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OpenTrials
Completed

NCT Number: NCT01383252

Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

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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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacramento VA Medical Center

Mather, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water infusion in lieu of air insufflation

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.

Other names: Water method, Screening colonoscopy

Air method

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.

Other names: Screening colonoscopy

Primary outcomes

  1. Success of colonoscopy

    Time frame: 24 months

    successful cecal intubation

Secondary outcomes

  1. Polyp detection

    Time frame: 24 months

    Adenoma detection rate

Sponsors and collaborators

Lead sponsor

VA Northern California Health Care System

Fed

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2011
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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