Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

Colorectal Cancer Clinical Trial

Official title:

Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035775
• Other study ID #: 0909-22
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyps

Intervention

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

Locations

Country	Name	City	State
United States	Beltway Surgery Center	Indianapolis	Indiana
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		During colonoscopy
Secondary	Sedation dose		During colonoscopy
Secondary	Post procedural pain scores		Within 1 hour of colonoscopy
Secondary	Proportion of patients with at least one adenoma detected		During colonoscopy