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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Hernia Incisional; Exercise

Treatments: Other: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03808584

2018-00958

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 588 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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588 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Physiotherapy