Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
Primary Purpose
Colon Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
water immersion
water exchange
air insufflation
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Neoplasm focused on measuring colonoscopy, pain, sedation, water
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite
Exclusion Criteria:
- request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
Sites / Locations
- Dalin Tzu Chi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
water immersion
water exchange
air insufflation
Arm Description
infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.
infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase
standard colonoscopy using traditional air insufflation during insertion
Outcomes
Primary Outcome Measures
Proportions of patients requiring sedation
Secondary Outcome Measures
patient pain during insertion
Full Information
NCT ID
NCT01699399
First Posted
September 30, 2012
Last Updated
May 19, 2019
Sponsor
Dalin Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01699399
Brief Title
Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
Official Title
A Randomized, Controlled Trial Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalin Tzu Chi General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective, randomized controlled trial compares traditional air insufflation with water immersion and water exchange in patients undergoing colonoscopy using on demand sedation. We test the hypothesis that compared with air insufflation the proportion of patients who require on demand sedation during colonoscopy will be significantly lowered by water immersion and water exchange, and water exchange will produce the greatest reduction
Detailed Description
The patients will be allocated into 3 groups by computerized randomization. In group A (water exchange), water will be infused and removed at the same time throughout the entire colon during the insertion phase with the air pump turned off. In group B (water immersion), water will be infused in the insertion phase and removed in the withdrawal phase. The water will be used mainly to open the lumen, without attempting to clear the colon contents. In group A and B, warm-to-touch water will be infused mainly infused through the accessory channel of the colonoscope using a foot-switch controlled water pump (JW2, Fujinon, Saitama, Japan). Air insufflation not used until the cecum has been reached. . In group C, air insufflation will be used throughout the procedure. Aliquots of 30 to 50 ml of water will be used for washing residual stool, as needed. In all three groups, loop reduction maneuvers, abdominal compression and change of patient position will be utilized at the discretion of the colonoscopist and recorded. Intubation of the cecum will be defined as successful only if the base of the cecum is touched with the tip of the colonoscope. Detailed examinations will be undertaken during the withdrawal phase.
During colonoscopy, a study nurse will ask the patient to report the level of pain (0 = none, 10 = most severe) at 2 to 3-minute intervals or at any time the patient voiced discomfort. For pain scores ≧2, maneuvers to minimize pain will be implemented. Immediately thereafter, the nurse will offer sedation, which the patients can accept or decline. If accepted, after an initial bolus of 1 mg/kg or 0.5 mg/kg for patients over 65 years propofol (Diprivan, Astra-Zeneca, Stockholm, Sweden) will be titrated in 20- to 30-mg increments to achieve an adequate level of sedation. The need of additional drug will be estimated by patient pain response (moans, grimaces and movements). Usually no more propofol will be added during the withdrawal phase. The initial amount of propofol, and those before and after arrival to the cecum will be recorded.
The following parameters will be evaluated and recorded on the patient data sheet: quality of bowel preparation, cecal intubation time, withdrawal time total procedure time, use of abdominal pressure, need for changing position, presence of polyps and reasons for incomplete colonoscopy.
The procedure will be recorded and stored as digital files.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Neoplasm
Keywords
colonoscopy, pain, sedation, water
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
water immersion
Arm Type
Experimental
Arm Description
infuse water during insertion phase of colonoscopy instead of air insufflation; remove the water during withdrawal phase.
Arm Title
water exchange
Arm Type
Experimental
Arm Description
infuse and remove water during the insertion phase of colonoscopy. Air insufflation is used only in the withdrawal phase
Arm Title
air insufflation
Arm Type
Active Comparator
Arm Description
standard colonoscopy using traditional air insufflation during insertion
Intervention Type
Procedure
Intervention Name(s)
water immersion
Intervention Type
Procedure
Intervention Name(s)
water exchange
Intervention Type
Procedure
Intervention Name(s)
air insufflation
Primary Outcome Measure Information:
Title
Proportions of patients requiring sedation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
patient pain during insertion
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
post-procedure discomforts and 30 days complication rate
Description
telephone follow up for post-procedure discomforts and 30 days complication rate
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing colonoscopy performed by the endoscopist at our endoscopic suite
Exclusion Criteria:
request for sedation, indicated for bidirectional endoscopy, obstructive lesions of the colon, allergy to meperidine or propofol, American Society of Anesthesiology (ASA) risk Class 3 or higher, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsi Hsieh, M.D.
Organizational Affiliation
Dalin Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalin Tzu Chi General Hospital
City
Chia-Yi
ZIP/Postal Code
622
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21633535
Citation
Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
Results Reference
background
PubMed Identifier
20619405
Citation
Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
Results Reference
background
PubMed Identifier
20883846
Citation
Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
Results Reference
background
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Comparing Water Exchange, Water Immersion and Air Insufflation Methods During Colonoscopy With the Option of on Demand Sedation
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