NCT00234650

Brief Summary

The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes. This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice. May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV).

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 not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

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

October 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 2, 2009

Status Verified

December 1, 2008

First QC Date

October 5, 2005

Last Update Submit

April 1, 2009

Conditions

Polyps

Keywords

position changeadenomacolonoscopy

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate for position 1 compared to position 2

Secondary Outcomes (1)

  • percentage of adenomas detected in all the participants for each position

Interventions

ColonoscopyPROCEDURE

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred ot colonoscopy, age between 50 - 70 years

You may not qualify if:

  • Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North West London NHS Trust

London, Middlesex, HA1 3UJ, United Kingdom

Location

Related Publications (1)

  • East JE, Bassett P, Arebi N, Thomas-Gibson S, Guenther T, Saunders BP. Dynamic patient position changes during colonoscope withdrawal increase adenoma detection: a randomized, crossover trial. Gastrointest Endosc. 2011 Mar;73(3):456-63. doi: 10.1016/j.gie.2010.07.046. Epub 2010 Oct 15.

    PMID: 20950801DERIVED

MeSH Terms

Conditions

PolypsAdenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Brian Saunders, MD

    St Mark's Hospital, North West London NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 7, 2005

Study Start

October 1, 2005

Study Completion

September 1, 2007

Last Updated

April 2, 2009

Record last verified: 2008-12

Locations

GB(1)