Positioning During Colonoscopy

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT01254435
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mucosal visualisation [3 months]

   Made by video assessment of colonoscopic withdrawal

2. Luminal distension []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients requiring colonoscopy

Exclusion Criteria:

• Polyp surveillance

• Cancer surveillance

• Infirmity

• Pregnancy

• Colectomy

• Poor tolerance

• Failed colonoscopy

• Poor bowel preparation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheffield Teaching Hospitals NHS Trust	Sheffield	South Yorkshire	United Kingdom	S5 7AU

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01254435
• Other Study ID Numbers: STH14709
• First Posted: Dec 6, 2010
• Last Update Posted: Dec 6, 2010
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Colonoscopy; Positioning in colonoscopy; Quality control
• Additional relevant MeSH terms: Colonic Polyps

Study Results

No Results Posted as of Dec 6, 2010