Tubular AdenomaNCT01729416
Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting
A study testing Water Exchange Colonoscopy and Air Colonoscopy in people with Tubular Adenoma and Colon Cancer, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Tubular Adenoma, Colon Cancer, Hyperplastic Polyp
- What is being tested?
- Water Exchange Colonoscopy and Air Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Elk Grove PCN, University of California, Davis
Elk Grove, California, 95758
About this study
Official title: Prospective Randomized Controlled Trial Comparing Water Exchange Colonoscopy and Air Colonoscopy in a Community Based Setting
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.
Read the 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.
- Conditions
- Tubular Adenoma, Colon Cancer, Hyperplastic Polyp
- Being tested
- Water Exchange Colonoscopy, Air Colonoscopy
- Keywords
- colon, cancer, screening, water exchange, air, method, polyp, adenoma, detection, rate, sedation, time, procedure
- Medical subject headings
- Colonic Neoplasms, Neoplasms, Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Exchange ColonoscopyOther
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 ColonoscopyOther
Air will be infused into the colon during colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Water Exchange Colonoscopy | Experimental | The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy. Receives: Other: Water Exchange Colonoscopy |
| Air colonoscopy | Active comparator | The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy. Receives: Other: Air Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Adenoma detection
Presence of adenoma detected anywhere between the cecum and the splenic flexure
Measured: Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is collected only once per patient.
Secondary outcomes (21)
Total adenoma detection
Adenoma detection anywhere in the colon during colonoscopy.
Measured: Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is only collected once per patient.
Sedation requirements
The amount of sedation required to complete the patient's colonoscopy.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Total procedure time
The total time it takes to complete colonoscopy.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Cecal intubation time
The time it takes to reach the cecum during colonoscopy.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Patient position change during procedure
The need for patient's position to be changed from left lateral to other positions, to enable advancement of the colonoscope forward.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Use of colonoscope stiffener during procedure
The need to stiffen the colonoscope to enable to forward movement of the scope during procedure
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Abdominal pressure by assistant during procedure
Need for abdominal pressure by endoscopist's assistant during procedure to enable forward movement of colonoscope.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Length of colonoscope at time of cecal intubation
Assessment of length of the colonoscope inserted into the colon to reach the cecum.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Procedure-related pain score
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.
Measured: Data collected during and post procedure after recovery from sedation, which is usually within 1 hour post procedure
Reason for air insufflation, and length of colon when air insufflation started, while performing water colonoscopy
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.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Volume of water used during water colonoscopy
Assessment of volume of water introduced into the colon during procedure.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Patient perception regarding air and water colonoscopy
Assessment of patient's perception about the 2 methods of colonoscopy.
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Advanced adenoma detection rate
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Smoking history
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Alcohol consumption
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tubular AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sooraj Tejaswi, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729416
- Sponsor's protocol ID
- 297959
- Other IDs
- 297959-4
- Status last verified
- May 2017
- First submitted
- 2 Nov 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22356322Rex 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.
PubMed 8978338Leung 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.
PubMed 19231497Leung 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.
PubMed 21686105Leung 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.
PubMed 20619405Leung 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.
PubMed 21184876Leung 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.
PubMed 21686106Ramirez 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.
PubMed 22163084Lai 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.
PubMed 19136102
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Water Exchange Colonoscopy and Air Colonoscopy in a Community Based Setting
- ClinicalTrials.gov ID
- NCT01729416
- Acronym / sponsor ID
- 297959
- Conditions
- Tubular Adenoma, Colon Cancer, Hyperplastic Polyp
- Keywords
- colon, cancer, screening, water exchange, air, method, polyp, adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Exchange Colonoscopy | Experimental | Other: Water Exchange ColonoscopyThe intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy. |
| Air colonoscopy | Active comparator | Other: Air ColonoscopyThe intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Exchange ColonoscopyWe 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. | Other | Water Exchange Colonoscopy |
| Air ColonoscopyAir will be infused into the colon during colonoscopy. | Other | Air colonoscopy |
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.
Presence of adenoma detected anywhere between the cecum and the splenic flexure
21 secondary outcomes
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.
Sedation requirements
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Total procedure time
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Cecal intubation time
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
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.
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.
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.
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.
Procedure-related pain score
Time frame: Data collected during and post procedure after recovery from sedation, which is usually within 1 hour post procedure
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.
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.
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.
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 procedure appointment which is expected to be 2 to 3 hours in length
Smoking history
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Alcohol consumption
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 22356322Zauber 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.
- Background: PubMed 8978338Rex 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.
- Background: PubMed 19231497Leung 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.
- Background: PubMed 21686105Leung 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.
- Background: PubMed 20619405Leung 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.
- Background: PubMed 21184876Leung 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.
- Background: PubMed 21686106Leung 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.
- Background: PubMed 22163084Ramirez 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.
- Background: PubMed 19136102Lai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sooraj Tejaswi, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Exchange Colonoscopy and Air Colonoscopy in people with Tubular Adenoma and Colon Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729416, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.