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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.
All procedures will be recorded and stored as digital files.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| air insufflation | Placebo Comparator | Use air insufflation during colonoscopy |
|
| water immersion | Active Comparator | infuse water during insertion, remove water during withdrawal of colonoscopy |
|
| water exchange | Active Comparator | infuse and remove water during insertion phase of colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| air insufflation | Procedure | insufflate air during the insertion of colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Without Pain | proportion of patients without insertion pain during colonoscopy | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 9 to 12 months |
| Patient Satisfaction Score |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure Discomforts and 30 Day Complication Rate | telephone follow up for post-procedure discomforts and 30 day complication rate | one month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Hsi Hsieh, Dr. | Dalin Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalin Tzu Chi General Hospital | Chiayi City | Taiwan | 622 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21633535 | Background | 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. | |
| 22163081 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Insufflation | Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy |
| FG001 | Water Immersion | infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal |
| FG002 | Water Exchange | infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients underwent endoscopy by YHH
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Insufflation | Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy |
| BG001 | Water Immersion | infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Without Pain | proportion of patients without insertion pain during colonoscopy | Posted | Number | participants | up to 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air Insufflation | Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| perforation | Gastrointestinal disorders | Non-systematic Assessment | one patient received polypectomy during withdrawal phase. Perforation was found immediately and hemoclips were applied. She recovered uneventfully after supportive care. |
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Single center; single endoscopist
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yu-Hsi Hsieh | Dalin Tzu Chi Hospital | 88652648000 | 5241 | hsieh.yuhsi@msa.hinet.net |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| water immersion |
| Procedure |
infuse water during insertion, aspirate water during withdrawal |
|
| water exchange | Procedure | infuse and remove water during insertion phase of colonoscopy |
|
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
| 9 to 12 months |
| Number of Participants With at Least One Adenoma | the number of participants with at least one adenoma in each of the study groups. | 9 to 12 months |
| 21184876 | Background | 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. |
| 19555938 | Background | 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. |
| BG002 | Water Exchange | infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Water Exchange |
infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy Proportion of no pain: 61.1% |
|
|
| Secondary | 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) | Posted | Median | Full Range | units on a scale | 9 to 12 months |
|
|
|
| Secondary | Patient Satisfaction Score | satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied | Posted | Median | Full Range | units on a scale | 9 to 12 months |
|
|
|
| Secondary | Number of Participants With at Least One Adenoma | the number of participants with at least one adenoma in each of the study groups. | Posted | Number | participants | 9 to 12 months |
|
|
|
| Other Pre-specified | Post-procedure Discomforts and 30 Day Complication Rate | telephone follow up for post-procedure discomforts and 30 day complication rate | Not Posted | one month |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | Water Immersion | infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal | 0 | 90 | 0 | 90 |
| EG002 | Water Exchange | infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy | 1 | 90 | 0 | 90 |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |