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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03808584
Enrollment
588
Registered
2019-01-17
Start date
2019-05-20
Completion date
2030-12-31
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Hernia Incisional

Keywords

Core muscle exercise, rehabilitation, Incisional hernia

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.

Interventions

OTHERPhysiotherapy

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

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of incisional hernia 24 months postsurgery24 months postsurgeryIncidence of incisional hernia diagnosed by ultrasound and clinical examination

Secondary

MeasureTime frameDescription
Incidence of Chronic postsurgical pain2 months, 12 months, 24 months after surgeryAbdominal 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.
Exercise2 days after surgery, at discharge, 2 months after surgeryExercise type and number of repetitions
Length of hospital stayEnd of hospital stay, expected to be up to 4 weeksLength of hospital stay
Readmission rate2 months, 12 months, 24 months after surgeryHospital readmission
Re-operation rate2 months, 12 months, 24 months after surgeryRe-operation
Incidence of Sarcopenia2 months and 24 months after surgeryMuscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons

Countries

Germany, Switzerland

Contacts

CONTACTGuido Beldi, MD
guido.beldi@insel.ch31 632 48 18
CONTACTStéphanie Perrodin, MD
stephanie.perrodin@insel.ch31 632 48 18
STUDY_DIRECTORGuido Beldi, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026