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Positioning During Colonoscopy

NCT ID: NCT01254435

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Polyps

Keywords

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Colonoscopy Positioning in colonoscopy Quality control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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'Free' positioning withdrawal

Withdrawal of the colonoscope with the patient positioned at the discretion of the endoscopist

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

Recording of colonoscopic extubation

'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

Group Type EXPERIMENTAL

Colonoscopy

Intervention Type PROCEDURE

Recording of colonoscopic extubation

Interventions

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Colonoscopy

Recording of colonoscopic extubation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring colonoscopy

Exclusion Criteria

* Polyp surveillance
* Cancer surveillance
* Infirmity
* Pregnancy
* Colectomy
* Poor tolerance
* Failed colonoscopy
* Poor bowel preparation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Sheffield Teaching Hospitals NHS Trust

Principal Investigators

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Steven R Brown, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Stuart Riley, FRCP

Role: STUDY_DIRECTOR

Sheffield Teaching Hospitals NHS Foundation Trust

Wal Baraza, MRCS

Role: STUDY_CHAIR

University of Sheffield

Locations

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Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH14709

Identifier Type: -

Identifier Source: org_study_id