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

NCT03808584 | Recruiting

• 1 other identifier: 2018-00958
• Study Type: interventional
• Target: 588
• Locations: 2 countries
• Sites: 5

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.

Conditions

Hernia Incisional; Exercise

Keywords

Core muscle exercise; rehabilitation; Incisional hernia

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia 24 months postsurgery

  Incidence of incisional hernia diagnosed by ultrasound and clinical examination

  24 months postsurgery

Secondary Outcomes (6)

• Incidence of Chronic postsurgical pain

  2 months, 12 months, 24 months after surgery

• Exercise

  2 days after surgery, at discharge, 2 months after surgery

• Length of hospital stay

  End of hospital stay, expected to be up to 4 weeks

• Readmission rate

  2 months, 12 months, 24 months after surgery

• Re-operation rate

  2 months, 12 months, 24 months after surgery

Study Arms (2)

Control group

NO INTERVENTION

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

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.

Other: Physiotherapy

Interventions

Physiotherapy OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (5)

BundeswehrZentralkrankenhaus

Koblenz, 56070, Germany

RECRUITING

Kantonsspital Olten

Olten, Canton of Solothurn, 4600, Switzerland

TERMINATED

University Hospital of Bern, Inselspital

Bern, 3010, Switzerland

RECRUITING

CHUV, University Hospital of Lausanne

Lausanne, 1010, Switzerland

RECRUITING

Bürgerspital Solothurn

Solothurn, 4500, Switzerland

WITHDRAWN

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Incisional Hernia; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Guido Beldi, MD

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

  STUDY DIRECTOR

Central Study Contacts

Guido Beldi, MD

CONTACT

31 632 48 18; guido.beldi@insel.ch

Stéphanie Perrodin, MD

CONTACT

31 632 48 18; stephanie.perrodin@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: May 20, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4); DE (1)