Reducing Steatosis prior to Liver Resection (RESOLVE)
Research type
Research Study
Full title
A feasibility multi-centre randomised controlled trial to test if a pre-operative two-week very low-calorie diet reduces intra-operative blood loss and improve post-operative outcomes following liver surgery, compared with a control group
IRAS ID
323252
Contact name
Somaiah Aroori
Contact email
Sponsor organisation
University Hospitals NHS Trust
ISRCTN Number
ISRCTN19701345
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Fatty liver (steatosis) occurs when too much fat builds up in liver cells. Although it is normal to have a tiny amount of fat in these cells, the liver is considered fatty if more than 5% of it is fat. Patients with tumours that have spread to the liver may have part of their liver removed in an operation. Having a fatty liver can lead to more difficulties when operating and may lead to more complications, particularly bleeding during the operation. This can impact a patient’s recovery after surgery and may cause long-term problems.
The aim of this study is to determine if a very low-calorie diet (VLCD) for two weeks prior to surgery is tolerated and acceptable to patients in several hospitals in the UK. A planned larger future study will test whether the diet is effective in reducing the complications of surgery. Participants with fatty livers will be randomly allocated (like the toss of a coin) to a Very Low-Calorie diet (VCLD) for two weeks prior to the operation, or usual treatment. VCLD has been used successfully for many years before for gallbladder and weight loss surgery. Participants will have four sachets per day of commercially available liquid meal replacements and be able to eat vegetables and drink sugar free drinks. They will complete a food diary to evaluate adherence and mood, supervised by a qualified dietitian. All participants will complete quality of life measures before surgery, one and three months after. Some will participate in focus groups to discuss their involvement (optional).
In this study we can test out all the research processes and diet before the larger one is developed for more hospitals to test how effective the diet is in reducing complications of surgery.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0046
Date of REC Opinion
22 Mar 2023
REC opinion
Further Information Favourable Opinion