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| ID | Type | Description | Link |
|---|---|---|---|
| 41580 | Other Identifier | The regional committee of health research ethics |
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The purpose of this study is to investigate the attachment of a transparent hood ("cap") on the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce investigation time, and increases the success rate of the sigmoidoscopy. The study focus on the less-experienced endoscopist.
The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.
Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point (60cm from anus). The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cap | Experimental | Sigmoidoscopy with cap |
|
| No cap | No Intervention | Sigmoidoscopy without cap |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable distal attachment | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS recording of pain | the registration is performed when the endoscopist has advanced the scope to the 60 cm mark. | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Time | Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark. | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of success | recording the rate of examinations that reached the intubation endpoint at 60cm from anus | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Ploug, MD | Koege Hospital, Surgical Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical department, endoscopy unit, Koege Hospital, Denmark | Koege | Region Sjælland | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28762140 | Derived | Ploug M, Poulsen JK, Jensen HQ, Achiam M. The use of a transparent cap in sigmoidoscopy-A randomized controlled clinical trial on pain, time and success rate. Indian J Gastroenterol. 2017 Jul;36(4):318-322. doi: 10.1007/s12664-017-0776-y. Epub 2017 Aug 1. |
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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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| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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