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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Informed Consent as documented by signature (Appendix Informed Consent Form)

Age > 18 years

Capable of judgment

Undergoing elective or emergency abdominal surgery

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physiotherapy

    Other intervention

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

Treatment groups

588 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of incisional hernia 24 months postsurgery

Incidence of incisional hernia diagnosed by ultrasound and clinical examination

Time frame
24 months postsurgery

Secondary outcomes

1

Incidence of Chronic postsurgical pain

Abdominal pain assessment by Visual Analog Scale (VAS). VAS score ranges from 0 (no pain) to 10 (worst possible pain). The mean VAS in the last 24 hours will be documented.

Time frame
2 months, 12 months, 24 months after surgery
2

Exercise

Exercise type and number of repetitions

Time frame
2 days after surgery, at discharge, 2 months after surgery
3

Length of hospital stay

Length of hospital stay

Time frame
End of hospital stay, expected to be up to 4 weeks
4

Readmission rate

Hospital readmission

Time frame
2 months, 12 months, 24 months after surgery

Other outcomes

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