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CompletedNCT01035775Updated Nov 16, 2018

Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

An interventional study of Inspection during insertion and Inspection during withdrawal in Colorectal Cancer and Colorectal Polyps, sponsored by Indiana University School of Medicine. Completed at 2 sites in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-16.

Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
340
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Colorectal Polyps

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Keywords

  • Colonoscopy
  • Adenoma detection
  • Colorectal polyps
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
340 participants (actual)

Study arms

  • Experimental
    Insertion

    Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.

    Procedure: Inspection during insertion

  • Active comparator
    Withdrawal

    Inspection during withdrawal (usual care) without deliberate inspection during insertion.

    Procedure: Inspection during withdrawal

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.

05

What researchers measure

Primary outcomes

  1. Adenoma detection rate

    Time frame: During colonoscopy

Secondary outcomes

  1. Sedation dose

    Time frame: During colonoscopy

  2. Post procedural pain scores

    Time frame: Within 1 hour of colonoscopy

  3. Proportion of patients with at least one adenoma detected

    Time frame: During colonoscopy

06

Study locations

2 sites
  • Indiana University Hospital
    Indianapolis, Indiana 46202, United States
  • Beltway Surgery Center
    Indianapolis, Indiana 46280, United States
07

References and documents

Publications

  • Hewett DG, Rex DK. Inspection on instrument insertion during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2012 Aug;76(2):381-7. doi: 10.1016/j.gie.2012.04.454. PubMed 22817789 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT01035775
Lead sponsor
Indiana University School of Medicine
Responsible party
Douglas K. Rex (Douglas K. Rex, MD, Indiana University) — Principal investigator
First posted
Dec 21, 2009
Start date
Dec 2009
Primary completion
Dec 2010
Completion
Jan 2011
Last update
Nov 16, 2018

Study contacts

Douglas K Rex, M.D.
principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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