Condition category
Digestive System
Date applied
28/07/2009
Date assigned
04/09/2009
Last edited
04/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gregorios Paspatis

ORCID ID

Contact details

Benizelion General Hospital
Knossou Avenue
Heraklion
71409
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of standard versus high definition colonoscopy for polyp detection: a randomised controlled trial

Acronym

Study hypothesis

We sought to compare the performance of colonoscopy using a high definition (HD), wide-angle endoscope versus a standard colonoscope (SC) for the detection of polyps.

Ethics approval

Ethics Committee of the Benizelion General Hospital approved in July 2009

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal polyps, colonoscopy

Intervention

In the SC group, a standard-resolution, standard-angle (140°) videocolonoscope - Olympus (Tokyo, Japan) was used with a high-definition 1080-line screen - Olympus (OEV191H, Tokyo, Japan).

In the HD group, colonoscopy was performed with a wide-angle (170°), high-resolution videocolonoscope - Olympus (CFH180AL, Tokyo, Japan) with the same HD screen.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Performance of the colonoscopy, measured 10/10/2008.

Secondary outcome measures

Detection of small polyps (less than or equal to 5 mm), measured 10/10/2009.

Overall trial start date

07/05/2008

Overall trial end date

10/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients were eligible if they were aged 50 years and older, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

390

Participant exclusion criteria

1. Polyposis syndromes
2. Hereditary nonpolyposis colorectal cancer (CRC)
3. Previous surgical resection of the colon or rectum
4. Active anticoagulation
5. Inflammatory bowel disease

Recruitment start date

07/05/2008

Recruitment end date

10/10/2008

Locations

Countries of recruitment

Greece

Trial participating centre

Benizelion General Hospital
Heraklion
71409
Greece

Sponsor information

Organisation

Benizelion General Hospital (Greece)

Sponsor details

Knossou Avenue
Heraklion
71409
Greece

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Benizelion General Hospital (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes