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Positioning During Colonoscopy

Primary Purpose

Colonic Polyps

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Polyps focused on measuring Colonoscopy, Positioning in colonoscopy, Quality control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 3, 2010
Last Updated
December 3, 2010
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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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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