A Comparison of Two Colonoscopic Withdrawal Techniques

NCT ID: NCT01554098

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

Brief 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.

Detailed 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.

Conditions

Intestinal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Strategy : supine first

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.

Withdrawal in supine position followed by withdrawal with dynamic position change

Group Type: ACTIVE_COMPARATOR

Strategy : Supine first

Intervention Type: PROCEDURE

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

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.

Group Type: ACTIVE_COMPARATOR

Strategy : dynamic first

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Dynamic position change; Supine position

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart A Riley, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

Ball AJ, Johal SS, Riley SA. Position change during colonoscope withdrawal increases polyp and adenoma detection in the right but not in the left side of the colon: results of a randomized controlled trial. Gastrointest Endosc. 2015 Sep;82(3):488-94. doi: 10.1016/j.gie.2015.01.035. Epub 2015 Apr 22.

Reference Type: DERIVED

PMID: 25910661 (View on PubMed)

Other Identifiers

STH16220

Identifier Type: -

Identifier Source: org_study_id