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A Comparison of Methods to Detect Polyps During Colonoscopy

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Inspection Colonoscopy
Dual Inspection Colonoscopy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colonoscopy, adenoma detection, polyps

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients
  • Patients able to provide an informed consent
  • Patients undergoing colonoscopy

Exclusion Criteria:

  • Pregnant women
  • Patients with Familial Adenomatous Polyposis Syndromes (FAP)
  • Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC)
  • Patients who have undergone previous surgical resection of the colon
  • Patients who have been diagnosed with inflammatory bowel disease

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Standard Inspection Colonoscopy

Dual Inspection Colonoscopy

Arm Description

The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.

The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.

Outcomes

Primary Outcome Measures

Adenoma detection rates for each method

Secondary Outcome Measures

Comparison of procedure times for each method
Percentage of patients with at least one adenoma detected by each method
Comparison of percentage of adenomas classified as high risk for each method

Full Information

First Posted
December 2, 2009
Last Updated
March 26, 2012
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01025960
Brief Title
A Comparison of Methods to Detect Polyps During Colonoscopy
Official Title
Comparison of Detection of Polyps During Both Insertion and Withdrawal Phases of Colonoscopy Versus the Standard Practice of Detection of Polyps During the Withdrawal Phase of Colonoscopy: A Prospective Quality Improvement Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer. Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colonoscopy, adenoma detection, polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
768 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Inspection Colonoscopy
Arm Type
Other
Arm Description
The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.
Arm Title
Dual Inspection Colonoscopy
Arm Type
Active Comparator
Arm Description
The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
Intervention Type
Procedure
Intervention Name(s)
Standard Inspection Colonoscopy
Intervention Description
The large bowel will be inspected for polyps during the withdrawal of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
Intervention Type
Procedure
Intervention Name(s)
Dual Inspection Colonoscopy
Intervention Description
The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
Primary Outcome Measure Information:
Title
Adenoma detection rates for each method
Time Frame
within the first 30 days after colonoscopy
Secondary Outcome Measure Information:
Title
Comparison of procedure times for each method
Time Frame
1 year
Title
Percentage of patients with at least one adenoma detected by each method
Time Frame
1 year
Title
Comparison of percentage of adenomas classified as high risk for each method
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients Patients able to provide an informed consent Patients undergoing colonoscopy Exclusion Criteria: Pregnant women Patients with Familial Adenomatous Polyposis Syndromes (FAP) Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC) Patients who have undergone previous surgical resection of the colon Patients who have been diagnosed with inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhusudhan Sanaka, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25037727
Citation
Sanaka MR, Parsi MA, Burke CA, Barnes D, Church J, Rizk M, Zein N, Joseph R, Thota PN, Lopez R, Kiran RP. Adenoma detection at colonoscopy by polypectomy in withdrawal only versus both insertion and withdrawal: a randomized controlled trial. Surg Endosc. 2015 Mar;29(3):692-9. doi: 10.1007/s00464-014-3723-3. Epub 2014 Jul 19.
Results Reference
derived

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A Comparison of Methods to Detect Polyps During Colonoscopy

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