Comparing Warm Versus Cool Temperature Water During Colonoscopy
1 other identifier
interventional
175
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 25, 2012
May 1, 2012
10 months
March 24, 2011
May 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose of sedation medication used (fentanyl and midazolam)
Duration of the colonoscopy; Up to 3 hours
Secondary Outcomes (1)
Patient pain/discomfort score
During the day of the procedure; Up to 1 day
Study Arms (2)
Warm water
ACTIVE COMPARATORBody temperature (95-100 degrees F) water
Cool water
EXPERIMENTALRoom temperature (68-73 degrees F) water
Interventions
Body vs Room temperature water used during insertion of colonoscopy
Eligibility Criteria
You may qualify if:
- Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (1)
Lee BY, Katon R, Herzig D, Fennerty MB. Warm water infusion during sedated colonoscopy does not decrease amount of sedation medication used. Gastrointest Endosc. 2012 Dec;76(6):1182-7. doi: 10.1016/j.gie.2012.08.002. Epub 2012 Sep 26.
PMID: 23021168DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
M. Brian Fennerty, MD
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 25, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 25, 2012
Record last verified: 2012-05