Support Care Cancer (2013) 21:707–714 DOI 10.1007/s00520-012-1570-0

ORIGINAL ARTICLE

Fast-track rehabilitation program and conventional care after esophagectomy: a retrospective controlled cohort study Shouqiang Cao & Guibin Zhao & Jian Cui & Qing Dong & Sihua Qi & Yanzhong Xin & Baozhong Shen & Qingfeng Guo

Received: 9 April 2012 / Accepted: 13 August 2012 / Published online: 30 August 2012 # Springer-Verlag 2012

Abstract Purpose The purpose of this article is to evaluate fast-track rehabilitation program and conventional care after esophagectomy using a retrospective controlled cohort study in esophageal cancer patients. Methods Fifty-five patients underwent fast-track rehabilitation program and 57 patients underwent conventional care after esophagectomy. Fast-track rehabilitation program was performed to patients who have early movement, epidural analgesia control, fluid infusion volume control and enteral nutrition for early discharge. The other 57 patients underwent conventional care after esophagectomy. The average of hospital stay and complications were calculated in the patients between the two groups. Results The median length of hospital stay in the patients was significantly shorter after fast-track rehabilitation program than after conventional care (7.7 vs 14.8 day, P<0.01). The percentage of patients who developed complications was significantly lower 30 day after fast-track rehabilitation program than after conventional care (29.1 vs 47.4 %, P<0.05). 87.3 % in patients of the fast-track rehabilitation program group and 54.4 % in those of the conventional care

S. Cao : G. Zhao : J. Cui : Q. Dong : Y. Xin : Q. Guo (*) Department of Thoracic Surgery, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China e-mail: [email protected] S. Qi Department of Anesthesiology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China B. Shen Department of Radiology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China

group reported excellent to very good satisfaction with their pain control (P00.000). Conclusions The fast-track rehabilitation program results in fewer complications, less postoperative pain, a reduction in the hospital length of stay, and quicker return to work and normal activities after esophagectomy. Keywords Esophagectomy . Fast track . Rehabilitation . Esophageal cancer . Postoperative

Introduction The term ‘fast track’ in surgery was first used by Professor Henrik Kehlet [1]. Originally concerned primarily with patients’ pain and length of hospital stay, it has evolved to mean different things to different parties. The concept of fast track was introduced to esophageal surgical practice by Robert James Cerfolio [2] in 2004. The concept of fasttrack rehabilitation has been recently introduced with the intent to improve postoperative recovery rates, reduce the length of hospital stay and reduce cost of patients after resection of esophageal cancer. To date, no existing data has been proved whether fasttrack rehabilitation is superior to conventional care after esophagectomy by retrospective controlled cohort study. In this study, we compared the complications, pain control, and hospital stay time of postoperative esophageal cancer patients after fast-track rehabilitation program or conventional care.

Patients and methods Hundred and eighty-seven patients underwent esophagectomy for esophageal cancer in department of thoracic

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surgery, the Fourth Affiliated Hospital of Harbin Medical University between December 2007 and October 2011. The initially design of our study was comprised of two cohorts. Group 1 (N098) consisted of patients underwent fast-track rehabilitation. The patients who underwent conventional care made up group 2 (N089), the cohort of ‘control’. But we found some confounding factors might have a huge impact on the results of both controlled and observational studies. Some patients needed to be excluded from our study. The exclusion of patients for the study was based on the tumor of hypopharynx or cervical esophagus; serious comorbidity, ASA III–IV; preoperative distant metastasis; and perioperative instability. Patients were also excluded when presenting with moderate risk factors, e.g., previous coronary artery bypass graft surgery, moderate chronic obstructive pulmonary disease, Karnofsky index less than 60, age 65–75 with hypertension, diabetes or vascular disease. Owing to the above factors, 24 patients in group 1 and 28 patients in group 2 were excluded from our study. Patients excluded from the study would undergo esophagectomy after adequate preoperative preparation for about 1–2 weeks. Part of the patients also would receive adjuvant chemotherapy, radiotherapy or supportive therapy. Patients with high risk factors were not suitable for surgery, e.g., previous ischaemic stroke/TIA or thromboembolic event, clinical evidence of valve disease, heart failure, impaired LV function on echocardiography, or age >75 with hypertension, diabetes or vascular disease(coronary artery disease or peripheral artery disease). Eight patients in group 1 failed to undergo conventional care because they had serious postoperative complication. They were transferred to the intensive care unit (ICU). Fifteen patients in group 2 failed to undergo fast-track rehabilitation. Nine patients who had serious postoperative complication could not be fast tracked. Seven of them were transferred to ICU and two others were transferred to other hospital for treatment. The other six patients could not or did not want to go home on the planned discharge day despite the fact they were medically ready. Finally, 112 patients were analyzed in this study. Fifty-five patients underwent fast-track rehabilitation and 57 patients underwent conventional care. The relevant characteristics of patients and the types of surgery are shown in Table 1. None of these patients received preoperative chemotherapy or radiotherapy. Gastroscope and barium meal of upper gastrointestine were systematically performed for tumors before operations. All patients underwent further workup to assess the medical operability. This included evaluation of pulmonary and cardiac function, cervical and abdominal ultrasonography, chest CT (or MRI), and hematological examinations. The fast-track rehabilitation program used was developed by the authors on the basis of published protocols [2, 3]. The variables recorded included postoperative mortality, length of hospital stay and compliance with the protocol. The study

Support Care Cancer (2013) 21:707–714 Table 1 Characteristics of patients and their diagnosis Characteristics

Fast-track rehabilitation group (n055)

Conventional care group (n057)

Median age 55.6±7.5 55.5±8.2 Gender Male 38 (69.1) 42 (73.7) Female 17 (30.9) 15 (26.3) Operative incision One 30 (54.6) 33 (57.9) Two 19 (34.5) 17 (29.8) Three 6 (10.9) 7 (12.3) TNM I 12 (21.8) 16 (28.1) II 34 (61.8) 33 (57.9) III 9 (16.2) 8 (14.0) IV 0 (0) 0 (0) Pathology Adenocarcinoma 5 (9.1) 8 (14.1) Squamous cell carcinoma 47 (85.5) 45 (78.9) Other 3 (5.4) 4 (7.0) Tumor location Upper esophagus Mid-esophagus Distal esophagus Malnutrition

9 (16.4) 13 (23.6) 33 (60.0) 21 (38.2)

11 16 30 19

(19.3) (28.1) (52.6) (33.3)

P value

0.928 0.591

0.863

0.737

0.656

0.734

0.592

was presented to the Hospital Ethical Board and accepted as a retrospective cohort study based on the best available evidence. The research was conducted conformed to the Helsinki Declaration and local legislation. Patients gave informed consent to participate in the study. In the fast-track rehabilitation group, patients were educated by the esophageal clinical nurse consultant during an unhurried interview at the preadmission clinic with the provision of an information booklet and received an outline of the protocol, which listed the planned activities for each postoperative day (POD). Nutritional assessment was performed to everyone by professional doctor before operation. The patients were supplied with fructose and protein at the day before surgery and permitted to drink clear fluids up to 2 h prior to surgery. No routine was used of nasogastric tubes before operation. Epidural catheters were placed in the holding area prior to double channel lumen intubation general anesthesia. All the surgical treatments were completed by the same group of surgeons. Administration of needle catheter jejunostomy was a key facet in fast-track esophagus surgery rehabilitation [4], but jejunostomy tube was just one part of a multimodal approach to enteral feeding management in these patients. Enteral nutrition support of Nutrison fibre (NUTRICIA) was given to all patients. Restrictive intraoperative fluid and avoiding transfusion were

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challenged perioperatively. Aggressive control of patient temperature during esophageal surgery became the standard of our fast-track rehabilitation. The patients went to the recovery room for 0.5–4 h and then to a floor bed with continuous monitored blood pressure, pulse, and saturation of blood oxygen. Principles of the fast-track rehabilitation program and conventional care are shown in Table 2. The contents of postoperative fast-track rehabilitation program included epidural PCA analgesia, early removal of bladder catheters, jejunostomy tube feeding, chest physical therapy and early postoperative mobilization program, etc. Principles of the postoperative fast-track rehabilitation and conventional care are shown in Table 3. Discharge criteria: the patients could tolerate semiliquid or soft diet and walk freely in ward. Data were collected prospectively and retrieved from our database. Complete follow-up was available until one month postoperatively. Statistical analysis Outcome data were analyzed using chi-squared test or Fisher’s exact test. All analyses were performed with the statistical package SPSS (version 13.0). A P value of<0.05 was considered significant.

Results Of the 187 patients who underwent esophagectomy, 112 were analyzed (55 in the fast-track rehabilitation program group and 57 in the conventional care group). There were 80

men and 32 women. The ratio of male to female was 2.5: 1. The average age was 55.5 years, ranging from 39 to 71. Tumors were located in distal esophagus in 63 cases (56.3 %), in mid-esophagus in 29 cases (25.9 %), and in upper esophagus in 20 cases (17.8 %). The rates of malnutrition (BMI≤18.5) of the fast-track rehabilitation program group and conventional care group were 38.2 and 33.3 %, respectively. The relevant characteristics of patients and the types of surgery are shown in Table 1. No significant differences were observed in age, gender, operative incision, pathology, tumor location, stages and malnutrition between the two groups. The incidence of complications was 29.1 % in patients of the fast-track rehabilitation program group and 47.4 % in those of the conventional care group during the first 30 postoperative days. The overall incidence of complications was lower in patients of the fast-track rehabilitation program group than that in the conventional care group (P<0.05). No significant differences were observed in readmission rate between the two groups within 30 days after resection of esophageal cancer. One patient died in the fast-track rehabilitation program group due to cardiac arrest. Three patients died in the conventional care group due to respiratory failure, pulmonary embolism and cardiac arrest, respectively. The median postoperative hospital stay time was 7.7 days (range, 6–15 days) and 14.8 days (range, 12–28 days), respectively, for the patients in the fast-track rehabilitation program group and conventional care group (P<0.01). 48 of the 55(87.3 %) underwent fast-track rehabilitation and 31 of the 57(54.4 %) underwent conventional care reported

Table 2 Principles of Fast-track rehabilitation program and conventional care

Preoperative education Day before surgery Diet Fructose and protein loading Day of surgery Nasogastric tube Pre-anesthetic medication Anesthesia Maintaining normothermia Transfusion Abdomen tube Cervical tube Early postoperative care Analgesia Enteral nutrition

Fast-track rehabilitation program

Conventional program

Patients were educated systematically by the esophageal clinical nurse consultant

Patients were educated in the standard manner

Last drink 2 h and diet 6 h before operation Yes

Last drink and diet at midnight No

No routine use of nasogastric tube No General anesthesia + Epidural anesthesia Earily extubation Yes Autologous blood transfusion or limit allogenic blood transfusion No routine use of drains No routine use of drains Patient sent to floor Epidural PCA Jejunostomy tube feeding

Routine use of nasogastric tube Diazepam 10 mg General anesthesia Late extubation No Allogenic blood transfusion Routine placement; Remove at POD3 Routine placement; remove at POD2 Patient sent to ICU Analgesia by morphine or vein PCA Nasojejunal tube feeding

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Table 3 Daily guideline of postoperative care of patients with fast-track rehabilitation vs conventional care Day POD1

Fast-track rehabilitation

Conventional care

Jejunostomy tube feeding 500 mL (starting at 20 mL/h)

Total parenteral nutrition

Early postoperative mobilization program (>2 h out of bed)

Bed rest

Physical therapy and nebulizers Remove urine catheter

Gastrointestinal decompression Closed thoracic drainage

Head of bed put at 30° Supply albumin Chest tube to suction Promoted to lung recruitment POD2

Jejunostomy tube feeding 1,000 mL (40 mL/h)

Nasojejunal tube feeding 500 mL (starting at 20 mL/h)

Chest tube to suction Expand mobilization(>4 h out of bed)

Remove urine catheter With help, sit in the chair 2 times during the day for at least 30 min each time Gastrointestinal decompression

Continue physical therapy and nebulizers POD3

Continue supply albumin

Closed thoracic drainage

Jejunostomy tube feeding 1,500 mL (60–80 mL/h) Remove chest tube

Nasojejunal tube feeding 1,000 mL (40 mL/h) Sit in the chair 3 times for at least 30–60 min each time. With help, walk twice in the hallway.

Remove epidural catheter Expand mobilization (>6 h out of bed)

POD4

POD5

Do deep breathing exercise

Continue physical therapy and nebulizers

Remove nasogastric tube

Continue supply albumin Gastrograffin opacification of upper gastrointestine

Closed thoracic drainage Nasojejunal tube feeding 1,000 mL (40 mL/h)

If swallow shows no leak, advance patient to oral drink

Sit in the chair 3 times today for at least 30–60 min each time.

Jejunostomy tube feeding 1,500 mL (60–80 mL/h) Continue physical therapy and nebulizers

Walk the length of the hallway 3 times Continue to do breathing exercises

Education on aspiration precaution

Closed thoracic drainage

Education on chewing and swallowing Jejunostomy tube feeding 1,500 mL (60–80 mL/h)

Nasojejunal tube feeding 1,500 mL (60–80 mL/h)

Advance patient to a full liquid diet

Walk the length of the hallway 4–5 times. Sit in the chair 3 times today for at least 30–60 min

Continue aspiration precautions POD6

POD7

POD8

Continue physical therapy and nebulizers

Continue to do breathing exercises

Increase liquid diet Decrease jejunostomy tube feeding(500 or 1,000 mL)

Nasojejunal tube feeding 1,500 mL (60–80 mL/h) Remove chest tube

Continue aspiration precautions

Walk the length of the hallway 4–5 times. Sit in the chair 3 times today for at least 30–60 min

Continue physical therapy and nebulizers

Continue to do breathing exercises

Remove jejunostomy tube Full liquid diet

Gastrograffin opacification of upper gastrointestine If swallow shows no leak, advance patient to oral drink

Discharge home on soft diet and liquid diet

Nasojejunal tube feeding 1,500 mL (60–80 mL/h)

Continue aspiration precautions

Expand mobilization( >4 h out of bed) Continue to do breathing exercises Increase liquid diet Decrease jejunostomy tube feeding(500 or 1,000 mL) Expand mobilization (>6 h out of bed) Continue to do breathing exercises

POD9

Remove nasojejunal tube Full liquid diet Expand mobilization (>6 h out of bed) Continue to do breathing exercises

POD10-11

Soft diet and liquid diet Nearly out of bed Observe whether there is delayed anastomotic leakage

POD12

Discharge home on soft diet and liquid diet

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excellent to very good satisfaction with their analgesia (P00.000; VAS,1–3 score). The types of morbidity and mortality are listed in Table 4, and the other outcomes are listed in Table 5.

Discussion The concept of fast track was introduced to colorectal surgical practice by Kehlet in 1999 to improve postoperative recovery rates and reduce the length of hospital stay [1]. Traditional beliefs about the perioperative care of esophageal surgery patients have been challenged by recent study. The concept of fast track was introduced to esophageal surgical in 2004 [2]. Although several articles have evaluated fast-track concepts after esophagectomy [5–7], this is the first study to the best of our knowledge that evaluated the morbidity, mortality, and hospital stay between fast-track rehabilitation program and conventional care for patients after esophagectomy by retrospective controlled cohort study. We found that preoperative education of patient, intra-operative maintaining normothermia, restrictive fluids, epidural anesthesia or analgesia, early postoperative ambulation and enteral nutrition are the important predictors for the rehabilitation of patients after esophagectomy. Proper Table 4 Postoperative morbidity and mortality

Variables Morbidity Pulmonary Pneumonia Atelectasis Pulmonary edema Respiratory insufficiency Anastomotic Leak Hemorrhage Abdominal complications Ileus Cardiac Atrial arrhythmia Supraventricular arrhythmia Ventricular arrhythmia Other Hoarseness Chylothorax Gastroplegia Mortality Respiratory failure Pulmonary embolism Cardiac arrest

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education of patients prior to surgery is an important step to having a successful fast-track rehabilitation program [8], which makes patients better understand the detailed treatment plan, different stages of fast-track rehabilitation program and relevant measures for fast-track recovery. To participate in a fast-track rehabilitation entails that patients take on the responsibility of following the instructions. Participating in a fast-track rehabilitation implies that the patient will live up to the professionals' expectations and the patient’s own expectations of being a good and cooperative patient, who actively works toward the goal. Maintaining normothermia is also an important element of fast-track rehabilitation program. Intra-operative hypothermia occurs in as many as 20 % of surgical patients and is usually due to the cold environment of the operating theater in addition to impaired thermoregulation associated with anesthesia [9]. Hypothermia may result in increased postoperative discomfort and predispose the patient to perioperative wound infection and morbid cardiac events [10]. However, maintaining intra-operative normothermia is likely to decrease infectious complications and shorten hospitalization in patients undergoing surgery [11]. Liberal use of intra-operative and post-operative intravenous fluids increases cardiopulmonary morbidity, delays return of gastrointestinal function and prolongs hospital stay

Fast-track rehabilitation group

Conventional care group

16 (29.1) 6 (10.9) 1 3 0 2 5 (9.1) 4 1 0 (0) 0 2 (3.6) 1

27(47.4) 11 (19.3) 3 4 1 3 7 (12.3) 6 1 1 (1.8) 1 4 (7.0) 2

1 0 3 (5.5) 2 1 0 1 (1.8) 0 0 1

1 1 4 (7.0) 2 1 1 3 (5.3) 1 1 1

P value 0.047 0.216

0.585

1.000 0.679

1.000

0.618

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Table 5 Outcomes Outcomes

Fast-track rehabilitation group

Median length of postoperative stay

7.7±1.4

Analgesia with good satisfaction (VAS: 1–3 score) 30-day readmission rate

[12]. On the contrary, restrictive intra- and postoperative fluid resuscitation are found to be associated with fewer complications, earlier return of gastrointestinal function, and shorter hospital stay [13]. Moreover, restricting intraoperative fluid administration reduced postoperative pulmonary complications and shortened the in-hospital recovery period [14]. It is worth mentioning that a significant reduction in esophagectomy-related morbidity with standardized multimodal management and intra-operative fluid restriction [15]. There is growing evidence that blood transfusion is associated with clinical factors that can lead to transfusioninduced immunosuppression. This effect can be deleterious. Blood transfusion might have a significant adverse effect on late survival after esophageal resection for carcinoma [16]. Especially, allogenic blood transfusion was associated with an increase in noninfectious complications and that the short-term survival in transfused patients was derived from the clinical circumstances necessitating the transfusion rather than the immunosuppressive effects of transfusion in patients with esophageal carcinoma [17]. Every effort should be made to the use of autologous blood transfusion or limit the amount of allogenic blood with the absolutely essential requirements. Attention to restricted intraoperative fluid balance, limited blood loss, anesthetic technique, and epidural use permits most patients undergoing esophageal resection to be safely extubated immediately postresection in the operating room [18]. Fact has proved that transhiatal esophagectomy was associated with reduced complications when extubated early [19]. Nasogastric (NG) tubes are commonly placed during the surgery and are kept after the operation without any supporting evidence in reference books. But the NG tube needs to be avoided in fast-track esophageal surgery patients. Patient discomfort and concern for increased risk of pulmonary and other complications lead many investigators to question the utility of routine NG tube use after esophageal surgery. NG tubes impede expectoration and increase the risk of postoperative respiratory tract infection. Daryaei et al. [20] detected that the incidence of anastomosis leak was significantly higher in the patients who used NG tube after esophageal surgery. Nguyen et al. [21] demonstrated that NG tubes delayed discharge and increased pulmonary complications. Beyond avoiding NG tube use, is it safe to feed patients and will this further enhance fast-track recovery?

48 (87.3) 2 (3.6)

Conventional care group

P value

14.8±3.7

<0.01

31 (54.4) 3 (5.3)

0.000 1.000

Fears related to early feeding include the risk of aspiration and anastomotic leak. However, early drinking and liquid diet have several theoretical advantages. There has been no proof that late diet can reduce this kind of complication. Recent research showed that severe complications were mainly related to the condition of patients before operation and surgical techniques [22]. No significant differences were observed in anastomotic leakage between the two groups in our study. No evidence indicated leakage related to early diet. Chest tube is thought to reduce the risk of anastomotic dehiscence and allow for early detection and management of anastomotic leakage. In spite of its postoperative importance, the chest tube drain limits patient mobility and causes pain, occasionally leading to hypoventilation, atelectasis or lung infections, as well as reducing cough efficiency [23]. In this study, chest tube was removed at POD3 in the fast-track rehabilitation program group and at POD6 in the conventional care group. There were no significant differences between the two groups in terms of anastomotic leak rates and respiratory complications. The early removal of chest tube was one of several factors that shorten the hospital stay. Adriana et al. [24] suggested that postoperative chest physical therapy in esophagectomy patients reduced the rate of respiratory complications, the need for antibiotics, the thoracic drainage time, and the need to return to mechanical ventilation. Chest physical therapy stimulates lung expansion and improves lung ventilation, thereby preventing or eliminating the build-up of liquid in the pleural space, meeting the drainage removal criteria (less than 100 mL in 24 h) earlier and facilitating the removal of the drain [25]. We believe that early and adequate nutritional support is crucial after esophageal surgery and that enteral feeding is the preferable route of feeding. Early enteral feeding is an important part of any fast-track program. Enteral feeding via feeding tube was shown to reduce anastomotic leak, wound and other infections, pneumonia, and mortality. There is an associated reduction of length of stay as well [26]. Needle catheter jejunostomy is found to be an effective method to provide nutritional support during the postoperative period. It requires only minimal additional operating time and has a low cost [4]. Early ambulation of patients after esophageal surgery is a universally accepted part of a fast-track plan. Jakobsen et al. [27] studied the effects of early mobilization in a fast-track program after patients were sent home and showed significant improvement in such parameters as fatigue, sleep, return to

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leisure activity and activities of daily living. Early ambulation also could decrease postoperative thrombopoiesis and respiratory complications. Postoperative pain is a major factor in the recovery of patients after esophageal surgery and one of the principle contributing factors as to why patients stay in the hospital after surgery. In 1996, Tsui et al. [28] found that adequate pain control contributed to decreased cardiopulmonary complications, shorter hospital stay, and decreased mortality in patients undergoing transthoracic esophagectomy. Epidural analgesia has a number of potential benefits after esophageal surgery. There are clear benefits in some important areas including pain relief [29], reduction in respiratory complications and mortality after esophagectomy [28]. It also has been suggested that epidural analgesia is associated with a decreased incidence of anastomotic leakage [30]. We found that epidural analgesia was a valuable adjunct to general anesthesia for major thoracic surgeries and important for effective cough, vigorous physiotherapy, and mobilization in the early postoperative period. In this study, 87.3 % in the patients who used postoperative epidural PCA (patient-controlled analgesia) and 54.4 % in the patients who used vein PCA reported excellent to very good satisfaction with their pain control. In summary, fast-track rehabilitation is an efficient and cost-effective approach that can be applied to esophagectomy for esophageal cancer. Fast-track rehabilitation program has the potential to decrease morbidity, hospital stay, and algesthesia when compared with conventional care. Postoperatively, limiting the use of nasogastric decompression and optimizing the use of epidural anesthesia or analgesia. Maintaining normothermia and fluid restriction should be employed to decrease morbidity postoperatively. Early ambulation, early removal of chest tube and early oral feeding facilitates early discharge of patients. These factors mentioned above are the effective measures for fast-track rehabilitation of patients after resection of esophageal cancer. Fast-track rehabilitation can be safely performed with optimal anesthetic and pain control, minimal complications, early discharge, and reduce costs in esophageal surgery. Acknowledgments The authors would like to acknowledge the assistance of Dr. Jianjun Wang and others for their assistance in establishing the fast-track rehabilitation program protocol. Financial support for this study was provided by Science Foundation of Heilongjiang Health Department and China Postdoctoral Science Foundation. Conflict of interest The authors declare no conflict of interest.

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