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Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.
The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.
The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not 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 will be also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warm Water Immersion Colonoscopy | Experimental | Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
| Cool Water Immersion Colonoscopy | Active Comparator | Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warm Water Immersion Colonoscopy | Procedure | Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cecal Intubation Time | 3 months | |
| Cecal Intubation Time | = time between introduction of the colonoscope into the anus and reaching the cecum. | 1-30 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort During Insertion Phase of the Colonoscopy | 3 months |
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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 |
|---|---|---|---|
| 23819909 | Background | Falt P, Smajstrla V, Fojtik P, Tvrdik J, Urban O. Cool water vs warm water immersion for minimal sedation colonoscopy: a double-blind randomized trial. Colorectal Dis. 2013;15(10):e612-7. doi: 10.1111/codi.12336. |
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Subjects were not included if they did not fulfill inclusion criteria.
Patients older than 18 years referred to our unit for diagnostic outpatient colonoscopy. Subjects were excluded if they has a history of colorectal surgery, known diagnosis of IBD, chronic benzodiazepine use and if they refused sedation.
The period between June and October 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Warm Water Immersion Colonoscopy | Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| FG001 | Cool Water Immersion Colonoscopy | Colonoscopy using purely room temperature water (20-24°C) infusion 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 | Warm Water Immersion Colonoscopy | Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| BG001 | Cool 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 | Not Posted | 3 months | |||||||||||||
| Secondary | Patient Comfort During Insertion Phase of the Colonoscopy | Not Posted | 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 | Warm Water Immersion Colonoscopy | Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Premysl Falt, MD | Vitkovice Hospital | +420595633 | 205 | faltprem@centrum.cz |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Cool Water Immersion Colonoscopy | Procedure | Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal. |
|
Colonoscopy using purely room temperature water (20-24°C) infusion 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 |
|
| Primary |
| Cecal Intubation Time |
= time between introduction of the colonoscope into the anus and reaching the cecum. |
| Posted |
| Mean |
| Standard Deviation |
| minute |
| 1-30 |
|
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| EG001 | Cool Water Immersion Colonoscopy | Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | 0 | 106 | 0 | 106 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |