NCT01254435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
Last Updated

December 6, 2010

Status Verified

March 1, 2009

Enrollment Period

3 months

First QC Date

December 3, 2010

Last Update Submit

December 3, 2010

Conditions

Keywords

ColonoscopyPositioning in colonoscopyQuality control

Outcome Measures

Primary Outcomes (2)

  • Mucosal visualisation

    Made by video assessment of colonoscopic withdrawal

    3 months

  • Luminal distension

Study Arms (2)

'Free' positioning withdrawal

ACTIVE COMPARATOR

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

Procedure: Colonoscopy

'Fixed' position withdrawal

EXPERIMENTAL

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

Interventions

ColonoscopyPROCEDURE

Recording of colonoscopic extubation

'Fixed' position withdrawal'Free' positioning withdrawal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring colonoscopy

You may not qualify if:

  • Polyp surveillance
  • Cancer surveillance
  • Infirmity
  • Pregnancy
  • Colectomy
  • Poor tolerance
  • Failed colonoscopy
  • Poor bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Steven R Brown, MD FRCS

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
  • Stuart Riley, FRCP

    Sheffield Teaching Hospitals NHS Foundation Trust

    STUDY DIRECTOR
  • Wal Baraza, MRCS

    University of Sheffield

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

May 1, 2009

Primary Completion

August 1, 2009

Study Completion

September 1, 2010

Last Updated

December 6, 2010

Record last verified: 2009-03

Locations