<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/NCT01735266</url>
  </required_header>
  <id_info>
    <org_study_id>20121108-5</org_study_id>
    <nct_id>NCT01735266</nct_id>
  </id_info>
  <brief_title>Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.</brief_title>
  <official_title>Comparative Efficacy of Whole-colon Water Exchange, Left-colon Water Exchange and Air Methods of Colonoscopy on Cecum Intubation in Unsedated Outpatients - - - a Prospective, Randomized Controlled Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In most of situation, left colon (especially SD junction) is considered the most difficult&#xD;
      part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and&#xD;
      patients may feel pain or uncomfortable. It is suggested more than half of the whole time for&#xD;
      scope insertion should be used in left colon. Many methods, such as water immersion,&#xD;
      abdominal palpation, have been used to facilitate insertion in left colon.&#xD;
&#xD;
      Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing&#xD;
      medication used, pain experienced during colonoscopy, increasing the success rate of cecum&#xD;
      intubation and adenoma detection rate in sedated and unsedated patients undergoing screening&#xD;
      colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents&#xD;
      lengthening and distension of the colon during colonoscopy. This will facilitate the&#xD;
      colonoscopy in average or difficult colonoscopy. However, it is not known whether the&#xD;
      benefits of water exchange method of colonoscopy was mainly due to its effect on the left&#xD;
      colon.&#xD;
&#xD;
      We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect&#xD;
      regarding the maximal pain score and mean pain score in unsedated patients compared with&#xD;
      whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion&#xD;
      time compared with WWE. Here we performed a prospective, randomized controlled study to&#xD;
      investigate the efficacies of whole-colon water exchange, left-colon water exchange and air&#xD;
      methods of colonoscopy on pain score and insertion time in unsedated outpatients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cecum intubation time</measure>
    <time_frame>up to three months</time_frame>
    <description>Insertion time from rectum to reach the cecum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>up to two months</time_frame>
    <description>Pain scores include mean pain score and maximal pain score.&#xD;
Mean pain score: mean value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).&#xD;
Maximal pain score: maximal value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>up to six months</time_frame>
    <description>The proportion of subjects with at least one polyp.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>up to two months</time_frame>
    <description>Total time of colonoscopic procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecal intubation rate</measure>
    <time_frame>up to two months</time_frame>
    <description>Percentage of successful colonoscopy (insertion of colonoscope into cecum).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal time</measure>
    <time_frame>up to two month</time_frame>
    <description>Withdrawal time is defined as the time from withdrawal of the colonoscope from the cecum to anal verge. (This time is measured independent of any therapeutic maneuvers, such as biopsy or polypectomy.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients willingness to repeat colonoscopy using same method</measure>
    <time_frame>up to two month</time_frame>
    <description>When after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure difficulty evaluated by endoscopist</measure>
    <time_frame>up to two month</time_frame>
    <description>When after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure.&#xD;
0-very easy, 10-very difficult</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Polyp</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Air colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Air was insufflated during whole procedure of colonoscope insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole-colon water exchange colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The air pump was turned off before colonoscopy. During the whole procedure of the scope insertion, residual air in lumen was suctioned and 37°C (maintained with a water bath) water was infused with a peristaltic pump to obtain lumen visualization. Air was insufflated until cecum was reached or appendix opening was seen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>left-colon water exchange colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the left side of colon (including descending colon, sigmoid colon and rectum), water was infused instead of air to obtain lumen visualization as described above in whole-colon water exchange colonoscopy group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Air colonoscopy</intervention_name>
    <description>Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.</description>
    <arm_group_label>Air colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water exchange colonoscopy</intervention_name>
    <description>Water exchange method (The air pump was turned off before colonoscopy. During colonoscope insertion, residual air in lumen was suctioned and 37°C water was infused into lumen to obtain lumen visualization) was used in whole or left colon. Air was insufflated until cecum was reached or appendix opening was seen.</description>
    <arm_group_label>Whole-colon water exchange colonoscopy</arm_group_label>
    <arm_group_label>left-colon water exchange colonoscopy</arm_group_label>
    <other_name>Water aided colonoscopy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients with unsedated colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of colon resection&#xD;
&#xD;
          -  severe colonic stricture or obstructing tumor&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanglin Pan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endoscopic center, Xijing Hospital of Digestive Diseases</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>September 11, 2013</last_update_submitted>
  <last_update_submitted_qc>September 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Yanglin Pan</investigator_full_name>
    <investigator_title>Associated professor</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <!-- 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/NCT01735266
org study id: 20121108-5
nct id: NCT01735266
lead sponsor: 
has dmc: Yes
In most of situation, left colon (especially SD junction) is considered the most difficult
      part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and
      patients may feel pain or uncomfortable. It is suggested more than half of the whole time for
      scope insertion should be used in left colon. Many methods, such as water immersion,
      abdominal palpation, have been used to facilitate insertion in left colon.

      Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing
      medication used, pain experienced during colonoscopy, increasing the success rate of cecum
      intubation and adenoma detection rate in sedated and unsedated patients undergoing screening
      colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents
      lengthening and distension of the colon during colonoscopy. This will facilitate the
      colonoscopy in average or difficult colonoscopy. However, it is not known whether the
      benefits of water exchange method of colonoscopy was mainly due to its effect on the left
      colon.

      We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect
      regarding the maximal pain score and mean pain score in unsedated patients compared with
      whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion
      time compared with WWE. Here we performed a prospective, randomized controlled study to
      investigate the efficacies of whole-colon water exchange, left-colon water exchange and air
      methods of colonoscopy on pain score and insertion time in unsedated outpatients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
measure: Cecum intubation time
time frame: up to three months
description: Insertion time from rectum to reach the cecum.
measure: Pain scores
time frame: up to two months
description: Pain scores include mean pain score and maximal pain score.
Mean pain score: mean value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).
Maximal pain score: maximal value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).
measure: Polyp detection rate
time frame: up to six months
description: The proportion of subjects with at least one polyp.
measure: Total procedure time
time frame: up to two months
description: Total time of colonoscopic procedure.
measure: Cecal intubation rate
time frame: up to two months
description: Percentage of successful colonoscopy (insertion of colonoscope into cecum).
measure: Withdrawal time
time frame: up to two month
description: Withdrawal time is defined as the time from withdrawal of the colonoscope from the cecum to anal verge. (This time is measured independent of any therapeutic maneuvers, such as biopsy or polypectomy.)
measure: Patients willingness to repeat colonoscopy using same method
time frame: up to two month
description: When after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.
measure: Procedure difficulty evaluated by endoscopist
time frame: up to two month
description: When after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure.
0-very easy, 10-very difficult
arm group label: Air colonoscopy
arm group type: Active Comparator
description: Air was insufflated during whole procedure of colonoscope insertion.
arm group label: Whole-colon water exchange colonoscopy
arm group type: Experimental
description: The air pump was turned off before colonoscopy. During the whole procedure of the scope insertion, residual air in lumen was suctioned and 37°C (maintained with a water bath) water was infused with a peristaltic pump to obtain lumen visualization. Air was insufflated until cecum was reached or appendix opening was seen.
arm group label: left-colon water exchange colonoscopy
arm group type: Experimental
description: In the left side of colon (including descending colon, sigmoid colon and rectum), water was infused instead of air to obtain lumen visualization as described above in whole-colon water exchange colonoscopy group.
intervention type: Other
intervention name: Air colonoscopy
description: Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.
arm group label: Air colonoscopy
intervention type: Other
intervention name: Water exchange colonoscopy
description: Water exchange method (The air pump was turned off before colonoscopy. During colonoscope insertion, residual air in lumen was suctioned and 37°C water was infused into lumen to obtain lumen visualization) was used in whole or left colon. Air was insufflated until cecum was reached or appendix opening was seen.
arm group label: Whole-colon water exchange colonoscopy
arm group label: left-colon water exchange colonoscopy
other name: Water aided colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yanglin Pan, M.D.
role: Principal Investigator
affiliation: Air Force Military Medical University, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Yanglin Pan
investigator title: Associated professor