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/NCT06008834</url>
    </required_header>
    <id_info>
      <org_study_id>CIR2022020</org_study_id>
      <nct_id>NCT06008834</nct_id>
    </id_info>
    <brief_title>First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery</brief_title>
    <official_title>First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Corporacion Parc Tauli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Corporacion Parc Tauli</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 enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care&#xD;
        pathways designed to achieve early recovery after surgical procedures by maintaining&#xD;
        preoperative organ function and reducing the profound stress response following surgery. This&#xD;
        type of approach has led to an earlier hospital discharge of patients with a low rate of&#xD;
        postoperative complications.&#xD;
  &#xD;
        Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital&#xD;
        discharge and domiciliary follow-up for minimal invasive colectomy.&#xD;
  &#xD;
        Method: unicenter pilot study of patients with indication of minimally invasive right&#xD;
        colectomy or sigmidectomy who will follow an ERAS protocol according to international&#xD;
        guidelines and will be discharged the first day of surgery with a domiciliary follow-up.&#xD;
        Hospital readmission is considered as the primary outcome. A total sample of 40 cases is&#xD;
        considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both&#xD;
        techniques will be performed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal&#xD;
        perioperative care pathways designed to achieve early recovery after surgical procedures by&#xD;
        maintaining preoperative organ function and reducing the profound stress response following&#xD;
        surgery. The key elements of ERAS protocols include preoperative counselling, optimization of&#xD;
        nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type&#xD;
        of approach has led to an earlier hospital discharge of patients with a low rate of&#xD;
        postoperative complications.&#xD;
  &#xD;
        Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital&#xD;
        discharge and domiciliary follow-up for minimal invasive colectomy.&#xD;
  &#xD;
        Method: unicenter pilot study of patients with indication of minimally invasive right&#xD;
        colectomy or sigmidectomy who will follow an ERAS protocol according to international&#xD;
        guidelines and will be discharged the first day of surgery with a domiciliary follow-up.&#xD;
  &#xD;
        Outcomes:&#xD;
  &#xD;
          -  Primary: hospital readmission&#xD;
  &#xD;
          -  Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time&#xD;
             before final postoperative discharge, emergency department re-consulting.&#xD;
  &#xD;
        Sample: a total sample of 40 cases is considered, with 20 right colectomies and 20&#xD;
        sigmoidectomies.&#xD;
  &#xD;
        Analysis: an independent analysis of both techniques will be performed. Pilot study without&#xD;
        control branch.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single Group Interventional Pilot Study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Readmission</measure>
      <time_frame>30 days after surgery</time_frame>
      <description>Hospital readmission after first-day hospital discharge</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>30 days after surgery</time_frame>
      <description>Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency Department re-consultation</measure>
      <time_frame>30 days after surgery</time_frame>
      <description>Emergency Department re-consultation with no readmission after first-day hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Domiciliary Follow-up</measure>
      <time_frame>30 days after surgery</time_frame>
      <description>Domiciliary follow-up mean time before domiciliary discharge</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Colorectal Disorders</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Interventional group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>First-day discharge protocol</intervention_name>
      <description>Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up</description>
      <arm_group_label>Interventional group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pacients who undergo a minimal invasive sigmoidectomy or right colectomy.&#xD;
  &#xD;
            -  Benign or malignant desease.&#xD;
  &#xD;
            -  No expected stoma&#xD;
  &#xD;
            -  ASA ≤ III&#xD;
  &#xD;
            -  Family support&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  Anticoagulant therapy&#xD;
  &#xD;
            -  Recent immunosupresor therapy (less than one month)&#xD;
  &#xD;
            -  Anemia (Male Hb &gt;120 g/L, Female Hb &gt;110 g/L)&#xD;
  &#xD;
            -  Malnutrition (Albumine &gt;35 g/L)&#xD;
  &#xD;
            -  Dementia&#xD;
  &#xD;
            -  Moderate or high frailty&#xD;
  &#xD;
            -  Syncronic neoplasia&#xD;
  &#xD;
            -  Previous colorectal surgery&#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>Anna Pallisera-Lloveras, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Corporacio Parc Tauli. Parc Tauli University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Laura Mora-Lopez, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Corporacio Parc Tauli. Parc Tauli University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Oriol Pino-Perez, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Corporacio Parc Tauli. Parc Tauli University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna Pallisera-Lloveras, MD, PhD</last_name>
      <phone>34-93-723-1010</phone>
      <phone_ext>21490</phone_ext>
      <email>apallill@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laura Mora-Lopez, MD, PhD</last_name>
      <phone>34-93-723-1010</phone>
      <phone_ext>21490</phone_ext>
      <email>mora.lopez.laura@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Parc Tauli University Hospital</name>
        <address>
          <city>Sabadell</city>
          <state>Barcelona</state>
          <zip>08208</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
      <investigator_full_name>Anna Pallisera-Lloveras</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <!-- 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/NCT06008834
  org study id: CIR2022020
  nct id: NCT06008834
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care
        pathways designed to achieve early recovery after surgical procedures by maintaining
        preoperative organ function and reducing the profound stress response following surgery. This
        type of approach has led to an earlier hospital discharge of patients with a low rate of
        postoperative complications.
  
        Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital
        discharge and domiciliary follow-up for minimal invasive colectomy.
  
        Method: unicenter pilot study of patients with indication of minimally invasive right
        colectomy or sigmidectomy who will follow an ERAS protocol according to international
        guidelines and will be discharged the first day of surgery with a domiciliary follow-up.
        Hospital readmission is considered as the primary outcome. A total sample of 40 cases is
        considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both
        techniques will be performed.
  Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal
        perioperative care pathways designed to achieve early recovery after surgical procedures by
        maintaining preoperative organ function and reducing the profound stress response following
        surgery. The key elements of ERAS protocols include preoperative counselling, optimization of
        nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type
        of approach has led to an earlier hospital discharge of patients with a low rate of
        postoperative complications.
  
        Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital
        discharge and domiciliary follow-up for minimal invasive colectomy.
  
        Method: unicenter pilot study of patients with indication of minimally invasive right
        colectomy or sigmidectomy who will follow an ERAS protocol according to international
        guidelines and will be discharged the first day of surgery with a domiciliary follow-up.
  
        Outcomes:
  
          -  Primary: hospital readmission
  
          -  Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time
             before final postoperative discharge, emergency department re-consulting.
  
        Sample: a total sample of 40 cases is considered, with 20 right colectomies and 20
        sigmoidectomies.
  
        Analysis: an independent analysis of both techniques will be performed. Pilot study without
        control branch.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single Group Interventional Pilot Study.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Readmission
  time frame: 30 days after surgery
  description: Hospital readmission after first-day hospital discharge
  measure: Postoperative complications
  time frame: 30 days after surgery
  description: Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification
  measure: Emergency Department re-consultation
  time frame: 30 days after surgery
  description: Emergency Department re-consultation with no readmission after first-day hospital discharge
  measure: Domiciliary Follow-up
  time frame: 30 days after surgery
  description: Domiciliary follow-up mean time before domiciliary discharge
  arm group label: Interventional group
  arm group type: Experimental
  description: Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up
  intervention type: Procedure
  intervention name: First-day discharge protocol
  description: Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up
  arm group label: Interventional group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anna Pallisera-Lloveras, MD, PhD
  role: Principal Investigator
  affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
  last name: Laura Mora-Lopez, MD, PhD
  role: Study Director
  affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
  last name: Oriol Pino-Perez, MD
  role: Principal Investigator
  affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
  last name: Anna Pallisera-Lloveras, MD, PhD
  phone: 34-93-723-1010
  phone ext: 21490
  email: apallill@gmail.com
  last name: Laura Mora-Lopez, MD, PhD
  phone: 34-93-723-1010
  phone ext: 21490
  email: mora.lopez.laura@gmail.com
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Corporacion Parc Tauli
  investigator full name: Anna Pallisera-Lloveras
  investigator title: MD, PhD