NCT03808584 Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
| NCT ID | NCT03808584 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Hernia Incisional |
| Study Type | INTERVENTIONAL |
| Enrollment | 588 participants |
| Start Date | 2019-05-20 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 588 participants in total. It began in 2019-05-20 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current practice to avoid incisional hernia, one of the most frequent complications following abdominal surgery, is to minimize core muscle activity in the postoperative phase. However, there is no evidence to support the association of core muscle activity and increased incidence of incisional hernia. On the contrary, it is likely that reduced physical activity could lead to physical deconditioning, chronic postsurgical pain (CPSP), and sarcopenia. The investigators will conduct a prospective multicentric randomized clinical trial to compare standard of care to core muscle exercises targeting the abdominal muscles immediately postsurgery. The principle hypothesis is that neither specific exercises of core muscles before and after surgery nor physical restriction alter the incidence of incisional hernias. Secondly the impact of postoperative rehabilitation on CPSP and sarcopenia will be assessed.
Eligibility 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)
Contact & Investigator
Guido Beldi, MD
STUDY DIRECTOR
Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland
Frequently Asked Questions
Who can join the NCT03808584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hernia Incisional. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03808584 currently recruiting?
Yes, NCT03808584 is actively recruiting participants. Contact the research team at guido.beldi@insel.ch for enrollment information.
Where is the NCT03808584 trial being conducted?
This trial is being conducted at Koblenz, Germany, Olten, Switzerland, Bern, Switzerland, Lausanne, Switzerland and 1 additional location.
Who is sponsoring the NCT03808584 clinical trial?
NCT03808584 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Guido Beldi, MD at Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland. The trial plans to enroll 588 participants.