Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)

INTERVENTION: Participants in the intervention group will be provided Optifast by their consulting physician and given a food diary. The two weeks’ worth of Optifast (Optifast milkshakes), which consists of three replacement meals (150 kcal per meal replacement) per day, will be given to the patient and they will be advised of the daily water requirements and other low calorie they should include to provide a total daily energy intake of approximately 800 kcal (3.3MJ). Trial participants have a water requirement of at least 2 litres of fluid including the VLED every day. This amounts to 8 cups of water, milk‐free tea or coffee, low calorie soft drink, low calorie cordial every day. The only additional foods permitted include low calorie jelly, strained broth and certain vegetables. A teaspoon of vegetable or olive oil to the vegetable intake each day will be required to assist with gall bladder contraction in the absence of additional fat in the diet. The required water and the optional additional broth / vegetables will be provided by the participants. Participants will also complete a baseline QOL questionnaire CONDITION: Cancer ‐ Liver Diet and Nutrition ‐ Obesity Liver Cancer;Obesity; ; Liver Cancer ; Obesity Surgery ‐ Other surgery PRIMARY OUTCOME: Feasibility:; Composite primary outcome, conisisting of feasibility of patients undergoing a two‐week trial of VLCD will be assessed by the recruitment, retention and adherence of the participants. The recruitment will be calculated by the number of eligible participants recruited. Retention will be assessed by the proportion of patients in the intervention arm able to complete the intervention and adherence will be calculated by the percentage of the two‐week VLCD regimen that was able to be completed from food record diaries.[at end of study period] SECONDARY OUTCOME: bile leakage (defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis). from medical records[post‐surgery to discharge] Assessment of change in liver size using ultrasound‐guided elastography.[baseline and 2‐weeks post intervention] Assessment of change in liver steatosis with ultrasound‐guided elastography. [At baseline and at surgery] Assessment of the cost‐effectiveness of trial. Measured using the AQoL‐8D and Labour Force survey[at time of discharge] death as noted in medical records[30 days post surgery] Number of blood transfusion from medical records. [within 48hrs of surgery] post‐operative liver failure (defined as the impaired ability of the liver to maintain it synthetic, excretory and detoxifying function characterised by increased international normalized ratio and concomitant hyperbilirubinemia). from medical records[post‐surgery to discharge] presence of clear margins in the histopathological specimen , as noted in medical records[post‐surgery ] reoperation, from medical records[30 days post surgery] To assess if the use of VLCD/VLED makes surgery technically easier. This will be assessed using the NASA TLX[immediately post‐surgery] To assess is the use of VLED/VLCD impacts patient's Quality of life using the SF‐36[baseline, 2 weeks post intervention & 3 months post surgery] (ii) Undergoing liver resection surgery (iii) Presenting to an Upper Gastrointestinal surgeon 2 week prior to surgery. INCLUSION CRITERIA: (i) Body Mass Index (BMI) >30 (obese); or a BMI >27 and a waist circumference in obese range (Caucasian – female >88cm, male >102cm; Asian/Aboriginal – female >30cm, male >90cm)