Physiotherapy: 4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Incidence of incisional hernia 24 months postsurgery — 24 months postsurgery Incidence of incisional hernia diagnosed by ultrasound and clinical examination
Trial sites (5)
Facility
City
Region
Status
BundeswehrZentralkrankenhaus
Koblenz
Germany
Recruiting
Kantonsspital Olten
Olten
Canton of Solothurn
Terminated
University Hospital of Bern, Inselspital
Bern
Switzerland
Recruiting
CHUV, University Hospital of Lausanne
Lausanne
Switzerland
Recruiting
Bürgerspital Solothurn
Solothurn
Switzerland
Withdrawn
More Insel Gruppe AG, University Hospital Bern trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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