Clinical trial NCT01704820: Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon
Official title: RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Polyps
Colon Cancer Screening
Keywords: Colon Polyps
Colon Cancer screening
Colonoscopy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2012-10-11
Enrollment: 1020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

* • Patients \>18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluate the success rate of retroflexion in the proximal colon.
timeFrame: 1 day
measure: Identify risk factors for missing polyps on first examination of right colon
timeFrame: 1 day
measure: Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
timeFrame: 1 day
measure: Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
timeFrame: 1 day
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington University in St Louis
state: Missouri
city: Milwaukie
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.