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The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.

NCT ID: NCT02538406

Last Updated: 2020-10-28

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

TERMINATED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-04-02

Brief Summary

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Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.

Detailed Description

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Screening colonoscopy is an essential diagnostic tool in the early detection of precancerous colonic lesions, preventing the progression of these lesions to cancer. Population-based and case control studies found a 50% reduction in colo-rectal cancer (CRC) incidence and up to a one-third reduction in mortality from CRC after screening colonoscopy. The effectiveness of colonoscopy in preventing colon cancer is dependent on the adenoma detection rate (ADR) during the procedure. Studies have demonstrated that withdrawal times of 6 minutes or more had higher rates of detection of any neoplasia. In 2006 joint task force of the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy changed the recommendation to indicate that average withdrawal time should exceed 6 minutes in normal colonoscopies in which no polypectomies or biopsies were performed. Based on this recommendation, the 6-minute benchmark is the current standard of care. Longer mean withdrawal times are associated with increasing adenoma detection, mainly of small or right-sided adenomas and proximal serrated adenomas, presumably due to longer inspection of the right colon. However, it also have been showed withdrawal time using 6 minutes as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator. New CRC diagnosis within 3 years of negative screening colonoscopy can be as high as 6%. Right-sided lesions, flat polyps, and variability in endoscopist quality measures are all potential reasons why interval cancers develop. A recent observational study was published showing increase in ADR after implementation of a protocol of careful inspection during a minimum of 8 minutes was established. The investigators hypothesized that if colonoscopists would spend at least half of the time of the withdrawal time in the right side of the colon (referred as segmented protocol), ADR can increase mainly due to the detection of lesions in the right side, which could have been missed otherwise. The investigators are conducting a single center randomized trial investigating the utility of timed segmental withdrawal of at least 3 minutes each in both right and left side of the colon respectively, compared to the regular 6 minutes total withdrawal time regardless of where the time was spent in the colon.

Conditions

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Adenomatous Polyp of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non segmental withdrawal

A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon.

No interventions assigned to this group

Segmental withdrawal

A standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes)

Segmental withdrawal

Intervention Type OTHER

Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.

Interventions

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Segmental withdrawal

Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria

1. Patients with a prior history of colonic surgeries
2. Patient with Crohns colitis or ulcerative colitis
3. Patient with prior history of colon cancer
4. Patient with poor bowel preparation
5. Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Othman

M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed O. Othman, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-37320

Identifier Type: -

Identifier Source: org_study_id