Positioning During Colonoscopy

December 3, 2010 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Does Patient Position During Extubation at Colonoscopy Influence the Quality of Mucosal Visualisation?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S5 7AU
        • Sheffield Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring colonoscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal visualisation
Time Frame: 3 months
Made by video assessment of colonoscopic withdrawal
3 months
Luminal distension

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Steven R Brown, MD FRCS, Sheffield Teaching Hospitals NHS Foundation Trust
  • Study Director: Stuart Riley, FRCP, Sheffield Teaching Hospitals NHS Foundation Trust
  • Study Chair: Wal Baraza, MRCS, The University of Sheffield Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (ESTIMATE)

December 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 3, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH14709

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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