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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 January 2024
Main ID:  NCT03808584
Date of registration: 15/01/2019
Prospective Registration: Yes
Primary sponsor: Insel Gruppe AG, University Hospital Bern
Public title: Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Scientific title: Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Date of first enrolment: May 20, 2019
Target sample size: 588
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT03808584
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Germany Switzerland
Contacts
Name:     Guido Beldi, MD
Address: 
Telephone: 31 632 48 18
Email: guido.beldi@insel.ch
Affiliation: 
Name:     Guido Beldi, MD
Address: 
Telephone:
Email:
Affiliation:  Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland
Key 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Exercise
Hernia Incisional
Intervention(s)
Other: Physiotherapy
Primary Outcome(s)
Incidence of incisional hernia 24 months postsurgery [Time Frame: 24 months postsurgery]
Secondary Outcome(s)
Incidence of Chronic postsurgical pain [Time Frame: 2 months, 12 months, 24 months after surgery]
Re-operation rate [Time Frame: 2 months, 12 months, 24 months after surgery]
Exercise [Time Frame: 2 days after surgery, at discharge, 2 months after surgery]
Length of hospital stay [Time Frame: End of hospital stay, expected to be up to 4 weeks]
Incidence of Sarcopenia [Time Frame: 2 months and 24 months after surgery]
Readmission rate [Time Frame: 2 months, 12 months, 24 months after surgery]
Secondary ID(s)
2018-00958
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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