<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/NCT03002662</url>
  </required_header>
  <id_info>
    <org_study_id>2016.5/8-19</org_study_id>
    <nct_id>NCT03002662</nct_id>
  </id_info>
  <brief_title>Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</source>
  <brief_summary>
    <textblock>
      During colonoscopy, body mass index, waist circumference and waist / hip ratio is the&#xD;
      relationship between the cecal intubation difficulty aims to define.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 15, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index (kg/m2)</measure>
    <time_frame>12/01/2016- 05/01/2017</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>waist circumference (centimeter)</measure>
    <time_frame>12/01/2016- 05/01/2017</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>waist / hip ratio</measure>
    <time_frame>12/01/2016- 05/01/2017</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Endoscopy</condition>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>BMI &lt;18.5 underweight (Group 1)</arm_group_label>
    <description>BMI was calculated as weight in kilograms divided by the square of height in meters. BMI &lt;18.5 underweight (Group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMİ: 18.5 - 24.9 normal weight (Group 2)</arm_group_label>
    <description>BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 18.5 - 24.9 normal weight (Group 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMİ: 25- 29.9 overweight (Group 3)</arm_group_label>
    <description>BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 25- 29.9 overweight (Group 3)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMİ&gt;30 obese (Group 4)</arm_group_label>
    <description>BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ&gt;30 obese (Group 4)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>colonoscopy</intervention_name>
    <arm_group_label>BMI &lt;18.5 underweight (Group 1)</arm_group_label>
    <arm_group_label>BMİ: 18.5 - 24.9 normal weight (Group 2)</arm_group_label>
    <arm_group_label>BMİ: 25- 29.9 overweight (Group 3)</arm_group_label>
    <arm_group_label>BMİ&gt;30 obese (Group 4)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        There are cases of distant referral to the gastroenterology surgeon's polyclinic and&#xD;
        indications for colonoscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Above 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bad bowel preparation&#xD;
&#xD;
          2. Failure of cecum intubation&#xD;
&#xD;
          3. Inflammatory bowel disease&#xD;
&#xD;
          4. Colectomy story&#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_contact>
    <last_name>Mustafa Duman</last_name>
    <email>drmustafaduman@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eagle Run High Special Education and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ebubekir Gündeş</last_name>
      <email>ebubekir82@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ebubekir Gündeş</investigator_full_name>
    <investigator_title>Gastroenterogical Surgery</investigator_title>
  </responsible_party>
  <!-- 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/NCT03002662
org study id: 2016.5/8-19
nct id: NCT03002662
lead sponsor: 
During colonoscopy, body mass index, waist circumference and waist / hip ratio is the
      relationship between the cecal intubation difficulty aims to define.
observational model: Case-Control
time perspective: Prospective
measure: Body mass index (kg/m2)
time frame: 12/01/2016- 05/01/2017
measure: waist circumference (centimeter)
time frame: 12/01/2016- 05/01/2017
measure: waist / hip ratio
time frame: 12/01/2016- 05/01/2017
arm group label: BMI <18.5 underweight (Group 1)
description: BMI was calculated as weight in kilograms divided by the square of height in meters. BMI <18.5 underweight (Group 1)
arm group label: BMİ: 18.5 - 24.9 normal weight (Group 2)
description: BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 18.5 - 24.9 normal weight (Group 2)
arm group label: BMİ: 25- 29.9 overweight (Group 3)
description: BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 25- 29.9 overweight (Group 3)
arm group label: BMİ>30 obese (Group 4)
description: BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ>30 obese (Group 4)
intervention type: Other
intervention name: colonoscopy
arm group label: BMI <18.5 underweight (Group 1)
arm group label: BMİ: 18.5 - 24.9 normal weight (Group 2)
arm group label: BMİ: 25- 29.9 overweight (Group 3)
arm group label: BMİ>30 obese (Group 4)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mustafa Duman
email: drmustafaduman@hotmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
investigator full name: Ebubekir Gündeş
investigator title: Gastroenterogical Surgery