xml: <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/NCT05993923</url>
    </required_header>
    <id_info>
      <org_study_id>NIMAO/2022-2/CL-01</org_study_id>
      <nct_id>NCT05993923</nct_id>
    </id_info>
    <brief_title>Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer</brief_title>
    <acronym>DIGER</acronym>
    <official_title>Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer. Randomized Open-label Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Nīmes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Nīmes</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Health establishments encourage the development of specific care pathways for the elderly by&#xD;
        supporting Geriatric Peri-Operative Units (GPOU). Indeed, this shared care model has shown a&#xD;
        clear reduction in mortality and the number of re-hospitalizations in patients 6 months after&#xD;
        their care. The multidisciplinary approach of global management of the patient in the&#xD;
        perioperative period aims to reduce surgical stress as well as the rapid restoration of&#xD;
        previous physical and psychic abilities. Colorectal surgery, the main treatment for stage I&#xD;
        to III colon cancer, is a morbid surgery. Despite numerous efficacy data on improved&#xD;
        rehabilitation after colorectal surgery, care programs are not specific to the geriatric&#xD;
        population and geriatric assessment criteria to describe the functional status of patients&#xD;
        are not commonly used. The study investigators wish to evaluate the impact of GPOU treatment&#xD;
        following colorectal surgery, on the evolution of several clinical parameters such as:&#xD;
        functional status, morbidity mortality, quality of life, and lifestyle. The study&#xD;
        investigators hypothesize that management in the GPOU for colorectal cancer surgery in&#xD;
        patients aged 70 and over will improve functional status at 3 months, in comparison with&#xD;
        traditional management. The proposed intervention should also lead to an improvement in&#xD;
        patient satisfaction with care, complications and re-hospitalizations, nutritional status,&#xD;
        lifestyle and patient survival.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in functional status after colorectal cancer surgery between groups</measure>
      <time_frame>Baseline and Month 3</time_frame>
      <description>Instrumental Activities of Daily Living (IADL) score (score 0-8)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in functional status between groups</measure>
      <time_frame>Baseline and Month 6</time_frame>
      <description>Instrumental Activities of Daily Living (IADL) score (score 0-8)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in basic functional status between groups</measure>
      <time_frame>Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6</time_frame>
      <description>Katz index of independence in Activities of Daily Living scale (ADL) (score 0-6)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in patient motor ability between groups</measure>
      <time_frame>Baseline, Month 3</time_frame>
      <description>Time Up and Go test (Score 0-3 for each item, time in seconds)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction with care between groups</measure>
      <time_frame>Hospital discharge (an average of 10 days)</time_frame>
      <description>EORTC SATisfaction with IN-PATient cancer care (IN-PATSAT) 32 questionnaire (Score 32-160)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay between groups</measure>
      <time_frame>Hospital discharge (an average of 10 days)</time_frame>
      <description>Days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of medical complications during hospitalization between groups</measure>
      <time_frame>Hospital discharge (an average of 10 days)</time_frame>
      <description>Number of following events: diabetes decompensation, cardiorespiratory decompensation, pulmonary and urinary infections, acute renal failure, anemia. Aggravation of: confusion, pelvic exoneration disorders, fall, bedsores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The distribution of surgical complications between groups</measure>
      <time_frame>Hospital discharge (an average of 10 days)</time_frame>
      <description>Gravity of surgical complications according to the Clavien Dindo classification</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The distribution of surgical complications between groups</measure>
      <time_frame>Month 1</time_frame>
      <description>Gravity of surgical complications according to the Clavien Dindo classification</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Destination of patients on discharge from hospital between groups</measure>
      <time_frame>Hospital discharge (an average of 10 days)</time_frame>
      <description>Classified as: home / nursing home or institutionalization / transfer to Aftercare and Rehabilitation / transfer to another service / none (death during hospitalization).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the patient's weight between groups</measure>
      <time_frame>Baseline and Month 3</time_frame>
      <description>Percent change in Kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life between groups</measure>
      <time_frame>Month 3</time_frame>
      <description>EORTC-QLQ-C30 questionnaire score (Score 0-100)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life between groups</measure>
      <time_frame>Month 6</time_frame>
      <description>EORTC-QLQ-C30 questionnaire score (Score 0-100)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the patient's place of abode between groups</measure>
      <time_frame>Month 1, Month 3 and Month 6</time_frame>
      <description>Rate (%) of patients living at home/in nursing home/residential home</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival between groups.</measure>
      <time_frame>Month 1</time_frame>
      <description>Percentage of immediate mortality (during the hospital stay)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival between groups.</measure>
      <time_frame>Month 3</time_frame>
      <description>Percentage of immediate mortality (during the hospital stay)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival between groups.</measure>
      <time_frame>Month 6</time_frame>
      <description>Percentage of immediate mortality (during the hospital stay)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of early unscheduled re-hospitalizations or admissions to the emergency department between groups</measure>
      <time_frame>Month 1</time_frame>
      <description>Re-hospitalization in the month following discharge from hospital: yes/no.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Classical management in the digestive surgery department</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GPOU group</arm_group_label>
      <description>Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>GPOU</intervention_name>
      <description>Intervention upstream of the perioperative management according to the nutritional grade. Grade 4 Nutrition patients will be hospitalized earlier, i.e. 10 to 15 days before surgery for the start of artificial nutrition. A temporary return home can be organized with the supervision of a service provider until a second admission for surgical management. Grade 2 Nutrition patients will be called 24 to 48 hours before the surgical procedure.&#xD;
  Anticipation of discharge at admittance Early mobilization Comorbidity management Prevention of iatrogenia Management of geriatric frailties Daily medical and paramedical assessment Detailed discharge report</description>
      <arm_group_label>GPOU group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 70 and over scheduled to undergo colorectal surgery at the Nîmes University&#xD;
          Hospital validated by digestive surgery Multidisciplinary Consultation Meeting and after&#xD;
          onco-geriatric evaluation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient or their representative must have given their free and informed consent&#xD;
               and signed the consent form&#xD;
  &#xD;
            -  The patient must be a member or beneficiary of a health insurance plan&#xD;
  &#xD;
            -  Diagnosis of proven colorectal cancer.&#xD;
  &#xD;
            -  Patient to benefit from scheduled colorectal surgery at the University Hospital of&#xD;
               Nîmes validated in digestive surgery SPC after oncogeriatric evaluation.&#xD;
  &#xD;
            -  Surgical act: resection with anastomosis in one step.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The subject is participating in a category 1 interventional study, or is in a period&#xD;
               of exclusion determined by a previous study&#xD;
  &#xD;
            -  It is impossible to give the subject informed information&#xD;
  &#xD;
            -  The patient is under safeguard of justice or state guardianship&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>70 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Coralie Labarias</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU de Nimes</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Coralie Labarias</last_name>
      <phone>04.66.68.79.46</phone>
      <email>coralie.labarias@chu-nimes.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU de Nîmes</name>
        <address>
          <city>Nimes</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Anissa Megzari</last_name>
        <phone>04.66.68.42.36</phone>
        <email>drc@chu-nimes.fr</email>
      </contact>
      <investigator>
        <last_name>Coralie Labarias</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Martin Bertrand</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Luca Theuil</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laetitia GERONIMI ROBELIN</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Elderly</keyword>
    <keyword>Geriatric Unit</keyword>
    <keyword>Postoperative</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993923
  org study id: NIMAO/2022-2/CL-01
  nct id: NCT05993923
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Health establishments encourage the development of specific care pathways for the elderly by
        supporting Geriatric Peri-Operative Units (GPOU). Indeed, this shared care model has shown a
        clear reduction in mortality and the number of re-hospitalizations in patients 6 months after
        their care. The multidisciplinary approach of global management of the patient in the
        perioperative period aims to reduce surgical stress as well as the rapid restoration of
        previous physical and psychic abilities. Colorectal surgery, the main treatment for stage I
        to III colon cancer, is a morbid surgery. Despite numerous efficacy data on improved
        rehabilitation after colorectal surgery, care programs are not specific to the geriatric
        population and geriatric assessment criteria to describe the functional status of patients
        are not commonly used. The study investigators wish to evaluate the impact of GPOU treatment
        following colorectal surgery, on the evolution of several clinical parameters such as:
        functional status, morbidity mortality, quality of life, and lifestyle. The study
        investigators hypothesize that management in the GPOU for colorectal cancer surgery in
        patients aged 70 and over will improve functional status at 3 months, in comparison with
        traditional management. The proposed intervention should also lead to an improvement in
        patient satisfaction with care, complications and re-hospitalizations, nutritional status,
        lifestyle and patient survival.
  observational model: Case-Only
  time perspective: Prospective
  measure: Change in functional status after colorectal cancer surgery between groups
  time frame: Baseline and Month 3
  description: Instrumental Activities of Daily Living (IADL) score (score 0-8)
  measure: Change in functional status between groups
  time frame: Baseline and Month 6
  description: Instrumental Activities of Daily Living (IADL) score (score 0-8)
  measure: Change in basic functional status between groups
  time frame: Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6
  description: Katz index of independence in Activities of Daily Living scale (ADL) (score 0-6)
  measure: Change in patient motor ability between groups
  time frame: Baseline, Month 3
  description: Time Up and Go test (Score 0-3 for each item, time in seconds)
  measure: Patient satisfaction with care between groups
  time frame: Hospital discharge (an average of 10 days)
  description: EORTC SATisfaction with IN-PATient cancer care (IN-PATSAT) 32 questionnaire (Score 32-160)
  measure: Length of hospital stay between groups
  time frame: Hospital discharge (an average of 10 days)
  description: Days
  measure: The number of medical complications during hospitalization between groups
  time frame: Hospital discharge (an average of 10 days)
  description: Number of following events: diabetes decompensation, cardiorespiratory decompensation, pulmonary and urinary infections, acute renal failure, anemia. Aggravation of: confusion, pelvic exoneration disorders, fall, bedsores.
  measure: The distribution of surgical complications between groups
  time frame: Hospital discharge (an average of 10 days)
  description: Gravity of surgical complications according to the Clavien Dindo classification
  measure: The distribution of surgical complications between groups
  time frame: Month 1
  description: Gravity of surgical complications according to the Clavien Dindo classification
  measure: Destination of patients on discharge from hospital between groups
  time frame: Hospital discharge (an average of 10 days)
  description: Classified as: home / nursing home or institutionalization / transfer to Aftercare and Rehabilitation / transfer to another service / none (death during hospitalization).
  measure: The change in the patient's weight between groups
  time frame: Baseline and Month 3
  description: Percent change in Kg
  measure: Patient quality of life between groups
  time frame: Month 3
  description: EORTC-QLQ-C30 questionnaire score (Score 0-100)
  measure: Patient quality of life between groups
  time frame: Month 6
  description: EORTC-QLQ-C30 questionnaire score (Score 0-100)
  measure: Change in the patient's place of abode between groups
  time frame: Month 1, Month 3 and Month 6
  description: Rate (%) of patients living at home/in nursing home/residential home
  measure: Overall survival between groups.
  time frame: Month 1
  description: Percentage of immediate mortality (during the hospital stay)
  measure: Overall survival between groups.
  time frame: Month 3
  description: Percentage of immediate mortality (during the hospital stay)
  measure: Overall survival between groups.
  time frame: Month 6
  description: Percentage of immediate mortality (during the hospital stay)
  measure: The rate of early unscheduled re-hospitalizations or admissions to the emergency department between groups
  time frame: Month 1
  description: Re-hospitalization in the month following discharge from hospital: yes/no.
  arm group label: Control group
  description: Classical management in the digestive surgery department
  arm group label: GPOU group
  description: Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care
  intervention type: Other
  intervention name: GPOU
  description: Intervention upstream of the perioperative management according to the nutritional grade. Grade 4 Nutrition patients will be hospitalized earlier, i.e. 10 to 15 days before surgery for the start of artificial nutrition. A temporary return home can be organized with the supervision of a service provider until a second admission for surgical management. Grade 2 Nutrition patients will be called 24 to 48 hours before the surgical procedure.
  Anticipation of discharge at admittance Early mobilization Comorbidity management Prevention of iatrogenia Management of geriatric frailties Daily medical and paramedical assessment Detailed discharge report
  arm group label: GPOU group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 70 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Coralie Labarias
  role: Principal Investigator
  affiliation: CHU de Nimes
  last name: Coralie Labarias
  phone: 04.66.68.79.46
  email: coralie.labarias@chu-nimes.fr
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms