NCT00237276

Brief Summary

The study looks at 2 hypotheses in 2 patient groups:

  1. 1.Are more experienced endoscopists better at detecting subtle lesions (polyps) on the lining of the colon (large bowel) than less experienced endoscopists?
  2. 2.Do existing and new techniques that can highlight lesions on the lining of the bowel improve endoscopists ability to spot them? This will be tested using video footage of endoscopies from 2 patient groups: those with a normal colon linig and those with colitis (bowel lining inflamation)

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

October 10, 2005

Last Update Submit

September 21, 2007

Conditions

Keywords

colonoscopy, chromoendoscopy, autoflurescence, narrow band imaging, high definition endoscopy, colorectal cancer, colitis, polyp, DALM, adenoma, video

Outcome Measures

Primary Outcomes (1)

  • The difference in adenoma detection rate on video between consultants endoscopist vs. trainee endoscopists who have performed more than 200 endoscopies vs. trainee endospopists who have performed less than 200 endoscopies

Secondary Outcomes (2)

  • For each technique:

  • differences in adenoma detection rate between endoscopist of varying abilities with and without techniques to highlight polyps. Differences in adenoma detection rate in terms of esperience.

Interventions

colonoscopyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients: over 18 years of age, with clinical indication for colonoscopy who are considered by the endoscopist to be fit for the procedure
  • Endoscopists who have started colonoscopy training on a recognised training rotation. Consultants who perform colonoscopy regularly

You may not qualify if:

  • patients under 18 years, patients with previous colorectal surgery or known familial polyposis, patients unable to give informed consent, pregnant patients, patients for whom coloscope insertion was difficult or uncomfortable, patients whose colon is not sufficiently cleared of stool, those unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North West London Hospitals NHS Trust - St Mark's Hospital

London, HA1 3Uj, United Kingdom

RECRUITING

MeSH Terms

Conditions

PolypsColorectal NeoplasmsColitisAdenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGastroenteritisNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

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, FRCP

    London North West Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Saunders, MD, FRCP

CONTACT

James East, MBChB, MRCP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations