Clinical trial NCT03808584: Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Official title: Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernia Incisional
Exercise
Keywords: Core muscle exercise
rehabilitation
Incisional hernia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility 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)

Primary outcomes:
measure: Incidence of incisional hernia 24 months postsurgery
timeFrame: 24 months postsurgery
Secondary outcomes:
measure: Incidence of Chronic postsurgical pain
timeFrame: 2 months, 12 months, 24 months after surgery
measure: Exercise
timeFrame: 2 days after surgery, at discharge, 2 months after surgery
measure: Length of hospital stay
timeFrame: End of hospital stay, expected to be up to 4 weeks
measure: Readmission rate
timeFrame: 2 months, 12 months, 24 months after surgery
measure: Re-operation rate
timeFrame: 2 months, 12 months, 24 months after surgery
measure: Incidence of Sarcopenia
timeFrame: 2 months and 24 months after surgery
Other outcomes:
Locations:
city: Koblenz
country: Germany
facility: BundeswehrZentralkrankenhaus
city: Olten
country: Switzerland
facility: Kantonsspital Olten
state: Solothurn
city: Bern
country: Switzerland
facility: University Hospital of Bern, Inselspital
city: Lausanne
country: Switzerland
facility: CHUV, University Hospital of Lausanne
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
Study officials:
affiliation: Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland
name: Guido Beldi, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.