The Utility of Timed Segmental Withdrawal During Screening Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-07-31

Brief Summary

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The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer. The doctor performing the procedure will first advance the colonoscope to the end of the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the colonoscope. The period of time that the doctor spent examining the colon called "withdrawal time". Usually doctors will spend at least 6 minutes examining the colon after he reached the cecum. The investigators are proposing that dedicating half of the withdrawal time during colonoscopy in examining the right side of the colon, will increase the detection of polyps in the right side of the colon.

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Detailed Description

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Research design: This is a prospective, randomized trial comparing the ADR between patients undergoing a screening colonoscopy in four different groups: 1) at least 3 minutes from the total withdrawal time dedicated to the right side of the colon, 2) at least 4 minutes from the total withdrawal time dedicated to the right side of the colon, 3) 6 minutes total withdrawal time regardless of time spent in any segment, 4) 8 minutes total withdrawal time regardless of the time spent in any segment. Randomization will be done in blocks after stratification. Four gastroenterologists and two fellows matched base on similar ADR and stratified on each arm of the study (segmental versus non-segmental withdrawal) will be performing the procedures. The estimated sample size of the four arms of the study is 400 patients.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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3 minutes in the right side colon

Colonoscopy, at least 3 minutes in the right side colon from the total withdrawal time

Group Type EXPERIMENTAL

colonoscopy

Intervention Type PROCEDURE

colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer

4 minutes in the right side colon

Colonoscopy, at least 4 minutes in the right side colon from the total withdrawal time

Group Type EXPERIMENTAL

colonoscopy

Intervention Type PROCEDURE

colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer

6 minutes whole withdrawal time

Colonoscopy, at least 6 minutes whole withdrawal time regardless of time spent in any segment

Group Type NO_INTERVENTION

No interventions assigned to this group

8 minutes whole withdrawal time

Colonoscopy, at least 8 minutes whole withdrawal time regardless of time spent in any segment

Group Type EXPERIMENTAL

colonoscopy

Intervention Type PROCEDURE

colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer

Interventions

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colonoscopy

colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer

Intervention Type PROCEDURE