<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/NCT01699399</url>
  </required_header>
  <id_info>
    <org_study_id>DTCRD101(2)-E-03</org_study_id>
    <nct_id>NCT01699399</nct_id>
  </id_info>
  <brief_title>Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation</brief_title>
  <official_title>A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalin Tzu Chi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalin Tzu Chi General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, randomized controlled trial compares traditional air insufflation with&#xD;
      water immersion and water exchange in patients undergoing colonoscopy using on demand&#xD;
      sedation. We test the hypothesis that compared with air insufflation the proportion of&#xD;
      patients who require on demand sedation during colonoscopy will be significantly lowered by&#xD;
      water immersion and water exchange, and water exchange will produce the greatest reduction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be allocated into 3 groups by computerized randomization. In group A (water&#xD;
      exchange), water will be infused and removed at the same time throughout the entire colon&#xD;
      during the insertion phase with the air pump turned off. In group B (water immersion), water&#xD;
      will be infused in the insertion phase and removed in the withdrawal phase. The water will be&#xD;
      used mainly to open the lumen, without attempting to clear the colon contents. In group A and&#xD;
      B, warm-to-touch water will be infused mainly infused through the accessory channel of the&#xD;
      colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air&#xD;
      insufflation not used until the cecum has been reached. . In group C, air insufflation will&#xD;
      be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing&#xD;
      residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal&#xD;
      compression and change of patient position will be utilized at the discretion of the&#xD;
      colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the&#xD;
      base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be&#xD;
      undertaken during the withdrawal phase.&#xD;
&#xD;
      During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none,&#xD;
      10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort.&#xD;
      For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter,&#xD;
      the nurse will offer sedation, which the patients can accept or decline. If accepted, after&#xD;
      an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan,&#xD;
      Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an&#xD;
      adequate level of sedation. The need of additional drug will be estimated by patient pain&#xD;
      response (moans, grimaces and movements). Usually no more propofol will be added during the&#xD;
      withdrawal phase. The initial amount of propofol, and those before and after arrival to the&#xD;
      cecum will be recorded.&#xD;
&#xD;
      The following parameters will be evaluated and recorded on the patient data sheet: quality of&#xD;
      bowel preparation, cecal intubation time, withdrawal time total procedure time, use of&#xD;
      abdominal pressure, need for changing position, presence of polyps and reasons for incomplete&#xD;
      colonoscopy.&#xD;
&#xD;
      The procedure will be recorded and stored as digital files.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportions of patients requiring sedation</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient pain during insertion</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>post-procedure discomforts and 30 days complication rate</measure>
    <time_frame>one month</time_frame>
    <description>telephone follow up for post-procedure discomforts and 30 days complication rate</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Colon Neoplasm</condition>
  <arm_group>
    <arm_group_label>water immersion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water exchange</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>air insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard colonoscopy using traditional air insufflation during insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>water immersion</intervention_name>
    <arm_group_label>water immersion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>water exchange</intervention_name>
    <arm_group_label>water exchange</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>air insufflation</intervention_name>
    <arm_group_label>air insufflation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  request for sedation, indicated for bidirectional endoscopy, obstructive lesions of&#xD;
             the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA)&#xD;
             risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal&#xD;
             to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Hsi Hsieh, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalin Tzu Chi General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dalin Tzu Chi General Hospital</name>
      <address>
        <city>Chia-Yi</city>
        <zip>622</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.</citation>
    <PMID>21633535</PMID>
  </reference>
  <reference>
    <citation>Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.</citation>
    <PMID>20619405</PMID>
  </reference>
  <reference>
    <citation>Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.</citation>
    <PMID>20883846</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>May 19, 2019</last_update_submitted>
  <last_update_submitted_qc>May 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalin Tzu Chi General Hospital</investigator_affiliation>
    <investigator_full_name>Yu-Hsi hsieh</investigator_full_name>
    <investigator_title>Chief of department of gastroenterology and hepatology</investigator_title>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>pain</keyword>
  <keyword>sedation</keyword>
  <keyword>water</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</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/NCT01699399
org study id: DTCRD101(2)-E-03
nct id: NCT01699399
lead sponsor: 
has dmc: No
This prospective, randomized controlled trial compares traditional air insufflation with
      water immersion and water exchange in patients undergoing colonoscopy using on demand
      sedation. We test the hypothesis that compared with air insufflation the proportion of
      patients who require on demand sedation during colonoscopy will be significantly lowered by
      water immersion and water exchange, and water exchange will produce the greatest reduction
The patients will be allocated into 3 groups by computerized randomization. In group A (water
      exchange), water will be infused and removed at the same time throughout the entire colon
      during the insertion phase with the air pump turned off. In group B (water immersion), water
      will be infused in the insertion phase and removed in the withdrawal phase. The water will be
      used mainly to open the lumen, without attempting to clear the colon contents. In group A and
      B, warm-to-touch water will be infused mainly infused through the accessory channel of the
      colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air
      insufflation not used until the cecum has been reached. . In group C, air insufflation will
      be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing
      residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal
      compression and change of patient position will be utilized at the discretion of the
      colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the
      base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be
      undertaken during the withdrawal phase.

      During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none,
      10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort.
      For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter,
      the nurse will offer sedation, which the patients can accept or decline. If accepted, after
      an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan,
      Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an
      adequate level of sedation. The need of additional drug will be estimated by patient pain
      response (moans, grimaces and movements). Usually no more propofol will be added during the
      withdrawal phase. The initial amount of propofol, and those before and after arrival to the
      cecum will be recorded.

      The following parameters will be evaluated and recorded on the patient data sheet: quality of
      bowel preparation, cecal intubation time, withdrawal time total procedure time, use of
      abdominal pressure, need for changing position, presence of polyps and reasons for incomplete
      colonoscopy.

      The procedure will be recorded and stored as digital files.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Proportions of patients requiring sedation
time frame: 3 months
measure: patient pain during insertion
time frame: 3 months
measure: post-procedure discomforts and 30 days complication rate
time frame: one month
description: telephone follow up for post-procedure discomforts and 30 days complication rate
arm group label: water immersion
arm group type: Experimental
description: infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.
arm group label: water exchange
arm group type: Experimental
description: infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase
arm group label: air insufflation
arm group type: Active Comparator
description: standard colonoscopy using traditional air insufflation during insertion
intervention type: Procedure
intervention name: water immersion
arm group label: water immersion
intervention type: Procedure
intervention name: water exchange
arm group label: water exchange
intervention type: Procedure
intervention name: air insufflation
arm group label: air insufflation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yu-Hsi Hsieh, M.D.
role: Principal Investigator
affiliation: Dalin Tzu Chi General Hospital
facility: 
country: Taiwan
citation: Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
PMID: 21633535
citation: Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
PMID: 20619405
citation: Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PMID: 20883846
responsible party type: Principal Investigator
investigator affiliation: Dalin Tzu Chi General Hospital
investigator full name: Yu-Hsi hsieh
investigator title: Chief of department of gastroenterology and hepatology
mesh term: Colonic Neoplasms