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Completed

NCT Number: NCT02243930

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

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgical department, endoscopy unit, Koege Hospital, Denmark

Koege, Region Sjælland, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disposable distal attachment

Device

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

Primary outcomes

  1. VAS recording of pain

    Time frame: 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 outcomes

  1. Time

    Time frame: 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 outcomes

  1. rate of success

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 18, 2014
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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