Positioning During Colonoscopy
Primary Purpose
Colonic Polyps
Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by

About this trial
This is an interventional prevention trial for Colonic Polyps focused on measuring Colonoscopy, Positioning in colonoscopy, Quality control
Eligibility Criteria
Inclusion Criteria:
- Patients requiring colonoscopy
Exclusion Criteria:
- Polyp surveillance
- Cancer surveillance
- Infirmity
- Pregnancy
- Colectomy
- Poor tolerance
- Failed colonoscopy
- Poor bowel preparation
Sites / Locations
- Sheffield Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
'Free' positioning withdrawal
'Fixed' position withdrawal
Arm Description
Withdrawal of the colonoscope with the patient positioned at the discretion of the endoscopist
Patient positioned in the left lateral position to visualise the caecum, ascending colon and hepatic flexure; supine to visualise the transverse colon; and in the right lateral position to visualise the splenic flexure, descending colon and the sigmoid colon
Outcomes
Primary Outcome Measures
Mucosal visualisation
Made by video assessment of colonoscopic withdrawal
Luminal distension
Secondary Outcome Measures
Full Information
NCT ID
NCT01254435
First Posted
December 3, 2010
Last Updated
December 3, 2010
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01254435
Brief Title
Positioning During Colonoscopy
Official Title
Does Patient Position During Extubation at Colonoscopy Influence the Quality of Mucosal Visualisation?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Colonoscopy is the gold standard investigation in the screening of colorectal neoplasms. The investigators hypothesise that visualisation of the colonic mucosa on extubation may be improved by changing patient position as follows: left lateral position for the right colon, supine for the transverse colon and right lateral position for the left colon(fixed positioning). The investigators aim to validate our hypothesis by performing a randomised control study, comparing mucosal visualisation in patients placed in the 'routine' positions at the discretion of the endoscopist with visualisation in those placed in the above described positions. The hypothesis is that fixed positioning confers an advantage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonoscopy, Positioning in colonoscopy, Quality control
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
'Free' positioning withdrawal
Arm Type
Active Comparator
Arm Description
Withdrawal of the colonoscope with the patient positioned at the discretion of the endoscopist
Arm Title
'Fixed' position withdrawal
Arm Type
Experimental
Arm Description
Patient positioned in the left lateral position to visualise the caecum, ascending colon and hepatic flexure; supine to visualise the transverse colon; and in the right lateral position to visualise the splenic flexure, descending colon and the sigmoid colon
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Recording of colonoscopic extubation
Primary Outcome Measure Information:
Title
Mucosal visualisation
Description
Made by video assessment of colonoscopic withdrawal
Time Frame
3 months
Title
Luminal distension
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring colonoscopy
Exclusion Criteria:
Polyp surveillance
Cancer surveillance
Infirmity
Pregnancy
Colectomy
Poor tolerance
Failed colonoscopy
Poor bowel preparation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Brown, MD FRCS
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Riley, FRCP
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wal Baraza, MRCS
Organizational Affiliation
The University of Sheffield Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
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Positioning During Colonoscopy
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