ORANGE II PLUS
Research type
Research Study
Full title
The ORANGE II PLUS Trial: An international multicentre randomised controlled trial of open versus laparoscopic hemihepatectomy.
IRAS ID
123453
Contact name
John Primrose
Contact email
Sponsor organisation
University Hospital Maastricht
Clinicaltrials.gov Identifier
Research summary
Surgical removal of part of the liver is primarily indicated as a treatment for cancer, either a cancer which has arisen in the liver or has spread from elsewhere, commonly the bowel. The number of such operations performed is increasing year on year due to improvements in non surgical treatments for cancer and in surgical expertise which yields more patients suitable for surgery. The standard method by which this surgery is performed is through a large abdominal incision. Increasingly the keyhole approach is advocated as resulting in less pain after surgery, better cosmesis and a quicker recovery. However to date there is a lack of good quality evidence to support the use of keyhole surgery over the traditional open approach. The proposed research trial should address this knowledge gap.
The research will be carried out in centres in the UK capable of performing such specialist surgery, Southampton and Cardiff. A random process will be used to allocate patients to either the open or keyhole approach. The main determinant of which operation is superior will be the time it takes for patients to recover from the surgery. Other criteria that will be assessed include duration of hospital stay, complications, quality of life, cost of treatment and overall survival.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0530
Date of REC Opinion
14 Oct 2013
REC opinion
Favourable Opinion