NCT00253812

Brief Summary

The purpose of this study is to establish whether new techniques that may make polyps (adenomas) stand out better from the background help increase the number of polyps visible at sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard sigmoidoscopy alone.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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

November 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

November 11, 2005

Last Update Submit

September 21, 2007

Conditions

Familial Adenomatous Polyposis

Keywords

colonoscopy, sigmoidoscopy, chromoendoscopy, autofluorescence, narrow band imaging, colorectal cancer, polyp, adenoma,rectal remnant, FAP

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be the mean number of adenomas detected on the blinded video review for each endoscopy

Secondary Outcomes (2)

  • Adenoma detection rate for each of the modalities compared with each other.

  • Primary endoscopist adenoma count for each modality.

Interventions

flexible sigmoidoscopyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination

You may not qualify if:

  • poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norht West London Hospitals NHS Trust

London, Middlesex, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Adenomatous Polyposis ColiColorectal NeoplasmsPolypsAdenoma

Condition Hierarchy (Ancestors)

Adenomatous PolypsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Saunders, MD, FRCP

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

    STUDY DIRECTOR

Central Study Contacts

James East, BSc, MBChB, MRCP

CONTACT

0044 208 235 4025jameseast@yahoo.com

Brian Saunders, MD, FRCP

CONTACT

0044 0208423 3588b.saunders@imperial.ac.uk

Study Design

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

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

November 1, 2005

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

GB(1)