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NCT Number: NCT03808584

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BundeswehrZentralkrankenhaus, Koblenz, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

Physiotherapy

Other

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

Primary outcomes

  1. Incidence of incisional hernia 24 months postsurgery

    Time frame: 24 months postsurgery

    Incidence of incisional hernia diagnosed by ultrasound and clinical examination

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Guido Beldi, MD

CONTACT

[email protected]

31 632 48 18 ext. 0041

Stéphanie Perrodin, MD

CONTACT

[email protected]

31 632 48 18 ext. 0041

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jan 17, 2019
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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