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


N/A
18 Years
N/A
Open (Enrolling)
Both
Adenoma and/or Adenocarcinoma, Adenoma

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Trial Information

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


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.


Inclusion Criteria:



- Age > 18

- Already scheduled for colonoscopy

Exclusion Criteria:

- Age < 18

- Pregnant women

- Mentally disabled

- Decisionally challenged

- Cancer subjects

- Healthy volunteers

- Prisoners

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Polyp/Adenoma Detection Rate

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Subhas Banerjee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

IRB-25203

NCT ID:

NCT01802008

Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Adenoma and/or Adenocarcinoma
  • Adenoma
  • Polyp/adenoma detection rate
  • Polyp/adenoma miss rate
  • Colonoscopy withdrawal time
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenoma

Name

Location

Stanford UniversityStanford, California  94305
Veterans Administration Hospital (Palo Alto)Palo Alto, California  94304