A Comparison of Two Colonoscopic Withdrawal Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01554098
First received: February 27, 2012
Last updated: March 27, 2014
Last verified: March 2014

February 27, 2012
March 27, 2014
February 2012
February 2014   (final data collection date for primary outcome measure)
Colonic polyps [ Time Frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01554098 on ClinicalTrials.gov Archive Site
  • Colonic polyps [ Time Frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes. ] [ Designated as safety issue: No ]
    The absolute numbers of polyps, the size of polyps and histological type of polyp detected.
  • Luminal distension [ Time Frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes. ] [ Designated as safety issue: No ]
    Compare the luminal distension of bowel segments in the supine position and with dynamic position change
Same as current
Not Provided
Not Provided
 
A Comparison of Two Colonoscopic Withdrawal Techniques
A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Intestinal Polyps
  • Procedure: Strategy : Supine first
    The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal in the supine position and then with dynamic position change.
    Other Names:
    • Dynamic position change
    • Supine position
  • Procedure: Strategy : dynamic first
    The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal with dynamic position change first followed by the supine position.
  • Active Comparator: Strategy : supine first

    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

    Intervention: Procedure: Strategy : Supine first
  • Active Comparator: Strategy : dynamic first
    This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
    Intervention: Procedure: Strategy : dynamic first
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01554098
STH16220
No
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Not Provided
Principal Investigator: Stuart A Riley, MB ChB Sheffield Teaching Hospitals
Sheffield Teaching Hospitals NHS Foundation Trust
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP