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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Disposable distal attachment

• Registration Number: NCT02243930
• Lead Sponsor: Zealand University Hospital

Brief 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.

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 Timeline

• Study Start: 2014-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Study First Posted: 2014-09-18
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cap	Disposable distal attachment	Sigmoidoscopy with cap

Primary Outcome Measures

Name	Time	Method
VAS recording of pain	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 Outcome Measures

Name	Time	Method
Time	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.

Trial Locations

Locations (1)

Surgical department, endoscopy unit, Koege Hospital, Denmark; 🇩🇰 Koege, Region Sjaelland, Denmark