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Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| warm water | Experimental | warm water irrigation during the insertion phase of colonoscopy |
|
| air | Active Comparator | air insufflation during the insertion phase of colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warm water irrigation | Procedure | warm water irrigation during insertion phase of colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Undergoing Complete Unsedated Colonoscopy | 6-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pain and Tolerability Scores | Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable) | 6-9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valduce Hospital | Como | CO | 22100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20883846 | Derived | 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. |
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no patient excluded from the study flow after being allocated in the study or control arm
medical clinic since march 2009 until sample size was reached
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| ID | Title | Description |
|---|---|---|
| FG000 | Warm Water | warm water irrigation during the insertion phase of colonoscopy |
| FG001 | Air Insufflation | air insufflation during the insertion phase of colonoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Warm Water | warm water irrigation during the insertion phase of colonoscopy |
| BG001 | Air Insufflation | air insufflation during the insertion phase of colonoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients Undergoing Complete Unsedated Colonoscopy | Posted | Number | participants | 6-9 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 | Warm Water | warm water irrigation during the insertion phase of colonoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vittorio Terruzzi, MD | Valduce Hospital - Como - Italy | +39031324009 | vterruzzi@valduce.it |
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| air insufflation |
| Procedure |
air insufflation during the insertion phase of colonoscopy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Evaluation of Pain and Tolerability Scores | Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable) | Posted | Median | Inter-Quartile Range | Scores on a VAS scale | 6-9 months |
|
|
|
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | Air Insufflation | air insufflation during the insertion phase of colonoscopy | 0 | 114 | 0 | 114 |
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