Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
30/07/2013
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

Mr Phillip Drew

ORCID ID

Contact details

Academic Surgical Unit
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
+44 (0)1482 875875

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084125093

Study information

Scientific title

Acronym

Study hypothesis

To evaluate comparative cosmetic outcome between open and minimal invasive surgery.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Breast lesions

Intervention

Randomised controlled trial (RCT) comparing:
1. Minimally invasive surgery
2. Open surgery

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Cosmetic outcomes

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/04/2003

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

40 patients with benign breast legions will be recruited

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

10/04/2003

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Surgical Unit
Cottingham
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Not defined

Funder name

The North and South Bank Research and Development Consortium (UK)

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