Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colon Neoplasm Pain |
Procedure: air insufflation Procedure: water immersion Procedure: water exchange |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial |
- Proportion of patients without pain [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
- patient pain score [ Time Frame: 9 to 12 months ] [ Designated as safety issue: No ]
- patient satisfaction score [ Time Frame: 9 to 12 months ] [ Designated as safety issue: No ]
- polyp detetion rate [ Time Frame: 9 to 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: air insufflation
Use air insufflation during colonoscopy
|
Procedure: air insufflation
insufflate air during the insertion of colonoscopy
|
|
Active Comparator: water immersion
infuse water during insertion, remove water during withdrawal of colonoscopy
|
Procedure: water immersion
infuse water during insertion, aspirate water during withdrawal
|
|
Active Comparator: water exchange
infuse and remove water during insertion phase of colonoscopy
|
Procedure: water exchange
infuse and remove water during insertion phase of colonoscopy
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Yu-Hsi Hsieh, M.D. | hsieh.yuhsi@msa.hinet.net |
| Taiwan | |
| Dalin Tzu Chi General Hospital | Recruiting |
| Chia-Yi, Taiwan, 622 | |
| Contact: Yu-Hsi Hsieh, MD 886052648000 ext 5242 hsieh.yuhsi@msa.hinet.net | |
| Principal Investigator: Yu-Hsi Hsieh, M.D. | |
| Dalin Tzu Chi General Hospital | Recruiting |
| Chiayi, Taiwan, 622 | |
| Contact: Yu-hsi Hsieh, MD 886052648536 hsieh.yuhsi@msa.hinet.net | |
| Principal Investigator: Yu-hsi Hsieh, MD | |
| Principal Investigator: | Yu-Hsi Hsieh, Dr. | Dalin Tzu Chi General Hospital |
More Information
Publications:
| Responsible Party: | Yu-Hsi hsieh, Chief of department of gastroenterology and hepatology, Dalin Tzu Chi General Hospital |
| ClinicalTrials.gov Identifier: | NCT01535326 History of Changes |
| Other Study ID Numbers: | DalinTCGH-hsieh-01 |
| Study First Received: | February 11, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Dalin Tzu Chi General Hospital:
|
colonoscopy |
Additional relevant MeSH terms:
|
Colonic Neoplasms Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013