<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/NCT03758209</url>
  </required_header>
  <id_info>
    <org_study_id>48931-2/2018/EKU ETT-TUKEB</org_study_id>
    <nct_id>NCT03758209</nct_id>
  </id_info>
  <brief_title>Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.</brief_title>
  <acronym>PrehabVsERAS</acronym>
  <official_title>Comparison of Preoperative Multimodal Preparation Program (Prehabilitation) With Enhanced Recovery Program for Elective Colorectal Cancer Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Borbala Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Borbala Hospital, Department of Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Semmelweis University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Borbala Hospital</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>
      Elective surgery is the most effective treatment option for colorectal cancer, however it has&#xD;
      been recognized to be associated with high morbidity and mortality risks.&#xD;
&#xD;
      ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package,&#xD;
      which has been well investigated and proved to be effective in reducing early postoperative&#xD;
      morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good&#xD;
      proportion of patients are not suitable for ERAS program, mainly based on lack of compliance&#xD;
      and the impaired physical function before surgery.&#xD;
&#xD;
      Prehabilitation Program is a recently introduced trimodal preoperative preparation (training)&#xD;
      program, which addresses improvement of physical, mental and nutritional status of the high&#xD;
      risk elective surgery patients.&#xD;
&#xD;
      This study aims to investigate the benefit of all efforts of a 4-6-week preoperative&#xD;
      preparation program (Prehabilitation) being added to an established ERAS protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim:&#xD;
&#xD;
      Colorectal cancer patients with a planned resection are tested if a complex, trimodal&#xD;
      rehabilitation program can hold functional and morbidity benefit for them.&#xD;
&#xD;
      In the prospective, randomized (1:1) study control patient group will be the well established&#xD;
      and tested ERAS (enhanced recovery after surgery) Program.&#xD;
&#xD;
      Study protocol in details:&#xD;
&#xD;
        1. First visit: Outpatient Department of Surgery&#xD;
&#xD;
           On both arms:&#xD;
&#xD;
           • History taking (including family history and oncologic history);&#xD;
&#xD;
           • Physical examination&#xD;
&#xD;
             -  Operation indication, type of procedure and date of procedure agreed;&#xD;
&#xD;
             -  Organizing further investigations, anesthesia;&#xD;
&#xD;
             -  Operative risk assessment (&quot;ACS - surgical risk calculator&quot;);&#xD;
&#xD;
             -  Study patient identifier Nr generated;&#xD;
&#xD;
        2. Nurse-led ERAS/Prehab clinic: randomization&#xD;
&#xD;
           On both arms:&#xD;
&#xD;
           • Randomization (Prehabilitation Program / ERAS Program).&#xD;
&#xD;
           • Nurse led clinic assessment (&quot;study nurse&quot;): .i. CaseReportForm (CRF) filled in.&#xD;
&#xD;
           .ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI,&#xD;
           MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol&#xD;
           consumption, anxiety, depression, sleeping disorders).&#xD;
&#xD;
           .v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum&#xD;
           score). .vii. Preoperative counseling (operation type, preparation, pain management,&#xD;
           discharge plan).&#xD;
&#xD;
           .viii. Preoperative nutritional planning (education, nutrient prescription). .ix.&#xD;
           Alcohol intake and smoking cessation - information given. .x. Stoma education started.&#xD;
           .xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral.&#xD;
&#xD;
        3. Physiotherapy, first visit&#xD;
&#xD;
           Both on control and interventional arms:&#xD;
&#xD;
             -  Respiratory function test recorded.&#xD;
&#xD;
             -  Physical status tested (6MWD) on a treadmill.&#xD;
&#xD;
           Just on Prehabilitation arm:&#xD;
&#xD;
           • Respiratory training education.&#xD;
&#xD;
           • Respiratory trainer device usage educated.&#xD;
&#xD;
           • Daily activity (walking) planned.&#xD;
&#xD;
        4. Physiotherapy - second/third/fourth visit (weekly)&#xD;
&#xD;
           Just on Prehabilitation arm:&#xD;
&#xD;
             -  Previous week activity reviewed as to workbook.&#xD;
&#xD;
             -  Physical assessment: 6MWD, FVC.&#xD;
&#xD;
             -  Next week activity planned.&#xD;
&#xD;
        5. Psychic preparation&#xD;
&#xD;
           Just on Prehabilitation arm:&#xD;
&#xD;
           • Once a week half an hour group relaxation training - regardless of the stage of&#xD;
           prehabilitation program.&#xD;
&#xD;
        6. Admission to the Surgical Ward a day before surgery&#xD;
&#xD;
           Both on control and interventional arm:&#xD;
&#xD;
           • Preoperative assessment: .i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular&#xD;
           stage (resting HR and RR), ECG. .iii. Respiratory function tests.&#xD;
&#xD;
           .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale&#xD;
           (HADS)) assessment.&#xD;
&#xD;
           • Preoperative preparation (as to ERAS protocol).&#xD;
&#xD;
           • Postoperative care (ITU, pain management, mobilization, oral nutrition built up,&#xD;
           drains early removal, complications recorded (Clavien-Dindo-classification)).&#xD;
&#xD;
           • Stoma education.&#xD;
&#xD;
             -  Dietary education.&#xD;
&#xD;
             -  On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND&#xD;
                Medical Outcomes Study).&#xD;
&#xD;
        7. Postoperative follow up:&#xD;
&#xD;
      Both on control and interventional arms:&#xD;
&#xD;
      • Assessment (4th and 8th week post op.):&#xD;
&#xD;
      .i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii.&#xD;
      Respiratory function tests. .iv. Physical status (6MWD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>
    <intervention_model_description>Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation.&#xD;
1:1 randomization will be performed.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigators and assessors will be blinded regarding preoperative preparation. Both randomization process and rehabilitation process will be carried out by a trained nurse, physiotherapist and psychotherapist, neither of them will be involved in outcome assessment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>within 45 days</time_frame>
    <description>Postoperative length of hospital stay in days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of days spent on ICU (Intensive care unit).</measure>
    <time_frame>within 45 days postoperative</time_frame>
    <description>Number of days observed on ICU right after operation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity (early) classified after Clavien-Dindo.</measure>
    <time_frame>7 days (until 8th postoperative day) postoperative</time_frame>
    <description>7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity (long term) classified after Clavien-Dindo.</measure>
    <time_frame>30 days (until 31st postoperative day)</time_frame>
    <description>30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days postoperative</time_frame>
    <description>30-day mortality of each patient will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>90-day mortality of each patient will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in preoperative functional status - 6MWD by operation</measure>
    <time_frame>Measured points: 4 weeks before surgery, on day of hospital admission</time_frame>
    <description>6MWD (6-minute walking distance test)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in postoperative functional status - 6MWD by the end of rehabilitation</measure>
    <time_frame>Measured points: 4 weeks before surgery, 8 weeks after operation</time_frame>
    <description>6MWD (6-minute walking distance test)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in preoperative functional status - FVC by operation</measure>
    <time_frame>Measured points: 4 weeks before surgery, on day of hospital admission</time_frame>
    <description>FVC (forced vital capacity) will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in preoperative functional status - FVC by the end of rehabilitation</measure>
    <time_frame>Measured points: 4 weeks before surgery, 8 weeks after operation</time_frame>
    <description>FVC (forced vital capacity) will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).</measure>
    <time_frame>within 8 weeks, if adjuvant oncotherapy is needed</time_frame>
    <description>Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Prehabilitation + ERAS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving a formal preoperative preparation on:&#xD;
Physical status (walking, respiratory training)&#xD;
Nutrition (nutritional supplements)&#xD;
Mental status (weekly groups led by clinical psychologist on anxiety and depression management).&#xD;
Each patient will be treated in an ERAS program preoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prehabilitation + ERAS</intervention_name>
    <description>Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.</description>
    <arm_group_label>Prehabilitation + ERAS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERAS</intervention_name>
    <description>Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.</description>
    <arm_group_label>ERAS</arm_group_label>
    <arm_group_label>Prehabilitation + ERAS</arm_group_label>
    <other_name>Enhanced Recovery After Surgery Program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with histologically proven primary colorectal adenocarcinoma&#xD;
&#xD;
          -  any stage of colorectal cancer&#xD;
&#xD;
          -  elective operation&#xD;
&#xD;
          -  curative intention&#xD;
&#xD;
          -  informed consent signed by patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency operation&#xD;
&#xD;
          -  palliative operation&#xD;
&#xD;
          -  non-colorectal, second malignancy&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patient not giving consent&#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>Balázs Bánky, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Surgery, St. Borbala Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, St. Borbala Hospital</name>
      <address>
        <city>Tatabánya</city>
        <zip>2800</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <reference>
    <citation>Souwer ETD, Bastiaannet E, de Bruijn S, Breugom AJ, van den Bos F, Portielje JEA, Dekker JWT. Comprehensive multidisciplinary care program for elderly colorectal cancer patients: &quot;From prehabilitation to independence&quot;. Eur J Surg Oncol. 2018 Dec;44(12):1894-1900. doi: 10.1016/j.ejso.2018.08.028. Epub 2018 Sep 8.</citation>
    <PMID>30266205</PMID>
  </reference>
  <reference>
    <citation>Bousquet-Dion G, Awasthi R, Loiselle SE, Minnella EM, Agnihotram RV, Bergdahl A, Carli F, Scheede-Bergdahl C. Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Acta Oncol. 2018 Jun;57(6):849-859. doi: 10.1080/0284186X.2017.1423180. Epub 2018 Jan 12.</citation>
    <PMID>29327644</PMID>
  </reference>
  <reference>
    <citation>Chen BP, Awasthi R, Sweet SN, Minnella EM, Bergdahl A, Santa Mina D, Carli F, Scheede-Bergdahl C. Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer. Support Care Cancer. 2017 Jan;25(1):33-40. doi: 10.1007/s00520-016-3379-8. Epub 2016 Aug 18.</citation>
    <PMID>27539131</PMID>
  </reference>
  <reference>
    <citation>Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002.</citation>
    <PMID>27913000</PMID>
  </reference>
  <reference>
    <citation>Banky B, Lakatos M, Varga K, Hansagi E, Horvath E, Jaray G. [Enhanced Recovery Program in colorectal surgery]. Magy Seb. 2018 Mar;71(1):3-11. doi: 10.1556/1046.71.2018.1.1. Hungarian.</citation>
    <PMID>29536753</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Borbala Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Balázs Bánky PhD</investigator_full_name>
    <investigator_title>Head of the Department of Surgery, St. Borbala Hospital</investigator_title>
  </responsible_party>
  <keyword>Morbidity, Mortality, Complication, Prehabilitation, ERAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <!-- 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/NCT03758209
org study id: 48931-2/2018/EKU ETT-TUKEB
nct id: NCT03758209
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Elective surgery is the most effective treatment option for colorectal cancer, however it has
      been recognized to be associated with high morbidity and mortality risks.

      ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package,
      which has been well investigated and proved to be effective in reducing early postoperative
      morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good
      proportion of patients are not suitable for ERAS program, mainly based on lack of compliance
      and the impaired physical function before surgery.

      Prehabilitation Program is a recently introduced trimodal preoperative preparation (training)
      program, which addresses improvement of physical, mental and nutritional status of the high
      risk elective surgery patients.

      This study aims to investigate the benefit of all efforts of a 4-6-week preoperative
      preparation program (Prehabilitation) being added to an established ERAS protocol.
Aim:

      Colorectal cancer patients with a planned resection are tested if a complex, trimodal
      rehabilitation program can hold functional and morbidity benefit for them.

      In the prospective, randomized (1:1) study control patient group will be the well established
      and tested ERAS (enhanced recovery after surgery) Program.

      Study protocol in details:

        1. First visit: Outpatient Department of Surgery

           On both arms:

           • History taking (including family history and oncologic history);

           • Physical examination

             -  Operation indication, type of procedure and date of procedure agreed;

             -  Organizing further investigations, anesthesia;

             -  Operative risk assessment ("ACS - surgical risk calculator");

             -  Study patient identifier Nr generated;

        2. Nurse-led ERAS/Prehab clinic: randomization

           On both arms:

           • Randomization (Prehabilitation Program / ERAS Program).

           • Nurse led clinic assessment ("study nurse"): .i. CaseReportForm (CRF) filled in.

           .ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI,
           MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol
           consumption, anxiety, depression, sleeping disorders).

           .v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum
           score). .vii. Preoperative counseling (operation type, preparation, pain management,
           discharge plan).

           .viii. Preoperative nutritional planning (education, nutrient prescription). .ix.
           Alcohol intake and smoking cessation - information given. .x. Stoma education started.
           .xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral.

        3. Physiotherapy, first visit

           Both on control and interventional arms:

             -  Respiratory function test recorded.

             -  Physical status tested (6MWD) on a treadmill.

           Just on Prehabilitation arm:

           • Respiratory training education.

           • Respiratory trainer device usage educated.

           • Daily activity (walking) planned.

        4. Physiotherapy - second/third/fourth visit (weekly)

           Just on Prehabilitation arm:

             -  Previous week activity reviewed as to workbook.

             -  Physical assessment: 6MWD, FVC.

             -  Next week activity planned.

        5. Psychic preparation

           Just on Prehabilitation arm:

           • Once a week half an hour group relaxation training - regardless of the stage of
           prehabilitation program.

        6. Admission to the Surgical Ward a day before surgery

           Both on control and interventional arm:

           • Preoperative assessment: .i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular
           stage (resting HR and RR), ECG. .iii. Respiratory function tests.

           .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale
           (HADS)) assessment.

           • Preoperative preparation (as to ERAS protocol).

           • Postoperative care (ITU, pain management, mobilization, oral nutrition built up,
           drains early removal, complications recorded (Clavien-Dindo-classification)).

           • Stoma education.

             -  Dietary education.

             -  On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND
                Medical Outcomes Study).

        7. Postoperative follow up:

      Both on control and interventional arms:

      • Assessment (4th and 8th week post op.):

      .i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii.
      Respiratory function tests. .iv. Physical status (6MWD).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation.
1:1 randomization will be performed.
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: Investigators and assessors will be blinded regarding preoperative preparation. Both randomization process and rehabilitation process will be carried out by a trained nurse, physiotherapist and psychotherapist, neither of them will be involved in outcome assessment.
measure: Length of hospital stay
time frame: within 45 days
description: Postoperative length of hospital stay in days.
measure: Number of days spent on ICU (Intensive care unit).
time frame: within 45 days postoperative
description: Number of days observed on ICU right after operation.
measure: Morbidity (early) classified after Clavien-Dindo.
time frame: 7 days (until 8th postoperative day) postoperative
description: 7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
measure: Morbidity (long term) classified after Clavien-Dindo.
time frame: 30 days (until 31st postoperative day)
description: 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
measure: 30-day mortality
time frame: 30 days postoperative
description: 30-day mortality of each patient will be recorded.
measure: 90-day mortality
time frame: 90 days postoperative
description: 90-day mortality of each patient will be recorded.
measure: Change in preoperative functional status - 6MWD by operation
time frame: Measured points: 4 weeks before surgery, on day of hospital admission
description: 6MWD (6-minute walking distance test)
measure: Change in postoperative functional status - 6MWD by the end of rehabilitation
time frame: Measured points: 4 weeks before surgery, 8 weeks after operation
description: 6MWD (6-minute walking distance test)
measure: Change in preoperative functional status - FVC by operation
time frame: Measured points: 4 weeks before surgery, on day of hospital admission
description: FVC (forced vital capacity) will be measured.
measure: Change in preoperative functional status - FVC by the end of rehabilitation
time frame: Measured points: 4 weeks before surgery, 8 weeks after operation
description: FVC (forced vital capacity) will be measured.
measure: Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).
time frame: within 8 weeks, if adjuvant oncotherapy is needed
description: Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded.
arm group label: Prehabilitation + ERAS
arm group type: Experimental
description: Patients receiving a formal preoperative preparation on:
Physical status (walking, respiratory training)
Nutrition (nutritional supplements)
Mental status (weekly groups led by clinical psychologist on anxiety and depression management).
Each patient will be treated in an ERAS program preoperatively.
arm group label: ERAS
arm group type: Active Comparator
description: Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements.
intervention type: Procedure
intervention name: Prehabilitation + ERAS
description: Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.
arm group label: Prehabilitation + ERAS
intervention type: Procedure
intervention name: ERAS
description: Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.
arm group label: ERAS
arm group label: Prehabilitation + ERAS
other name: Enhanced Recovery After Surgery Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Balázs Bánky, PhD
role: Study Director
affiliation: Department of Surgery, St. Borbala Hospital
facility: 
country: Hungary
citation: Souwer ETD, Bastiaannet E, de Bruijn S, Breugom AJ, van den Bos F, Portielje JEA, Dekker JWT. Comprehensive multidisciplinary care program for elderly colorectal cancer patients: "From prehabilitation to independence". Eur J Surg Oncol. 2018 Dec;44(12):1894-1900. doi: 10.1016/j.ejso.2018.08.028. Epub 2018 Sep 8.
PMID: 30266205
citation: Bousquet-Dion G, Awasthi R, Loiselle SE, Minnella EM, Agnihotram RV, Bergdahl A, Carli F, Scheede-Bergdahl C. Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Acta Oncol. 2018 Jun;57(6):849-859. doi: 10.1080/0284186X.2017.1423180. Epub 2018 Jan 12.
PMID: 29327644
citation: Chen BP, Awasthi R, Sweet SN, Minnella EM, Bergdahl A, Santa Mina D, Carli F, Scheede-Bergdahl C. Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer. Support Care Cancer. 2017 Jan;25(1):33-40. doi: 10.1007/s00520-016-3379-8. Epub 2016 Aug 18.
PMID: 27539131
citation: Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002.
PMID: 27913000
citation: Banky B, Lakatos M, Varga K, Hansagi E, Horvath E, Jaray G. [Enhanced Recovery Program in colorectal surgery]. Magy Seb. 2018 Mar;71(1):3-11. doi: 10.1556/1046.71.2018.1.1. Hungarian.
PMID: 29536753
responsible party type: Principal Investigator
investigator affiliation: St. Borbala Hospital
investigator full name: Dr. Balázs Bánky PhD
investigator title: Head of the Department of Surgery, St. Borbala Hospital
mesh term: Colorectal Neoplasms
mesh term: Insulin Resistance