Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
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|ClinicalTrials.gov Identifier: NCT01035775|
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Polyps||Procedure: Inspection during insertion Procedure: Inspection during withdrawal||Not Applicable|
Background: Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Thus, colonoscopy is typically performed by rapidly passing the instrument through the loops and bends of the colon in order to reach the tip of the cecum, and then performing a slow withdrawal in which the tip of the instrument is systematically deflected, and the mucosa is careful cleaned and suctioned, to expose all of the colonic mucosa for viewing.
Many experienced colonoscopists recognize that small polyps seen incidentally but not removed during insertion are sometimes quite difficult to find during withdrawal. The reason for this observation is probably because the colon is in a very different anatomical conformation during endoscope insertion and withdrawal. During insertion, the colon is in its natural conformation in which the sigmoid and transverse colon has several sharp bends or flexures, and the overall length has not yet been shortened. In this phase, the colon is often significantly stretched because of the formation of loops and bends in the colonoscope. This greatly affects the conformation of the colonic wall visualized proximal to the instrument tip. During withdrawal, the colon is shortened and pleated over the colonoscope, with successive regions of the colon being inspected as they slip off the end of the instrument. Thus, segments of visualized colon are often much straighter during withdrawal than during insertion. The insertion and withdrawal phases, therefore, expose somewhat different sections of the mucosal surface to the colonoscope and inspection on insertion and withdrawal are, quite possibly, complementary.
Aims: This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Study procedure: In this study, we plan to investigate whether a specified interval of inspection during insertion can increase overall adenoma detection. We will conduct a randomized controlled trial, in which patients will be randomized to have all of the inspection performed during the withdrawal phase (as is usual care) versus having several minutes of examination specifically devoted to inspection during insertion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2011|
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
Procedure: Inspection during insertion
The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
Active Comparator: Withdrawal
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
Procedure: Inspection during withdrawal
The colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum. The instrument will be inserted to the cecum without deliberate inspection.
- Adenoma detection rate [ Time Frame: During colonoscopy ]
- Sedation dose [ Time Frame: During colonoscopy ]
- Post procedural pain scores [ Time Frame: Within 1 hour of colonoscopy ]
- Proportion of patients with at least one adenoma detected [ Time Frame: During colonoscopy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035775
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Beltway Surgery Center|
|Indianapolis, Indiana, United States, 46280|
|Principal Investigator:||Douglas K Rex, M.D.||Indiana University School of Medicine|