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/NCT06010225</url>
    </required_header>
    <id_info>
      <org_study_id>DRCiptoMGH</org_study_id>
      <nct_id>NCT06010225</nct_id>
    </id_info>
    <brief_title>Effects of Implementing an ERAS Protocol</brief_title>
    <official_title>The Enhanced Recovery After Surgery (ERAS) Protocol Implementation in a National Tertiary-level Hospital: A Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ridho Ardhi Syaiful</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr Cipto Mangunkusumo General Hospital</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>
        Introduction: Successful colorectal surgery is determined based on postoperative mortality&#xD;
        and morbidity rates, complication rates, and cost-effectiveness. One of the methods to obtain&#xD;
        an excellent postoperative outcome is the Enhanced Recovery After Surgery (ERAS) protocol.&#xD;
        This study aims to see the effects of implementing an ERAS protocol in colorectal surgery&#xD;
        patients.&#xD;
  &#xD;
        Methods: Eighty-four patients who underwent elective colorectal surgery at National&#xD;
        Tertiary-level Hospital were included between January 2021 and July 2022. Patients were then&#xD;
        placed into ERAS and control groups according to the criteria. The Patients in the ERAS group&#xD;
        underwent a customized 18-component ERAS protocol and were assessed for adherence.&#xD;
        Postoperatively, both groups were monitored for up to 30 days and assessed for complications&#xD;
        and readmission. The investigators then analyzed the length of stay and total patient costs&#xD;
        in both groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators aimed to determine whether applying the ERAS protocol to patients&#xD;
        undergoing colorectal surgery could improve surgical outcomes (length of stay, complications,&#xD;
        readmission, and total costs) in the National Tertiary Hospital clinical setting.&#xD;
  &#xD;
        This prospective cohort study to analyze the implementation of ERAS protocol in colorectal&#xD;
        patients and its effect on length of stay, readmission rate, complications, and costs in Dr.&#xD;
        Cipto Mangunkusumo General Hospital, an Indonesian tertiary-level hospital, from January 2021&#xD;
        to July 2022. ERAS protocol used in this study was arranged based on the guidelines of the&#xD;
        ERAS ® Society, with certain adjustments made to fit Indonesia's population characteristics.&#xD;
        The sampling process was performed for all patients undergoing elective colorectal surgeries&#xD;
        in The Central Surgery Room during the study period, who continued their medical care at&#xD;
        Integrated Medical Ward Unit and fulfilled all inclusion and exclusion criteria. In this&#xD;
        study, the investigators also used a multidisciplinary team approach that carried out various&#xD;
        protocol points in all phases, according to their areas of expertise. This team comprised&#xD;
        surgeons, anesthesiologists, physical medicine, internists, rehabilitation specialists,&#xD;
        general physicians, dietitians, nurses, pharmacists, surgery admission staff, medical record&#xD;
        staff, and hospital administration staff.&#xD;
  &#xD;
        Study participants The investigators evaluated patients in two different groups: ERAS and&#xD;
        non-ERAS. In both groups, the investigators included patients who underwent&#xD;
        elective/non-emergency colorectal surgery above 18 years of age, with a maximum of two&#xD;
        different comorbidities to minimize postoperative complications, a body mass index above 18.5&#xD;
        kg/m2, and an ASA below 2. In the ERAS group, patients were first evaluated for eligibility&#xD;
        for the ERAS protocol and their willingness to follow a series of ERAS protocols at the&#xD;
        outpatient clinic of the Cipto Mangunkusumo Hospital. The Patients registered in the ERAS&#xD;
        group followed the protocol of the ERAS research team. For the control group, patients&#xD;
        selected through examination in the outpatient clinic would undergo conventional/traditional&#xD;
        surgery.&#xD;
  &#xD;
        The sample size was calculated using an unpaired numerical, analytical research sample size&#xD;
        formula, with an alpha of 5%, a beta of 10%, a combined standard deviation of four based on&#xD;
        previous studies, and an assumed mean outcome difference of 3. To obtain a minimum sample&#xD;
        size for each group of 37 subjects.&#xD;
  &#xD;
        Outcomes The primary outcomes of this study were: (1) the length of hospitalization, (2)&#xD;
        postoperative complications, (3) readmission rate, and (4) total medical costs. The length of&#xD;
        hospitalization was calculated from the day of admission to the hospital ward until&#xD;
        discharge. Postoperative complications were defined as infection on the surgical site or&#xD;
        systemic infection, wound dehiscence, and other complications found after surgery. The&#xD;
        readmission rate was calculated from discharge to one month after surgery. Total medical&#xD;
        costs were calculated based on direct medical costs recorded in the hospital billing data.&#xD;
        The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the&#xD;
        September 1, 2022, conversion rate of USD 1 = IDR 14,200.&#xD;
  &#xD;
        In addition, the investigators assessed the adherence of patients in the ERAS group to the&#xD;
        ERAS protocol. Each implemented protocol component was recorded, and the number of protocols&#xD;
        that could be implemented for each patient was calculated. The adherence to the eighteen ERAS&#xD;
        protocols was grouped into: &lt;90%, 90-95%, 96-100% for readmission, complications, length of&#xD;
        stay &lt;7 days, and costs &lt; USD 3,000 for patients in the ERAS group based on a previous study.&#xD;
        The controlled price of USD 3,000 is determined based on hospital's average cost of the&#xD;
        non-ERAS group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2020</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 10, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>30 Days</target_duration>
    <primary_outcome>
      <measure>length of hospitalization</measure>
      <time_frame>day 1 until day 30</time_frame>
      <description>The length of hospitalization was calculated from the day of admission to the hospital ward until the discharge</description>
    </primary_outcome>
    <primary_outcome>
      <measure>postoperative complications</measure>
      <time_frame>day 1 until day 30</time_frame>
      <description>Postoperative complications were defined as infection on the surgical site or systemic infection, wound dehiscence, and other complications found after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>readmission rate</measure>
      <time_frame>day 1 until day 30</time_frame>
      <description>The readmission rate was calculated from discharge to one month after surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total medical costs</measure>
      <time_frame>day 1 until day 30</time_frame>
      <description>Total medical costs were calculated based on direct medical costs recorded in the hospital billing data. The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the September 1, 2022, conversion rate of USD 1 = IDR 14,200.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>adherence to the ERAS protocols</measure>
      <time_frame>day 1 until day 30</time_frame>
      <description>The adherence to the eighteen ERAS protocols was grouped into: &lt;90%, 90-95%, 96-100% for readmission, complications, length of stay &lt;7 days, and costs &lt; USD 3,000 for patients in the ERAS group based on a previous study</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">84</enrollment>
    <condition>Enhanced Recovery After Surgery (ERAS) Protocol</condition>
    <condition>Colorectal Surgery</condition>
    <condition>Effectivity</condition>
    <condition>Colorectal Neoplasms</condition>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>ERAS group</arm_group_label>
      <description>Patients who met the inclusion criteria and consented were assigned to the ERAS group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>Patients who met the inclusion criteria and did not consent were assigned to the ERAS group</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Colorectal cancer patients undergoing surgery at Dr. Cipto Mangunkusumo General Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  maximum of two different comorbidities&#xD;
  &#xD;
            -  body mass index above 18.5 kg/m2&#xD;
  &#xD;
            -  ASA below 2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  More than 2 comorbidities&#xD;
  &#xD;
            -  Refused to take part in the research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Dr. Cipto Mangunkusumo General Hospital</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10440</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <reference>
      <citation>Andreoni B, Chiappa A, Bertani E, Bellomi M, Orecchia R, Zampino M, Fazio N, Venturino M, Orsi F, Sonzogni A, Pace U, Monfardini L. Surgical outcomes for colon and rectal cancer over a decade: results from a consecutive monocentric experience in 902 unselected patients. World J Surg Oncol. 2007 Jul 4;5:73. doi: 10.1186/1477-7819-5-73.</citation>
      <PMID>17610720</PMID>
    </reference>
    <reference>
      <citation>Tevis SE, Kennedy GD. Postoperative Complications: Looking Forward to a Safer Future. Clin Colon Rectal Surg. 2016 Sep;29(3):246-52. doi: 10.1055/s-0036-1584501.</citation>
      <PMID>27582650</PMID>
    </reference>
    <reference>
      <citation>Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.</citation>
      <PMID>30207593</PMID>
    </reference>
    <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>Tan JKH, Ang JJ, Chan DKH. Enhanced recovery program versus conventional care after colorectal surgery in the geriatric population: a systematic review and meta-analysis. Surg Endosc. 2021 Jun;35(6):3166-3174. doi: 10.1007/s00464-020-07673-7. Epub 2020 May 28.</citation>
      <PMID>32468264</PMID>
    </reference>
    <reference>
      <citation>Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.</citation>
      <PMID>24781574</PMID>
    </reference>
    <reference>
      <citation>Li L, Jin J, Min S, Liu D, Liu L. Compliance with the enhanced recovery after surgery protocol and prognosis after colorectal cancer surgery: A prospective cohort study. Oncotarget. 2017 Jun 22;8(32):53531-53541. doi: 10.18632/oncotarget.18602. eCollection 2017 Aug 8. Erratum In: Oncotarget. 2017 Oct 27;8(52):90605.</citation>
      <PMID>28881829</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Dr Cipto Mangunkusumo General Hospital</investigator_affiliation>
      <investigator_full_name>Ridho Ardhi Syaiful</investigator_full_name>
      <investigator_title>Medical Doctor, Digestive Surgery</investigator_title>
    </responsible_party>
    <keyword>Enhanced Recovery After Surgery (ERAS) protocol</keyword>
    <keyword>Outcome</keyword>
    <keyword>colorectal surgery</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/NCT06010225
  org study id: DRCiptoMGH
  nct id: NCT06010225
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: Successful colorectal surgery is determined based on postoperative mortality
        and morbidity rates, complication rates, and cost-effectiveness. One of the methods to obtain
        an excellent postoperative outcome is the Enhanced Recovery After Surgery (ERAS) protocol.
        This study aims to see the effects of implementing an ERAS protocol in colorectal surgery
        patients.
  
        Methods: Eighty-four patients who underwent elective colorectal surgery at National
        Tertiary-level Hospital were included between January 2021 and July 2022. Patients were then
        placed into ERAS and control groups according to the criteria. The Patients in the ERAS group
        underwent a customized 18-component ERAS protocol and were assessed for adherence.
        Postoperatively, both groups were monitored for up to 30 days and assessed for complications
        and readmission. The investigators then analyzed the length of stay and total patient costs
        in both groups.
  The investigators aimed to determine whether applying the ERAS protocol to patients
        undergoing colorectal surgery could improve surgical outcomes (length of stay, complications,
        readmission, and total costs) in the National Tertiary Hospital clinical setting.
  
        This prospective cohort study to analyze the implementation of ERAS protocol in colorectal
        patients and its effect on length of stay, readmission rate, complications, and costs in Dr.
        Cipto Mangunkusumo General Hospital, an Indonesian tertiary-level hospital, from January 2021
        to July 2022. ERAS protocol used in this study was arranged based on the guidelines of the
        ERAS ® Society, with certain adjustments made to fit Indonesia's population characteristics.
        The sampling process was performed for all patients undergoing elective colorectal surgeries
        in The Central Surgery Room during the study period, who continued their medical care at
        Integrated Medical Ward Unit and fulfilled all inclusion and exclusion criteria. In this
        study, the investigators also used a multidisciplinary team approach that carried out various
        protocol points in all phases, according to their areas of expertise. This team comprised
        surgeons, anesthesiologists, physical medicine, internists, rehabilitation specialists,
        general physicians, dietitians, nurses, pharmacists, surgery admission staff, medical record
        staff, and hospital administration staff.
  
        Study participants The investigators evaluated patients in two different groups: ERAS and
        non-ERAS. In both groups, the investigators included patients who underwent
        elective/non-emergency colorectal surgery above 18 years of age, with a maximum of two
        different comorbidities to minimize postoperative complications, a body mass index above 18.5
        kg/m2, and an ASA below 2. In the ERAS group, patients were first evaluated for eligibility
        for the ERAS protocol and their willingness to follow a series of ERAS protocols at the
        outpatient clinic of the Cipto Mangunkusumo Hospital. The Patients registered in the ERAS
        group followed the protocol of the ERAS research team. For the control group, patients
        selected through examination in the outpatient clinic would undergo conventional/traditional
        surgery.
  
        The sample size was calculated using an unpaired numerical, analytical research sample size
        formula, with an alpha of 5%, a beta of 10%, a combined standard deviation of four based on
        previous studies, and an assumed mean outcome difference of 3. To obtain a minimum sample
        size for each group of 37 subjects.
  
        Outcomes The primary outcomes of this study were: (1) the length of hospitalization, (2)
        postoperative complications, (3) readmission rate, and (4) total medical costs. The length of
        hospitalization was calculated from the day of admission to the hospital ward until
        discharge. Postoperative complications were defined as infection on the surgical site or
        systemic infection, wound dehiscence, and other complications found after surgery. The
        readmission rate was calculated from discharge to one month after surgery. Total medical
        costs were calculated based on direct medical costs recorded in the hospital billing data.
        The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the
        September 1, 2022, conversion rate of USD 1 = IDR 14,200.
  
        In addition, the investigators assessed the adherence of patients in the ERAS group to the
        ERAS protocol. Each implemented protocol component was recorded, and the number of protocols
        that could be implemented for each patient was calculated. The adherence to the eighteen ERAS
        protocols was grouped into: <90%, 90-95%, 96-100% for readmission, complications, length of
        stay <7 days, and costs < USD 3,000 for patients in the ERAS group based on a previous study.
        The controlled price of USD 3,000 is determined based on hospital's average cost of the
        non-ERAS group.
  observational model: Cohort
  time perspective: Prospective
  measure: length of hospitalization
  time frame: day 1 until day 30
  description: The length of hospitalization was calculated from the day of admission to the hospital ward until the discharge
  measure: postoperative complications
  time frame: day 1 until day 30
  description: Postoperative complications were defined as infection on the surgical site or systemic infection, wound dehiscence, and other complications found after surgery
  measure: readmission rate
  time frame: day 1 until day 30
  description: The readmission rate was calculated from discharge to one month after surgery.
  measure: Total medical costs
  time frame: day 1 until day 30
  description: Total medical costs were calculated based on direct medical costs recorded in the hospital billing data. The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the September 1, 2022, conversion rate of USD 1 = IDR 14,200.
  measure: adherence to the ERAS protocols
  time frame: day 1 until day 30
  description: The adherence to the eighteen ERAS protocols was grouped into: <90%, 90-95%, 96-100% for readmission, complications, length of stay <7 days, and costs < USD 3,000 for patients in the ERAS group based on a previous study
  arm group label: ERAS group
  description: Patients who met the inclusion criteria and consented were assigned to the ERAS group
  arm group label: control group
  description: Patients who met the inclusion criteria and did not consent were assigned to the ERAS group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  facility: 
  country: Indonesia
  citation: Andreoni B, Chiappa A, Bertani E, Bellomi M, Orecchia R, Zampino M, Fazio N, Venturino M, Orsi F, Sonzogni A, Pace U, Monfardini L. Surgical outcomes for colon and rectal cancer over a decade: results from a consecutive monocentric experience in 902 unselected patients. World J Surg Oncol. 2007 Jul 4;5:73. doi: 10.1186/1477-7819-5-73.
  PMID: 17610720
  citation: Tevis SE, Kennedy GD. Postoperative Complications: Looking Forward to a Safer Future. Clin Colon Rectal Surg. 2016 Sep;29(3):246-52. doi: 10.1055/s-0036-1584501.
  PMID: 27582650
  citation: Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
  PMID: 30207593
  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: Tan JKH, Ang JJ, Chan DKH. Enhanced recovery program versus conventional care after colorectal surgery in the geriatric population: a systematic review and meta-analysis. Surg Endosc. 2021 Jun;35(6):3166-3174. doi: 10.1007/s00464-020-07673-7. Epub 2020 May 28.
  PMID: 32468264
  citation: Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.
  PMID: 24781574
  citation: Li L, Jin J, Min S, Liu D, Liu L. Compliance with the enhanced recovery after surgery protocol and prognosis after colorectal cancer surgery: A prospective cohort study. Oncotarget. 2017 Jun 22;8(32):53531-53541. doi: 10.18632/oncotarget.18602. eCollection 2017 Aug 8. Erratum In: Oncotarget. 2017 Oct 27;8(52):90605.
  PMID: 28881829
  responsible party type: Sponsor-Investigator
  investigator affiliation: Dr Cipto Mangunkusumo General Hospital
  investigator full name: Ridho Ardhi Syaiful
  investigator title: Medical Doctor, Digestive Surgery
  mesh term: Colorectal Neoplasms