Clinical evidence for enhanced recovery in surgery

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1 Clinical evidence for enhanced recovery in surgery Released: March 31, 2011 Authors: Alex Almoudaris, Omar Faiz, Robin Kennedy Background The highest level of evidence at present is from a meta-analysis by K.K. Varadhan et al. Clinical Nutrition (in press 2010) concerning open elective colorectal surgery [Paper 1]. Six Randomised Controlled Trials (RCTs) fulfilled the inclusion criteria including 452 patients for analysis [see figure 1]. A second meta-analysis again in colorectal surgery was undertaken in 2009 by Gouvas et al. Int J Colorectal Disease. Their methodology included eleven studies for analysis including four randomized controlled trials and seven controlled clinical trials [see figure 2] included 1,021 patients [Paper 2]. The evidence base is predominantly focused on colorectal surgery; however evidence does is exist from other surgical specialties including obstetrics and gynaecology and urology. Where this is the case this has been expressly cited. There are no Randomised control trials to support ERPs in urology but there are a number of longitudinal series examining individual components of ERPs in urological procedures. In addition, there is no intuitive reason to suggest that the colorectal studies would not translate across to a comparable group of patients undergoing comparable pelvic surgery. The overall benefits of ERP in colorectal surgery demonstrated in both meta-analyses show reduction in lengths of stay, reduction in hospital morbidities and complication rates [Papers 1-2]. Introduction of ERAS practises have also been shown to reduce LOS in patients undergoing pelvic-floor surgery and hysterectomies (laparoscopic, open and vaginal) [Paper 10]. Furthermore, post operative convalescence periods for women undergoing non-malignant gynaecological surgery have shown significant reductions from 6 weeks to 1-3 weeks with the introduction of an ERP programme [Paper 11]. In urology this has also been shown with a reduction in LOS, equal re-admission and morbidity rates for patients undergoing radical cystectomies when comparing those enrolled in an ERP programme and those not. [Paper 18] Although published economic benefits are limited to small cohort series the inferred savings from the aforementioned are likely to be significant when applied nationwide across surgical specialties. Economic evaluations have been undertaken in one study that demonstrates reduction in costs associated with ERP but under powering of the study limited statistical significance. However a trend to a reduction in costs was demonstrated [Figure 3]. A formal economic cost evaluation of the benefit of ERP is currently the subject of a grant proposal being considered by NIHR led by the senior authors of this document. Additional benefits Promotion of multi disciplinary team working- Benefits outside the immediate clinical domain include the potential for improved collaboration within the multidisciplinary team as the principles

2 of ERP include many components necessitating collaboration between surgeons, anaesthetists, surgical nurses, and physiotherapists is required. [Paper 14] Reduction in nursing workload- In one cohort study of gynaecological nursing practise, nursing duties and time spent on routine activities was analysed. It was shown that there was a reduction in the total time used for nursing activities during the patients stays by an average of 39% during the observation period without increase an in complications. The nurses were questioned on their views of implementing ERP de novo into a unit and two quotes from nurses involved in the deployment of ERP were given by the study authors- The experiences we made indicate that the expected gains of implementing ERAS are achieved without compromising the workload or work environment of ward nursing staff In spite of my scepticism, it is turning out very well! This evidence comes from comparisons between a cohort of 100 women operated on in a Norwegian University Hospital with the introduction of ERP versus a retrospective review of non- ERP patients operated on at the same institute.[paper 10] Promotion of novel technologies- The findings from a recent non-randomised cohort study by the Technology Adoption Centre in conjunction with York Health Economics Consortium evaluated the potential impact of Doppler guided intra-operative fluid management in major surgical procedures. Use of Doppler intra-operatively is part of the ERP protocol. These included urological cancer, orthopaedic, solid organ transplant and upper gastrointestinal surgery patients. The intervention (use of Doppler) was compared to conventional fluid management practices. The findings demonstrated a 57% decrease in operative mortality between the intervention and the control group (3% vs 7%). Median LOS was reduced by 3 days in the Doppler group (16 days vs 19 days) both of which were statistically significant. These findings reflect the wider published literature [Paper 17]. Limitations of the above study include non-case mix adjusted findings and statistically different preoperative Physiological and Operative Severity Score (POSSUM) scores between the two groups. Improved patient satisfaction- Evidence exists indicating patients are more happy and less anxious and a trend for decreasing thirst, hunger, anxiety and malaise in patients allowed to consume carbohydrate drinks pre-operatively with no associated morbidity. [Paper 15]. Furthermore evidence exists to show that patients do not feel any less satisfied with the care they receive when enrolled in an ERAS programme in colorectal surgery [Paper 16]. This is also reflected in urological surgery in patients having undergone radical prostatectomies [Paper 21]. Early mobilisation- Bed rest not only increases insulin resistance and muscle loss but also decreases muscle strength, pulmonary function and tissue oxygenation. Bed bound patients are known to be exposed to an increased risk of thrombo-embolism and the associated morbidity attached. Early mobilization addresses in part these risks. [Paper 6] Reduction of surgical stress - the elements of ERP aim to address pain, peri-operative catabolism, immuno-dysfunction, nausea/vomiting, delayed gut function, impaired pulmonary

3 function, increased cardiac demands, clotting dysfunction, cerebral dysfunction, fluid homeostasis alteration, sleep disturbances and fatigue by a panned and coordinated approach to stress reduction. [Paper 14] Early resumption of oral intake- Early resumption of oral intake has been shown to be feasible and safe moreover, significant reduction in length of stay was demonstrated in gynaecological oncology surgery as well as significantly higher patient satisfaction [Paper 12]. This has also been shown to be safe in urological surgery too. [Paper19] Utilisation of technologies- in a recent meta-analysis including twelve trials (3346 patients) reported long-term outcome on the feasibility as safety of the use of laparoscopic surgery for colon cancer resections. No significant differences were found between laparoscopic and open surgery or in the occurrence of complications. [Paper 13] Summary of findings Length of stay The results from both the meta-analyses suggest reduction in length of hospital stay with ERP. Varadhan et al find that the implementation of four or more elements of the ERAS pathway leads to a reduction in length of hospital stay by more than 2 days. LOS appears to be reduced amongst the surgical specialties in which ERP has been trialled. Figure 4 demonstrates published LOS across a variety of surgical specialties incorporating ERP practices. Complication rates Both meta-analyses found significant reductions in morbidity and complication rates. Implementation of four or more elements of the ERAS pathway leads to a reduction in length of hospital stay by more than 2 days and an almost 50% reduction in complication rates in patients undergoing major open colonic/colorectal surgery in the Varadhan et al study. Furthermore, adoption of technologies such as laparoscopic surgery confers no greater risk to patients and utilisation of intra-operative Doppler seems to aid in reduction of complication rates. Equivalent complication rates are seen in the limited evidence from urological surgery between ERP and non-erp patients undergoing major procedures. Readmission rates No significant difference was noted in readmission rates by both meta-analyses. Sub-group analysis by Gouvas et al did demonstrate reduction in readmission rates favouring ERP. This has also been shown in gynaecological and urological surgery. Mortality rates No significant difference was noted in mortality between the groups by both meta-analyses. This has also been shown in non-colorectal specialties.

4 Utilisation of novel technologies The use of laparoscopic surgery and Doppler monitoring intra-operatively have both been shown to be safe and in the case of the use of Doppler use, it has been shown to contribute to a reduction in complication rates and length of stay across many surgical specialties and in intensive care patients [Paper 17]. Potential limitations A general limitation of many studies is that from the literature we are unable to derive how many patients complied with complete protocol and the outcomes of protocol violators. Case mix adjustment between ERP and non-erp groups is generally limited. Literature list Paper 1- The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: A meta-analysis of randomized controlled trials. Krishna K. Varadhan, Keith R. Neal, Cornelius H.C. Dejong, Kenneth C.H. Fearon, Olle Ljungqvist, Dileep N. Lobo Clinical Nutrition (in press) Paper 2- Fast-track vs standard care in colorectal surgery: a meta-analysis update. Nikolaos Gouvas & Emile Tan & Alistair Windsor & Evaghelos Xynos & Paris P. Tekkis Int. Journal Colorectal Disease Paper 3- Management of patients in fast track surgery. Douglas W Wilmore, Henrik Kehlet BMJ 2001 Paper 4- Rapid rehabilitation in elderly patients after laparoscopic colonic resection. Bardram L, Funch-Jensen P, Kehlet H. British Journal of Surgery 2000 Paper 5- A Clinical Pathway to Accelerate Recovery After Colonic Resection. Linda Basse, Dorthe Hjort Jakobsen, Per Billesbølle, Mads Werner, Henrik Kehlet, Annals of Surgery 2000 Paper 6- Enhanced recovery after surgery: A consensus review of clinical care for patients undergoing colonic resection. K.C.H. Fearon, O. Ljungqvistb, M. Von Meyenfeldtc, A. Revhaugd, C. Dejongc, K. Lassend, J. Nygrenb, J. Hauselb, M. Soopb, J. Andersene, H. Kehlet Clinical Nutrition 2005 Paper 7- Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme. P. King, J. Blazeby, P. Ewings, P. Franks, R. Longman, A. Kendrick, R. Kipling and R. H. Kennedy British Journal of Surgery 2005 Paper 8- The influence of an Enhanced Recovery Programme on clinical outcomes, costs and quality of life after surgery for colorectal cancer. P. M. King, J. M. Blazeby, P. Ewings, R. J. Longman, R. M. Kipling, P. J. Franks, and R. H. Kennedy Colorectal Disease 2006

5 Paper 9- Early oral versus traditional postoperative feeding in gyecologic oncology patients undergoing intestinal resection: a randomized controlled trial. Minig L, Biffi R, Zanagnolo V et al Ann Surg Oncol 2009; 16: Paper 10- Improving quality by introducing enhanced recovery after surgery in a gynaecological department: consequences for ward nursing practice. S Sjetne,U Krogstad, Sodega, M E Engh. Qual Saf Health Care 2009;18: Paper 11- Following fast track vaginal surgery prospective shows reduction in convalescent period from 6 weeks to only 1-3 weeks. Ottesen M, Sørensen M, Kehlet H, Ottesen B. Acta Obstet Gynecol Scand Apr;82(4): Paper 12- Early oral versus traditional postoperative feeding in gyecologic oncology patients undergoing intestinal resection: a randomized controlled trial. Minig L, Biffi R, Zanagnolo V et al Ann Surg Oncol 2009; 16: Paper 13- Long-term outcome of laparoscopic surgery for colorectal cancer: A Cochrane systematic review of randomised controlled trials. Esther Kuhry, Wolfgang Schwenk, Robin Gaupset, Ulla Romild. This paper is based on a Cochrane Review published in the Cochrane Library 2008 Paper 14- Evidence-Based Surgical Care and the Evolution of Fast-Track Surgery. Henrik Kehlet, Douglas W. Wilmore Annals of Surgery Volume 248, Number 2, August 2008 Paper 15- Consensus Review of Optimal Perioperative Care in Colorectal Surgery Enhanced Recovery After Surgery (ERAS) Group Recommendations. Kristoffer Lassen, MD, PhD; Mattias Soop Arch Surg Vol 144 (NO. 10), Oct 2009 Paper 16- Implementation of a fast-track perioperative care program: what are the difficulties? Polle SW, Wind J, Fuhring JW Dig Surg. 2007;24(6): Sep 13 Paper 17- Systematic review of the clinical effectiveness and cost-effectiveness of oesophageal Doppler monitoring in critically ill and high-risk surgical patients. Mowatt G, Houston G, Hernández R Health Technol Assess Jan;13(7) Paper 18- Introduction of an enhanced recovery protocol for radical cystectomy. Arumainayagam N, McGrath J, Jefferson KP, Gillatt DA. BJU Int Mar;101(6): Epub 2008 Jan 8. Paper 19- Reducing time to oral diet and hospital discharge in patients undergoing radical cystectomy using a perioperative care plan. Pruthi RS, Chun J, Richman M. Urology Oct;62(4):661-5;

6 Paper 20-Early removal of nasogastric tube after cystectomy with urinary diversion: does postoperative ileus risk increase? Park HK, Kwak C, Byun SS, Lee E, Lee SE. Urology May;65(5): The study concluded that early NGT removal after cystectomy is not correlated with development of a bowel ileus. Paper 21- Effective analgesia and decreased length of stay for patients undergoing radical prostatectomy: Effectiveness of a clinical pathway. McLellan RA, Bell DG, Rendon RA. Can J Urol Oct;13(5): Sixty-eight consecutive patients underwent a RRP following ERAS implementation and were compared to a historical cohort of 147 pre-cp patients. Median LOS decreased by 50% (4 days versus 2 days, p < ) while complication and readmission rates were unchanged. Patient satisfaction was high in all domains. Paper 22- Safely reducing length of stay after open radical retropubic prostatectomy under the guidance of a clinical care pathway. Chang SS, Cole E, Smith JA Jr, Baumgartner R, Wells N, Cookson MS. Cancer Aug 15;104(4): A total of 561 patients were managed on a 3-day LOS pathway, 172 were managed during the transition period from 3 to 2 days, and 261 were managed on a 2-day LOS pathway. Statistical analysis was performed comparing preoperative variables and complications among the three groups. Overall, greater than 90% of patients were discharged within 2-3 days of surgery. Transition from a 3-day LOS to a 2-day LOS can be done successfully without compromising patient safety. Paper 23- Fast track program in patients undergoing radical cystectomy: results in 362 consecutive patients. Pruthi RS, Nielsen M, Smith A, Nix J, Schultz H, Wallen EM. J Am Coll Surg Jan;210(1):93-9. This paper supports ERAS role in cysectomy and is the largest current series worldwide (362 patients). Paper 24 Improvement of an enhanced recovery protocol for radical Cystectomy. A. Koupparis, J. Dunn, D. Gillatt, E. Rowe. British Journal of Medical & Surgical Urology. Volume 3, Issue 6, Pages , November 2010 This paper shows that chewing gum as 'sham feeding' further improves ERAS benefits in patients undergoing radical cystectomy.

7 FIGURES Figure 1- RCT inclusion into meta-analysis Figure 2- RCT and CRC inclusion into Meta-analysis

8 Figure 3- Economic evaluation of ERP versus conventional surgery from King et al. [Paper 8] Figure 4- Table adapted from Kehlet and Wilmore Annals of Surgery Volume 248, Number 2, August 2