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Positioning During Colonoscopy

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ClinicalTrials.gov Identifier: NCT01254435
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : December 6, 2010
Sponsor:
Collaborator:
Sheffield Teaching Hospitals NHS Foundations Trust
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Procedure: Colonoscopy Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Patient Position During Extubation at Colonoscopy Influence the Quality of Mucosal Visualisation?
Study Start Date : May 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2010

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mucosal visualisation [ Time Frame: 3 months ]
    Made by video assessment of colonoscopic withdrawal

  2. Luminal distension


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Steven Brown, Sheffield Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01254435     History of Changes
Other Study ID Numbers: STH14709
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: March 2009

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