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Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times

NCT ID: NCT01802008

Last Updated: 2015-04-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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The objective of this study is to determine the optimal withdrawal time for colonoscopy. A 6-minute withdrawal time is currently the standard of care but has only been evaluated in an observational fashion. The investigators believe that this should be validated in a standardized fashion. If the benefits of a 6 minute withdrawal are proven in this study (ie a low polyp/adenoma miss rate and a high polyp/adenoma detection rate), then this will support widespread adoption of a 6 minute withdrawal as the standard of care. This in turn may decrease the occurence of 'interval colon cancers', which are early colon cancers arising in subjects despite their having undergone colonoscopy. Our hypothesis is that the polyp/adenoma detection rate will be unacceptably low and the polyp/adenoma miss rate will be unacceptably high in the 3-minute withdrawal group when compared to the 6-minute withdrawal group.

Detailed Description

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Eligible patients will be randomized to colonoscopy with either a 6-minute withdrawal time or a 3-minute withdrawal time. Patients will then undergo colonoscopy. All colonoscopies will be performed by a GI attending (standard of care). The colonoscopy is typically performed under conscious sedation using medications such as fentanyl and midazolam for comfort (standard of care). Occasional patients undergo colonoscopy under general anesthesia. For all patients, advancement of the colonoscope to the cecum will be followed by segmental withdrawal of the colonoscope in each of 3 segments of the examined colon (right side of colon, transverse colon and left side of colon). Following examination of each individual segment, the colonoscope will be readvanced to the proximal end of the segment and a 2 minute withdrawal will be re-performed. For those randomized to the 6-minute withdrawal each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist. For those randomized to the 3-minute withdrawal time, advancement to the cecum will also be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist. All patients will therefore undergo a second look colonoscopy with a 6-minute withdrawal time ('de-facto' standard of care). Polyp/adenoma detection and miss rates will then be calculated and compared between the two groups.

Conditions

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Adenoma and/or Adenocarcinoma Adenoma

Keywords

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Polyp/adenoma detection rate Polyp/adenoma miss rate Colonoscopy withdrawal time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3-minute withdrawal time

For subjects randomized to the 3-minute withdrawal time, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist.

Group Type ACTIVE_COMPARATOR

3-minute withdrawal time

Intervention Type PROCEDURE

For subjects randomized to the 3-minute withdrawal time, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist.

6-minute withdrawal time

For subjects randomized to the 6-minute withdrawal, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist.

Group Type ACTIVE_COMPARATOR

6-minute withdrawal time

Intervention Type PROCEDURE

For subjects randomized to the 6-minute withdrawal, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist.

Interventions

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3-minute withdrawal time

For subjects randomized to the 3-minute withdrawal time, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist.

Intervention Type PROCEDURE

6-minute withdrawal time

For subjects randomized to the 6-minute withdrawal, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Already scheduled for colonoscopy

Exclusion Criteria

* Age \< 18
* Pregnant women
* Mentally disabled
* Decisionally challenged
* Cancer subjects
* Healthy volunteers
* Prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Subhas Banerjee

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Subhas Banerjee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Veterans Administration Hospital (Palo Alto)

Palo Alto, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Kumar S, Thosani N, Ladabaum U, Friedland S, Chen AM, Kochar R, Banerjee S. Adenoma miss rates associated with a 3-minute versus 6-minute colonoscopy withdrawal time: a prospective, randomized trial. Gastrointest Endosc. 2017 Jun;85(6):1273-1280. doi: 10.1016/j.gie.2016.11.030. Epub 2016 Dec 6.

Reference Type DERIVED
PMID: 27931951 (View on PubMed)

Other Identifiers

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IRB-25203

Identifier Type: -

Identifier Source: org_study_id