NCT02243930

Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success

Cap-assisted Sigmoidoscopy - Reduction in Pain, Reduction in Investigation Time and Increased Rate of Success, When Examined by the Less-experienced Endoscopist. A Prospective Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Disposable distal attachment

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-09-18
• Last updated: 2014-09-18

Locations

1 site across 1 country: Denmark