Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates

NCT00577083 | Completed Results DMC

• 1 other identifier: 0501-30
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a test in which a thin, black, flexible tube with a lighting system on the end is passed through the anus, into the rectum, in order to examine the large bowel or intestine, also called the colon. Colonoscopy is a very good test for examining the colon for polyps (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy because they are hiding behind folds and bends in the colon. This research study is being done to determine if performing colonoscopy with a cap on the tip of the colonoscope will reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed against a fold or ridge in order to flatten it, so that the lining on the other side can be more easily seen. This may reduce the miss rate for colon polyps.

Conditions

Polyps

Keywords

miss rates

Outcome Measures

Primary Outcomes (1)

• Number of Adenomas

  Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.

  after the second colonoscopy is completed

Secondary Outcomes (1)

• Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.

  after 2nd colonoscopy was completed in 24hrs

Study Arms (2)

Initial cap-fitted

EXPERIMENTAL

Initial cap-fitted colonoscopy for the first insertion

Device: Cap-fitted colonoscopy

Initial regular

ACTIVE COMPARATOR

Initial regular no cap on the end of the colonoscope for the first insertion

Device: Cap-fitted colonoscopy

Interventions

Cap-fitted colonoscopy DEVICE

Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.

Also known as: cap-assisted colonoscopy, colonoscopy with detachable hood

Initial cap-fitted; Initial regular

Eligibility Criteria

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

You may qualify if:

• years of age or older, undergoing scheduled colonoscopy and able to give informed consent.

You may not qualify if:

• Previous surgical resection of the colon or rectum
• American Society of Anesthesiology class III or higher
• Inflammatory bowel disease
• Current use of anticoagulants.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.

  PMID: 20579648 DERIVED

MeSH Terms

Conditions

Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Douglas K Rex, MD
• Organization: Indiana University

drex@iu.edu

317-948-8741

Study Officials

• Douglas K Rex, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 19, 2007
• Study Start: November 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 10, 2018
• Results First Posted: February 22, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)