Clinical trial NCT01802008: Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times
Official title: Comparison of Adenoma Detection and Miss Rates at Colonoscopy Associated With a Six-minute Withdrawal Time vs a Three-minute Withdrawal Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma and/or Adenocarcinoma
Adenoma
Keywords: Polyp/adenoma detection rate
Polyp/adenoma miss rate
Colonoscopy withdrawal time
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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 criteria: Inclusion Criteria:

* Age \> 18
* Already scheduled for colonoscopy

Exclusion Criteria:

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

Primary outcomes:
measure: Polyp/Adenoma Detection Rate
timeFrame: This will be calculated up to one week after data collection.
measure: Polyp/adenoma Miss Rate
timeFrame: Polyp/adenoma miss rate will be calculated up to one week after data collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Administration Hospital (Palo Alto)
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Subhas Banerjee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.