Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT01704820

Conditions

Colon Polyps

Colon Cancer Screening

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Retroflexion in the right colon

Study Details

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.

Conditions

Colon Polyps

Colon Cancer Screening

Study ID

NCT01704820

Start date

Sep, 2012

Status verified date

May, 2013

Completion date

Nov, 2014

Anticipated

Primary completion date

Sep, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1020 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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

placebo comparator: Forward view arm

Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.

Interventions

Retroflexion in the right colon

Primary outcome measure

  • Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study). [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Vladimir M Kushnir, MD

3144548201vkushnir@wustl.edu

Locations

Washington University in St Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Vladimir M Kushnir, MD

314-454-8201vkushnir@wustl.edu

Principal Investigator:

Early Dayna, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

May 31, 2013

Last verified

May, 2013

Keywords

  • Colon Polyps
  • Colon Cancer screening
  • Colonoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2013-05-31.