A Comparison of Two Colonoscopic Withdrawal Techniques

Phase 4

Completed

• Conditions: Intestinal Polyps

• Registration Number: NCT01554098
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.

Null Hypothesis:

On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.

Alternative Hypothesis:

On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.

Detailed Description

The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Having a diagnostic colonoscopy
• Age >40 and <80

Exclusion Criteria

• Inflammatory bowel disease
• Known polyposis syndrome
• Poor mobility which would limit a patients ability to turn

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Colonic polyps	Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.	The primary outcome for this study is the presence or absence of polyps, detected during colonoscope withdrawal in either the supine position or with dynamic position change.

Secondary Outcome Measures

Name	Time	Method
Colonic polyps	Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.	The absolute numbers of polyps, the size of polyps and histological type of polyp detected.
Luminal distension	Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.	Compare the luminal distension of bowel segments in the supine position and with dynamic position change

Trial Locations

Locations (1)

Sheffield Teaching Hospitals; 🇬🇧 Sheffield, South Yorkshire, United Kingdom