A Comparison of Two Colonoscopic Withdrawal Techniques

NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Intestinal Polyps

Treatments: Procedure: Strategy : Supine first; Procedure: Strategy : dynamic first

Study type: Interventional

Funder types: Other

Identifiers

NCT01554098

STH16220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Strategy : supine first

Active Comparator group

Description:

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change. Withdrawal in supine position followed by withdrawal with dynamic position change

Treatment:

Procedure: Strategy : Supine first

Strategy : dynamic first

Active Comparator group

Description:

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.

Treatment:

Procedure: Strategy : dynamic first