A Comparison of Two Colonoscopic Withdrawal Techniques
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
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Intestinal Polyps |
Procedure: Colonoscope withdrawal strategy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial |
- 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.
- 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
| Estimated Enrollment: | 130 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Withdrawal in supine position
This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
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Procedure: Colonoscope withdrawal strategy
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 both the supine position and with dynamic position change. The order in which this will be done will be randomised.
Other Names:
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Active Comparator: Withdrawal with dynamic position change
This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
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Procedure: Colonoscope withdrawal strategy
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 both the supine position and with dynamic position change. The order in which this will be done will be randomised.
Other Names:
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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| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Alex J Ball, MB ChB(Hons) | 01142434343 ext 14331 | alex_ball81@yahoo.co.uk |
| Contact: Stuart A Riley, MB ChB | 01142434343 ext 14826 | stuart.riley@sth.nhs.uk |
| United Kingdom | |
| Sheffield Teaching Hospitals | Recruiting |
| Sheffield, South Yorkshire, United Kingdom, S10 4GG | |
| Sub-Investigator: Alex J Ball, MB ChB(Hons) | |
| Principal Investigator: Stuart A Riley, MB BS | |
| Sub-Investigator: Shawinder S Johal, MB ChB | |
| Principal Investigator: | Stuart A Riley, MB ChB | Sheffield Teaching Hospitals |
More Information
No publications provided
| Responsible Party: | Sheffield Teaching Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01554098 History of Changes |
| Other Study ID Numbers: | STH16220 |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 12, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
|
Polyp detection Supine Colonoscope withdrawal Patient position Dynamic position change |
Additional relevant MeSH terms:
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Intestinal Polyps Polyps Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013