A Comparison of Two Colonoscopic Withdrawal Techniques

Intestinal Polyps Clinical Trial

Official title:

A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554098
• Other study ID #: STH16220
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2012
• Last updated: March 27, 2014
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.

Null Hypothesis:

On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.

Alternative Hypothesis:

On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.

Description:

The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Having a diagnostic colonoscopy

• Age >40 and <80

Exclusion Criteria:

• Inflammatory bowel disease

• Known polyposis syndrome

• Poor mobility which would limit a patients ability to turn

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intestinal Polyps
• Polyps

Intervention

Procedure:
• Strategy : Supine first
The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal in the supine position and then with dynamic position change.
• Strategy : dynamic first
The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal with dynamic position change first followed by the supine position.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic polyps	The primary outcome for this study is the presence or absence of polyps, detected during colonoscope withdrawal in either the supine position or with dynamic position change.	Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.	No
Secondary	Colonic polyps	The absolute numbers of polyps, the size of polyps and histological type of polyp detected.	Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.	No
Secondary	Luminal distension	Compare the luminal distension of bowel segments in the supine position and with dynamic position change	Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.	No