<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03808584</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00958</org_study_id>
    <nct_id>NCT03808584</nct_id>
  </id_info>
  <brief_title>Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery</brief_title>
  <official_title>Impact of Core Muscle Training on Incisional Hernia and Pain After Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current practice to avoid incisional hernia, one of the most frequent complications&#xD;
      following abdominal surgery, is to minimize core muscle activity in the postoperative phase.&#xD;
      However, there is no evidence to support the association of core muscle activity and&#xD;
      increased incidence of incisional hernia. On the contrary, it is likely that reduced physical&#xD;
      activity could lead to physical deconditioning, chronic postsurgical pain (CPSP), and&#xD;
      sarcopenia. The investigators will conduct a prospective multicentric randomized clinical&#xD;
      trial to compare standard of care to core muscle exercises targeting the abdominal muscles&#xD;
      immediately postsurgery. The principle hypothesis is that neither specific exercises of core&#xD;
      muscles before and after surgery nor physical restriction alter the incidence of incisional&#xD;
      hernias. Secondly the impact of postoperative rehabilitation on CPSP and sarcopenia will be&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current practice to avoid incisional hernia, one of the most frequent complications&#xD;
      following abdominal surgery, is to minimize core muscle activity in the postoperative phase.&#xD;
      Therefore the patients are instructed not to bear or lift weights and to limit physical&#xD;
      activities in the first 8-12 weeks after surgery. However, there is no evidence to support&#xD;
      the association of core muscle activity and increased incidence of incisional hernia. On the&#xD;
      contrary, it is likely that reduced physical activity and deconditioning of the core muscles&#xD;
      is associated with muscle catabolism, which may lead to physical deconditioning, chronic&#xD;
      postsurgical pain (CPSP), and sarcopenia. CPSP is primarily a major burden in terms of&#xD;
      reduced quality of life and resource utilization whereas sarcopenia in addition is&#xD;
      increasingly recognized as an important independent risk factor for numerous adverse clinical&#xD;
      outcomes and mortality.&#xD;
&#xD;
      The investigators will conduct a prospective multicentric randomized clinical trial to&#xD;
      compare standard of care to core muscle exercises targeting the abdominal muscles immediately&#xD;
      postsurgery. The principle hypothesis is that neither specific exercises of core muscles&#xD;
      before and after surgery nor physical restriction alter the incidence of incisional hernias.&#xD;
      Secondly the impact of postoperative rehabilitation on CPSP and sarcopenia will be assessed.&#xD;
      The patients will be divided into two study arms, one receiving standard of care and the&#xD;
      other receiving the intervention. The intervention consists of four specific core muscle&#xD;
      exercises to perform daily during the first two months after surgery. Follow-up will be at&#xD;
      two, twelve and twenty-four months with clinical examination and ultrasound to detect&#xD;
      incisional hernias, assessment chronic postsurgical pain and its treatment and evaluation of&#xD;
      muscle mass on CT scans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of incisional hernia 24 months postsurgery</measure>
    <time_frame>24 months postsurgery</time_frame>
    <description>Incidence of incisional hernia diagnosed by ultrasound and clinical examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Chronic postsurgical pain</measure>
    <time_frame>2 months, 12 months, 24 months after surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise</measure>
    <time_frame>2 days after surgery, at discharge, 2 months after surgery</time_frame>
    <description>Exercise type and number of repetitions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>End of hospital stay, expected to be up to 4 weeks</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>2 months, 12 months, 24 months after surgery</time_frame>
    <description>Hospital readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operation rate</measure>
    <time_frame>2 months, 12 months, 24 months after surgery</time_frame>
    <description>Re-operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Sarcopenia</measure>
    <time_frame>2 months and 24 months after surgery</time_frame>
    <description>Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">588</enrollment>
  <condition>Hernia Incisional</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At the University Hospital of Bern, Kantonsspital Solothurn and Olten and&#xD;
             BundeswehrZentralkrankenhaus Koblenz:&#xD;
&#xD;
               -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
               -  Age &gt; 18 years&#xD;
&#xD;
               -  Capable of judgment&#xD;
&#xD;
               -  Undergoing elective or emergency abdominal surgery&#xD;
&#xD;
               -  Laparoscopic or open surgery, midline or transverse incision&#xD;
&#xD;
          2. At the University Hospital of Lausanne:&#xD;
&#xD;
               -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
               -  Age &gt; 18 years&#xD;
&#xD;
               -  Capable of judgment&#xD;
&#xD;
               -  Undergoing elective open abdominal surgery&#xD;
&#xD;
               -  Midline or transverse incision&#xD;
&#xD;
        Exclusion criteria (in all four participating centres):&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders (chronic depression, under antidepressants or neuroleptics),&#xD;
             dementia, etc. of the participant&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
&#xD;
          -  Neuromuscular diseases (such as myasthenia gravis or wheelchair-bound patient)&#xD;
&#xD;
          -  Preexisting chronic pain disorder, patients under chronic opioid therapy (WHO II and&#xD;
             III) or pain modulating drugs (antidepressive medication or antiepileptic medication)&#xD;
&#xD;
          -  End-stage disease&#xD;
&#xD;
          -  Patients with preexisting abdominal wall mesh, with the exception of inguinal mesh&#xD;
             (after inguinal hernia repair)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guido Beldi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guido Beldi, MD</last_name>
    <phone>31 632 48 18</phone>
    <phone_ext>0041</phone_ext>
    <email>guido.beldi@insel.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stéphanie Perrodin, MD</last_name>
    <phone>31 632 48 18</phone>
    <phone_ext>0041</phone_ext>
    <email>stephanie.perrodin@insel.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BundeswehrZentralkrankenhaus</name>
      <address>
        <city>Koblenz</city>
        <zip>56070</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Arnulf Willms, PD</last_name>
      <phone>26128122801</phone>
      <phone_ext>0049</phone_ext>
      <email>ArnulfWillms@bundeswehr.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Olten</name>
      <address>
        <city>Olten</city>
        <state>Solothurn</state>
        <zip>4600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulrich Dietz, Prof.</last_name>
      <phone>32 627 35 49</phone>
      <phone_ext>0041</phone_ext>
      <email>ulrich.dietz@spital.so.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of Bern, Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guido Beldi, Prof</last_name>
      <phone>+41316324818</phone>
      <email>guido.beldi@insel.ch</email>
    </contact>
    <contact_backup>
      <last_name>Stéphanie Perrodin, MD</last_name>
      <phone>+41316324818</phone>
      <email>stephanie.perrodin@insel.ch</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CHUV, University Hospital of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>1010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Hubner, Prof</last_name>
      <phone>79 556 88 38</phone>
      <phone_ext>0041</phone_ext>
      <email>martin.hubner@chuv.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bürgerspital Solothurn</name>
      <address>
        <city>Solothurn</city>
        <zip>4500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ulrich Dietz, Prof</last_name>
      <phone>+41623114343</phone>
      <email>ulrich.dietz@spital.so.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23712287</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26436600</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16741597</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27718001</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25123379</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Core muscle exercise</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>Incisional hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808584
org study id: 2018-00958
nct id: NCT03808584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Incidence of incisional hernia 24 months postsurgery
time frame: 24 months postsurgery
description: Incidence of incisional hernia diagnosed by ultrasound and clinical examination
measure: Incidence of Chronic postsurgical pain
time frame: 2 months, 12 months, 24 months after surgery
description: 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.
measure: Exercise
time frame: 2 days after surgery, at discharge, 2 months after surgery
description: Exercise type and number of repetitions
measure: Length of hospital stay
time frame: End of hospital stay, expected to be up to 4 weeks
description: Length of hospital stay
measure: Readmission rate
time frame: 2 months, 12 months, 24 months after surgery
description: Hospital readmission
measure: Re-operation rate
time frame: 2 months, 12 months, 24 months after surgery
description: Re-operation
measure: Incidence of Sarcopenia
time frame: 2 months and 24 months after surgery
description: Muscle mass as assessed by comparing preoperative and postoperative CT scans in subgroup of patients who underwent these examinations for other medical reasons
arm group label: Control group
arm group type: No Intervention
description: 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
arm group label: Intervention group
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Physiotherapy
description: 4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guido Beldi, MD
role: Study Director
affiliation: Department for visceral surgery, University Hospital Bern, Inselspital, Switzerland
last name: Guido Beldi, MD
phone: 31 632 48 18
phone ext: 0041
email: guido.beldi@insel.ch
last name: Stéphanie Perrodin, MD
phone: 31 632 48 18
phone ext: 0041
email: stephanie.perrodin@insel.ch
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Germany
country: Switzerland
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: No