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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
Sooraj Tejaswi, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01729416
First received: November 2, 2012
Last updated: February 8, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Tubular Adenoma
Colon Cancer
Hyperplastic Polyp
Other: Water Exchange Colonoscopy
Other: Air Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Controlled Trial Comparing Water Exchange Colonoscopy and Air Colonoscopy in a Community Based Setting

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Presence of adenoma detected anywhere between the cecum and the splenic flexure


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Smoking history [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length ] [ Designated as safety issue: No ]
  • Alcohol consumption [ Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length ] [ Designated as safety issue: No ]

Estimated Enrollment: 178
Study Start Date: February 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Water Exchange Colonoscopy
The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy.
Other: Water Exchange Colonoscopy

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.

Active Comparator: Air colonoscopy
The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy.
Other: Air Colonoscopy
Air will be infused into the colon during colonoscopy.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥50 years
  • Individuals able to provide informed consent
  • Individuals presenting for average-risk colorectal cancer screening by colonoscopy
  • Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps as per the US multi-society taskforce on colorectal cancer

Exclusion Criteria:

  • Patients who decline to participate
  • Prior partial or complete colectomy
  • Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Patients with prior history of colorectal cancer
  • Patients with history of screening colonoscopy within the past 10 years
  • Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis, Lynch Syndrome)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729416

Contacts
Contact: Sooraj Tejaswi, M.D. 916-734-3751 sooraj.tejaswi@ucdmc.ucdavis.edu
Contact: Jesse Stondell, M.D. 530-219-7578 jesse.stondell@ucdmc.ucdavis.edu

Locations
United States, California
Elk Grove PCN, University of California, Davis Recruiting
Elk Grove, California, United States, 9758
Contact: Sooraj Tejaswi, M.D.    916-734-3751    sooraj.tejaswi@ucdmc.ucdavis.edu   
Contact: Jesse Stondell, M.D.    530-219-7578    jesse.stondell@ucdmc.ucdavis.edu   
Principal Investigator: Sooraj Tejaswi, M.D.         
Sub-Investigator: Jesse Stondell, M.D.         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Sooraj Tejaswi, M.D. University of California, Davis
  More Information

Publications:

Responsible Party: Sooraj Tejaswi, MD, Assistant Clinical Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01729416     History of Changes
Other Study ID Numbers: 297959-4
Study First Received: November 2, 2012
Last Updated: February 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
colon
cancer
screening
water exchange
air
method
polyp
adenoma
detection
rate
sedation
time
procedure

Additional relevant MeSH terms:
Adenoma
Colonic Neoplasms
Hyperplasia
Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014