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Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cap-assisted water immersion colonoscopy | Experimental | Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
| water immersion colonoscopy | Active Comparator | Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope | Device | Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Cecal Intubation Time | The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort During Insertion Phase of the Colonoscopy | 3 months | |
| Success Rate of Minimal Sedation Colonoscopy | A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Premysl Falt, MD | Digestive Diseases Center, Vitkovice Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Diseases Center, Vitkovice Hospital | Ostrava | 703 84 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23808948 | Result | Falt P, Smajstrla V, Fojtik P, Liberda M, Kliment M, Tvrdik J, Urban O. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc. 2013 Jul;25(4):434-9. doi: 10.1111/j.1443-1661.2012.01402.x. Epub 2012 Dec 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cap-assisted Water Immersion Colonoscopy | Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| FG001 | Water Immersion Colonoscopy | Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cap-assisted Water Immersion Colonoscopy | Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| BG001 | Water Immersion 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 | Cecal Intubation Time | The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum. | Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant. | Posted | Number | 95% Confidence Interval | minutes | 3 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 | Cap-assisted Water Immersion Colonoscopy | Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
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There were no complications recorded in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Přemysl Falt MD | Digestive Diseases Center, Vítkovice Hospital, Ostrava, Czech Republic | +420602689561 | faltprem@centrum.cz |
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| water immersion colonoscopy | Procedure | Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal. |
|
| 3 months |
Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
| 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 |
|
Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
|
| Secondary | Patient Comfort During Insertion Phase of the Colonoscopy | Not Posted | 3 months |
| Secondary | Success Rate of Minimal Sedation Colonoscopy | A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. | Posted | Number | percentage of all subjects in arm | 3 months |
|
|
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Water Immersion Colonoscopy | Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | 0 | 0 | 0 | 0 |
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