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NCT Number: NCT01802008

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

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.

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Key information

Conditions

Adenoma and/or Adenocarcinoma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18
  • Already scheduled for colonoscopy

Exclusion criteria

  • Age < 18
  • Pregnant women
  • Mentally disabled
  • Decisionally challenged
  • Cancer subjects
  • Healthy volunteers
  • Prisoners

Treatment and study plan

3-minute withdrawal time

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

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.

Primary outcomes

  1. Polyp/Adenoma Detection Rate

    Time frame: This will be calculated up to one week after data collection.

    Polyp/adenoma detection rate will be calculated for each segment of the tandem colonoscopy- this will be calculated as the number of polyps/adenomas that are discovered and resected for each segment of the tandem colonoscopy.

  2. Polyp/adenoma Miss Rate

    Time frame: Polyp/adenoma miss rate will be calculated up to one week after data collection.

    Polyp/adenoma miss rate will be calculated for each segment of the tandem colonoscopy- this will be calculated as the number of polyps/adenomas that are discovered and resected on the tandem portion of each segment of the colonoscopy, divided by the total number of polyps/adenomas that are discovered/resected.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Comparison of Adenoma Detection and Miss Rates at Colonoscopy Associated With a Six-minute Withdrawal Time vs a Three-minute Withdrawal Time

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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