Clinical trial NCT00577083: Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates
Official title: Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyps
Keywords: miss rates
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Detailed description: Patient will undergo tandem colonoscopy on the same day using propofol sedation. Patients will undergo one colonoscopy without the cap and a second colonoscopy with the cap on. We will endeavor to keep the total examination time equal between the groups and approximately six minutes. The order in which patients receive the two colonoscopies (i.e. cap or without cap first) will be randomized. Any polyps detected during the first colonoscopy will be removed during that procedure. During the withdrawal phase, the 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. The stopwatch will also be stopped for suctioning fluid or washing debris from the colon surface. Any polyp detected and removed during the first colonoscopy will be counted as the detection for that procedure. During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Adenomas
timeFrame: after the second colonoscopy is completed
Secondary outcomes:
measure: 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.
timeFrame: after 2nd colonoscopy was completed in 24hrs
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.