<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/NCT03803280</url>
  </required_header>
  <id_info>
    <org_study_id>GERM03</org_study_id>
    <nct_id>NCT03803280</nct_id>
  </id_info>
  <brief_title>Implementation of Enhanced Recovery Protocol in Spain</brief_title>
  <acronym>IMPRICA</acronym>
  <official_title>Implementation of the Enhanced Recovery in Abdominal Surgery Pathway in the National Health Network (IMPRICA Project)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Español de Rehabilitación Multimodal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Investigación Sanitaria Aragón</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Aragones de Ciencias de la Salud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Español de Rehabilitación Multimodal</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>
      The main objective is the multicenter and uniform implementation of a agreed upon&#xD;
      perioperative evidence based program emanated from the Enhanced Recovery for abdominal&#xD;
      surgery pathway (RICA) published by the Spanish National Health Service and the Aragon&#xD;
      Institute of Health, in hospitals of the National Health Network.&#xD;
&#xD;
      The evaluation and outcomes of such implementation is proposed as a secondary objective.&#xD;
      Different established indicator will compared traditional care results with those from the&#xD;
      new program in the short and medium term. 10 interested hospital centers are selected. In&#xD;
      each of them a retrospective study will be conducted to analyze the clinical results obtained&#xD;
      in abdominal surgery in the past six months. After making the necessary training to clinical&#xD;
      teams and assure the project development and implementation in each center, a prospective&#xD;
      study in which all patients in the program are being recruited will be held. Hospital stay as&#xD;
      well as perioperative mortality and morbidity will be collected. We will analyze data from:&#xD;
      days of hospital stay (potential and actual), efficiency (cost/procedure), quality of care,&#xD;
      time to complete reintegration into family, social and labor environment and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A uniform, consensual and multicentric implementation of the multidisciplinary Perioperative&#xD;
      Medicine Program is proposed, the program comes form the Clinical Pathway of Intensified&#xD;
      Recovery in Abdominal Surgery -RICA-, published by the Spanish National Health System as&#xD;
      clinical guideline.&#xD;
&#xD;
      It covers the perioperative area in complex abdominal surgery and extends from the moment of&#xD;
      diagnosis in the Surgery office until the last revision performed one year after surgery.&#xD;
&#xD;
      It is proposed as a double study; a first retrospective analysis of the results and&#xD;
      perioperative complications referred and available in the Centers involved in the study; and&#xD;
      a second analysis of results after the implementation of the Program, in the same Centers.&#xD;
      Once both are finished, the comparison between them and their communication will be carried&#xD;
      out using the appropriate reports.&#xD;
&#xD;
      Actors: Multidisciplinary teams made up of nurses, surgeons, anesthesiologists, nutritionists&#xD;
      / endocrinologists, physiotherapists and rehabilitators.&#xD;
&#xD;
      Patients: All patients recruited in the different hospitals for the RICA Perioperative&#xD;
      Medicine Program susceptible to performing complex abdominal surgery.&#xD;
&#xD;
      Variables under study: Perioperative complications according to the Clavien-Dindo&#xD;
      classification and the European Perioperative Clinical Outcome definitions (EPCO); Times of&#xD;
      global hospital stay and in critical care units; the rate of readmissions and the&#xD;
      complications derived from them, the rate of surgical reoperations, the analysis of cost per&#xD;
      process (including the total cost in the study period-two years-), the time until complete&#xD;
      reincorporation into the family environment and socio-labor, the indices of quality perceived&#xD;
      by the patient and / or their caregivers, the final quality of life index obtained by each&#xD;
      patient (resulting quality of life).&#xD;
&#xD;
      Data collection and analysis: Record of described variables were be included in an &quot;on&#xD;
      line&quot;database available to all centers.&#xD;
&#xD;
      Limitations of the Study: impossibility to include all the patients that can be recruited in&#xD;
      surgery consultations due to rejection of the staff (negative to the benchmarking and / or to&#xD;
      the program) or negative of the patient. Loss of data in follow-up due to the failure of&#xD;
      patients. Difficulty in analyzing costs due to lack of economic data in the Centers. Lack of&#xD;
      motivation in the multidisciplinary teams. Rupture of the program in case of emergency /&#xD;
      emergency.&#xD;
&#xD;
      Material and Methodology:&#xD;
&#xD;
      Participating Centers: Previously selected for their well-known Organizational capacity and&#xD;
      their experience and interest.&#xD;
&#xD;
      First Phase: Realization of retrospective study of existing results in each Center in the six&#xD;
      months prior to the implementation of the Program and Conformation of the multidisciplinary&#xD;
      teams that will implement the Intensified Recovery Program.&#xD;
&#xD;
      Second phase: Training of the Teams in IACS (Instituto Aragones Ciencias de la Salud) on the&#xD;
      implementation of enhanced recovery programs provided with online training through platform&#xD;
      built &quot;ad hoc&quot; and in person for training with experts. Development of the Normalized Work&#xD;
      Protocol (NTP) in each assigned Center and implementation of the forms and database in the&#xD;
      Clinical History of the Centers (considering electronic Clinical History).&#xD;
&#xD;
      Third phase: Progressive recruitment of patients and inclusion in the Program (on-line&#xD;
      database) and start of the one-year prospective study from the patient's inclusion.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      -Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant&#xD;
      or benign causes. (It is defined as complex major surgery that lasts more than two hours, it&#xD;
      is estimated that it may require the transfusion of at least 2 red cell concentrates or it is&#xD;
      estimated a loss greater than or equal to 15% of the patient's blood volumen).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with postoperative complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>complications after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 years</time_frame>
    <description>Number of patients dead after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long term mortality</measure>
    <time_frame>5 years</time_frame>
    <description>Number of patients dead after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>perioperative stay</time_frame>
    <description>Days of stay in hospital after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compliance of the protocol</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Rate of compliance of each ERAS (Enhanced Recovery After Surgery) item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-admission</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>patient needing hospital stay after being at home after primary surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Price of the intervention</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Major Surgery</condition>
  <arm_group>
    <arm_group_label>Traditional care</arm_group_label>
    <description>Patients with major abdominal surgery without before a enhanced recovery program was stablished</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERAS care</arm_group_label>
    <description>Patients with major abdominal surgery within a enhanced recovery program was stablished</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERAS program</intervention_name>
    <description>ERAS pathway according to the Spanish Via RICA</description>
    <arm_group_label>ERAS care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years old, scheduled for major abdominal surgical surgery, due to&#xD;
        malignant or benign causes (It is defined as complex major surgery that lasts more than two&#xD;
        hours or it is estimated that it may require the transfusion of at least 2 red cell&#xD;
        concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood&#xD;
        volumen).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients over 18 years old, scheduled for major abdominal surgical surgery, due to&#xD;
        malignant or benign causes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urgent Surgery.&#xD;
&#xD;
          -  Patients ASA (American Society of Anesthesiology) IV or higher.&#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>Jose M Calvo, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Grupo Español de Rehabilitación Multimodal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jose M Ramirez, Prof</last_name>
    <phone>+34 639776364</phone>
    <email>jramirez@unizar.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier Ripollés Melchor, MD</last_name>
      <phone>649337762</phone>
      <email>ripo542@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Eugenio Martínez Hurtado, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alfredo Abad Gurumeta, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elena Sáez Ruiz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ane Abad Motos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Norma Aracil Escoda, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Beatriz Nozal Mateo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rut Salvachua, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oliver Marín Pena</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Maria Calvo Vecino, Prof</last_name>
      <email>joscalvo@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Domingo Bustos García</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>María Angoso Clavijo</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Manuel Ramírez Rodriguez, Prof</last_name>
      <email>jramirez@unizar.es</email>
    </contact>
    <investigator>
      <last_name>Rubén Casans Francés, Phd</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manuela Elia Guedea</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elena Córdoba Díaz de Laspra</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>José A Gracia Solanas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julia Guillén Antón</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tomás Ruiz Garcés</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Vorwald P, Bruna Esteban M, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after esophageal resection. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):401-409. doi: 10.1016/j.ciresp.2018.02.010. Epub 2018 Mar 21. English, Spanish.</citation>
    <PMID>29573788</PMID>
  </results_reference>
  <results_reference>
    <citation>Bruna M, Navarro C, Baez C, Ramirez JM, Ortiz MA. Results of a national survey about perioperative care in gastric resection surgery. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):410-418. doi: 10.1016/j.ciresp.2018.03.004. Epub 2018 Apr 24. English, Spanish.</citation>
    <PMID>29699695</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruiz-Tovar J, Munoz JL, Royo P, Duran M, Redondo E, Ramirez JM; Grupo Espanol de Rehabilitacion Multimodal (GERM). Implementation of the Spanish ERAS program in bariatric surgery. Minim Invasive Ther Allied Technol. 2018 Dec;27(6):365-372. doi: 10.1080/13645706.2018.1446988. Epub 2018 Mar 8.</citation>
    <PMID>29519184</PMID>
  </results_reference>
  <results_reference>
    <citation>Bruna Esteban M, Vorwald P, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after surgery in gastric resections. Cir Esp. 2017 Feb;95(2):73-82. doi: 10.1016/j.ciresp.2016.10.013. Epub 2017 Feb 6. English, Spanish.</citation>
    <PMID>28185641</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez AB, Longas J, Ramirez JM. A model for lymphocyte activation in open versus laparoscopic surgery in colorectal cancer patients in enhanced recovery after surgery (ERAS) protocols. Int J Colorectal Dis. 2017 Jun;32(6):913-916. doi: 10.1007/s00384-016-2731-2. Epub 2016 Nov 30.</citation>
    <PMID>27900463</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruiz-Tovar J, Royo P, Munoz JL, Duran M, Redondo E, Ramirez JM; GERM. Implementation of the Spanish National Enhanced Recovery Program (ERAS) in Bariatric Surgery: A Pilot Study. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):439-443. doi: 10.1097/SLE.0000000000000323.</citation>
    <PMID>27753710</PMID>
  </results_reference>
  <results_reference>
    <citation>Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.</citation>
    <PMID>27227930</PMID>
  </results_reference>
  <results_reference>
    <citation>Gonzalez-Ayora S, Pastor C, Guadalajara H, Ramirez JM, Royo P, Redondo E, Arroyo A, Moya P, Garcia-Olmo D. Enhanced recovery care after colorectal surgery in elderly patients. Compliance and outcomes of a multicenter study from the Spanish working group on ERAS. Int J Colorectal Dis. 2016 Sep;31(9):1625-31. doi: 10.1007/s00384-016-2621-7. Epub 2016 Jul 4.</citation>
    <PMID>27378580</PMID>
  </results_reference>
  <results_reference>
    <citation>Esteban F, Cerdan FJ, Garcia-Alonso M, Sanz-Lopez R, Arroyo A, Ramirez JM, Moreno C, Morales R, Navarro A, Fuentes M. A multicentre comparison of a fast track or conventional postoperative protocol following laparoscopic or open elective surgery for colorectal cancer surgery. Colorectal Dis. 2014 Feb;16(2):134-40. doi: 10.1111/codi.12472.</citation>
    <PMID>24164975</PMID>
  </results_reference>
  <results_reference>
    <citation>Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; 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 rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):285-305. doi: 10.1007/s00268-012-1787-6. No abstract available.</citation>
    <PMID>23052796</PMID>
  </results_reference>
  <results_reference>
    <citation>Arroyo A, Ramirez JM, Callejo D, Vinas X, Maeso S, Cabezali R, Miranda E; Spanish Working Group in Fast Track Surgery (GERM). Influence of size and complexity of the hospitals in an enhanced recovery programme for colorectal resection. Int J Colorectal Dis. 2012 Dec;27(12):1637-44. doi: 10.1007/s00384-012-1497-4. Epub 2012 May 27.</citation>
    <PMID>22645075</PMID>
  </results_reference>
  <results_reference>
    <citation>Ramirez JM, Blasco JA, Roig JV, Maeso-Martinez S, Casal JE, Esteban F, Lic DC; Spanish working group on fast track surgery. Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg. 2011 Apr 14;11:9. doi: 10.1186/1471-2482-11-9.</citation>
    <PMID>21489315</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03803280
org study id: GERM03
nct id: NCT03803280
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The main objective is the multicenter and uniform implementation of a agreed upon
      perioperative evidence based program emanated from the Enhanced Recovery for abdominal
      surgery pathway (RICA) published by the Spanish National Health Service and the Aragon
      Institute of Health, in hospitals of the National Health Network.

      The evaluation and outcomes of such implementation is proposed as a secondary objective.
      Different established indicator will compared traditional care results with those from the
      new program in the short and medium term. 10 interested hospital centers are selected. In
      each of them a retrospective study will be conducted to analyze the clinical results obtained
      in abdominal surgery in the past six months. After making the necessary training to clinical
      teams and assure the project development and implementation in each center, a prospective
      study in which all patients in the program are being recruited will be held. Hospital stay as
      well as perioperative mortality and morbidity will be collected. We will analyze data from:
      days of hospital stay (potential and actual), efficiency (cost/procedure), quality of care,
      time to complete reintegration into family, social and labor environment and quality of life.
A uniform, consensual and multicentric implementation of the multidisciplinary Perioperative
      Medicine Program is proposed, the program comes form the Clinical Pathway of Intensified
      Recovery in Abdominal Surgery -RICA-, published by the Spanish National Health System as
      clinical guideline.

      It covers the perioperative area in complex abdominal surgery and extends from the moment of
      diagnosis in the Surgery office until the last revision performed one year after surgery.

      It is proposed as a double study; a first retrospective analysis of the results and
      perioperative complications referred and available in the Centers involved in the study; and
      a second analysis of results after the implementation of the Program, in the same Centers.
      Once both are finished, the comparison between them and their communication will be carried
      out using the appropriate reports.

      Actors: Multidisciplinary teams made up of nurses, surgeons, anesthesiologists, nutritionists
      / endocrinologists, physiotherapists and rehabilitators.

      Patients: All patients recruited in the different hospitals for the RICA Perioperative
      Medicine Program susceptible to performing complex abdominal surgery.

      Variables under study: Perioperative complications according to the Clavien-Dindo
      classification and the European Perioperative Clinical Outcome definitions (EPCO); Times of
      global hospital stay and in critical care units; the rate of readmissions and the
      complications derived from them, the rate of surgical reoperations, the analysis of cost per
      process (including the total cost in the study period-two years-), the time until complete
      reincorporation into the family environment and socio-labor, the indices of quality perceived
      by the patient and / or their caregivers, the final quality of life index obtained by each
      patient (resulting quality of life).

      Data collection and analysis: Record of described variables were be included in an "on
      line"database available to all centers.

      Limitations of the Study: impossibility to include all the patients that can be recruited in
      surgery consultations due to rejection of the staff (negative to the benchmarking and / or to
      the program) or negative of the patient. Loss of data in follow-up due to the failure of
      patients. Difficulty in analyzing costs due to lack of economic data in the Centers. Lack of
      motivation in the multidisciplinary teams. Rupture of the program in case of emergency /
      emergency.

      Material and Methodology:

      Participating Centers: Previously selected for their well-known Organizational capacity and
      their experience and interest.

      First Phase: Realization of retrospective study of existing results in each Center in the six
      months prior to the implementation of the Program and Conformation of the multidisciplinary
      teams that will implement the Intensified Recovery Program.

      Second phase: Training of the Teams in IACS (Instituto Aragones Ciencias de la Salud) on the
      implementation of enhanced recovery programs provided with online training through platform
      built "ad hoc" and in person for training with experts. Development of the Normalized Work
      Protocol (NTP) in each assigned Center and implementation of the forms and database in the
      Clinical History of the Centers (considering electronic Clinical History).

      Third phase: Progressive recruitment of patients and inclusion in the Program (on-line
      database) and start of the one-year prospective study from the patient's inclusion.

      Inclusion Criteria:

      -Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant
      or benign causes. (It is defined as complex major surgery that lasts more than two hours, it
      is estimated that it may require the transfusion of at least 2 red cell concentrates or it is
      estimated a loss greater than or equal to 15% of the patient's blood volumen).
observational model: Cohort
time perspective: Other
measure: Number of patients with postoperative complications
time frame: 30 days after surgery
description: complications after surgery
measure: Mortality
time frame: 3 years
description: Number of patients dead after surgery
measure: Long term mortality
time frame: 5 years
description: Number of patients dead after surgery
measure: Hospital stay
time frame: perioperative stay
description: Days of stay in hospital after surgery
measure: compliance of the protocol
time frame: 1 month after surgery
description: Rate of compliance of each ERAS (Enhanced Recovery After Surgery) item
measure: re-admission
time frame: 1 month after surgery
description: patient needing hospital stay after being at home after primary surgery
measure: Cost
time frame: 1 month after surgery
description: Price of the intervention
arm group label: Traditional care
description: Patients with major abdominal surgery without before a enhanced recovery program was stablished
arm group label: ERAS care
description: Patients with major abdominal surgery within a enhanced recovery program was stablished
intervention type: Procedure
intervention name: ERAS program
description: ERAS pathway according to the Spanish Via RICA
arm group label: ERAS care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose M Calvo, Dr
role: Study Chair
affiliation: Grupo Español de Rehabilitación Multimodal
last name: Jose M Ramirez, Prof
phone: +34 639776364
email: jramirez@unizar.es
facility: 
status: Recruiting
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country: Spain
citation: Vorwald P, Bruna Esteban M, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after esophageal resection. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):401-409. doi: 10.1016/j.ciresp.2018.02.010. Epub 2018 Mar 21. English, Spanish.
PMID: 29573788
citation: Bruna M, Navarro C, Baez C, Ramirez JM, Ortiz MA. Results of a national survey about perioperative care in gastric resection surgery. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):410-418. doi: 10.1016/j.ciresp.2018.03.004. Epub 2018 Apr 24. English, Spanish.
PMID: 29699695
citation: Ruiz-Tovar J, Munoz JL, Royo P, Duran M, Redondo E, Ramirez JM; Grupo Espanol de Rehabilitacion Multimodal (GERM). Implementation of the Spanish ERAS program in bariatric surgery. Minim Invasive Ther Allied Technol. 2018 Dec;27(6):365-372. doi: 10.1080/13645706.2018.1446988. Epub 2018 Mar 8.
PMID: 29519184
citation: Bruna Esteban M, Vorwald P, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after surgery in gastric resections. Cir Esp. 2017 Feb;95(2):73-82. doi: 10.1016/j.ciresp.2016.10.013. Epub 2017 Feb 6. English, Spanish.
PMID: 28185641
citation: Martinez AB, Longas J, Ramirez JM. A model for lymphocyte activation in open versus laparoscopic surgery in colorectal cancer patients in enhanced recovery after surgery (ERAS) protocols. Int J Colorectal Dis. 2017 Jun;32(6):913-916. doi: 10.1007/s00384-016-2731-2. Epub 2016 Nov 30.
PMID: 27900463
citation: Ruiz-Tovar J, Royo P, Munoz JL, Duran M, Redondo E, Ramirez JM; GERM. Implementation of the Spanish National Enhanced Recovery Program (ERAS) in Bariatric Surgery: A Pilot Study. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):439-443. doi: 10.1097/SLE.0000000000000323.
PMID: 27753710
citation: Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
PMID: 27227930
citation: Gonzalez-Ayora S, Pastor C, Guadalajara H, Ramirez JM, Royo P, Redondo E, Arroyo A, Moya P, Garcia-Olmo D. Enhanced recovery care after colorectal surgery in elderly patients. Compliance and outcomes of a multicenter study from the Spanish working group on ERAS. Int J Colorectal Dis. 2016 Sep;31(9):1625-31. doi: 10.1007/s00384-016-2621-7. Epub 2016 Jul 4.
PMID: 27378580
citation: Esteban F, Cerdan FJ, Garcia-Alonso M, Sanz-Lopez R, Arroyo A, Ramirez JM, Moreno C, Morales R, Navarro A, Fuentes M. A multicentre comparison of a fast track or conventional postoperative protocol following laparoscopic or open elective surgery for colorectal cancer surgery. Colorectal Dis. 2014 Feb;16(2):134-40. doi: 10.1111/codi.12472.
PMID: 24164975
citation: Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; 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 rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):285-305. doi: 10.1007/s00268-012-1787-6. No abstract available.
PMID: 23052796
citation: Arroyo A, Ramirez JM, Callejo D, Vinas X, Maeso S, Cabezali R, Miranda E; Spanish Working Group in Fast Track Surgery (GERM). Influence of size and complexity of the hospitals in an enhanced recovery programme for colorectal resection. Int J Colorectal Dis. 2012 Dec;27(12):1637-44. doi: 10.1007/s00384-012-1497-4. Epub 2012 May 27.
PMID: 22645075
citation: Ramirez JM, Blasco JA, Roig JV, Maeso-Martinez S, Casal JE, Esteban F, Lic DC; Spanish working group on fast track surgery. Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg. 2011 Apr 14;11:9. doi: 10.1186/1471-2482-11-9.
PMID: 21489315
responsible party type: Sponsor
sharing ipd: Undecided