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

Overview

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

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.

Interventions

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

Primary outcome measures

• Incidence of incisional hernia 24 months postsurgery [Time frame: 24 months postsurgery]

Secondary outcome measures (6)

• Incidence of Chronic postsurgical pain [Time frame: 2 months, 12 months, 24 months after surgery]
• Exercise [Time frame: 2 days after surgery, at discharge, 2 months after surgery]
• Length of hospital stay [Time frame: End of hospital stay, expected to be up to 4 weeks]
• Readmission rate [Time frame: 2 months, 12 months, 24 months after surgery]
• Re-operation rate [Time frame: 2 months, 12 months, 24 months after surgery]
• Incidence of Sarcopenia [Time frame: 2 months and 24 months after surgery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Switzerland · 4 centers

• Kantonsspital Olten — Olten
• University Hospital of Bern, Inselspital — Bern
• CHUV, University Hospital of Lausanne — Lausanne
• Bürgerspital Solothurn — Solothurn

Germany · 1 center

• BundeswehrZentralkrankenhaus — Koblenz

Publications

• Pommergaard HC, Burcharth J, Danielsen A, Angenete E, Haglind E, Rosenberg J. No consensus on restrictions on physical activity to prevent incisional hernias after surgery. Hernia. 2014 Aug;18(4):495-500. doi: 10.1007/s10029-013-1113-8. Epub 2013 May 28. PMID 23712287
• Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2. PMID 26436600
• Bruce J, Krukowski ZH. Quality of life and chronic pain four years after gastrointestinal surgery. Dis Colon Rectum. 2006 Sep;49(9):1362-70. doi: 10.1007/s10350-006-0575-5. PMID 16741597
• Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Yamaguchi J, Nagino M. Surgery-Related Muscle Loss and Its Association with Postoperative Complications After Major Hepatectomy with Extrahepatic Bile Duct Resection. World J Surg. 2017 Feb;41(2):498-507. doi: 10.1007/s00268-016-3732-6. PMID 27718001
• Itatsu K, Yokoyama Y, Sugawara G, Kubota H, Tojima Y, Kurumiya Y, Kono H, Yamamoto H, Ando M, Nagino M. Incidence of and risk factors for incisional hernia after abdominal surgery. Br J Surg. 2014 Oct;101(11):1439-47. doi: 10.1002/bjs.9600. Epub 2014 Aug 14. PMID 25123379

Identifiers

NCT: NCT03808584 · 2018-00958

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗