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Positioning During Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
Sheffield Teaching Hospitals NHS Foundations Trust
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01254435
First received: December 3, 2010
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Colonic Polyps
 Procedure: Colonoscopy
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Patient Position During Extubation at Colonoscopy Influence the Quality of Mucosal Visualisation?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Mucosal visualisation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Made by video assessment of colonoscopic withdrawal

  • Luminal distension [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 'Free' positioning withdrawal
Withdrawal of the colonoscope with the patient positioned at the discretion of the endoscopist
 Procedure: Colonoscopy
Recording of colonoscopic extubation
Experimental: 'Fixed' position withdrawal
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
 Procedure: Colonoscopy
Recording of colonoscopic extubation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring colonoscopy

Exclusion Criteria:

  • Polyp surveillance
  • Cancer surveillance
  • Infirmity
  • Pregnancy
  • Colectomy
  • Poor tolerance
  • Failed colonoscopy
  • Poor bowel preparation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254435

Locations
United Kingdom
Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundations Trust
Investigators
Principal Investigator: Steven R Brown, MD FRCS Sheffield Teaching Hospitals NHS Trust
Study Director: Stuart Riley, FRCP Sheffield Teaching Hospitals NHS Trust
Study Chair: Wal Baraza, MRCS The University of Sheffield Medical School
  More Information

No publications provided

Responsible Party: Steven Brown, Sheffield Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01254435     History of Changes
Other Study ID Numbers: STH14709
Study First Received: December 3, 2010
Last Updated: December 3, 2010
Health Authority: United Kingdom: Yorkshire and the Humber SHA

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Colonoscopy
Positioning in colonoscopy
Quality control

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013