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Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01035775
Enrollment
340
Registered
2009-12-21
Start date
2009-12-31
Completion date
2011-01-31
Last updated
2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Polyps

Keywords

Colonoscopy, Adenoma detection, Colorectal polyps

Brief summary

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. 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.

Detailed description

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.

Interventions

PROCEDUREInspection during insertion

The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.

PROCEDUREInspection 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.

Sponsors

Indiana University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 50 years * Patients undergoing colonoscopy for screening or surveillance indications

Exclusion criteria

* Previous surgical resection of all or part of the colon. * Inability to give informed consent. * Ulcerative colitis or Crohn's disease. * Polyposis syndrome or Lynch syndrome (HNPCC) * Any comorbid condition which the investigator deems would put the patient at increased risk from a slightly prolonged procedure

Design outcomes

Primary

MeasureTime frame
Adenoma detection rateDuring colonoscopy

Secondary

MeasureTime frame
Sedation doseDuring colonoscopy
Post procedural pain scoresWithin 1 hour of colonoscopy
Proportion of patients with at least one adenoma detectedDuring colonoscopy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026