A Comparison of Two Colonoscopic Withdrawal Techniques
Primary Purpose
Intestinal Polyps
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Strategy : Supine first
Strategy : dynamic first
Sponsored by
About this trial
This is an interventional diagnostic trial for Intestinal Polyps focused on measuring Polyp detection, Supine, Colonoscope withdrawal, Patient position, Dynamic position change
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
Sites / Locations
- Sheffield Teaching Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Strategy : supine first
Strategy : dynamic first
Arm 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
This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
Outcomes
Primary Outcome Measures
Colonic polyps
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
Colonic polyps
The absolute numbers of polyps, the size of polyps and histological type of polyp detected.
Luminal distension
Compare the luminal distension of bowel segments in the supine position and with dynamic position change
Full Information
NCT ID
NCT01554098
First Posted
February 27, 2012
Last Updated
March 27, 2014
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01554098
Brief Title
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
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Polyps
Keywords
Polyp detection, Supine, Colonoscope withdrawal, Patient position, Dynamic position change
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strategy : supine first
Arm Type
Active Comparator
Arm 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
Arm Title
Strategy : dynamic first
Arm Type
Active Comparator
Arm Description
This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
Intervention Type
Procedure
Intervention Name(s)
Strategy : Supine first
Other Intervention Name(s)
Dynamic position change, Supine position
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Strategy : dynamic first
Intervention Description
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.
Primary Outcome Measure Information:
Title
Colonic polyps
Description
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.
Time Frame
Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Secondary Outcome Measure Information:
Title
Colonic polyps
Description
The absolute numbers of polyps, the size of polyps and histological type of polyp detected.
Time Frame
Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
Title
Luminal distension
Description
Compare the luminal distension of bowel segments in the supine position and with dynamic position change
Time Frame
Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A Riley, MB ChB
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 4GG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25910661
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.
Results Reference
derived
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A Comparison of Two Colonoscopic Withdrawal Techniques
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