Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
Primary Purpose
Colon Neoplasm, Pain
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
air insufflation
water immersion
water exchange
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Neoplasm focused on measuring colonoscopy
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing minimally sedated colonoscopy
Exclusion Criteria:
- Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
Sites / Locations
- Dalin Tzu Chi General Hospital
- Dalin Tzu Chi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
air insufflation
water immersion
water exchange
Arm Description
Use air insufflation during colonoscopy
infuse water during insertion, remove water during withdrawal of colonoscopy
infuse and remove water during insertion phase of colonoscopy
Outcomes
Primary Outcome Measures
Proportion of Patients Without Pain
proportion of patients without insertion pain during colonoscopy
Secondary Outcome Measures
Patient Pain Score
The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Patient Satisfaction Score
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Number of Participants With at Least One Adenoma
the number of participants with at least one adenoma in each of the study groups.
Full Information
NCT ID
NCT01535326
First Posted
February 11, 2012
Last Updated
July 28, 2014
Sponsor
Dalin Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01535326
Brief Title
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
Official Title
Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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
In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).
This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.
Detailed Description
All procedures 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, Pain
Keywords
colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
air insufflation
Arm Type
Placebo Comparator
Arm Description
Use air insufflation during colonoscopy
Arm Title
water immersion
Arm Type
Active Comparator
Arm Description
infuse water during insertion, remove water during withdrawal of colonoscopy
Arm Title
water exchange
Arm Type
Active Comparator
Arm Description
infuse and remove water during insertion phase of colonoscopy
Intervention Type
Procedure
Intervention Name(s)
air insufflation
Intervention Description
insufflate air during the insertion of colonoscopy
Intervention Type
Procedure
Intervention Name(s)
water immersion
Intervention Description
infuse water during insertion, aspirate water during withdrawal
Intervention Type
Procedure
Intervention Name(s)
water exchange
Intervention Description
infuse and remove water during insertion phase of colonoscopy
Primary Outcome Measure Information:
Title
Proportion of Patients Without Pain
Description
proportion of patients without insertion pain during colonoscopy
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Patient Pain Score
Description
The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Time Frame
9 to 12 months
Title
Patient Satisfaction Score
Description
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Time Frame
9 to 12 months
Title
Number of Participants With at Least One Adenoma
Description
the number of participants with at least one adenoma in each of the study groups.
Time Frame
9 to 12 months
Other Pre-specified Outcome Measures:
Title
Post-procedure Discomforts and 30 Day Complication Rate
Description
telephone follow up for post-procedure discomforts and 30 day 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 minimally sedated colonoscopy
Exclusion Criteria:
Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, 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, Dr.
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
Facility Name
Dalin Tzu Chi General Hospital
City
Chiayi
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
22163081
Citation
Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):114-120. doi: 10.4161/jig.1.3.18510. Epub 2011 Jul 1.
Results Reference
background
PubMed Identifier
21184876
Citation
Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
Results Reference
background
PubMed Identifier
19555938
Citation
Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
Results Reference
background
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Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
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