Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-06-30

Brief Summary

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In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:

1. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
2. Study method improves bowel preparation and increases polyp pickup rate

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Detailed Description

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Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.

The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.

In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.

Conditions

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Colon Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Water method

Water infusion in lieu of air insufflation for screening and surveillance colonoscopy

Group Type EXPERIMENTAL

Water infusion in lieu of air insufflation

Intervention Type PROCEDURE

Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.

Air method

Air insufflation for screening and surveillance colonoscopy

Group Type ACTIVE_COMPARATOR

Air method

Intervention Type PROCEDURE

Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.

Interventions

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Water infusion in lieu of air insufflation

Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.

Intervention Type PROCEDURE

Air method

Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.

Intervention Type PROCEDURE

Other Intervention Names

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Water method Screening colonoscopy Screening colonoscopy

Eligibility Criteria

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Inclusion Criteria

* Adult (\>50 years old)
* Male and female patients
* Scheduled and consented for screening or surveillance colonoscopy without medications
* Accept randomization to the study or the conventional method
* Agree to complete study questionnaires
* The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.