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

Z

Zealand University Hospital

Status

Completed

Conditions

Pain

Treatments

Device: Disposable distal attachment

Study type

Interventional

Funder types

Other

Identifiers

NCT02243930
KOESURG-41580
41580 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

193 participants in 2 patient groups

Cap
Experimental group
Description:
Sigmoidoscopy with cap
Treatment:
Device: Disposable distal attachment
No cap
No Intervention group
Description:
Sigmoidoscopy without cap

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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