<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/NCT04500405</url>
  </required_header>
  <id_info>
    <org_study_id>202003113RINB</org_study_id>
    <nct_id>NCT04500405</nct_id>
  </id_info>
  <brief_title>Outcomes of Patients With Diverticulitis and Risk Factors for Recurrence</brief_title>
  <official_title>Long-term Outcomes of Patients With Diverticulitis and Risk Factors for Recurrence: a Multi-center Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <brief_summary>
    <textblock>
      In the Emergency Department (ED), patients with acute diverticulitis usually present with&#xD;
      acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the&#xD;
      diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent&#xD;
      diverticulitis cost medical burden. The studies focusing on potential risk factors of&#xD;
      recurrent diverticulitis, especially for those after an episode of acute diverticulitis, are&#xD;
      limited.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diverticular disease of the colon is common in industrial countries and has significant&#xD;
      impact on patient health as well as health care cost. It is common in both Western countries&#xD;
      and some Asian countries. For example, in the past, colonic diverticulosis was rare in Japan;&#xD;
      with detection rates as low as approximately 2% in 1960. The detection rate increased to&#xD;
      approximately 20% in the 1980s and 1990s. Studies have reported that increasing rates of&#xD;
      diverticulosis are caused by westernization of the diet in Asian countries and are becoming a&#xD;
      medical concern. Diverticular disease-associated hospital admissions have risen steeply in&#xD;
      the recent past, which are not completely accounted for by the increasingly aging population&#xD;
      of western countries. Approximately 130,000 hospitalizations occurring every year in the&#xD;
      United States are attributable to diverticular disease. An analysis of the age-adjusted&#xD;
      hospitalization rate of diverticulitis in the United States showed an increase from 62 per&#xD;
      100,000 in 1998 to 76 per 100,000 in 2005. These admission rates increased most in younger&#xD;
      patients (&lt; 45 years old) and have remained unchanged in patients older than 65 years. In&#xD;
      spite of low mortality rate in patients with acute diverticulitis, moderate to severe&#xD;
      comorbidities occur in specific patient group.&#xD;
&#xD;
      Painter and Burkitt hypothesized it in their article in 1960s and 1970s. They based their&#xD;
      hypothesis on the observation that individuals in different geographic locations such as&#xD;
      western industrialized countries versus those in developing countries were noted to have&#xD;
      different rates of prevalence. They postulated that those in industrialized nations tended to&#xD;
      eat processed food that was low in fiber compared with individuals in Africa and Asia, where&#xD;
      the disease was previously unknown.&#xD;
&#xD;
      The USA Health Professional study showed a higher risk of diverticulitis in men with higher&#xD;
      body mass index (BMI), waist-to-hip ratio and waist circumference [8]. Obesity also&#xD;
      significantly increases costs associated with management of the disease and its complications&#xD;
      [9]. The effect of obesity on the risk of recurrent diverticulitis is unknown.&#xD;
&#xD;
      In the Emergency Department (ED), patients with acute diverticulitis usually present with&#xD;
      acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the&#xD;
      diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent&#xD;
      diverticulitis cost medical burden. The studies focusing on potential risk factors of&#xD;
      recurrent diverticulitis, especially for those after an episode of acute diverticulitis, are&#xD;
      limited.&#xD;
&#xD;
      This is a retrospective cohort study conduct from Oct 2008 to Sep 2018. The patients were&#xD;
      recruited from National Taiwan University Hospital (NTUH), NTUH Hsin-Chu Branch (HCH), and&#xD;
      NTUH Yun-Lin Branch.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Actual">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 31, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>recurrence after the first episode of diverticulitis</measure>
    <time_frame>5 years</time_frame>
    <description>recurrence after the first episode of diverticulitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The diagnostic accuracy between the sonographic diagnosis and final diagnosis</measure>
    <time_frame>one month</time_frame>
    <description>The final diagnosis was referred to the diagnosis that two expert physicians reviewed the medical records</description>
  </secondary_outcome>
  <enrollment type="Actual">1500</enrollment>
  <condition>Recurrence</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who (a) visited ED from Oct 2008 to Sep 2018; (b) were diagnosed as&#xD;
        diverticulitis by computed tomography (CT); (c) were aged over 20.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patients who (a) visited ED from Oct 2008 to Sep 2018; (b) were diagnosed as&#xD;
             diverticulitis by computed tomography (CT); (c) were aged over 20.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patients who (a) received CT at other hospital and lost image; (b) lost the&#xD;
             follow-up after index ED admission.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wan-Ching Lien, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lien</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diverticulitis</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- 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/NCT04500405
org study id: 202003113RINB
nct id: NCT04500405
lead sponsor: 
In the Emergency Department (ED), patients with acute diverticulitis usually present with
      acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the
      diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent
      diverticulitis cost medical burden. The studies focusing on potential risk factors of
      recurrent diverticulitis, especially for those after an episode of acute diverticulitis, are
      limited.
Diverticular disease of the colon is common in industrial countries and has significant
      impact on patient health as well as health care cost. It is common in both Western countries
      and some Asian countries. For example, in the past, colonic diverticulosis was rare in Japan;
      with detection rates as low as approximately 2% in 1960. The detection rate increased to
      approximately 20% in the 1980s and 1990s. Studies have reported that increasing rates of
      diverticulosis are caused by westernization of the diet in Asian countries and are becoming a
      medical concern. Diverticular disease-associated hospital admissions have risen steeply in
      the recent past, which are not completely accounted for by the increasingly aging population
      of western countries. Approximately 130,000 hospitalizations occurring every year in the
      United States are attributable to diverticular disease. An analysis of the age-adjusted
      hospitalization rate of diverticulitis in the United States showed an increase from 62 per
      100,000 in 1998 to 76 per 100,000 in 2005. These admission rates increased most in younger
      patients (< 45 years old) and have remained unchanged in patients older than 65 years. In
      spite of low mortality rate in patients with acute diverticulitis, moderate to severe
      comorbidities occur in specific patient group.

      Painter and Burkitt hypothesized it in their article in 1960s and 1970s. They based their
      hypothesis on the observation that individuals in different geographic locations such as
      western industrialized countries versus those in developing countries were noted to have
      different rates of prevalence. They postulated that those in industrialized nations tended to
      eat processed food that was low in fiber compared with individuals in Africa and Asia, where
      the disease was previously unknown.

      The USA Health Professional study showed a higher risk of diverticulitis in men with higher
      body mass index (BMI), waist-to-hip ratio and waist circumference [8]. Obesity also
      significantly increases costs associated with management of the disease and its complications
      [9]. The effect of obesity on the risk of recurrent diverticulitis is unknown.

      In the Emergency Department (ED), patients with acute diverticulitis usually present with
      acute abdominal pain. Sometimes, or mostly, it is an exclusive diagnosis, meaning that the
      diagnosis would be made after other emergent and acute abdomens are excluded. The recurrent
      diverticulitis cost medical burden. The studies focusing on potential risk factors of
      recurrent diverticulitis, especially for those after an episode of acute diverticulitis, are
      limited.

      This is a retrospective cohort study conduct from Oct 2008 to Sep 2018. The patients were
      recruited from National Taiwan University Hospital (NTUH), NTUH Hsin-Chu Branch (HCH), and
      NTUH Yun-Lin Branch.
observational model: Cohort
time perspective: Retrospective
measure: recurrence after the first episode of diverticulitis
time frame: 5 years
description: recurrence after the first episode of diverticulitis
measure: The diagnostic accuracy between the sonographic diagnosis and final diagnosis
time frame: one month
description: The final diagnosis was referred to the diagnosis that two expert physicians reviewed the medical records
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Wan-Ching Lien, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Diverticulitis
mesh term: Recurrence