Warm Water Versus Room Temperature Water Immersion Colonoscopy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Warm Water Immersion Colonoscopy
Cool Water Immersion Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colonoscopy, warm water immersion, cool water immersion
Eligibility Criteria
Inclusion Criteria:
- outpatient diagnostic colonoscopy
- bowel prep with macrogolum
- initial 2 mg of midazolam i.v.
- signed informed consent form
Exclusion Criteria:
- planned therapeutic intervention
- colorectal surgery in history
- known inflammatory bowel disease or colorectal cancer
- refusal of sedation
Sites / Locations
- Digestive Diseases Center, Vitkovice Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Warm Water Immersion Colonoscopy
Cool Water Immersion Colonoscopy
Arm Description
Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Outcomes
Primary Outcome Measures
Cecal Intubation Time
Cecal Intubation Time
= time between introduction of the colonoscope into the anus and reaching the cecum.
Secondary Outcome Measures
Patient Comfort During Insertion Phase of the Colonoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01582178
Brief Title
Warm Water Versus Room Temperature Water Immersion Colonoscopy
Official Title
Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitkovice Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.
The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.
The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colonoscopy, warm water immersion, cool water immersion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Warm Water Immersion Colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Arm Title
Cool Water Immersion Colonoscopy
Arm Type
Active Comparator
Arm Description
Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Intervention Type
Procedure
Intervention Name(s)
Warm Water Immersion Colonoscopy
Intervention Description
Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
Intervention Type
Procedure
Intervention Name(s)
Cool Water Immersion Colonoscopy
Intervention Description
Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
Primary Outcome Measure Information:
Title
Cecal Intubation Time
Time Frame
3 months
Title
Cecal Intubation Time
Description
= time between introduction of the colonoscope into the anus and reaching the cecum.
Time Frame
1-30
Secondary Outcome Measure Information:
Title
Patient Comfort During Insertion Phase of the Colonoscopy
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
outpatient diagnostic colonoscopy
bowel prep with macrogolum
initial 2 mg of midazolam i.v.
signed informed consent form
Exclusion Criteria:
planned therapeutic intervention
colorectal surgery in history
known inflammatory bowel disease or colorectal cancer
refusal of sedation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Premysl Falt, MD
Organizational Affiliation
Digestive Diseases Center, Vitkovice Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Diseases Center, Vitkovice Hospital
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
23819909
Citation
Falt P, Smajstrla V, Fojtik P, Tvrdik J, Urban O. Cool water vs warm water immersion for minimal sedation colonoscopy: a double-blind randomized trial. Colorectal Dis. 2013;15(10):e612-7. doi: 10.1111/codi.12336.
Results Reference
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Warm Water Versus Room Temperature Water Immersion Colonoscopy
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