Feasibility study of a randomised controlled trial of pre and postoperative nutritional supplementation in major lung surgery

Abstract

AbstractObjectivesMalnutrition and weight loss are important risk factors for complications after lung surgery. However, it is uncertain whether modifying or optimising perioperative nutritional state with oral supplements results in a reduction in malnutrition, complications, and quality of life.DesignA randomised, open label, controlled feasibility study was conducted to assess the feasibility of carrying out a large multicentre randomised trial of nutritional intervention. The intervention consisted of preoperative carbohydrate-loading drinks (4x 200mls evening before surgery and 2x 200mls the morning of surgery), and early postoperative nutritional protein supplement drinks twice a day for 2 weeks following surgery compared to the control group receiving an equivalent volume of water. Qualitative interviews were conducted with participants to help determine the acceptance of the study.SettingSingle adult thoracic centre in the UK.ParticipantsAll patients admitted for major lung surgery. Participants were included if were able to take nutritional drinks prior to surgery and were able to give written informed consent. Patients were excluded if they were likely unable to comply with completion of the study questionnaires, they had a body mass index (BMI) < 18.5 kg/m2, were receiving parenteral nutrition or known pregnancy.ResultsAll patients presenting for major lung surgery were screened over a 6-month period, with 163 patients screened, 99 excluded and 64 (41%) patients randomised. Feasibility criteria were met and the study completed recruitment 5 months ahead of target. The 2 groups were well balanced, and tools used to measure outcomes were robust. 97% of patients were compliant with pre-surgery nutritional drinks and 89% of the questionnaires at 3 months were returned fully completed. The qualitative interviews demonstrated that the trial and the intervention were acceptable to patients. Patients felt the questionnaires used captured their experience of recovery from surgery well.ConclusionA large multicentre randomised controlled trial of nutritional intervention in major lung surgery is feasible. It is possible to randomise eligible patients and follow up with high fidelity. A pre-op carbohydrate-loading and post-surgery supplementation is highly acceptable to patients with good compliance to both intervention and trial measures. A large multi-centre clinical trial is required to test clinical efficacy in improving outcomes after surgery.Trial registration numberISRCTN16535341Strengths and limitation of this studyThis randomised, feasibility study had pre-planned feasibility to assess whether a larger randomised trial would be feasible.The study included a large regional thoracic surgical centre and cohort of patients undergoing major lung surgery predominantly for cancer, which would be representative of full trial national recruitment.The study was not designed and powered to be large enough to provide conclusive evidence to support the use of nutritional intervention in major lung surgery, but provided evidence that a larger, substantive randomised controlled trial is feasible.