims to determine whether engaging in these exercises affects the development of hernias and the severity of CPSP, as well as the potential for sarcopenia. The trial will be conducted across multiple centers, including the University Hospital of Bern and other locations in Switzerland and Germany.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing elective or emergency abdominal surgery with midline or transverse incisions.
Not a fit: Patients who are unable to follow study procedures due to language barriers, psychological disorders, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the incidence of incisional hernias and alleviate chronic pain for patients recovering from abdominal surgery.
How similar studies have performed: While the approach of core muscle training post-surgery is relatively novel, existing literature suggests that physical activity may positively influence recovery outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. At the University Hospital of Bern, Kantonsspital Solothurn and Olten and BundeswehrZentralkrankenhaus Koblenz: * Informed Consent as documented by signature (Appendix Informed Consent Form) * Age \> 18 years * Capable of judgment * Undergoing elective or emergency abdominal surgery * Laparoscopic or open surgery, midline or transverse incision 2. At the University Hospital of Lausanne: * Informed Consent as documented by signature (Appendix Informed Consent Form) * Age \> 18 years * Capable of judgment * Undergoing elective open abdominal surgery * Midline or transverse incision Exclusion criteria (in all four participating centres): * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders (chronic depression, under antidepressants or neuroleptics), dementia, etc. of the participant * Enrolment of the investigator, his/her family members, employees and other dependent persons * Neuromuscular diseases (such as myasthenia gravis or wheelchair-bound patient) * Preexisting chronic pain disorder, patients under chronic opioid therapy (WHO II and III) or pain modulating drugs (antidepressive medication or antiepileptic medication) * End-stage disease * Patients with preexisting abdominal wall mesh, with the exception of inguinal mesh (after inguinal hernia repair)
Where this trial is running
Koblenz and 4 other locations
- BundeswehrZentralkrankenhaus — Koblenz, Germany (Recruiting)
- Kantonsspital Olten — Olten, Canton of Solothurn, Switzerland (Terminated)
- University Hospital of Bern, Inselspital — Bern, Switzerland (Recruiting)
- CHUV, University Hospital of Lausanne — Lausanne, Switzerland (Recruiting)
- Bürgerspital Solothurn — Solothurn, Switzerland (Withdrawn)
Study contacts
- Study coordinator: Guido Beldi, MD
- Email: guido.beldi@insel.ch
- Phone: 31 632 48 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.