Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting
NCT ID: NCT01729416
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
178 participants
INTERVENTIONAL
2014-02-28
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
NCT01607255
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
NCT05080673
Colorectal Polyps Screening With Low-dose CT Colonoscopy
NCT03064828
Stool Sample Collection Study
NCT06294873
Evaluation of Computer-assisted, Non-cathartic CT Colonography
NCT01200303
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Water Exchange Colonoscopy
The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy.
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.
Air colonoscopy
The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy.
Air Colonoscopy
Air will be infused into the colon during colonoscopy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Air Colonoscopy
Air will be infused into the colon during colonoscopy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Davis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sooraj Tejaswi, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Elk Grove PCN, University of California, Davis
Elk Grove, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
297959-4
Identifier Type: OTHER
Identifier Source: secondary_id
297959
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.