NCT01554098

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

February 27, 2012

Last Update Submit

March 27, 2014

Conditions

Intestinal Polyps

Keywords

Polyp detectionSupineColonoscope withdrawalPatient positionDynamic position change

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Colonic polyps

    Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.

  • Luminal distension

    Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes.

Study Arms (2)

Strategy : supine first

ACTIVE COMPARATOR

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

Procedure: Strategy : Supine first

Strategy : dynamic first

ACTIVE COMPARATOR

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

Procedure: Strategy : dynamic first

Interventions

Strategy : Supine firstPROCEDURE

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.

Also known as: Dynamic position change, Supine position
Strategy : supine first
Strategy : dynamic firstPROCEDURE

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.

Strategy : dynamic first

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a diagnostic colonoscopy
  • Age \>40 and \<80

You may not qualify if:

  • Inflammatory bowel disease
  • Known polyposis syndrome
  • Poor mobility which would limit a patients ability to turn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, S10 4GG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25910661DERIVED

MeSH Terms

Conditions

Intestinal PolypsDeception

Interventions

Supine Position

Condition Hierarchy (Ancestors)

PolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stuart A Riley, MB ChB

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 14, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

GB(1)