Comparing Warm Versus Cool Temperature Water During Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01322724
First received: March 24, 2011
Last updated: May 24, 2012
Last verified: May 2012
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient pain/discomfort score [ Time Frame: During the day of the procedure; Up to 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by OHSU Knight Cancer Institute

Additional 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
Study First Received: March 24, 2011
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014