Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
Primary Purpose
Colorectal Cancer, Colorectal Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspection during insertion
Inspection during withdrawal
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy, Adenoma detection, Colorectal polyps
Eligibility Criteria
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
Sites / Locations
- Indiana University Hospital
- Beltway Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insertion
Withdrawal
Arm Description
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
Outcomes
Primary Outcome Measures
Adenoma detection rate
Secondary Outcome Measures
Sedation dose
Post procedural pain scores
Proportion of patients with at least one adenoma detected
Full Information
NCT ID
NCT01035775
First Posted
December 18, 2009
Last Updated
November 15, 2018
Sponsor
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01035775
Brief Title
Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
Official Title
Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Polyps
Keywords
Colonoscopy, Adenoma detection, Colorectal polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insertion
Arm Type
Experimental
Arm Description
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
Arm Title
Withdrawal
Arm Type
Active Comparator
Arm Description
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
Intervention Type
Procedure
Intervention Name(s)
Inspection during insertion
Intervention Description
The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
Intervention Type
Procedure
Intervention Name(s)
Inspection during withdrawal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Time Frame
During colonoscopy
Secondary Outcome Measure Information:
Title
Sedation dose
Time Frame
During colonoscopy
Title
Post procedural pain scores
Time Frame
Within 1 hour of colonoscopy
Title
Proportion of patients with at least one adenoma detected
Time Frame
During colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, M.D.
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Beltway Surgery Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22817789
Citation
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.
Results Reference
derived
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Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
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