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Comparing Warm Versus Cool Temperature Water During Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322724
First Posted: March 25, 2011
Last Update Posted: May 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
  Purpose
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.

Condition Intervention
Colonoscopy Procedure: Warm vs Cool water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: Comparing Warm Versus Cool Temperature Water During Colonoscopy

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Dose of sedation medication used (fentanyl and midazolam) [ Time Frame: Duration of the colonoscopy; Up to 3 hours ]

Secondary Outcome Measures:
  • Patient pain/discomfort score [ Time Frame: During the day of the procedure; Up to 1 day ]

Enrollment: 175
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Warm water
Body temperature (95-100 degrees F) water
Procedure: Warm vs Cool water
Body vs Room temperature water used during insertion of colonoscopy
Experimental: Cool water
Room temperature (68-73 degrees F) water
Procedure: Warm vs Cool water
Body vs Room temperature water used during insertion of colonoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322724


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: M. Brian Fennerty, MD Oregon Health and Science University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01322724     History of Changes
Other Study ID Numbers: 00007299
First Submitted: March 24, 2011
First Posted: March 25, 2011
Last Update Posted: May 28, 2012
Last Verified: May 2012

Keywords provided by OHSU Knight Cancer Institute:
colonoscopy
colon cancer screening
patient discomfort scores
sedation medication requirements
water insertion method