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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808584
• Other study ID #: 2018-00958
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Guido Beldi, MD
• Phone: 31 632 48 18
• Email: guido.beldi[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Exercise
• Hernia
• Hernia Incisional
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Germany	BundeswehrZentralkrankenhaus	Koblenz
Switzerland	University Hospital of Bern, Inselspital	Bern
Switzerland	CHUV, University Hospital of Lausanne	Lausanne
Switzerland	Kantonsspital Olten	Olten	Solothurn
Switzerland	Bürgerspital Solothurn	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (5)

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. — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of incisional hernia 24 months postsurgery	Incidence of incisional hernia diagnosed by ultrasound and clinical examination	24 months postsurgery
Secondary	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
Secondary	Exercise	Exercise type and number of repetitions	2 days after surgery, at discharge, 2 months after surgery
Secondary	Length of hospital stay	Length of hospital stay	End of hospital stay, expected to be up to 4 weeks
Secondary	Readmission rate	Hospital readmission	2 months, 12 months, 24 months after surgery
Secondary	Re-operation rate	Re-operation	2 months, 12 months, 24 months after surgery
Secondary	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