Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?

NCT01035775 | Completed

• 1 other identifier: 0909-22
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Colorectal Polyps

Keywords

Colonoscopy; Adenoma detection; Colorectal polyps

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  During colonoscopy

Secondary Outcomes (3)

• Sedation dose

  During colonoscopy

• Post procedural pain scores

  Within 1 hour of colonoscopy

• Proportion of patients with at least one adenoma detected

  During colonoscopy

Study Arms (2)

Insertion

EXPERIMENTAL

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

Procedure: Inspection during insertion

Withdrawal

ACTIVE COMPARATOR

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

Procedure: Inspection during withdrawal

Interventions

Inspection during insertion PROCEDURE

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

Insertion

Inspection during withdrawal PROCEDURE

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.

Withdrawal

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (2)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Beltway Surgery Center

Indianapolis, Indiana, 46280, United States

Location

Related Publications (1)

• 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.

  PMID: 22817789 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Douglas K Rex, M.D.

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Douglas K. Rex, MD

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)