<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/NCT03791229</url>
  </required_header>
  <id_info>
    <org_study_id>SAU14113</org_study_id>
    <nct_id>NCT03791229</nct_id>
  </id_info>
  <brief_title>Pain and Discomfort After Appendectomy in Children</brief_title>
  <official_title>The Evaluation of Pain and Discomfort After Appendectomy in Children and Their Effects on Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya 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>
      Appendectomy is the most common surgical procedure. Chronic abdominal pain is an uncommon&#xD;
      complication following appendectomy. It is observed that pediatric patients who have&#xD;
      undergone abdominal surgical procedure complained of pain and discomfort in the postoperative&#xD;
      period and these complaints may affect quality of life. We aimed to investigate the presence&#xD;
      of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent&#xD;
      appendectomy and their social and physical effects. The records of children aged 8-18 years&#xD;
      who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA)&#xD;
      classification score, the type of surgical procedure, and anesthetic technique were obtained.&#xD;
      Children had inclusions crietrias, pain was assessed using numerical rating scale and their&#xD;
      effects on life were assessed Pediatric Quality of Life Inventory parent and child versions&#xD;
      questionnaire at sixth months after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute appendicitis is a diagnosis with clinical findings, laboratory tests and radiological&#xD;
      imaging. The main pathology of appendicitis is usually the onset of the inflammatory process&#xD;
      in the appendix vermiformis in the right lower abdomen. If untreated, the inflammatory&#xD;
      process may progress to the perforation of the appendix and develop peritonitis. Appendectomy&#xD;
      is an emergency surgical procedure for treatments of patients diagnosed with acute&#xD;
      appendicitis and is the most common surgical procedure (1). Complications of appendectomy are&#xD;
      wound site infection, postoperative intestinal adhesions and obstruction, peritonitis,&#xD;
      bleeding, inguinal hernia, and chronic abdominal pain.&#xD;
&#xD;
      It is observed that pediatric patients who have undergone abdominal surgical procedure&#xD;
      complained of pain and discomfort in the postoperative period (2). It should be noted that&#xD;
      these complaints may affect quality of life. To the best of our knowledge, since there is no&#xD;
      study in the literature, we aimed to investigate the presence of postoperative chronic&#xD;
      abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their&#xD;
      social and physical effects.&#xD;
&#xD;
      After Local Ethics Committee approval had been obtained, the records of children aged 8-18&#xD;
      years who underwent appendectomy, such as age, gender, American Society of Anesthesiology&#xD;
      (ASA) classification score, the type of surgical procedure, and anesthetic technique were&#xD;
      obtained from hospital information management system and anesthetic charts. Inclusion&#xD;
      criterias were children between the ages of 8-18 years who underwent appendectomy, had ASA I&#xD;
      physical score, and those who agree to participate for this research. Children who aged under&#xD;
      8 and over 18 years, had ASA II and those with higher physical score, had previously&#xD;
      undergone surgery from the right lower abdomen, had preoperative pain complaint over 6 month,&#xD;
      had psychiatric disorders, and whose parents do not agree to participate were excluded in&#xD;
      this study. By calling parents, at the 6th month after the surgical procedure, the presence&#xD;
      of chronic pain and discomfort were asked via face to face or talking on the phone. The&#xD;
      primary endpoint of this study is to investigate the prevalence of chronic pain and&#xD;
      discomfort at the 6th month after appendectomy in pediatric patients. The secondary endpoint&#xD;
      is to determine the effects of chronic pain on the children's quality of life.&#xD;
&#xD;
      Pain was defined as the presence of intermittent or continuous hurtfully sensation.&#xD;
      Discomfort was defined as an abnormal bad feeling. Children were asked whether they felt pain&#xD;
      or discomfort while resting, coughing, and exercise. Pain was assessed using verbal numeric&#xD;
      rating scale. Their effects on life were assessed Pediatric Quality of Life Inventory parent&#xD;
      and child versions questionnaire at sixth months after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Prevalence of chronic pain</measure>
    <time_frame>at the 6th month after appendectomy in pediatric patients</time_frame>
    <description>The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort. Chronic pain is going to be assessed using numeric rating scale (NRS). The NRS for pain is a unidimensional measure of pain intensity in adults and children. The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., &quot;nopain&quot;) and 10 representing the other pain extreme (e.g.,&quot;pain as bad as you can imagine&quot; and &quot;worst pain imag-inable&quot;). 0 point represents &quot;no pain&quot;, 1-3 &quot;mild pain&quot;, 4-6 &quot;moderate pain&quot;, 7-10 &quot;severe pain&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the effects of chronic pain on quality of life</measure>
    <time_frame>at the 6th month after appendectomy in pediatric patients</time_frame>
    <description>The secondary endpoint is to determine the effects of chronic pain on the children's quality of life. Pediatric Quality of Life Inventory Parent and Child Versions (PedQL-P and C) is going to apply to children which report chronic pain and discomfort for evaluating their effects on quality of life.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Appendicitis</condition>
  <condition>Chronic Post-Procedural Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 8-18 years who underwent appendectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between the ages of 8-18 years who underwent appendectomy,&#xD;
&#xD;
          -  who had ASA I physical score&#xD;
&#xD;
          -  who agree to participate for this research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who aged under 8 and over 18 years,&#xD;
&#xD;
          -  who had ASA II and those with higher physical score,&#xD;
&#xD;
          -  who had previously undergone surgery from the right lower abdomen,&#xD;
&#xD;
          -  who had preoperative pain complaint over 6 month,&#xD;
&#xD;
          -  who had psychiatric disorders,&#xD;
&#xD;
          -  who do not agree to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Onur Palabiyik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakarya University School of Medicine, Department of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sakarya University School of Medicine Department of Anesthesiology</name>
      <address>
        <city>Sakarya</city>
        <state>Adapazari</state>
        <zip>54100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>Onur Palabiyik</investigator_full_name>
    <investigator_title>Assistant Professor, Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Appendectomy</keyword>
  <keyword>Chronic abdominal pain</keyword>
  <keyword>Discomfort</keyword>
  <keyword>Numerical rating scale</keyword>
  <keyword>Pediatric quality of life inventory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 9, 2021</submitted>
    <returned>January 29, 2021</returned>
  </pending_results>
  <!-- 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/NCT03791229
org study id: SAU14113
nct id: NCT03791229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Appendectomy is the most common surgical procedure. Chronic abdominal pain is an uncommon
      complication following appendectomy. It is observed that pediatric patients who have
      undergone abdominal surgical procedure complained of pain and discomfort in the postoperative
      period and these complaints may affect quality of life. We aimed to investigate the presence
      of postoperative chronic abdominal pain and discomfort in children aged 8-18 years underwent
      appendectomy and their social and physical effects. The records of children aged 8-18 years
      who underwent appendectomy, such as age, gender, American Society of Anesthesiology (ASA)
      classification score, the type of surgical procedure, and anesthetic technique were obtained.
      Children had inclusions crietrias, pain was assessed using numerical rating scale and their
      effects on life were assessed Pediatric Quality of Life Inventory parent and child versions
      questionnaire at sixth months after surgery.
Acute appendicitis is a diagnosis with clinical findings, laboratory tests and radiological
      imaging. The main pathology of appendicitis is usually the onset of the inflammatory process
      in the appendix vermiformis in the right lower abdomen. If untreated, the inflammatory
      process may progress to the perforation of the appendix and develop peritonitis. Appendectomy
      is an emergency surgical procedure for treatments of patients diagnosed with acute
      appendicitis and is the most common surgical procedure (1). Complications of appendectomy are
      wound site infection, postoperative intestinal adhesions and obstruction, peritonitis,
      bleeding, inguinal hernia, and chronic abdominal pain.

      It is observed that pediatric patients who have undergone abdominal surgical procedure
      complained of pain and discomfort in the postoperative period (2). It should be noted that
      these complaints may affect quality of life. To the best of our knowledge, since there is no
      study in the literature, we aimed to investigate the presence of postoperative chronic
      abdominal pain and discomfort in children aged 8-18 years underwent appendectomy and their
      social and physical effects.

      After Local Ethics Committee approval had been obtained, the records of children aged 8-18
      years who underwent appendectomy, such as age, gender, American Society of Anesthesiology
      (ASA) classification score, the type of surgical procedure, and anesthetic technique were
      obtained from hospital information management system and anesthetic charts. Inclusion
      criterias were children between the ages of 8-18 years who underwent appendectomy, had ASA I
      physical score, and those who agree to participate for this research. Children who aged under
      8 and over 18 years, had ASA II and those with higher physical score, had previously
      undergone surgery from the right lower abdomen, had preoperative pain complaint over 6 month,
      had psychiatric disorders, and whose parents do not agree to participate were excluded in
      this study. By calling parents, at the 6th month after the surgical procedure, the presence
      of chronic pain and discomfort were asked via face to face or talking on the phone. The
      primary endpoint of this study is to investigate the prevalence of chronic pain and
      discomfort at the 6th month after appendectomy in pediatric patients. The secondary endpoint
      is to determine the effects of chronic pain on the children's quality of life.

      Pain was defined as the presence of intermittent or continuous hurtfully sensation.
      Discomfort was defined as an abnormal bad feeling. Children were asked whether they felt pain
      or discomfort while resting, coughing, and exercise. Pain was assessed using verbal numeric
      rating scale. Their effects on life were assessed Pediatric Quality of Life Inventory parent
      and child versions questionnaire at sixth months after surgery.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of chronic pain
time frame: at the 6th month after appendectomy in pediatric patients
description: The primary endpoint of this study is to investigate the prevalence of chronic pain and discomfort. Chronic pain is going to be assessed using numeric rating scale (NRS). The NRS for pain is a unidimensional measure of pain intensity in adults and children. The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "nopain") and 10 representing the other pain extreme (e.g.,"pain as bad as you can imagine" and "worst pain imag-inable"). 0 point represents "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain".
measure: the effects of chronic pain on quality of life
time frame: at the 6th month after appendectomy in pediatric patients
description: The secondary endpoint is to determine the effects of chronic pain on the children's quality of life. Pediatric Quality of Life Inventory Parent and Child Versions (PedQL-P and C) is going to apply to children which report chronic pain and discomfort for evaluating their effects on quality of life.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Onur Palabiyik, MD
role: Principal Investigator
affiliation: Sakarya University School of Medicine, Department of Anesthesiology
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: Onur Palabiyik
investigator title: Assistant Professor, Medical Doctor
mesh term: Appendicitis
mesh term: Pain, Procedural
sharing ipd: No
submitted: January 9, 2021
returned: January 29, 2021