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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 patients are instructed not to bear or lift weights and to limit physical activities in the first 8-12 weeks after surgery. 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 and deconditioning of the core muscles is associated with muscle catabolism, which may lead to physical deconditioning, chronic postsurgical pain (CPSP), and sarcopenia. CPSP is primarily a major burden in terms of reduced quality of life and resource utilization whereas sarcopenia in addition is increasingly recognized as an important independent risk factor for numerous adverse clinical outcomes and mortality. 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. The patients will be divided into two study arms, one receiving standard of care and the other receiving the intervention. The intervention consists of four specific core muscle exercises to perform daily during the first two months after surgery. Follow-up will be at two, twelve and twenty-four months with clinical examination and ultrasound to detect incisional hernias, assessment chronic postsurgical pain and its treatment and evaluation of muscle mass on CT scans.

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

Conditions
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Hernia Incisional, Exercise

Intervention / Treatment
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* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The patients in the control group will receive standard physiotherapy and will be instructed to limit core muscle activity and weight bearing according to their pain symptomatology. Standard physiotherapy for all hospitalised patients includes early mobilization and exercises to prevent thrombosis and pulmonary complications (atelectasis, pneumonia, diaphragmatic deconditioning), balance training and endurance and exercise training | |
| Experimental: Intervention group<br>The patients in the intervention group will be given exercises to perform postoperatively.They will be instructed by a physiotherapist in how to perform the four specific exercises targeting core muscles. The patient will perform these exercises daily during hospitalization under the supervision of the physiotherapist and then at home for two months after the operation. The intensity of the exercises will be adjusted daily to the physical capabilities of the patient. They will also benefit from standard physiotherapy as described above. | Other: Physiotherapy<br>* 4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of incisional hernia 24 months postsurgery | Incidence of incisional hernia diagnosed by ultrasound and clinical examination | 24 months postsurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months, 12 months, 24 months after surgery | 
| Exercise | Exercise type and number of repetitions | 2 days after surgery, at discharge, 2 months after surgery | 
| Length of hospital stay | Length of hospital stay | End of hospital stay, expected to be up to 4 weeks | 
| Readmission rate | Hospital readmission | 2 months, 12 months, 24 months after surgery | 
| Re-operation rate | Re-operation | 2 months, 12 months, 24 months after surgery | 
| Incidence of Sarcopenia | Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons | 2 months and 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Core muscle exercise, rehabilitation, Incisional hernia