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/NCT05962320</url>
    </required_header>
    <id_info>
      <org_study_id>KaradenizTU</org_study_id>
      <nct_id>NCT05962320</nct_id>
    </id_info>
    <brief_title>Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy</brief_title>
    <official_title>Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karadeniz Technical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karadeniz Technical University</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>
        Acute appendicitis is the most common abdominal emergency with more than 15 million cases&#xD;
        reported worldwide. Although appendectomy is considered a safe surgical procedure, the&#xD;
        incidence of complications is up to 10%. The Enhanced Recovery After Surgery (ERAS) has&#xD;
        developed guidelines to improve postoperative patient outcomes. The protocol, which consists&#xD;
        of more than 20 interventions in the preoperative, intraoperative and postoperative periods,&#xD;
        shows that early discharge can be possible with multidisciplinary care given to surgical&#xD;
        patients without risking patient safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Appendicitis is a common clinical condition and often requires emergency treatment. Although&#xD;
        appendectomy is a safe surgical procedure, there is a risk of complications. Pain is common,&#xD;
        especially in the postoperative period, and the lack of care management leads to delayed&#xD;
        mobilization and oral intake, delayed recovery and prolonged length of hospital stay.&#xD;
        However, pain, nausea-vomiting, thirst, fear and stress could be managed with perioperative&#xD;
        care. In addition, it is reported that the care provided based on the ERAS protocol shortens&#xD;
        the length of hospital stay. In this respect, the aim of this study was to investigate the&#xD;
        effect of ERAS protocol-based care on the length of hospital stay of children who were&#xD;
        planned to undergo appendectomy. Postoperative pain level, stress and fear level, time to&#xD;
        first mobilization, flatulence, defecation and oral intake, nausea, thirst were the secondary&#xD;
        outcomes of this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hospital length of stay</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>up to 30 days after discharge</time_frame>
      <description>Postoperative minor and major complications will be recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission</measure>
      <time_frame>up to 30 days after discharge</time_frame>
      <description>Readmission to the hospital will be recorded in hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative fear</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative anxiety</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nausea-vomiting</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative thirst</measure>
      <time_frame>up to the first oral intake, an average 2 days</time_frame>
      <description>Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of first mobilization</measure>
      <time_frame>up to the first mobilization, an average 12 hours</time_frame>
      <description>The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of first defecation</measure>
      <time_frame>up to the first defecation, an average 3 days</time_frame>
      <description>The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>ERAS</condition>
    <condition>Surgery</condition>
    <condition>Appendicitis</condition>
    <arm_group>
      <arm_group_label>mERAS Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Education and counselling of patients and their parents&#xD;
  Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible&#xD;
  Stimulation of intestinal motility in the postoperative period&#xD;
  Initiation of oral intake in the early postoperative period&#xD;
  Early removal of the patient by reducing postoperative IV fluid infusion&#xD;
  Initiation of early mobilization of the patient in the postoperative period&#xD;
  Reducing opioid use and ensuring pain management&#xD;
  Implement nausea and vomiting prophylaxis&#xD;
  Management of thirsty&#xD;
  Management of fear and stress</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standart Care Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education and counselling</intervention_name>
      <description>Education and counselling of patients and their parents</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Avoiding the use of nasogastric catheters, drains and urinary catheters</intervention_name>
      <description>Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stimulation of intestinal motility in the postoperative period</intervention_name>
      <description>Stimulation of intestinal motility in the postoperative period</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Initiation of oral intake in the early postoperative period</intervention_name>
      <description>Initiation of oral intake in the early postoperative period</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Early removal of the patient by reducing postoperative IV fluid infusion</intervention_name>
      <description>Early removal of the patient by reducing postoperative IV fluid infusion</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Initiation of early mobilization of the patient in the postoperative period</intervention_name>
      <description>Initiation of early mobilization of the patient in the postoperative period</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Reducing opioid use and ensuring pain management</intervention_name>
      <description>Reducing opioid use and ensuring pain management</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Implement nausea and vomiting prophylaxis</intervention_name>
      <description>Implement nausea and vomiting prophylaxis</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Management of thirsty</intervention_name>
      <description>Management of thirsty</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Management of fear and stress</intervention_name>
      <description>Use of recommended non-pharmacological interventions in the management of fear and stress</description>
      <arm_group_label>mERAS Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥6 years and ≤18 years, girls or boys&#xD;
  &#xD;
            -  Underwent appendectomy&#xD;
  &#xD;
            -  Written informed consent or requirements of local/national ethical committee&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA (American Society of Anesthesiologists, ASA) score of ≥ 3&#xD;
  &#xD;
            -  Any comorbidity/contraindication that may prevent mobilization and oral feeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Buket MERAL, Msc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Karadeniz Technical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Buket MERAL, Msc</last_name>
      <phone>+90 4622300476</phone>
      <email>buketguvenir@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karadeniz Technical University</name>
        <address>
          <city>Trabzon</city>
          <zip>61080</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Buket MERAL</last_name>
        <phone>+90 4622300476</phone>
        <email>buketguvenir@hotmail.com</email>
      </contact>
      <investigator>
        <last_name>Birsen Mutlu, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hatice Sonay Yalcın Cömert, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
      <investigator_full_name>Buket MERAL</investigator_full_name>
      <investigator_title>Research asistant - MSc</investigator_title>
    </responsible_party>
    <keyword>Appendectomy</keyword>
    <keyword>Nurse</keyword>
    <keyword>Child</keyword>
    <keyword>Pain</keyword>
    <keyword>Length of Stay</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Fear</keyword>
    <keyword>Vomiting</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Appendicitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Analgesics, Opioid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05962320
  org study id: KaradenizTU
  nct id: NCT05962320
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Acute appendicitis is the most common abdominal emergency with more than 15 million cases
        reported worldwide. Although appendectomy is considered a safe surgical procedure, the
        incidence of complications is up to 10%. The Enhanced Recovery After Surgery (ERAS) has
        developed guidelines to improve postoperative patient outcomes. The protocol, which consists
        of more than 20 interventions in the preoperative, intraoperative and postoperative periods,
        shows that early discharge can be possible with multidisciplinary care given to surgical
        patients without risking patient safety.
  Appendicitis is a common clinical condition and often requires emergency treatment. Although
        appendectomy is a safe surgical procedure, there is a risk of complications. Pain is common,
        especially in the postoperative period, and the lack of care management leads to delayed
        mobilization and oral intake, delayed recovery and prolonged length of hospital stay.
        However, pain, nausea-vomiting, thirst, fear and stress could be managed with perioperative
        care. In addition, it is reported that the care provided based on the ERAS protocol shortens
        the length of hospital stay. In this respect, the aim of this study was to investigate the
        effect of ERAS protocol-based care on the length of hospital stay of children who were
        planned to undergo appendectomy. Postoperative pain level, stress and fear level, time to
        first mobilization, flatulence, defecation and oral intake, nausea, thirst were the secondary
        outcomes of this study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Hospital length of stay
  time frame: up to 2 weeks
  description: The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.
  measure: Complications
  time frame: up to 30 days after discharge
  description: Postoperative minor and major complications will be recorded.
  measure: Readmission
  time frame: up to 30 days after discharge
  description: Readmission to the hospital will be recorded in hours.
  measure: Postoperative pain
  time frame: up to 2 weeks
  description: Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome
  measure: Postoperative fear
  time frame: up to 2 weeks
  description: Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.
  measure: Postoperative anxiety
  time frame: up to 2 weeks
  description: Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.
  measure: Postoperative nausea-vomiting
  time frame: up to 2 weeks
  description: Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome
  measure: Postoperative thirst
  time frame: up to the first oral intake, an average 2 days
  description: Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.
  measure: Time of first mobilization
  time frame: up to the first mobilization, an average 12 hours
  description: The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.
  measure: Time of first defecation
  time frame: up to the first defecation, an average 3 days
  description: The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.
  arm group label: mERAS Group
  arm group type: Experimental
  description: Education and counselling of patients and their parents
  Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
  Stimulation of intestinal motility in the postoperative period
  Initiation of oral intake in the early postoperative period
  Early removal of the patient by reducing postoperative IV fluid infusion
  Initiation of early mobilization of the patient in the postoperative period
  Reducing opioid use and ensuring pain management
  Implement nausea and vomiting prophylaxis
  Management of thirsty
  Management of fear and stress
  arm group label: Standart Care Group
  arm group type: No Intervention
  description: Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.
  intervention type: Other
  intervention name: Education and counselling
  description: Education and counselling of patients and their parents
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Avoiding the use of nasogastric catheters, drains and urinary catheters
  description: Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Stimulation of intestinal motility in the postoperative period
  description: Stimulation of intestinal motility in the postoperative period
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Initiation of oral intake in the early postoperative period
  description: Initiation of oral intake in the early postoperative period
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Early removal of the patient by reducing postoperative IV fluid infusion
  description: Early removal of the patient by reducing postoperative IV fluid infusion
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Initiation of early mobilization of the patient in the postoperative period
  description: Initiation of early mobilization of the patient in the postoperative period
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Reducing opioid use and ensuring pain management
  description: Reducing opioid use and ensuring pain management
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Implement nausea and vomiting prophylaxis
  description: Implement nausea and vomiting prophylaxis
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Management of thirsty
  description: Management of thirsty
  arm group label: mERAS Group
  intervention type: Other
  intervention name: Management of fear and stress
  description: Use of recommended non-pharmacological interventions in the management of fear and stress
  arm group label: mERAS Group
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Buket MERAL, Msc
  role: Principal Investigator
  affiliation: Karadeniz Technical University
  last name: Buket MERAL, Msc
  phone: +90 4622300476
  email: buketguvenir@hotmail.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Karadeniz Technical University
  investigator full name: Buket MERAL
  investigator title: Research asistant - MSc
  mesh term: Appendicitis
  mesh term: Analgesics, Opioid
  sharing ipd: No