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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01802008
First received: February 27, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Adenoma and/or Adenocarcinoma
Adenoma
Procedure: 3-minute withdrawal time
Procedure: 6-minute withdrawal time

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Adenoma Detection and Miss Rates at Colonoscopy Associated With a Six-minute Withdrawal Time vs a Three-minute Withdrawal Time

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Polyp/Adenoma Detection Rate [ Time Frame: This will be calculated up to one week after data collection. ] [ Designated as safety issue: No ]
    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.

  • Polyp/adenoma Miss Rate [ Time Frame: Polyp/adenoma miss rate will be calculated up to one week after data collection. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Already scheduled for colonoscopy

Exclusion Criteria:

  • Age < 18
  • Pregnant women
  • Mentally disabled
  • Decisionally challenged
  • Cancer subjects
  • Healthy volunteers
  • Prisoners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802008

Contacts
Contact: Subhas Banerjee, MD (650) 736-5555 subhas.banerjee@stanford.edu
Contact: Sheila Kumar, MD (650) 736-5555 skumar7@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Subhas Banerjee, M.D.    650-736-5555    subhas.banerjee@stanford.edu   
Contact: Sheila Kumar, M.D.    (650) 736-5555    skumar7@stanford.edu   
Veterans Administration Hospital (Palo Alto) Recruiting
Palo Alto, California, United States, 94304
Contact: Shai Friedland, M.D.    650-787-7099      
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Subhas Banerjee, M.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01802008     History of Changes
Other Study ID Numbers: IRB-25203
Study First Received: February 27, 2013
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Polyp/adenoma detection rate
Polyp/adenoma miss rate
Colonoscopy withdrawal time

Additional relevant MeSH terms:
Adenocarcinoma
Adenoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 26, 2014