Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01035775
First received: December 18, 2009
Last updated: June 22, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention
Colorectal Cancer
Colorectal Polyps
Procedure: Inspection during insertion
Procedure: Inspection during withdrawal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Adenoma detection rate [ Time Frame: During colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sedation dose [ Time Frame: During colonoscopy ] [ Designated as safety issue: Yes ]
  • Post procedural pain scores [ Time Frame: Within 1 hour of colonoscopy ] [ Designated as safety issue: Yes ]
  • Proportion of patients with at least one adenoma detected [ Time Frame: During colonoscopy ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insertion
Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum.
Procedure: Inspection during insertion
The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
Active Comparator: Withdrawal
Inspection during withdrawal (usual care) without deliberate inspection during insertion.
Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035775

Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Beltway Surgery Center
Indianapolis, Indiana, United States, 46280
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Douglas K Rex, M.D. Indiana University School of Medicine
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas K. Rex, M.D., Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT01035775     History of Changes
Other Study ID Numbers: 0909-22
Study First Received: December 18, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Colonoscopy
Adenoma detection
Colorectal polyps

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Polyps
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Intestinal Polyps

ClinicalTrials.gov processed this record on July 23, 2014