Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon
RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON
1 other identifier
interventional
1,020
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 8, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 31, 2013
May 1, 2013
2 years
October 8, 2012
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 weeks
Secondary Outcomes (4)
Evaluate the success rate of retroflexion in the proximal colon.
1 day
Identify risk factors for missing polyps on first examination of right colon
1 day
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
1 day
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
1 day
Study Arms (2)
Retroflexion arm
EXPERIMENTALRetroflexion 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 COMPARATORColonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.
Interventions
Eligibility Criteria
You may qualify if:
- Patients \>18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington University in St Louis
St Louis, Missouri, 63110, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 21679946BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2012
First Posted
October 11, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
November 1, 2014
Last Updated
May 31, 2013
Record last verified: 2013-05