Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon

NCT ID: NCT01704820

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Polyps Colon Cancer Screening

Keywords

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Colon Polyps Colon Cancer screening Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Retroflexion arm

Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps

Group Type EXPERIMENTAL

Retroflexion in the right colon

Intervention Type PROCEDURE

Forward view arm

Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Retroflexion in the right colon

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University in St Louis

St Louis, Missouri, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Vladimir M Kushnir, MD

Role: CONTACT

Phone: 3144548201

Email: [email protected]

Facility Contacts

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Vladimir M Kushnir, MD

Role: primary

Young (Danny) Oh, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21679946 (View on PubMed)

Other Identifiers

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Retro-View

Identifier Type: -

Identifier Source: org_study_id