Evaluation of Enhanced Recovery Protocol for Elective Colorectal Surgical Operations in Assiut University Hospital

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1 Med. J. Cairo Univ., Vol. 85, No. 5, September: , Evaluation of Enhanced Recovery Protocol for Elective Colorectal Surgical Operations in Assiut University Hospital MOHY EL-DIEN EL-SHAFIE, M.D.; SAMIR A. AMMAR, M.D.; ASHRAF A. HELMY, M.D. and MOHAMED S. HAMED, M.Sc. The Department of General Surgery, Faculty of Medicine, Assiut University Abstract Introduction: Enhanced recovery after surgery (ERAS) program is a new set of protocols that is applied to the patient in the peri-operative period to fasten the recovery and decrease the convalescence and thus improving the surgical outcome. It is also named as Fast track surgery. Patients and Methods: In our study we had 24 patients who underwent elective colorectal surgical operations. The ERAS protocol was implemented on group A with multiple pre, intra and postoperative elements, while group B was managed traditionally. Both groups were evaluated during the postoperative period and one month after discharge. Results: Patients of group A have developed less complications (33%) than group B (50%). In our study there were 3 cases in group A (25%) that needed readmission during the first postoperative month and only 2 cases in group B (17%). There was an obvious and significant earlier unaided mobilization in group A than group B Patients receiving ERAS protocol stayed shorter period of time in hospital postoperatively. It was also noticed a clear and obvious satisfaction between patients of ERAS group in the form of early mobilization, return to normal activities and pain free. Conclusion: Enhanced recovery after surgery program could be applied safely and effectively in our hospitals. It led to better outcomes, such as a shorter length of hospital stay, early mobilization and more patient satisfaction without an increased in 30 days readmission or a higher rate of postoperative complication. Key Words: ERAS FTS Fast-track Enhanced recovery. Introduction RECENT efforts to improve patient outcomes and to reduce hospital stay focus on enhancing postoperative recovery with a multimodal approach. The concept of fast-track surgery, also called enhanced recovery after surgery (ERAS) involves using various strategies to facilitate better conditions for surgery and recovery in an effort to achieve faster Correspondence to: Dr. Mohy El-Dien El-Shafie, mohamedsaad2900@yahoo.com discharge from hospital and more rapid resumption of normal activities after both major and minor surgical procedures, without an increase in complications or readmissions [1]. Patient education, optimising organ function before surgery, improved anaesthetic and postoperative analgesic techniques and better understanding of perioperative care principles with early oral feeding and ambulation have resulted in enhanced postoperative recovery [2]. The main purpose of this integrated approach is to reduce psychological and physiological stresses associated with surgical illness, in order to reduce tissue catabolism [3]. Fast-track surgery has evolved as a result of recent evidence-based advances in the care of surgical patients. Studies investigating the effects of standard/conventional care have been performed, and show that many of the traditional approaches to surgical care, such as preoperative bowel clearance, the use of nasogastric tubes, drains placed in cavities, enforced bed rest, and the use of graduated diets are unnecessary or even harmful. Fast-track programs originated in Denmark during the year 2008 by Henrik Kehlet [4], and are now being taken up worldwide. Although various specialities have embraced fasttrack programs, they are currently most used in relation to colonic and rectal surgery. The actual elements used in fast-track programs may differ widely between surgical units, but share many common features such as patient education, preoperative oral carbohydrates, improved anaesthetic and postoperative Abbreviations: ERAS : Enhanced recovery after surgery. FTS : Fast track surgery. ASA : American society of anathesiologists. CI : Confidence interval. 1911

2 1912 Evaluation of Enhanced Recovery Protocol for Elective Colorectal Surgical Operations analgesic techniques, early oral feeding and ambulation [4]. Elective colorectal surgical operations are defined as any surgery undertaken on a planned basis for any condition of the colon or rectum uiring bowel resection and primary anastomosis including colorectal carcinoma and inflammatory bowel disease. Patients and Methods Our study has been conducted at Assiut University Hospital, General Surgery Department, in a period of 6 months (from 1 May 2016 till 31 October 2016) on 24 patients undergoing elective colorectal surgical operations after excluding the following criteria: Age more than 50 or less than 18. Haemoglobin less than 12g/dl. Albumin less than 3g/dl. Patients with clinically evident organ dysfunction. Patients with ongoing infections or immunosuppressive diseases. The study is a non randomized control study. The study group is compared with age, sex, comorbidity (according to ASA physical status classification patients are classified as following 1- Completely fit patient 2- Patient with mild systemic disease 3- Patient with severe systemic disease that is not incapacitating 4- Patient with incapacitating disease that is a constant threat to life 5-a moribund patient who is not expected to live 24 hour with or without surgery) and type of operation matched control group treated in traditional care during the same period. All patients were operated on by laparotomy. Group A is the Enhanced Recovery After Surgery (ERAS) or study group and includes 12 patients, while group B is the non ERAS or control group and includes 12 patients. As opposed to the fast track group the main elements of traditional management includes: Bowel preparation in left colonic and rectal anastomosis. Over night fasting. Fasting 3 days then oral fluids for 3 days followed by gradual introduction of food. No restricted amount of intravenous fluids as soon as patient is fasting. Traditional analgesia including opiates. Patients of group A (ERAS or study group) are subjected to a multimodal approach through pre, peri and postoperative components as follow: Preoperative components: 1- Preoperative counseling: Patients should be informed with the ERAS strategy in details. 2- Curtailed fasting and preoperative carbohydrate loading: Patients should be fasting for 6 hours to solids but are allowed small amounts of clear free fluids for up to 2 hours before induction of general anaesthesia. In addition, a clear carbohydrate rich drink can be administered orally the night before surgery and 3 hours prior to induction of anaesthesia. 3- Avoidance of mechanical bowel preparation: If clearance of the rectum is required for a left sided anastomosis, a single enema can be used. 4- Deep vein thrombosis prophylaxis: All patients start on a once daily low molecular weight heparin (Enoxaparin 20mg) the night before surgery and continue for the entire length of the patient s hospital stay. 5- Antibiotic prophylaxis: A single dose of antibiotic, covering both aerobic and anaerobic organisms e.g. fluroquinolones, is administered just prior to incising the skin. In prolonged procedures (more than 4 hours) a second dose can be administered. Peri-operative components: 1- High inspired oxygen concentration: Eighty percent (80%) oxygen should be administered during anaesthesia and then continue for at least 6 hours postoperatively. A face mask is required to deliver this high concentration of oxygen. 2- Prevention of hypothermia: If the procedure is expected to last for more than an hour, then warmed intravenous fluids are used. 3- Surgical approach and incision: The length of the incision should be kept as short as possible. 4- Avoidance of post-operative drains, nasogastric tubes and urinary catheters: Routine abdominal drains and nasogastric tubes and urinary catheters should be avoided. If gastric decompression is required during surgery, a nasogastric tube may be inserted temporarily and removed at the end of the procedure. However drain is not inserted unless there is extensive intraabdominal procedure or profuse bleeding. Urinary catheter was only inserted according to demand of the anasthetist.

3 Mohy E. El-Shafie, et al Short duration of epidural analgesia and local blocks whenever possible: This is chosen upon the preference of the operating surgeon and anaesthetist. In case of epidural analgesia fine bore catheter placed into the epidural space at the level of T9 and T10 can be used to deliver a mixture of a short acting opiate (Fentanyl 2mcg/ml) and a local anaesthetic solution (Bupivacaine 0.15%). Post-operative components: 1-Avoidance of opiates and the use of paracetamol and non-steroidal anti-inflamatory drugs (NSAIDS): Post-operatively, patients should be prescribed regular Paracetamol and NSAIDS such as Ibuprofen or Diclofenac if there are no contraindications to their use. Opiates, including Codeine preparations and Tramadol, should only be reserved for breakthrough pain. Whenever opiates are used, attention should be paid to prevent nausea and vomiting and regular antiemetics prescribed. 2- Early post-operative diet: Patients are allowed to have oral fluids as tolerated on the day of surgery and built up to an oral diet over the next 24 hours. 3- Early post-operative mobilization: A structured mobilisation plan is followed. Patients should be helped to sit out in a chair on the evening of surgery and definitely by the first post-operative day. This should be followed by gentle assisted mobilisation either the same day or the next day. 4- Restricted amounts of intravenous fluids: It is not possible to recommend a single point in time by which all intravenous fluid administration should be stopped. However, in the majority of patients, this should be possible by the second post-operative day, by which time adequate oral fluids should be tolerated. Excessive amounts of intravenous fluid should be avoided. A daily regime of 1.5 to 2.5 L should suffice for most patients. 5- Close monitoring and follow-up. Results During the study period of 6 months, 24 patients undergoing elective colorectal surgical operations were included and distributed into ERAS and non- ERAS groups. The following are the results of the study for both groups: 1- Demographic distribution: There is no significant difference in both groups according to demographic distribution as in the Table (1). Table (1): Demographic distribution in both groups. Age, mean in years Male, n (%) ASA class, n (%) Group (58%) 8 4 Group (50%) 7 5 p-value Complications: There was a difference between both groups in number of complications. Patients of group A have proven less complications than group B. Group A showed 4 complicated cases (33%) and group B showed 6 cases (50%). One complicated case had more than one complication. p-value is 0.07 which means no significance, detailed complications showed increase incidence of wound infection in group B (3 cases-25%) than in group A (2 cases-17%) and more chest infection in group B (1 cases-8%) than group A (0 case-0%). Also increase in urinary tract infection (2 cases - 17%) than group A (0 case-0%). Nausea and vomiting (6 case-50%) in group B in relation to group A (3 cases-25%). 3- Readmission: Patients of both groups were compared to each other according to readmission rates. There were 5 cases that needed readmission during the first month postoperative, 3 cases in group A (25%) and only 2 cases in group B (17%). p-value Hospital stay: The length of hospital stay was categorized into 3 categories as shown in Table (2). Table (2): Hospital stay of both groups. Hospital stay <4 days 4-6 days >6 days Group 1 9 (75%) 3 (25%) 0 Group 2 4 (33%) 5 (42%) 3 (25%) p-value is 0.01 which is statistically significant. 5- Unaided mobilization: The time when the patient first move without assistance was recorded in both groups as in Table (3). Table (3): First day of unaided mobilization of both groups. Unaided mobilization <2 days 2-4 days >4 days Group 1 2 (17%) 10 (83%) 0 Group 2 0 (0%) 7 (58%) 5 (42%) p-value is 0.03 which is statistically significant. 6- Patient satisfaction: Patient satisfaction was categorized to total-mild and non-satisfaction according to pain control and quality of recovery in both groups as in Table (4). p-value

4 1914 Evaluation of Enhanced Recovery Protocol for Elective Colorectal Surgical Operations Table (4): Patient satisfaction of both groups. Satisfaction Group 1 Group 2 Total Discussion Mild No 8 (67%) 4 (33%) 0 2 (17%) 6 (50%) 4 (33%) ERAS protocol combines various techniques used in the care of patients undergoing surgery to provide improved standards of care by reducing morbidity and mortality associated with different surgeries while attempting to improve the overall quality of recovery. ERAS program involves preoperative education, and nutrition, specific intraoperative elements, minimally invasive techniques, optimal pain control, postoperative oral nutrition and ambulation. Patients from both groups have undergone elective colorectal surgical operations. Complications Surgical trauma remains associated with undesirable postoperative side effects such as pain, cardiopulmonary, infective and thromboembolic complications, gastrointestinal paralysis, fatigue, and prolonged convalescence. These postoperative organ dysfunction and morbidity are related to changes induced by surgical stress response that fast track surgery through its' multimodal package of techniques attenuates its' impact on organ dysfunction, thus reducing morbidity and mortality rates, leading to safe recovery and early discharge from hospital. In our study there was a differences between both groups in the number of complicated cases and the complications themselves. Patients of group A have developed less complications than group B. Group A showed 4 complicated cases (33%) and group B 6 cases (50%). p-value is 0.07 which means no significance. Detailed complications showed increase incidence of wound infection, chest infection, post operative nausea and vomiting also increase in UTI in group B than group A. p-value of each complication alone was also insignificant. According to other studies,wind et al. [5] reported that pooled data from the six studies (three RCTs and three non-randomised comparative studies) showed that morbidity was significantly lower for fast-track programs (relative risk 0.54, 95% CI 0.42 to 0.69). The absolute risk reduction of the pooled data was 0.15 (95% CI 0.28 to 0.02). No difference in mortality was found between the patient groups. Outcomes related to complications following surgery were reported by all studies. Readmission rate in our study there were 5 cases that needed readmission during the first postoperative month, 3 cases in group A (25%) and only 2 cases in group B (17%) but p-value is 0.6 which is insignificant. The causes of readmission were repeated vomiting and wound infection. Early readmission has not been a problem in many studies, the available data from (ERAS) program have not shown an increase in use of health services after discharge. Wind et al. [6] reported that after pooling available data from three RCts and three non-randomised comparative studies that readmission rates were not significantly different between the optimised and control groups (relative risk 1.17, 95% CI 0.73 to 1.86). Eight studies reported readmissions after the initial operation. Anderson et al. [7] reported that no patient was readmitted within 30 days of surgery. Readmission rates in the other six studies varied from 0 to 10% in the optimised group and 0 to 20% in the conventional group. Only one study reported a significant difference (which was in favour of optimisation) in readmission rates between the conventional and optimised groups. Length of hospital stay: Because hospital services are the most expensive component of health care systems, hospitals are under increasing pressure to enhance the efficiency of hospital care. Length of stay for in patient care is quoted as an important index of efficiency and several changes in health care have been induced the past decades to limit the length of hospitalization. The fast track measures are designed to reduce medically unnecessary hospital stays, during which the patient could have been discharged on clinical grounds. In our study there was a clear difference between both groups in this item. In group A, 2 patients (17%) have spent less than 4 days in comparison to 0 patients (0%) in group B, while 10 patients (83%) have spent 4-6 days in comparison to 7 patients (58%) in group B and 0 patients have spent more than 6 days in comparison to 5 patients (42%) in group B. p-value is 0.01 which means moderate significance. Therefore patients receiving ERAS protocol have stayed definitely shorter period postoperatively. Wind et al. [6] (2006) reported that after pooling available data (from three RCTs and two nonrandomised comparative studies), that primary hospital stay in the optimised group was significantly lower than in the control group (weighted mean difference 1.56 days, 95 per cent confidence interval (CI) 2.61 to 0.50 days). Length of hos-

5 Mohy E. El-Shafie, et al pital stay was reported by 11 studies. In many cases, fast-track (optimised) patients had a shorter stay in hospital than control patients. Mobilization time: Early mobilization in the post-operative period aims to mitigate the muscle loss, impaired pulmonary function and thromboembolic complications associated with bed rest. There was an obvious earlier unaided mobilization in our study in group A than group B. Mobilization here means the first time the patient can move without help. Outcomes relating to mobilisation were reported by four studies. Three studies reported the time from surgery to mobilisation to the toilet unaided. Anderson et al. [7] and Khoo et al. [8] reported that the optimised groups mobilised to the toilet significantly earlier than the conventional groups (p=0.043 and p<0.001 respectively), while Gatt et al. [9] reported no significant differences between the two groups. Patient Satisfaction: Patient satisfaction is an important measure of quality of care that can contribute to a balanced evaluation of the structure, process and the outcome of the medical service. Many factors contribute to patient satisfaction, including convenience of the service, institutional structure, inter personal relationship, competence of health professionals and patients own expectations and preference. It can be achieved by adequate pain control, early mobilization, and early resumption of normal daily activities. One study, Delaney [10] did not report a difference between the two groups for satisfaction in hospital stay or happiness to be discharged from hospital with. In our study there was evident differences between both groups in favour of ERAS group. Patients of ERAS group experienced more satisfaction in the form of pain free, early mobilization, resumption of normal activities and happiness on discharge. In conclusion ERAS program could be applied safely and effectively in our hospitals. It led to better outcomes, such as a shorter length of hospital stay, early mobilization and more patient satisfaction without an increased in 30 days read- mission or a higher rate of postoperative complication. Conflicts of interest: No conflict of interest has been declared. References 1- AARTS M.A., OKRAINEC A., GLICKSMAN A., et al.: Adoption of enhanced recovery after surgery (ERAS) strategies for colorectal surgery at academic teaching hospitals and impact on total length of hospital stay. Surgical Endoscopy, 26: , WILMNORE D.: Management of patients in fast track surgery. British Medical Journal, 322: , STEPHEN A.E. and BERGER D.L.: Shortened length of stay and hospital cost reduction with implementation of an accelerated clinical care pathway after elective colon resection. Surgery, 133: , KEHLET H. and WILMORE D.W.: Evidence-based surgical care and the evolution of fast-track surgery. Annals of Surgery, 2.48 (2): , WIND J., POLLE S.W., FUNG KON, et al.: Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group, Enhanced Recovery After Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. British Journal of Surgery, 93 (7): , WIND J., HOFLAND J., PRECKEL B., et al.: Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial). BioMedical Central of Surgery, 6: 16, 2006a. 7- ANDERSON A.D., McNAUGHT C.E., MACFIE J., et al.: Randomized clinical trial of multimodal optimization and standard perioperative surgical care. British Journal of Surgery, 90 (12): , KHOO C.K., VICKERY C.J., FORSYTH N., et al.: A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Annals of Surgery, 245 (6): , GATT M., ANDERSON A.D., REDDY B.S., et al.: Randomized clinical trial of multimodal optimization of surgical care in patients undergoing major colonic resection. British Journal of Surgery, 92 (11): , DELANEY C.P., ZUTSHI M., SENAGORE A.J., et al.: Prospective, randomised, controlled trial between a pathway controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Diseases of the Colon & Rectum, 46: , 2003.

6 1916 Evaluation of Enhanced Recovery Protocol for Elective Colorectal Surgical Operations