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Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01383252
Enrollment
10
Registered
2011-06-28
Start date
2010-02-28
Completion date
2013-06-30
Last updated
2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Polyp

Keywords

water method, air method, unsedated colonoscopy, adenoma detection

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREWater 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.

PROCEDUREAir 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.

Sponsors

VA Northern California Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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.

Exclusion criteria

* Patients who decline to participate * Unable to give informed consent or complete the questionnaires due to language or other difficulties

Design outcomes

Primary

MeasureTime frameDescription
Success of colonoscopy24 monthssuccessful cecal intubation

Secondary

MeasureTime frameDescription
Polyp detection24 monthsAdenoma detection rate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026