Abstract
Introduction Enhanced Recovery Programmes (ERP) have gained wide acceptance in many surgical specialities but there is limited evidence in Liver surgery. A number of pilot studies have shown it to be safe but only used historical controls. The primary aim of this thesis is to investigate whether an ERP is effective in reducing post-operative length of hospital stay. The secondary aims are to investigate the differences in time to medical fitness for discharge, morbidity, mortality, pain scores, quality of life, patient satisfaction and cost effectiveness when comparing an ERP to standard perioperative care for open liver resection surgery. Methods This was a single blinded randomised controlled trial (ISRCTN03274575) conducted at The Royal Surrey County Hospital NHS Foundation Trust from March 2010 till April 2011. A total of 104 consecutive patients were randomised in to two groups: the Intervention group (ERP group) or Control group (standard therapy group). Group allocation was un-blinded to patients and researchers, but to reduce bias both groups were treated by strict protocols, including a standard anaesthetic protocol for both groups. The intervention group was treated within a full ERP, which included amongst others pre-admission counselling / education, pre-operative nutritional supplements, pre-operative carbohydrate loading, goal directed fluid therapy for six hours post-operatively, early feeding and mobilisation. Primary end point was length of hospital stay. Secondary end points included time until medically fit for discharge (using strict criteria and a blinded assessor), morbidity, mortality, readmissions, pain control, quality of life (QoL) scores using the EQ-5D questionnaire and patient satisfaction. Calculation of resources used and direct healthcare costs were calculated over a four week period, prospectively from information on operative resources, including theatre overhead costs and hospital costs per level of care. Community costs were calculated from questionnaires, completed by patients on postoperative days 14 and 28. The cost and QoL elements were used to perform a cost effectiveness analysis. Results Ninety-one patients completed the study with the main exclusions being inoperability. There were no differences in patient demographics except that there were a higher number of patients with the diagnosis of colorectal metastases; and a correspondingly higher number of patients who had undergone preoperative chemotherapy in the ERP group. There was also a significantly higher P-POSSUM operative severity score in the ERP group. Despite undergoing more extensive operations the ERP group reached medical fitness for discharge sooner [3.0 versus 6.0 days, p<0.001] and hospital length of stay [4.0 versus 7.0 days, p<0.001]. Medical complications were significantly reduced [6.5% versus 26.7%, p=0.02], there was no difference in mortality (2.2% versus 2.2% (p=0.987), readmissions (4.4% versus 0%, p=0.495) or pain scores. There was an improved quality of life [p=0. 02] but no difference in satisfaction rates, and a cost saving of £837. 25 over the 28 day period. Discussion This study demonstrates the efficacy of a specifically designed ERP for significantly reducing both the time until being medically fit for discharge and hospital length of stay in patients undergoing open liver resection. The two previous ER in open liver resection studies both showed reduced length of hospital stays in the ER group. Lin and colleagues (2011) demonstrated a reduction from a median of 11 to 7 days, and the second study by van Dam and colleagues (2008) reduced their length of stay from a median of 8 to 6 days. However neither of these studies demonstrated any reduction in morbidity. A recent pilot study trialling an ERP for laparoscopic liver resection showed a median length of stay of 5 days (Stoot 2009) - one day longer than the median length of stay for patients having open surgery in this trial. Moreover we found a post-operative stay of only three days was readily achievable with 33% of patients in the treatment group leaving hospital on postoperative day three. In summary this study demonstrated that an ERP is a safe and effective intervention for patients undergoing open liver resection surgery. A comprehensive enhanced recovery programme with a high compliance to the different elements can result in a significant reduction in length of hospital stay and fewer postoperative medical complications.