Positioning During Colonoscopy
Does Patient Position During Extubation at Colonoscopy Influence the Quality of Mucosal Visualisation?
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 3, 2010
CompletedFirst Posted
Study publicly available on registry
December 6, 2010
CompletedDecember 6, 2010
March 1, 2009
3 months
December 3, 2010
December 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mucosal visualisation
Made by video assessment of colonoscopic withdrawal
3 months
Luminal distension
Study Arms (2)
'Free' positioning withdrawal
ACTIVE COMPARATORWithdrawal of the colonoscope with the patient positioned at the discretion of the endoscopist
'Fixed' position withdrawal
EXPERIMENTALPatient 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
Interventions
Recording of colonoscopic extubation
Eligibility Criteria
You may qualify if:
- Patients requiring colonoscopy
You may not qualify if:
- Polyp surveillance
- Cancer surveillance
- Infirmity
- Pregnancy
- Colectomy
- Poor tolerance
- Failed colonoscopy
- Poor bowel preparation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, S5 7AU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven R Brown, MD FRCS
Sheffield Teaching Hospitals NHS Foundation Trust
- STUDY DIRECTOR
Stuart Riley, FRCP
Sheffield Teaching Hospitals NHS Foundation Trust
- STUDY CHAIR
Wal Baraza, MRCS
University of Sheffield
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 3, 2010
First Posted
December 6, 2010
Study Start
May 1, 2009
Primary Completion
August 1, 2009
Study Completion
September 1, 2010
Last Updated
December 6, 2010
Record last verified: 2009-03