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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01254435
Other study ID # STH14709
Secondary ID
Status Completed
Phase Phase 0
First received December 3, 2010
Last updated December 3, 2010
Start date May 2009
Est. completion date September 2010

Study information

Verified date March 2009
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Yorkshire and the Humber SHA
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date September 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients requiring colonoscopy

Exclusion Criteria:

- Polyp surveillance

- Cancer surveillance

- Infirmity

- Pregnancy

- Colectomy

- Poor tolerance

- Failed colonoscopy

- Poor bowel preparation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Colonoscopy
Recording of colonoscopic extubation

Locations

Country Name City State
United Kingdom Sheffield Teaching Hospitals NHS Trust Sheffield South Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield Teaching Hospitals NHS Foundations Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mucosal visualisation Made by video assessment of colonoscopic withdrawal 3 months No
Primary Luminal distension No
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