Pain
Conditions
Keywords
Sigmoidoscopy with or without cap, Pain during sigmoidoscopy, Sigmoidoscopy and time
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDisposable distal attachment
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* planned to undergo sigmoidoscopy * informed consent
Exclusion criteria
* use of iv medication for pain and/or anxiety immediately before the endoscopy * lack of indication for a full sigmoidoscopy (eg just need to investigate the rectum) * lack or improper administration of standard bowel preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS recording of pain | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. | the registration is performed when the endoscopist has advanced the scope to the 60 cm mark. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. | Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark. |
Other
| Measure | Time frame | Description |
|---|---|---|
| rate of success | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. | recording the rate of examinations that reached the intubation endpoint at 60cm from anus |
Countries
Denmark
Outcome results
None listed