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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Cap

Sigmoidoscopy with cap

Group Type EXPERIMENTAL

Disposable distal attachment

Intervention Type DEVICE

No cap

Sigmoidoscopy without cap

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Disposable distal attachment

Intervention Type DEVICE

Other Intervention Names

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"cap" Model No. D-201-14304 - Olympus Dimentions: Ø15,0mm

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes