Clinical trial NCT01554098: A Comparison of Two Colonoscopic Withdrawal Techniques
Official title: A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intestinal Polyps
Keywords: Polyp detection
Supine
Colonoscope withdrawal
Patient position
Dynamic position change
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colonic polyps
timeFrame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Secondary outcomes:
measure: Colonic polyps
timeFrame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
measure: Luminal distension
timeFrame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Stuart A Riley, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ball AJ, Johal SS, Riley SA. Position change during colonoscope withdrawal increases polyp and adenoma detection in the right but not in the left side of the colon: results of a randomized controlled trial. Gastrointest Endosc. 2015 Sep;82(3):488-94. doi: 10.1016/j.gie.2015.01.035. Epub 2015 Apr 22.