Status:

RECRUITING

Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Conditions:

Hernia Incisional

Exercise

Eligibility:

All Genders

18+ years

Phase:

NA

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 n...

Detailed Description

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. Therefore the patie...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • 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)

Exclusion

    Key Trial Info

    Start Date :

    May 20 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2026

    Estimated Enrollment :

    588 Patients enrolled

    Trial Details

    Trial ID

    NCT03808584

    Start Date

    May 20 2019

    End Date

    December 1 2026

    Last Update

    December 22 2023

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    BundeswehrZentralkrankenhaus

    Koblenz, Germany, 56070

    2

    Kantonsspital Olten

    Olten, Canton of Solothurn, Switzerland, 4600

    3

    University Hospital of Bern, Inselspital

    Bern, Switzerland, 3010

    4

    CHUV, University Hospital of Lausanne

    Lausanne, Switzerland, 1010