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NCT01322724 Clinical Trial

Comparing Warm Versus Cool Temperature Water During Colonoscopy

Colonoscopy Clinical Trial

Official title:
Comparing Warm Versus Cool Temperature Water During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01322724
Other study ID # 00007299
Secondary ID
Status Completed
Phase N/A
First received March 24, 2011
Last updated May 24, 2012
Start date June 2011
Est. completion date April 2012

Study information
Verified date May 2012
Source OHSU Knight Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening

Exclusion Criteria:

- Patients undergoing colonoscopy for any other indication besides colon cancer screening

- Patients with prior colonic resections

- Patients with chronic narcotic or benzodiazepine use

- Poor bowel preparation (i.e. Boston bowel preparation score < 8)

- Patients with obstructing colonic lesions detected on colonoscopy

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Procedure:
• Warm vs Cool water
Body vs Room temperature water used during insertion of colonoscopy

Locations
Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose of sedation medication used (fentanyl and midazolam) Duration of the colonoscopy; Up to 3 hours No
Secondary Patient pain/discomfort score During the day of the procedure; Up to 1 day No
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