<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/NCT03289442</url>
  </required_header>
  <id_info>
    <org_study_id>position-2</org_study_id>
    <nct_id>NCT03289442</nct_id>
  </id_info>
  <brief_title>Supine Position for Colonoscopy Insertion</brief_title>
  <official_title>Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>No.85 Hospital, Changning, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai 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>
      The purpose of this study is to determine whether the supine position is better than the left&#xD;
      lateral horizontal body position to decrease cecal intubation time, patients' pain and the&#xD;
      difficulty of colonoscopy insertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence&#xD;
      has demonstrated its efficacy and advantages. Left lateral position for insertion, which&#xD;
      results in air rising away from the left colon and producing acute bends in the sigmoid,might&#xD;
      increase the risk of colonoscopy loop formation.When there is difficulty advancing the&#xD;
      colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we&#xD;
      perform a randomized controlled trial to compares supine position with left lateral position&#xD;
      for the safety and efficacy of colonoscopy insertion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cecal intubation time</measure>
    <time_frame>2 hour</time_frame>
    <description>Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>descending colon intubation time</measure>
    <time_frame>1 hour</time_frame>
    <description>Descending colon intubation time is the insertion time taken from first visualization of rectal mucosa to descending colon and descending colon was identified by the presence of straight colonic lumen and affirmed by an independent observer simultaneously.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients' pain score</measure>
    <time_frame>3 hour</time_frame>
    <description>patients' discomfort will be assessed by a 10-cm visual analog scale, in which a score of 0 denoted no pain and a score of 10 denoted unbearable pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination</measure>
    <time_frame>3 hour</time_frame>
    <description>when colonoscopy insertion is completed, patients will be asked whether they would accept similar unsedated or sedated colonoscopy in the future screening or examination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">347</enrollment>
  <condition>Colonoscopy Insertion</condition>
  <condition>Patient Position</condition>
  <arm_group>
    <arm_group_label>supine position group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>left lateral position</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>supine position</intervention_name>
    <description>patients were positioned on their supine position to receive colonoscopy insertion</description>
    <arm_group_label>supine position group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged between 18-75 years&#xD;
&#xD;
          2. underwent screening, surveillance, and diagnostic colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. &lt;18 or &gt;75 years old&#xD;
&#xD;
          2. major psychiatric disorders, colonic resection, pregnancy, presence of any&#xD;
             contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)&#xD;
&#xD;
          3. Patients with severe cardiopulmonary and renal disease&#xD;
&#xD;
          4. Patients who are unwilling or unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Changhai Hospital, Second Military Medical University</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Willcock H, Gold DM. Supine Colonoscopy: An Advantage over Left Lateral in Synchronous Proctological Surgery. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):475-7. doi: 10.1089/lap.2015.0609. Epub 2016 Mar 16.</citation>
    <PMID>26982385</PMID>
  </results_reference>
  <results_reference>
    <citation>Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.</citation>
    <PMID>2032597</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhaoshen Li</investigator_full_name>
    <investigator_title>Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03289442
org study id: position-2
nct id: NCT03289442
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether the supine position is better than the left
      lateral horizontal body position to decrease cecal intubation time, patients' pain and the
      difficulty of colonoscopy insertion.
Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence
      has demonstrated its efficacy and advantages. Left lateral position for insertion, which
      results in air rising away from the left colon and producing acute bends in the sigmoid,might
      increase the risk of colonoscopy loop formation.When there is difficulty advancing the
      colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we
      perform a randomized controlled trial to compares supine position with left lateral position
      for the safety and efficacy of colonoscopy insertion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cecal intubation time
time frame: 2 hour
description: Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.
measure: descending colon intubation time
time frame: 1 hour
description: Descending colon intubation time is the insertion time taken from first visualization of rectal mucosa to descending colon and descending colon was identified by the presence of straight colonic lumen and affirmed by an independent observer simultaneously.
measure: patients' pain score
time frame: 3 hour
description: patients' discomfort will be assessed by a 10-cm visual analog scale, in which a score of 0 denoted no pain and a score of 10 denoted unbearable pain
measure: patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination
time frame: 3 hour
description: when colonoscopy insertion is completed, patients will be asked whether they would accept similar unsedated or sedated colonoscopy in the future screening or examination
arm group label: supine position group
arm group type: Experimental
arm group label: left lateral position
arm group type: No Intervention
intervention type: Procedure
intervention name: supine position
description: patients were positioned on their supine position to receive colonoscopy insertion
arm group label: supine position group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
citation: Willcock H, Gold DM. Supine Colonoscopy: An Advantage over Left Lateral in Synchronous Proctological Surgery. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):475-7. doi: 10.1089/lap.2015.0609. Epub 2016 Mar 16.
PMID: 26982385
citation: Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.
PMID: 2032597
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhaoshen Li
investigator title: Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor
sharing ipd: No