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NCT01802008 · ClinicalTrials.gov registry record · NA
Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times
A NA study of Adenoma and Adenoma and/or Adenocarcinoma, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT01802008: Completed NA study of Adenoma and Adenoma and/or Adenocarcinoma, sponsored by Stanford University.
NCT01802008 is a NA study of Adenoma and Adenoma and/or Adenocarcinoma that has completed, run by Stanford University. The registered enrollment target is 200 participants, below the 679-participant average among 6 other Adenoma trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802008, a NA study of Adenoma and Adenoma and/or Adenocarcinoma, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE 3-minute withdrawal time
- PROCEDURE 6-minute withdrawal time
Study Locations (2)
California
- Veterans Administration Hospital (Palo Alto) - Palo Alto
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-08 |
| Phase | NA |
What the finished NCT01802008 record still lists
NCT01802008 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 679-participant average among 6 other Adenoma trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Adenoma appearing as the primary indexed condition, and to 2 interventions - of which 3-minute withdrawal time is the first listed.
NCT01802008 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01802008 about?
NCT01802008 is a clinical study titled "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 ben...
What is the current status of trial NCT01802008?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2012-09. Estimated completion is 2013-08.
What conditions does trial NCT01802008 study?
This clinical trial studies the following conditions: Adenoma, Adenoma and/or Adenocarcinoma.
What interventions are being tested in trial NCT01802008?
The interventions under investigation include: 3-minute withdrawal time (PROCEDURE), 6-minute withdrawal time (PROCEDURE).
Who is sponsoring clinical trial NCT01802008?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01802008 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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