Clinical Trial: Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Randomized Controlled Trial Comparing Water Exchange Colonoscopy and Air Colonoscopy in a Community Based Setting

Brief Summary: 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.

Detailed Summary:

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
Sponsor: University of California, Davis

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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. ]
  Adenoma detection anywhere in the colon during colonoscopy.
• Sedation requirements [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length. ]
  The amount of sedation required to complete the patient's colonoscopy.
• Total procedure time [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length. ]
  The total time it takes to complete colonoscopy.
• Cecal intubation time [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length. ]
  The time it takes to reach the cecum during colonoscopy.
• 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. ]
  The need for patient's position to be changed from left lateral to other positions, to enable advancement of the colonoscope forward.
• 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. ]
  The need to stiffen the colonoscope to enable to forward movement of the scope during procedure
• 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. ]
  Need for abdominal pressure by endoscopist's assistant during procedure to enable forward movement of colonoscope.
• 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. ]
  Assessment of length of the colonoscope inserted into the colon to reach the cecum.
• Procedure-related pain score [ Time Frame: Data collected during and post procedure after recovery from sedation, which is usually within 1 hour post procedure ]
  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.
• 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. ]
  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.
• 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. ]
  Assessment of volume of water introduced into the colon during procedure.
• 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. ]
  Assessment of patient's perception about the 2 methods of colonoscopy.
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• Body Mass Index (BMI) [ Time Frame: This will be collected at their p
  
  

  Original Secondary Outcome:

  • 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. ]
    Adenoma detection anywhere in the colon during colonoscopy.
  • Sedation requirements [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length. ]
    The amount of sedation required to complete the patient's colonoscopy.
  • Total procedure time [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length. ]
    The total time it takes to complete colonoscopy.
  • Cecal intubation time [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length. ]
    The time it takes to reach the cecum during colonoscopy.
  • 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. ]
    The need for patient's position to be changed from left lateral to other positions, to enable advancement of the colonoscope forward.
  • 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. ]
    The need to stiffen the colonoscope to enable to forward movement of the scope during procedure
  • 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. ]
    Need for abdominal pressure by endoscopist's assistant during procedure to enable forward movement of colonoscope.
  • 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. ]
    Assessment of length of the colonoscope inserted into the colon to reach the cecum.
  • Procedure-related pain score [ Time Frame: Data collected during and post procedure after recovery from sedation, which is usually within 1 hour post procedure ]
    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.
  • 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. ]
    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.
  • 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. ]
    Assessment of volume of water introduced into the colon during procedure.
  • 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. ]
    Assessment of patient's perception about the 2 methods of colonoscopy.
  
  
  Information By: University of California, Davis
  

  Dates:
  Date Received: November 2, 2012
  Date Started: February 2014
  Date Completion:
  Last Updated: December 16, 2015
  Last Verified: December 2015