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

Not Applicable

Recruiting

• Conditions: Hernia Incisional; Exercise
• Interventions: Other: Physiotherapy

• Registration Number: NCT03808584
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Study Start: 2019-05-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 588

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Incidence of incisional hernia 24 months postsurgery	24 months postsurgery	Incidence of incisional hernia diagnosed by ultrasound and clinical examination

Secondary Outcome Measures

Name	Time	Method
Exercise	2 days after surgery, at discharge, 2 months after surgery	Exercise type and number of repetitions
Length of hospital stay	End of hospital stay, expected to be up to 4 weeks	Length of hospital stay
Incidence of Chronic postsurgical pain	2 months, 12 months, 24 months after surgery	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.
Readmission rate	2 months, 12 months, 24 months after surgery	Hospital readmission
Re-operation rate	2 months, 12 months, 24 months after surgery	Re-operation
Incidence of Sarcopenia	2 months and 24 months after surgery	Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons

Trial Locations

Locations (5)

BundeswehrZentralkrankenhaus; 🇩🇪 Koblenz, Germany

Kantonsspital Olten; 🇨🇭 Olten, Solothurn, Switzerland

CHUV, University Hospital of Lausanne; 🇨🇭 Lausanne, Switzerland

Bürgerspital Solothurn; 🇨🇭 Solothurn, Switzerland

University Hospital of Bern, Inselspital; 🇨🇭 Bern, Switzerland