Prospective randomised study of minimal invasive vs open surgery for treatment of benign breast lesions.

ISRCTN	ISRCTN28820566
DOI	https://doi.org/10.1186/ISRCTN28820566
Protocol serial number	N0084125093
Sponsor	Department of Health
Funder	The North and South Bank Research and Development Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Phillip Drew
Scientific

Academic Surgical Unit
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Phone	+44 (0)1482 875875

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To evaluate comparative cosmetic outcome between open and minimal invasive surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Breast lesions
Intervention	Randomised controlled trial (RCT) comparing: 1. Minimally invasive surgery 2. Open surgery
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Cosmetic outcomes
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	40
Key inclusion criteria	40 patients with benign breast legions will be recruited
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	10/04/2003
Date of final enrolment	01/12/2005

Academic Surgical Unit

Cottingham
HU16 5JQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan