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

September 17, 2014 updated by: magnus Ploug, Zealand University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Sjaelland
      • Koege, Region Sjaelland, Denmark, 4600
        • Surgical department, endoscopy unit, Koege Hospital, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cap
Sigmoidoscopy with cap
Device: Disposable distal attachment
Other Names:
  • "cap"
  • Model No. D-201-14304 - Olympus
  • Dimentions: Ø15,0mm
No Intervention: No cap
Sigmoidoscopy without cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Magnus Ploug, MD, Koege Hospital, Surgical Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 18, 2014

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOESURG-41580
  • 41580 (Other Identifier: The regional committee of health research ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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