<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/NCT03814681</url>
  </required_header>
  <id_info>
    <org_study_id>EuroPOWER</org_study_id>
    <nct_id>NCT03814681</nct_id>
  </id_info>
  <brief_title>Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)</brief_title>
  <acronym>EuroPOWER</acronym>
  <official_title>Postoperative Outcomes Within/Without an Enhanced Recovery After Surgery Protocol in Colorectal Surgery Across Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Español de Rehabilitación Multimodal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GRACE Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>REDGERM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Español de Rehabilitación Multimodal</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Methods&#xD;
&#xD;
      30 days European Multicentre observational cohort study of postoperative complications&#xD;
      following elective colorectal surgery within any compliance of an ERAS protocol (including&#xD;
      patients with 0 compliance) in a participating hospital during the 30-day cohort period with&#xD;
      a planned overnight stay.&#xD;
&#xD;
      Research sites&#xD;
&#xD;
      Hospitals across Europe with an elective colorrectal surgical service&#xD;
&#xD;
      Objective&#xD;
&#xD;
      To provide detailed data describing post-operative complications and associated mortality To&#xD;
      provide detailed data describing adherence to ERAS protocol and its association to morbidity&#xD;
      and length of stay.&#xD;
&#xD;
      To provide detailed information on the influence of the volume of patients undergoing surgery&#xD;
      on each center and postoperative complications censured at 30 days after surgery.&#xD;
&#xD;
      Inclusion criteria All adult patients (aged ≥18 years) undergoing elective colorectal surgery&#xD;
      during the 30-day study period.&#xD;
&#xD;
      Statistical analysis Number of patients: All eligible patients undergoing elective colorectal&#xD;
      surgery during the study month in European participating hospitals.&#xD;
&#xD;
      Univariate analysis will be used to test factors (patient, surgical, and ERAS related)&#xD;
      associated with surgical complications, length of stay (LOS) and in-hospital death. Single&#xD;
      and multi-level logistic regression models will be constructed to identify factors&#xD;
      independently associated with these outcomes and to adjust for differences in confounding&#xD;
      factors. A stepwise approach will be used to enter new terms. A single final analysis is&#xD;
      planned at the end of the study.&#xD;
&#xD;
      Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose-&#xD;
      response dependence in percentage of patients with postoperative complications and LOS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The results of this study will allow to identify, on the one hand, the type of patients&#xD;
      presenting postoperative complications and, on the other hand, to identify those items of the&#xD;
      ERAS protocols that are independently associated with a reduction in postoperative&#xD;
      complications and hospital stay, which will allow to focus the perioperative efforts in those&#xD;
      items that actually improve the postoperative outcomes.&#xD;
&#xD;
        -  Aim 1 will establish the number of patients developing predefined postoperative&#xD;
           complications within 30 days of surgery in adult patients undergoing elective colorectal&#xD;
           surgery with any compliance of an ERAS protocol (including patients with 0 compliance).&#xD;
           This will allow us to determine the actual impact of these protocols.&#xD;
&#xD;
        -  Aim 2 will allow us to know the type of predefined complication presented by the&#xD;
           patients included in the ERAS protocols and in patients undergoing colorectal surgery;&#xD;
           This will allow, on the one hand, to have a starting point for future clinical trials,&#xD;
           and, on the other hand, to focus efforts to avoid these complications.&#xD;
&#xD;
        -  Aim 3 will allow us to identify those perioperative items of ERAS protocols that are&#xD;
           actually associated with a decrease in postoperative complications.&#xD;
&#xD;
      The proposed study will establish a real view of the number of patients presenting&#xD;
      postoperative complications that will overcome the limitations of available retrospective&#xD;
      studies and provide greater insight into the items of the protocols that are associated with&#xD;
      decreased complications; on the other hand, our hypothesis is that the number of patients who&#xD;
      develop predefined postoperative complications within 30 days of surgery decreases as there&#xD;
      is greater compliance with the predefined ERAS protocol items&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2019</start_date>
  <completion_date type="Anticipated">January 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2019</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>Predefined mild-moderate-severe postoperative complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine were published by the EPCO definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome mesures. infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital all-cause mortality</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>The number and percentage of deaths within 30 days of surgery will be reported for each surgical category</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with ERAS items</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society colon and rectal guidelines ERAS patients' guideline compliance will be categorised into quartiles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>The median hospital length of stay (LOS) following the start of surgery, overall, by survival status and by complication status will be reported. Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Perioperative Care</condition>
  <condition>Colorectal Surgery</condition>
  <condition>Postoperative Complications</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colorectal Surgery</intervention_name>
    <description>elective Colorectal Surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients (aged ≥18 years) undergoing primary elective colorectal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (aged ≥18 years) undergoing primary elective colorectal surgery and&#xD;
             by any approach (Includes surgery with laparoscopic, assisted laparoscopic approach or&#xD;
             open approach) in a participating hospital during the 30-day cohort period with a&#xD;
             planned overnight stay.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients submitted for emergency surgery&#xD;
&#xD;
               -  Patients with complex cancer who required resection of organs other than bowel.&#xD;
                  (i.e. kidney, gastric resection, ovarian)• Patients treated with endoscopic&#xD;
                  techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)&#xD;
&#xD;
               -  Bowel transit reconstruction surgery&#xD;
&#xD;
               -  Patients who refuse to participate&#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>Javier Ripollés-Melchor, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Infanta Leonor University Hospital, Madrid, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rupert Pearse, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Queen Mary University London, London, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José M Ramírez Rodríguez, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Lozano Blesa University Hospital, Zaragoza, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samir Jaber, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Hospitalier Universitaire de Montpellier, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karim Slim, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Président de GRACE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>César Aldecoa, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Río Hortega University Hospital, Valladolid, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nader Francis, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Yeovil District Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ane Abad-Motos, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Infanta Leonor University Hospital, Madrid, Spain</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Javier Ripollés-Melchor, MD</last_name>
    <phone>649337762</phone>
    <email>ripo542@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Javi Ripollés-Melchor</last_name>
    <phone>649337762</phone>
    <email>ripo542@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Alves A, Panis Y, Mathieu P, Mantion G, Kwiatkowski F, Slim K; Association Francaise de Chirurgie. Postoperative mortality and morbidity in French patients undergoing colorectal surgery: results of a prospective multicenter study. Arch Surg. 2005 Mar;140(3):278-83, discussion 284. doi: 10.1001/archsurg.140.3.278.</citation>
    <PMID>15781793</PMID>
  </reference>
  <reference>
    <citation>Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.</citation>
    <PMID>23052794</PMID>
  </reference>
  <reference>
    <citation>Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.</citation>
    <PMID>25058504</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03814681/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03814681
org study id: EuroPOWER
nct id: NCT03814681
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Methods

      30 days European Multicentre observational cohort study of postoperative complications
      following elective colorectal surgery within any compliance of an ERAS protocol (including
      patients with 0 compliance) in a participating hospital during the 30-day cohort period with
      a planned overnight stay.

      Research sites

      Hospitals across Europe with an elective colorrectal surgical service

      Objective

      To provide detailed data describing post-operative complications and associated mortality To
      provide detailed data describing adherence to ERAS protocol and its association to morbidity
      and length of stay.

      To provide detailed information on the influence of the volume of patients undergoing surgery
      on each center and postoperative complications censured at 30 days after surgery.

      Inclusion criteria All adult patients (aged ≥18 years) undergoing elective colorectal surgery
      during the 30-day study period.

      Statistical analysis Number of patients: All eligible patients undergoing elective colorectal
      surgery during the study month in European participating hospitals.

      Univariate analysis will be used to test factors (patient, surgical, and ERAS related)
      associated with surgical complications, length of stay (LOS) and in-hospital death. Single
      and multi-level logistic regression models will be constructed to identify factors
      independently associated with these outcomes and to adjust for differences in confounding
      factors. A stepwise approach will be used to enter new terms. A single final analysis is
      planned at the end of the study.

      Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose-
      response dependence in percentage of patients with postoperative complications and LOS.
The results of this study will allow to identify, on the one hand, the type of patients
      presenting postoperative complications and, on the other hand, to identify those items of the
      ERAS protocols that are independently associated with a reduction in postoperative
      complications and hospital stay, which will allow to focus the perioperative efforts in those
      items that actually improve the postoperative outcomes.

        -  Aim 1 will establish the number of patients developing predefined postoperative
           complications within 30 days of surgery in adult patients undergoing elective colorectal
           surgery with any compliance of an ERAS protocol (including patients with 0 compliance).
           This will allow us to determine the actual impact of these protocols.

        -  Aim 2 will allow us to know the type of predefined complication presented by the
           patients included in the ERAS protocols and in patients undergoing colorectal surgery;
           This will allow, on the one hand, to have a starting point for future clinical trials,
           and, on the other hand, to focus efforts to avoid these complications.

        -  Aim 3 will allow us to identify those perioperative items of ERAS protocols that are
           actually associated with a decrease in postoperative complications.

      The proposed study will establish a real view of the number of patients presenting
      postoperative complications that will overcome the limitations of available retrospective
      studies and provide greater insight into the items of the protocols that are associated with
      decreased complications; on the other hand, our hypothesis is that the number of patients who
      develop predefined postoperative complications within 30 days of surgery decreases as there
      is greater compliance with the predefined ERAS protocol items
observational model: Cohort
time perspective: Prospective
measure: Predefined mild-moderate-severe postoperative complications
time frame: 30 days after surgery
description: Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine were published by the EPCO definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome mesures. infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.
measure: In-hospital all-cause mortality
time frame: 30 days after surgery
description: The number and percentage of deaths within 30 days of surgery will be reported for each surgical category
measure: Compliance with ERAS items
time frame: 30 days after surgery
description: Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society colon and rectal guidelines ERAS patients' guideline compliance will be categorised into quartiles
measure: Duration of hospital stay
time frame: 30 days after surgery
description: The median hospital length of stay (LOS) following the start of surgery, overall, by survival status and by complication status will be reported. Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.
intervention type: Other
intervention name: Colorectal Surgery
description: elective Colorectal Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Ripollés-Melchor, MD
role: Study Chair
affiliation: Infanta Leonor University Hospital, Madrid, Spain
last name: Rupert Pearse, Prof
role: Study Chair
affiliation: Queen Mary University London, London, UK
last name: José M Ramírez Rodríguez, Prof
role: Study Chair
affiliation: Lozano Blesa University Hospital, Zaragoza, Spain
last name: Samir Jaber, Prof
role: Study Chair
affiliation: Hospitalier Universitaire de Montpellier, France
last name: Karim Slim, Prof
role: Study Chair
affiliation: Président de GRACE
last name: César Aldecoa, Prof
role: Study Chair
affiliation: Río Hortega University Hospital, Valladolid, Spain
last name: Nader Francis, Prof
role: Study Chair
affiliation: Yeovil District Hospital NHS Foundation Trust
last name: Ane Abad-Motos, MD
role: Study Chair
affiliation: Infanta Leonor University Hospital, Madrid, Spain
last name: Javier Ripollés-Melchor, MD
phone: 649337762
email: ripo542@gmail.com
last name: Javi Ripollés-Melchor
phone: 649337762
email: ripo542@gmail.com
facility: 
country: Spain
citation: Alves A, Panis Y, Mathieu P, Mantion G, Kwiatkowski F, Slim K; Association Francaise de Chirurgie. Postoperative mortality and morbidity in French patients undergoing colorectal surgery: results of a prospective multicenter study. Arch Surg. 2005 Mar;140(3):278-83, discussion 284. doi: 10.1001/archsurg.140.3.278.
PMID: 15781793
citation: Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
PMID: 23052794
citation: Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PMID: 25058504
responsible party type: Sponsor
mesh term: Postoperative Complications
sharing ipd: Undecided
provided document: 