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| Name | Class |
|---|---|
| Danish Medical Association | OTHER |
| Surgical Clinic, Allerød, Denmark | UNKNOWN |
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The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.
The study will investigate whether the endoguide improves success rate and the patient's perception of pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With endoguide | Experimental | Colonoscopy completed with endoguide |
|
| Without endoguide | No Intervention | Colonoscopy completed without endoguide |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoguide | Device | Use of endoguide to facilitate completion of endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completed Colonoscopy | immediately after colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of Pain | VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale | After endoscopy (within 10mins) and 1 day after endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Speciallægerne på Rolighedsvej | Birkerød | Birkerød | 3460 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23743108 | Derived | Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611. |
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| ID | Title | Description |
|---|---|---|
| FG000 | With Endoguide | Colonoscopy completed with endoguide |
| FG001 | Without Endoguide | Colonoscopy completed without endoguide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | With Endoguide | Colonoscopy completed with endoguide |
| BG001 | Without Endoguide | Colonoscopy completed without endoguide |
| 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 | Completed Colonoscopy | Choosen by randomization. | Posted | Number | participants | immediately after colonoscopy |
|
|
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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 | With Endoguide | Colonoscopy completed with endoguide |
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Early termination due to higher than expected eligible patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lene Hendel MD | Specialist Doctors Rolighedsvej | +4545819090 | lene@hendel.dk |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Perception of Pain | VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale | Posted | Mean | Standard Deviation | Scores on a scale 0-10 | After endoscopy (within 10mins) and 1 day after endoscopy |
|
|
|
| 0 |
| 555 |
| 0 |
| 555 |
| EG001 | Without Endoguide | Colonoscopy completed without endoguide | 0 | 449 | 0 | 449 |
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