RecruitingNot ApplicableNCT03808584

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


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

588 participants

Start Date

May 20, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria12

  • 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 Criteria6

  • 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)

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Interventions

OTHERPhysiotherapy

4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.


Locations(5)

BundeswehrZentralkrankenhaus

Koblenz, Germany

Kantonsspital Olten

Olten, Canton of Solothurn, Switzerland

University Hospital of Bern, Inselspital

Bern, Switzerland

CHUV, University Hospital of Lausanne

Lausanne, Switzerland

Bürgerspital Solothurn

Solothurn, Switzerland

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NCT03808584


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