Colon PolypsNCT01704820
Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon
A study testing Retroflexion in the right colon in people with Colon Polyps and Colon Cancer Screening, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
Colonoscopy is the gold standard screening test for colorectal cancer. Removal of pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over 50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon cancers, it provides only limited protection from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyps, Colon Cancer Screening
- What is being tested?
- Retroflexion in the right colon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,020 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients >18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance
Who cannot join
- • Failure to intubate the cecum during colonoscope insertion
- Prior right colon resection
- Known polyposis syndrome or polyposis identified at colonoscopy
- Inflammatory bowel disease
- Preparation of the colon is judged fair or poor using Boston Bowel Preparation Scale.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Young (Danny) Oh, MD, 414-955-6836, yoh@mcw.edu
Young (Danny) Oh, MD
- Recruiting
Washington University in St Louis
St Louis, Missouri, 63110
Vladimir M Kushnir, MD, 314-454-8201, vkushnir@wustl.edu
Early Dayna, MD
About this study
Official title: RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON
Colonoscopy is the gold standard screening test for colorectal cancer. Removal of pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over 50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon cancers, it provides only limited protection from cancer in the proximal (right side) colon. Our goal is to determine if additional pre-cancerous colon polyps can be identified by looking at the right side of the colon in retroflexion. During retroflexion the tip of the colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If additional polyps can be identified in this manner colonoscopy will become a more efficient method of screening for colon cancer.
In order to evaluate how effective right colon retroflexion is at detecting polyps in the proximal colon we plan on performing a randomized, controlled trial. Patients undergoing screening or follow up colonoscopy will be invited to participate in the study. Those patients who agree to participate will be randomized into one of two groups once the colonoscope is fully inserted. Group one will have the right side of their colon examined for polyps with the endoscope looking forward (traditional form of examination) followed by repeat examination of the right side of the colon with the colonosocpe in retroflexion (looking backwards). Polyps seen during each section of the exam will be removed and manner in which the polyps were found/ removed will be recorded. Following the two exams of the right side of the colon the colonoscopy will be completed in the usual manner. The duration of each portion of colonoscopy will be recorded. After the procedure is completed the physician performing the colonoscopy will rate difficulty of the procedure and confidence with quality of the examination. Pathology results for each polyp will be recorded once available. There will be no study related follow up after the pathology results are recorded.
- Conditions
- Colon Polyps, Colon Cancer Screening
- Being tested
- Retroflexion in the right colon
- Keywords
- Colon Polyps, Colon Cancer screening, Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroflexion in the right colonProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Retroflexion arm | Experimental | Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps Receives: Procedure: Retroflexion in the right colon |
| Forward view arm | Placebo comparator | Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.
Measured: 2 weeks
Secondary outcomes (4)
Evaluate the success rate of retroflexion in the proximal colon.
Evaluate the percent of patients in whom retroflexion can be performed.
Measured: 1 day
Identify risk factors for missing polyps on first examination of right colon
We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.
Measured: 1 day
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.
Measured: 1 day
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704820
- Sponsor's protocol ID
- Retro-View
- Status last verified
- May 2013
- First submitted
- 8 Oct 2012
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
PubMed 21679946
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON
- ClinicalTrials.gov ID
- NCT01704820
- Acronym / sponsor ID
- Retro-View
- Conditions
- Colon Polyps, Colon Cancer Screening
- Keywords
- Colon Polyps, Colon Cancer screening, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 11 Oct 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.
Colonoscopy is the gold standard screening test for colorectal cancer. Removal of pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over 50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon cancers, it provides only limited protection from cancer in the proximal (right side) colon. Our goal is to determine if additional pre-cancerous colon polyps can be identified by looking at the right side of the colon in retroflexion. During retroflexion the tip of the colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If additional polyps can be identified in this manner colonoscopy will become a more efficient method of screening for colon cancer.
In order to evaluate how effective right colon retroflexion is at detecting polyps in the proximal colon we plan on performing a randomized, controlled trial. Patients undergoing screening or follow up colonoscopy will be invited to participate in the study. Those patients who agree to participate will be randomized into one of two groups once the colonoscope is fully inserted. Group one will have the right side of their colon examined for polyps with the endoscope looking forward (traditional form of examination) followed by repeat examination of the right side of the colon with the colonosocpe in retroflexion (looking backwards). Polyps seen during each section of the exam will be removed and manner in which the polyps were found/ removed will be recorded. Following the two exams of the right side of the colon the colonoscopy will be completed in the usual manner. The duration of each portion of colonoscopy will be recorded. After the procedure is completed the physician performing the colonoscopy will rate difficulty of the procedure and confidence with quality of the examination. Pathology results for each polyp will be recorded once available. There will be no study related follow up after the pathology results are recorded.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retroflexion arm | Experimental | Procedure: Retroflexion in the right colonRetroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps |
| Forward view arm | Placebo comparator | –Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients >18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance
Key exclusion criteria (5 listed)
- • Failure to intubate the cecum during colonoscope insertion
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 |
|---|---|---|
| Retroflexion in the right colon | Procedure or surgery | Retroflexion arm |
Primary outcome
Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
Time frame: 2 weeks
The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.
4 secondary outcomes
Evaluate the success rate of retroflexion in the proximal colon.
Time frame: 1 day
Identify risk factors for missing polyps on first examination of right colon
Time frame: 1 day
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
Time frame: 1 day
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Background: PubMed 21679946Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retroflexion in the right colon in people with Colon Polyps and Colon Cancer Screening, run by Washington University School of Medicine at 2 sites 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir M Kushnir, MD (3144548201, vkushnir@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study). (time frame: 2 weeks). 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 NCT01704820, which also lists 1 linked publication.
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 2013.