NCT01383252

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. 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. 2.Study method improves bowel preparation and increases polyp pickup rate

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

3.3 years

First QC Date

June 21, 2011

Last Update Submit

June 13, 2013

Conditions

Colon Polyp

Keywords

water methodair methodunsedated colonoscopyadenoma detection

Outcome Measures

Primary Outcomes (1)

  • Success of colonoscopy

    successful cecal intubation

    24 months

Secondary Outcomes (1)

  • Polyp detection

    24 months

Study Arms (2)

Water method

EXPERIMENTAL

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

Procedure: Water infusion in lieu of air insufflation

Air method

ACTIVE COMPARATOR

Air insufflation for screening and surveillance colonoscopy

Procedure: Air method

Interventions

Water infusion in lieu of air insufflationPROCEDURE

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.

Also known as: Water method, Screening colonoscopy
Water method
Air methodPROCEDURE

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.

Also known as: Screening colonoscopy
Air method

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sacramento VA Medical Center

Mather, California, 95655, United States

Location

Related Publications (4)

  • Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.

    PMID: 19555938BACKGROUND

  • Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. doi: 10.1111/j.1365-2036.2007.03404.x.

    PMID: 17661766BACKGROUND

  • Leung FW, Mann SK, Salera R, Toomsen L, Cabrera H, Prather D, Gutierrez R, Leung JW. Options for screening colonoscopy without sedation: sequel to a pilot study in U.S. veterans. Gastrointest Endosc. 2008 Apr;67(4):712-7. doi: 10.1016/j.gie.2007.10.028. Epub 2008 Feb 14.

    PMID: 18279868BACKGROUND

  • Leung JW, Salera R, Toomsen L, Mann S, Leung FW. Pilot feasibility study of the method of water infusion without air insufflation in sedated colonoscopy. Dig Dis Sci. 2009 Sep;54(9):1997-2001. doi: 10.1007/s10620-008-0576-4. Epub 2008 Dec 5.

    PMID: 19058003BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Leung, MD

    Sacramento VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 28, 2011

Study Start

February 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

US(1)