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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243930
• Other study ID #: KOESURG-41580
• Secondary ID: 41580
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: September 17, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Koege Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Disposable distal attachment

Locations

Country	Name	City	State
Denmark	Surgical department, endoscopy unit, Koege Hospital, Denmark	Koege	Region Sjaelland

Sponsors (1)

Lead Sponsor	Collaborator
Koege Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of success	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.	No
Primary	VAS recording of pain	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.	No
Secondary	Time	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.	No