An interventional study of Disposable distal attachment in Pain, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-18.
Sponsored by Zealand University Hospital · Not applicable and Interventional
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.
Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sigmoidoscopy with cap
Device: Disposable distal attachment
Sigmoidoscopy without cap
Also known as: "cap", Model No. D-201-14304 - Olympus, Dimentions: Ø15,0mm
VAS recording of pain
the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.
Time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Time
Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark.
Time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
rate of success
recording the rate of examinations that reached the intubation endpoint at 60cm from anus
Time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Zealand University Hospital