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

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ClinicalTrials.gov Identifier: NCT03808584
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Hernia Incisional Exercise Other: Physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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
Experimental: 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.
Other: Physiotherapy
4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.




Primary Outcome Measures :
  1. Incidence of incisional hernia 24 months postsurgery [ Time Frame: 24 months postsurgery ]
    Incidence of incisional hernia diagnosed by ultrasound and clinical examination


Secondary Outcome Measures :
  1. Incidence of Chronic postsurgical pain [ Time Frame: 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.

  2. Exercise [ Time Frame: 2 days after surgery, at discharge, 2 months after surgery ]
    Exercise type and number of repetitions

  3. Length of hospital stay [ Time Frame: End of hospital stay, expected to be up to 4 weeks ]
    Length of hospital stay

  4. Readmission rate [ Time Frame: 2 months, 12 months, 24 months after surgery ]
    Hospital readmission

  5. Re-operation rate [ Time Frame: 2 months, 12 months, 24 months after surgery ]
    Re-operation

  6. Incidence of Sarcopenia [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808584


Contacts
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Contact: Guido Beldi, MD 31 632 48 18 ext 0041 guido.beldi@insel.ch
Contact: Stéphanie Perrodin, MD 31 632 48 18 ext 0041 stephanie.perrodin@insel.ch

Locations
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Germany
BundeswehrZentralkrankenhaus Not yet recruiting
Koblenz, Germany, 56070
Contact: Arnulf Willms, PD    26128122801 ext 0049    ArnulfWillms@bundeswehr.org   
Switzerland
Kantonsspital Olten Recruiting
Olten, Solothurn, Switzerland, 4600
Contact: Ulrich Dietz, Prof.    32 627 35 49 ext 0041    ulrich.dietz@spital.so.ch   
University Hospital of Bern, Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Guido Beldi, Prof    +41316324818    guido.beldi@insel.ch   
Contact: Stéphanie Perrodin, MD    +41316324818    stephanie.perrodin@insel.ch   
CHUV, University Hospital of Lausanne Recruiting
Lausanne, Switzerland, 1010
Contact: Martin Hubner, Prof    79 556 88 38 ext 0041    martin.hubner@chuv.ch   
Bürgerspital Solothurn Not yet recruiting
Solothurn, Switzerland, 4500
Contact: Ulrich Dietz, Prof    +41623114343    ulrich.dietz@spital.so.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Director: Guido Beldi, MD Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland
Publications of Results:
Other Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03808584    
Other Study ID Numbers: 2018-00958
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Core muscle exercise
rehabilitation
Incisional hernia
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes