<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/NCT04420117</url>
  </required_header>
  <id_info>
    <org_study_id>Atlas</org_study_id>
    <nct_id>NCT04420117</nct_id>
  </id_info>
  <brief_title>Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery</brief_title>
  <official_title>Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery- Atlas Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Fe</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>
      Evaluation of preoperative physical capacity and its evolution in the postoperative period in&#xD;
      older patients after undergoing laparoscopic surgery for colorectal cancer, with the test:&#xD;
&#xD;
      - Short Physical Performance Battery (SPPB)&#xD;
&#xD;
      After the inclusion of the first 10 patients, a preliminary feasibility study will be carried&#xD;
      out and thus we have coverage of this pilot study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the physical capacity</measure>
    <time_frame>21 days before surgery</time_frame>
    <description>Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the physical capacity</measure>
    <time_frame>21 days after surgery</time_frame>
    <description>Evaluation of the physical capacity only with the Short Physical Performance</description>
  </primary_outcome>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Colorectal Disorders</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perioperative assessment of physical capacity</intervention_name>
    <description>Evaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing laparoscopic colorectal surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age ≥65 years.&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  Patients with absence of cognitive deficit.&#xD;
&#xD;
          -  Informed consent signed prior to surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to participate in the study.&#xD;
&#xD;
          -  Patients with disabilities to give their consent.&#xD;
&#xD;
          -  ASA IV-V.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Health status that prevent physical exercise, such as unstable heart disease, severe&#xD;
             systematic disease, or serious orthopedic conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Fe</investigator_affiliation>
    <investigator_full_name>Oscar Diaz-Cambronero</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04420117
org study id: Atlas
nct id: NCT04420117
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of preoperative physical capacity and its evolution in the postoperative period in
      older patients after undergoing laparoscopic surgery for colorectal cancer, with the test:

      - Short Physical Performance Battery (SPPB)

      After the inclusion of the first 10 patients, a preliminary feasibility study will be carried
      out and thus we have coverage of this pilot study.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the physical capacity
time frame: 21 days before surgery
description: Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire
measure: Evaluation of the physical capacity
time frame: 21 days after surgery
description: Evaluation of the physical capacity only with the Short Physical Performance
intervention type: Other
intervention name: Perioperative assessment of physical capacity
description: Evaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Fe
investigator full name: Oscar Diaz-Cambronero
investigator title: Principal investigator