<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/NCT01729416</url>
  </required_header>
  <id_info>
    <org_study_id>297959</org_study_id>
    <secondary_id>297959-4</secondary_id>
    <nct_id>NCT01729416</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting</brief_title>
  <official_title>Prospective Randomized Controlled Trial Comparing Water Exchange Colonoscopy and Air Colonoscopy in a Community Based Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if screening colonoscopy performed on adults with&#xD;
      the water exchange method, as opposed to the air method, will have a higher adenoma detection&#xD;
      rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening colonoscopy with removal of pre-cancerous adenomas was recently shown to result in&#xD;
      a 53% reduction in mortality from colon cancer. While this clearly validates the practice of&#xD;
      screening colonoscopy, missed adenomas, especially in the proximal colon, defined as&#xD;
      including cecum, ascending colon, and transverse colon, remains a concern. This was&#xD;
      demonstrated in a study of 183 patients who underwent back-to-back colonoscopies. In this&#xD;
      population the overall miss rate for adenomas was 24% with proximal adenomas missed more&#xD;
      often (27%) than left colon adenomas (21%). Another study looked at 4192 patients in the SEER&#xD;
      (Surveillance, Epidemiology, and End Results) Medicare database who developed &quot;interval&#xD;
      cancers&quot;, that is colon cancer in a patient who had a colonoscopy done in the previous 6-36&#xD;
      months. These interval cancers were predominantly in the proximal colon (Proximal 68%, Distal&#xD;
      19.5%, rectum 10.4%, and unspecified 2.1%). This also suggests that pre-cancerous lesions are&#xD;
      being missed in the proximal colon. As such a method that can increase proximal adenoma&#xD;
      detection rate would be a welcome change.&#xD;
&#xD;
      One such emerging technique which shows promise for improving adenoma detection rate is water&#xD;
      colonoscopy. In one of the early studies employing the water method a trend towards a higher&#xD;
      ADR in the water method group was recognized (37% vs. 26%). The observation prompted a&#xD;
      retrospective analysis of 1178 cases of screening and surveillance colonoscopy performed by a&#xD;
      single endoscopist at the Sacramento VAMC, which showed an overall ADR (presence of at least&#xD;
      one adenoma) of 27% with air colonoscopy whereas that for the water method colonoscopy was&#xD;
      35% (p=0.007). In a subsequent combined analysis of two prospective RCT of air vs. water&#xD;
      colonoscopy for screening and surveillance using scheduled unsedated colonoscopy [5] and&#xD;
      on-demand sedation [6], more patients were found to have at least one diminutive adenoma in&#xD;
      the proximal colon in the water method group than in the air group (28% vs. 14%,&#xD;
      respectively, p=0.0298). Another quasi randomized study of screening patients performed at&#xD;
      Phoenix VAMC using high definition equipment confirmed a significantly higher overall ADR&#xD;
      with the water method (n=177) compared with the air method (n=191) (57% vs. 46%) (p=0.03).&#xD;
      The odds of detecting an adenoma was 81% higher with the water method (OR 1.81; 95% CI:&#xD;
      1.12-2.90) and independent of age, body mass index (BMI), current smoking and alcohol use,&#xD;
      withdrawal time &amp; quality of bowel preparation. In the proximal colon ADR was significantly&#xD;
      higher in patients examined with the water method than with air method (46% vs. 35%)&#xD;
      (p=0.03), particularly for adenomas &lt;10 mm in size (38% vs. 25%) (p=007). These encouraging&#xD;
      preliminary data reflect the potential benefits of water method colonoscopy.&#xD;
&#xD;
      Our current research question is whether this benefit is seen in a community based population&#xD;
      as opposed to the VA population which is mostly male and Caucasian.&#xD;
&#xD;
      The investigators plan to perform a prospective, randomized controlled trial comparing&#xD;
      proximal adenoma detection rate between a water exchange colonoscopy group and an air&#xD;
      colonoscopy group. The investigators intend to employ scheduled sedation, instead of&#xD;
      on-demand sedation, to continue the current protocol in place at our institution.&#xD;
&#xD;
      Patients in both the study arms will undergo a split bowel preparation before colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proximal Adenoma detection</measure>
    <time_frame>Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is collected only once per patient.</time_frame>
    <description>Presence of adenoma detected anywhere between the cecum and the splenic flexure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total adenoma detection</measure>
    <time_frame>Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is only collected once per patient.</time_frame>
    <description>Adenoma detection anywhere in the colon during colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation requirements</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>The amount of sedation required to complete the patient's colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>The total time it takes to complete colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecal intubation time</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>The time it takes to reach the cecum during colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient position change during procedure</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>The need for patient's position to be changed from left lateral to other positions, to enable advancement of the colonoscope forward.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of colonoscope stiffener during procedure</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>The need to stiffen the colonoscope to enable to forward movement of the scope during procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal pressure by assistant during procedure</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>Need for abdominal pressure by endoscopist's assistant during procedure to enable forward movement of colonoscope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of colonoscope at time of cecal intubation</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>Assessment of length of the colonoscope inserted into the colon to reach the cecum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure-related pain score</measure>
    <time_frame>Data collected during and post procedure after recovery from sedation, which is usually within 1 hour post procedure</time_frame>
    <description>Assessment of discomfort due to the procedure, as possible during procedure, and post procedure after recovery from sedation, being cognizant of limitations posed by sedation and attendant amnesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for air insufflation, and length of colon when air insufflation started, while performing water colonoscopy</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>Assessment of percentage of patient requiring air insufflation when water colon fails to open colonic lumen, and site of colon where this is most likely to happen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of water used during water colonoscopy</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>Assessment of volume of water introduced into the colon during procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perception regarding air and water colonoscopy</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.</time_frame>
    <description>Assessment of patient's perception about the 2 methods of colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Advanced adenoma detection rate</measure>
    <time_frame>Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is only collected once per patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of polypectomy (cold biopsy/cold snare/snare cautery/need for submucosal injection/need for clip placement)</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel preparation quality by Boston Bowel Prep Scale</measure>
    <time_frame>This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post procedure recovery time</measure>
    <time_frame>This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serrated polyp detection rate</measure>
    <time_frame>This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time- morning versus afternoon</measure>
    <time_frame>This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking history</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption</measure>
    <time_frame>This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Tubular Adenoma</condition>
  <condition>Colon Cancer</condition>
  <condition>Hyperplastic Polyp</condition>
  <arm_group>
    <arm_group_label>Water Exchange Colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water Exchange Colonoscopy</intervention_name>
    <description>We will turn off the air pump. The colonoscope will be inserted into the rectum and gently advanced. We will suction air pockets as scope is advanced towards the cecum. Water will be infused when encountering closed up lumen. All the infused water will be suctioned out. We will use all other techniques used with conventional air method as needed. For example abdominal pressure, shortening of scope to reduce looping, change of patient position etc.&#xD;
We will turn on air pump once cecum reached, or if unsuccessful with water method to open up a close lumen or to go past a tight turn.&#xD;
On withdrawal we will continue air insufflation as needed, and closely examine for polyps and remove all visualized polyps. If there is any residual fluid, it will be suctioned out as the scope is withdrawn.</description>
    <arm_group_label>Water Exchange Colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Air Colonoscopy</intervention_name>
    <description>Air will be infused into the colon during colonoscopy.</description>
    <arm_group_label>Air colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥50 years&#xD;
&#xD;
          -  Individuals able to provide informed consent&#xD;
&#xD;
          -  Individuals presenting for average-risk colorectal cancer screening by colonoscopy&#xD;
&#xD;
          -  Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps&#xD;
             as per the US multi-society taskforce on colorectal cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who decline to participate&#xD;
&#xD;
          -  Prior partial or complete colectomy&#xD;
&#xD;
          -  Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's&#xD;
             disease)&#xD;
&#xD;
          -  Patients with prior history of colorectal cancer&#xD;
&#xD;
          -  Patients with history of screening colonoscopy within the past 10 years&#xD;
&#xD;
          -  Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis,&#xD;
             Lynch Syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sooraj Tejaswi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elk Grove PCN, University of California, Davis</name>
      <address>
        <city>Elk Grove</city>
        <state>California</state>
        <zip>95758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.</citation>
    <PMID>22356322</PMID>
  </reference>
  <reference>
    <citation>Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.</citation>
    <PMID>8978338</PMID>
  </reference>
  <reference>
    <citation>Leung FW, Aharonian HS, Leung JW, Guth PH, Jackson G. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):546-50. doi: 10.1016/j.gie.2008.08.014.</citation>
    <PMID>19231497</PMID>
  </reference>
  <reference>
    <citation>Leung JW, Do LD, Siao-Salera RM, Ngo C, Parikh DA, Mann SK, Leung FW. Retrospective analysis showing the water method increased adenoma detection rate - a hypothesis generating observation. J Interv Gastroenterol. 2011 Jan;1(1):3-7. doi: 10.4161/jig.1.1.14585.</citation>
    <PMID>21686105</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>Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.</citation>
    <PMID>21184876</PMID>
  </reference>
  <reference>
    <citation>Leung FW, Leung JW, Siao-Salera RM, Mann SK. The water method significantly enhances proximal diminutive adenoma detection rate in unsedated patients. J Interv Gastroenterol. 2011 Jan;1(1):8-13. doi: 10.4161/jig.1.1.14587.</citation>
    <PMID>21686106</PMID>
  </reference>
  <reference>
    <citation>Ramirez FC, Leung FW. A head-to-head comparison of the water vs. air method in patients undergoing screening colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):130-135. doi: 10.4161/jig.1.3.18512. Epub 2011 Jul 1.</citation>
    <PMID>22163084</PMID>
  </reference>
  <reference>
    <citation>Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.</citation>
    <PMID>19136102</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 26, 2017</last_update_submitted>
  <last_update_submitted_qc>May 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colon</keyword>
  <keyword>cancer</keyword>
  <keyword>screening</keyword>
  <keyword>water exchange</keyword>
  <keyword>air</keyword>
  <keyword>method</keyword>
  <keyword>polyp</keyword>
  <keyword>adenoma</keyword>
  <keyword>detection</keyword>
  <keyword>rate</keyword>
  <keyword>sedation</keyword>
  <keyword>time</keyword>
  <keyword>procedure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT01729416
org study id: 297959
secondary id: 297959-4
nct id: NCT01729416
lead sponsor: 
has dmc: No
The purpose of this study is to determine if screening colonoscopy performed on adults with
      the water exchange method, as opposed to the air method, will have a higher adenoma detection
      rate.
Screening colonoscopy with removal of pre-cancerous adenomas was recently shown to result in
      a 53% reduction in mortality from colon cancer. While this clearly validates the practice of
      screening colonoscopy, missed adenomas, especially in the proximal colon, defined as
      including cecum, ascending colon, and transverse colon, remains a concern. This was
      demonstrated in a study of 183 patients who underwent back-to-back colonoscopies. In this
      population the overall miss rate for adenomas was 24% with proximal adenomas missed more
      often (27%) than left colon adenomas (21%). Another study looked at 4192 patients in the SEER
      (Surveillance, Epidemiology, and End Results) Medicare database who developed "interval
      cancers", that is colon cancer in a patient who had a colonoscopy done in the previous 6-36
      months. These interval cancers were predominantly in the proximal colon (Proximal 68%, Distal
      19.5%, rectum 10.4%, and unspecified 2.1%). This also suggests that pre-cancerous lesions are
      being missed in the proximal colon. As such a method that can increase proximal adenoma
      detection rate would be a welcome change.

      One such emerging technique which shows promise for improving adenoma detection rate is water
      colonoscopy. In one of the early studies employing the water method a trend towards a higher
      ADR in the water method group was recognized (37% vs. 26%). The observation prompted a
      retrospective analysis of 1178 cases of screening and surveillance colonoscopy performed by a
      single endoscopist at the Sacramento VAMC, which showed an overall ADR (presence of at least
      one adenoma) of 27% with air colonoscopy whereas that for the water method colonoscopy was
      35% (p=0.007). In a subsequent combined analysis of two prospective RCT of air vs. water
      colonoscopy for screening and surveillance using scheduled unsedated colonoscopy [5] and
      on-demand sedation [6], more patients were found to have at least one diminutive adenoma in
      the proximal colon in the water method group than in the air group (28% vs. 14%,
      respectively, p=0.0298). Another quasi randomized study of screening patients performed at
      Phoenix VAMC using high definition equipment confirmed a significantly higher overall ADR
      with the water method (n=177) compared with the air method (n=191) (57% vs. 46%) (p=0.03).
      The odds of detecting an adenoma was 81% higher with the water method (OR 1.81; 95% CI:
      1.12-2.90) and independent of age, body mass index (BMI), current smoking and alcohol use,
      withdrawal time & quality of bowel preparation. In the proximal colon ADR was significantly
      higher in patients examined with the water method than with air method (46% vs. 35%)
      (p=0.03), particularly for adenomas <10 mm in size (38% vs. 25%) (p=007). These encouraging
      preliminary data reflect the potential benefits of water method colonoscopy.

      Our current research question is whether this benefit is seen in a community based population
      as opposed to the VA population which is mostly male and Caucasian.

      The investigators plan to perform a prospective, randomized controlled trial comparing
      proximal adenoma detection rate between a water exchange colonoscopy group and an air
      colonoscopy group. The investigators intend to employ scheduled sedation, instead of
      on-demand sedation, to continue the current protocol in place at our institution.

      Patients in both the study arms will undergo a split bowel preparation before colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Proximal Adenoma detection
time frame: Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is collected only once per patient.
description: Presence of adenoma detected anywhere between the cecum and the splenic flexure
measure: Total adenoma detection
time frame: Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is only collected once per patient.
description: Adenoma detection anywhere in the colon during colonoscopy.
measure: Sedation requirements
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: The amount of sedation required to complete the patient's colonoscopy.
measure: Total procedure time
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: The total time it takes to complete colonoscopy.
measure: Cecal intubation time
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: The time it takes to reach the cecum during colonoscopy.
measure: Patient position change during procedure
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: The need for patient's position to be changed from left lateral to other positions, to enable advancement of the colonoscope forward.
measure: Use of colonoscope stiffener during procedure
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: The need to stiffen the colonoscope to enable to forward movement of the scope during procedure
measure: Abdominal pressure by assistant during procedure
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: Need for abdominal pressure by endoscopist's assistant during procedure to enable forward movement of colonoscope.
measure: Length of colonoscope at time of cecal intubation
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: Assessment of length of the colonoscope inserted into the colon to reach the cecum.
measure: Procedure-related pain score
time frame: Data collected during and post procedure after recovery from sedation, which is usually within 1 hour post procedure
description: Assessment of discomfort due to the procedure, as possible during procedure, and post procedure after recovery from sedation, being cognizant of limitations posed by sedation and attendant amnesia.
measure: Reason for air insufflation, and length of colon when air insufflation started, while performing water colonoscopy
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: Assessment of percentage of patient requiring air insufflation when water colon fails to open colonic lumen, and site of colon where this is most likely to happen.
measure: Volume of water used during water colonoscopy
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: Assessment of volume of water introduced into the colon during procedure.
measure: Patient perception regarding air and water colonoscopy
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
description: Assessment of patient's perception about the 2 methods of colonoscopy.
measure: Advanced adenoma detection rate
time frame: Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is only collected once per patient
measure: Type of polypectomy (cold biopsy/cold snare/snare cautery/need for submucosal injection/need for clip placement)
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
measure: Bowel preparation quality by Boston Bowel Prep Scale
time frame: This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length
measure: Post procedure recovery time
time frame: This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length
measure: Serrated polyp detection rate
time frame: This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length
measure: Procedure time- morning versus afternoon
time frame: This will be collected at the time of their procedure appointment which is expected to be 2 to 3 hours in length
measure: Body Mass Index (BMI)
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
measure: Smoking history
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
measure: Alcohol consumption
time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
arm group label: Water Exchange Colonoscopy
arm group type: Experimental
description: The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy.
arm group label: Air colonoscopy
arm group type: Active Comparator
description: The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy.
intervention type: Other
intervention name: Water Exchange Colonoscopy
description: We will turn off the air pump. The colonoscope will be inserted into the rectum and gently advanced. We will suction air pockets as scope is advanced towards the cecum. Water will be infused when encountering closed up lumen. All the infused water will be suctioned out. We will use all other techniques used with conventional air method as needed. For example abdominal pressure, shortening of scope to reduce looping, change of patient position etc.
We will turn on air pump once cecum reached, or if unsuccessful with water method to open up a close lumen or to go past a tight turn.
On withdrawal we will continue air insufflation as needed, and closely examine for polyps and remove all visualized polyps. If there is any residual fluid, it will be suctioned out as the scope is withdrawn.
arm group label: Water Exchange Colonoscopy
intervention type: Other
intervention name: Air Colonoscopy
description: Air will be infused into the colon during colonoscopy.
arm group label: Air colonoscopy
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Sooraj Tejaswi, M.D.
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
citation: Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
PMID: 22356322
citation: Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
PMID: 8978338
citation: Leung FW, Aharonian HS, Leung JW, Guth PH, Jackson G. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):546-50. doi: 10.1016/j.gie.2008.08.014.
PMID: 19231497
citation: Leung JW, Do LD, Siao-Salera RM, Ngo C, Parikh DA, Mann SK, Leung FW. Retrospective analysis showing the water method increased adenoma detection rate - a hypothesis generating observation. J Interv Gastroenterol. 2011 Jan;1(1):3-7. doi: 10.4161/jig.1.1.14585.
PMID: 21686105
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: Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
PMID: 21184876
citation: Leung FW, Leung JW, Siao-Salera RM, Mann SK. The water method significantly enhances proximal diminutive adenoma detection rate in unsedated patients. J Interv Gastroenterol. 2011 Jan;1(1):8-13. doi: 10.4161/jig.1.1.14587.
PMID: 21686106
citation: Ramirez FC, Leung FW. A head-to-head comparison of the water vs. air method in patients undergoing screening colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):130-135. doi: 10.4161/jig.1.3.18512. Epub 2011 Jul 1.
PMID: 22163084
citation: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PMID: 19136102
responsible party type: Sponsor
mesh term: Adenoma