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

NCT ID: NCT03808584

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2026-12-31

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.

Conditions

Hernia Incisional; Exercise

Keywords

Core muscle exercise; rehabilitation; Incisional hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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

Interventions

Physiotherapy

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

Intervention Type: OTHER

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Beldi, MD

Role: STUDY_DIRECTOR

Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland

Locations

BundeswehrZentralkrankenhaus

Koblenz, , Germany

Site Status: RECRUITING

Kantonsspital Olten

Olten, Canton of Solothurn, Switzerland

Site Status: TERMINATED

University Hospital of Bern, Inselspital

Bern, , Switzerland

Site Status: RECRUITING

CHUV, University Hospital of Lausanne

Lausanne, , Switzerland

Site Status: RECRUITING

Bürgerspital Solothurn

Solothurn, , Switzerland

Site Status: WITHDRAWN

Countries

Germany; Switzerland

Central Contacts

Guido Beldi, MD

Role: CONTACT

Phone: 31 632 48 18

Email: guido.beldi@insel.ch

Stéphanie Perrodin, MD

Role: CONTACT

Phone: 31 632 48 18

Email: stephanie.perrodin@insel.ch

Facility Contacts

Arnulf Willms, PD

Role: primary

Guido Beldi, Prof

Role: primary

Stéphanie Perrodin, MD

Role: backup

Martin Hubner, Prof

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 23712287 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26436600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16741597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27718001 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25123379 (View on PubMed)

Other Identifiers

2018-00958

Identifier Type: -

Identifier Source: org_study_id