Surg Endosc (2013) 27:1178–1185 DOI 10.1007/s00464-012-2572-1
and Other Interventional Techniques
Insights into fast-track colon surgery: a plea for a tailored program L. Pellegrino • F. Lois • C. Remue • P. Forget B. Crispin • D. Leonard • J. Jamart • A. Kartheuser
•
Received: 6 March 2012 / Accepted: 28 August 2012 / Published online: 17 October 2012 Ó Springer Science+Business Media New York 2012
Abstract Background This retrospective study compared the fasttrack colon surgery program to conventional perioperative care and assessed factors that influence postoperative length of stay. Design This retrospective study included 124 fast-track and 119 conventional care colon surgical patients. Exclusion criteria were primary rectal disease, stoma, American Society of Anesthesiologists score IV, and Association Franc¸aise de Chirurgie index 3 or 4. Laparoscopy was the preferred approach. Variables influencing length of stay were analyzed by multivariate linear and logistic regression. Results Overall mortality and complication rates were not significantly different between groups (fast-track vs. controls 0 vs. 0.8 %, 30.6 vs. 38.6 % respectively). As expected, median length of stay was significantly reduced in fast-track patients (3 vs. 6 days, p \ 0.001), but emergency readmission rate was higher (16.9 vs. 7.6 %, p = 0.026), although rehospitalization
L. Pellegrino C. Remue B. Crispin D. Leonard A. Kartheuser (&) Colorectal Surgery Unit, Department of Abdominal Surgery and Transplantation, St-Luc University Hospital, Universite´ Catholique de Louvain (UCL), 10 Avenue Hippocrate, 1200 Brussels, Belgium e-mail:
[email protected] C. Remue e-mail:
[email protected] F. Lois P. Forget Department of Anaesthesiology, St-Luc University Hospital, Universite´ Catholique de Louvain (UCL), 10 Avenue Hippocrate, 1200 Brussels, Belgium J. Jamart Department of Biostatistics, Cliniques Universitaires MontGodinne, Universite´ Catholique de Louvain, Yvoir, Belgium
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rates were similar (8 vs. 4.2 %, not significant). Independent risk factors of increased length of stay were identified as age [69 years (p = 0.001), laparotomy (p = 0.011), and conventional perioperative care (p \ 0.001). Conclusions The introduction of a fast-track program reduced postoperative length of stay without increasing complication rate. This study proposes a modulation of the program according to patient age and surgical approach. Keywords Fast-track surgery ERAS Colorectal surgery Laparoscopy Length of hospital stay Postoperative complications
At the end of the 20th century, H. Kehlet designed a multimodal program known as fast-track (FT) or enhanced recovery after surgery (ERAS) for accelerating the rehabilitation of patients undergoing major colon surgery [1]. The purpose of this project was to obtain a rapid restoration of patient autonomy, thus reducing the postoperative stay to 2 or 3 days [2]. The FT program is a set of multidisciplinary perioperative actions [3]. During the preoperative period, the importance of patient counselling to reduce emotional stress is emphasized. Preoperative fasting is reduced, analgesia is optimized by the use of epidural local anaesthetics, and nasogastric tube or abdominal drainage is not used to allow a faster mobilization and feeding in the postoperative period [4]. Recent studies, including randomized trials, have shown a superiority of the FT program compared with conventional perioperative care in terms of morbidity and length of hospital stay [5–7]. However, in most cases, the studies’ sample size was small and only a limited number of FT items have been applied [8]. Meta-analysis of FT, randomized, clinical trials are inconclusive [9–12]. In
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particular, the role of laparoscopy in the FT program continues to be debated [12–14]. We hypothesized that adding a FT recovery approach in colon surgery would enhance recovery and lead to a shorter length of hospital stay (LOS) without increasing postoperative complications. Therefore, the primary purpose of this study was to compare the result of the FT program to a retrospective control group treated with conventional perioperative care and to identify the factors influencing LOS in colon surgery. The secondary purpose was to set up a tailored FT program according to the type of patient and surgery.
Materials and methods After mobilization of a multidisciplinary team, a FT program was started in April 2007 in the colorectal surgery unit of St-Luc University Hospital. This unblinded prospective study with a historical control was approved by the institutional review board. A specific informed-consent form was required before inclusion of the FT patients in the study. All FT patients were included prospectively in a database according to the inclusion and exclusion criteria detailed in Table 1. This study compares the results of the FT group to a retrospective control group treated with conventional perioperative care. Patients in the control group who met the inclusion criteria and showed no exclusion criteria for the FT program (Table 1) were matched for age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, type of pathology, and type of surgery. Control group data were obtained retrospectively by means of a chart reviewing and collecting the same variables as for the FT group. For each, the following variables were considered: the Association Franc¸aise de Chirurgie (AFC) index [15],
Table 1 Inclusion and exclusion criteria for fast-track program implementation Inclusion criteria
Exclusion criteria
Patient consent
Patient refusal
Favorable familial context
Unfavorable familial context
Elective surgery
Emergency
ASA scores I, II, III
ASA score IV
Benign or malignant colonic disease
Rectal disease
AFC index 0, 1, 2
AFC index 3, 4
Laparoscopy or laparotomy approach
IBD Neuropsychiatric disease Diverting stoma
ASA American Society of Anesthesiologists score; AFC Association Franc¸aise de Chirurgie; IBD inflammatory bowel disease
comorbidity, indication and type of surgery performed, conversion rate, reason for conversion, and intraoperative complications. Main endpoints were postoperative mortality, morbidity, and LOS. The emergency readmission and rehospitalization rates were recorded and compared between the two groups. Follow-up was planned 8 days and 1 month after surgery. The postoperative 30-day morbidity rate was graded according to the Dindo–Clavien classification [16]. All patients underwent colon resection with primary anastomosis and without a protective stoma. The creation of a stoma was considered an exclusion criterion to create two homogeneous groups. The laparoscopic technique was preferred when possible, and in open surgery a midline incision was always performed. Extracorporeal handsewn and intracorporeal stapled anastomoses were fashioned for right and left colon resection respectively. Fast-track group All patients received extensive written and oral preoperative information on the operative procedure and FT program by the surgeon, anesthesiologist, and reference nurse. The dietician assessed the nutritional status and provided counselling to all patients. Patients were encouraged to stop alcohol and smoking. During the preoperative period, patients were neither given a special diet nor a mechanical bowel preparation. Premedication consisted of 150 lg of oral clonidine 2 h before surgery. No benzodiazepine was administered before surgery. The preoperative fasting was reduced to 6 h for solids and to 2 h for clear liquids. The patient was asked to drink 800 ml of a carbohydrate-rich solution the day before and 400 ml 2 h before surgery. In the operating room, IV access was achieved by a peripheral infusion device. No central venous catheter was used, and arterial access was only used in selected cases. The maintenance of intraoperative normothermia was provided by keeping room temperature [22 °C, by using a warm air blanket, and appliances for heating liquids and warm laparoscopic insufflation gas. The anesthesia procedure was standardized: a thoracic epidural catheter was placed, general anesthesia was induced with propofol, lidocaine, ketamine, low-dose sufentanil (0.1 lg/kg), and a muscle relaxant. Before incision, the patient received an epidural bolus injection of 5 ml of levobupivacaine 0.5 % associated to 75 lg of clonidine and 0–5 lg of sufentanil and was given a continuous infusion of 5 ml/h of levobupivacaine 0.25 % until the end of the procedure. General anesthesia was maintained by a continuous infusion of propofol and muscle relaxant. Diclofenac 75 mg, IV MgSO4 3 g and droperidol 0.625 mg were used systematically during anaesthesia. The minilaparotomy site and all of the trocar ports were infiltrated with 20 ml of
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levobupivacaine 0.25 % at the end of surgery. During the postoperative period, levobupivacaine 0.125 % with sufentanil 0–0.1 lg/ml (rate 5 ml/h, bolus dose 5 ml, bolus lockout: 50 min) was administered by a patient-controlled epidural analgesia (PCEA) device during 48 h. In case of contraindications or refusal of epidural anesthesia, an intravenous lidocaine infusion as described by Kaba et al. [17] was used during 24 h. The rescue and relay analgesia consisted of paracetamol, tramadol, and nonsteroidal antiinflammatory drugs (NSAIDs). The bladder catheter and nasogastric tube were withdrawn at the end of surgery. Abdominal drains were not used. Deep vein thrombosis prophylaxis with low molecular weight heparin and antibiotic cover with cefuroxime and metronidazole were routinely administered. The optimization of perioperative fluid management included a combination of fixed crystalloid administration (500 ml during the first hour of anesthesia, 5 ml/kg/h during surgery, and 65 ml/h on the morning of postoperative day 1 to replace extravascular losses and to avoid fluid excess, with an individualized goal-directed colloid administration. Where applicable, the dynamic parameters, such as Pleth variability index or pulse pressure variation, were preferred to static ones, such as central venous pressure, for hemodynamic monitoring. If PVI (or PPV) was higher than 13 % for more than 5 min, a 250-ml bolus of colloid (HES 6 %, Voluven, Fresenius Kabi) was administered. The dose was repeated if PVI remained higher than 13 %. We have shown previously that it is possible to improve fluid management with this protocol without increasing the total amount of fluids [18]. After surgery, persistent hypotension, defined as a fall in blood pressure ‘‘not responding to colloid filling’’ [20 % of baseline values, was treated by vasopressor agents, such as ephedrine [19]. The IV infusion was left in place until the morning of day 1 or until the patient had an oral intake of 500 ml of liquids per day. Two hours after return to the surgical unit, patients could drink and take a semi-solid meal. Patients were mobilized out of bed for at least 2 h on the day of surgery. Supplementary oxygen (2 l/min) was administered until the morning of day 1. On the first postoperative day, the patient was encouraged to drink at least 2 l of fluid, to resume a normal diet, and to be mobilized out of bed for at least 6 h. Oral magnesium was prescribed to improve bowel movements. The physiotherapist and nurses played a central role in stimulating early mobilization and postoperative recovery. On the second postoperative day, the patients were mobilized for more than 8 h out of bed. Hospital to home discharge was granted from the second postoperative day if all criteria were met. Discharge criteria were: pain control with oral analgesia, resumption of oral feeding, recovery of the initial motility, and the wish of the patient to leave the hospital. Any deviation from the FT program was recorded.
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First follow-up visit was scheduled 8 days after hospital discharge. Control group Patients in the control group were managed in the perioperative period according to a traditional approach based on the resumption of feeding after bowel movements, removing the nasogastric tube on day 1 and bladder catheter on day 2. Postoperative analgesia was provided by patient-controlled analgesia (PCA) morphine or epidural at the discretion of the anesthesiologist. Deep vein thrombosis prevention with low molecular weight heparin and antibiotic prophylaxis with cefuroxime and metronidazole were routinely administered. Mechanical bowel preparation was performed routinely in our colorectal surgery unit only until 2006 and then phased out. The laparoscopic approach was introduced in our center in 1998 and became the standard approach for colon resection. The discharge criteria used in the control group were similar to those of the FT group. All converted patients were analyzed in the laparoscopic group according to an intention to treat management of data. The endpoint of the study was to assess factors associated with reduction in LOS for the FT group, without increasing either postoperative morbidity or mortality. Statistical analysis Numerical results are reported as mean ± standard deviation or median (interquartile range) and categorical results by frequencies (percentage). Differences in patient characteristics and postoperative outcomes were compared between FT and control group by v2 for binary variables, Cochran test for ordinal variables, and Wilcoxon rank-sum test for continuous variables. The simultaneous influence of various risk factors on LOS was studied by multivariate linear and logistic regression, with backward selection of variables by likelihood ratio test. A receiver operating characteristic (ROC) curve was performed to identify cutoff value. All tests were two-sided. A p value inferior to 0.05 was considered as statistically significant. SPSS statistical software (SPSS Inc., Chicago, IL, USA) was used for the statistical analysis.
Results All items proposed by Kehlet’s original FT project were implemented [1]. Between April 2007 and December 2009, 124 patients were included in the FT group: 71 (57.3 %) men and 53 (42.7 %) women with a mean age of 58.5 ± 11.1 years and mean BMI of 25.4 ± 4.2 kg/m2
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(18–44.8 kg/m2). In the control group, 119 patients were treated with conventional perioperative care between October 2004 and April 2007: 64 (53.8 %) men and 55 (46.2 %) women with a mean age of 61.6 ± 13.2 years and mean BMI of 24.8 ± 3.9 kg/m2 (17–44.8 kg/m2). The characteristics of the two groups were comparable (Table 2). Surgical indications were similar in both groups: colon cancer, diverticular disease, and recurrent sigmoid volvulus (FT vs. control group: 66, 53, 1 vs. 66, 56, 4 cases respectively, i.e., 53.2, 42.8, 0.8 % vs. 53.2, 47, 3.1 %) with added symptomatic rectosigmoid endometriosis for four patients in the FT group (3.2 %). Seventy-five patients in the control group (i.e., 63 %) who were operated on before 2006 received a preoperative mechanical bowel preparation. The surgical procedures and the intraoperative data are summarized in Table 3. We performed 120 (96.8 %) laparoscopic procedures in the FT group and 109 (91.6 %) in the control group. The two groups had significantly different conversion rates (FT: 3.2 % vs. controls: 10.9 %, p = 0.0019). In the FT group, reasons for conversion (n = 4) were inflammation linked to diverticular disease (n = 2), difficult exposure due to intra-abdominal adiposity (n = 1), and advanced tumor stage (n = 1). In the control group, reasons for conversion (n = 13) were adhesions (n = 9), intraoperative bleeding (n = 2), and advanced tumour stage (n = 2). Postoperative mortality at 30 days was 0 % in the FT group, whereas in the control group, one patient (0.8 %) died of myocardial infarction on the eighth postoperative day. Postoperative complications were 30.6 % in the FT
group and 38.6 % in the control group (not significant). The postoperative 30-day complications were graded according the Dindo–Clavien classification and are reported in Fig. 1. There was no difference between the two groups concerning either minor (grades 1 and 2) or major complications (grades 3a, 3b, 4, and 5). Detailed complications are reported in Table 4. Anastomotic leakage occurred in a similar number of cases in the FT and control groups: five (4 %) vs. three patients (2.5 %) respectively (p = not significant), occurring on postoperative days 3, 4, 5, 10, and 16 (after hospital discharge for two patients) versus postoperative days 4, 7, and 7 (after hospital discharge for one patient). The median primary postoperative stay was 3 (range 2–16) days in the FT group and 6 (range 3–29) days (mean 7.86 ± 4.853 days) in the control group (p \ 0.001). Emergency consultations after hospital discharge occurred significantly more in the FT group: 21 patients (16.9 %) versus 9 (7.6 %) in the control group (p = 0.026). However,
Table 3 Perioperative data Fast-track group (n = 124)
Control group (n = 119)
p value
120 (96.8)
109 (91.6)
NS
Open procedure
4 (3.2)
10 (8.4)
NS
Right colectomy Left colectomy
22 (17.8) 100 (80.6)
26 (21.8) 93 (78.2)
NS NS
Laparoscopic procedure
Other procedures
2 (1.6)
Conversion
4 (3.2)
13 (10.9)
0 (0)
Intraoperative complications
2 (1.6)
3 (2.5)
NS 0.019 NS
Table 2 Patients’ characteristics
Male
Fast-track group (n = 124)
Control group (n = 119)
p value
71 (57.3)
64 (53.7)
NS
Data are numbers with percentages in parentheses unless otherwise indicated NS nonsignificant
Female
53 (42.7)
55 (46.3)
Mean age ± SD (yr)
58.5 ± 11.1
61.6 ± 13.2
NS
Mean BMI ± SD (kg/m2)
25.4 ± 4.2
24.8 ± 3.9
NS
ASA score I–II
115 (92.8)
109 (91.6)
NS
ASA score III Comorbidity
9 (7.2) 75 (60.5)
10 (8.4) 68 (57.1)
NS
Smoking
29 (23.4)
26 (21.8)
NS
Previous abdominal surgery
67 (54)
50 (42)
NS
Data are numbers with percentages in parentheses unless otherwise indicated BMI body mass index, ASA American Society of Anesthesiologists score, NS nonsignificant
Fig. 1 Postoperative 30-day complications were graded according the Dindo–Clavien classification
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Table 4 Postoperative complications Fast-track group (n = 124) Mortality
Control group (n = 119)
0
p value
1 (0.8)
NS
Morbidity
38 (30.6)
46 (38.6)
NS
Minor complications (Dindo–Clavien 1, 2)
32 (25.8)
36 (30.2)
NS
6 (4.8)
10 (8.4)
NS
Major complications (Dindo–Clavien 3a, 3b, 4, 5)
Data are numbers with percentages in parentheses unless otherwise indicated DVT deep vein thrombosis, NS nonsignificant
Table 5 Readmission and rehospitalization data Fast-track group (n = 124)
Control group (n = 119)
p value
Emergency readmission
21 (16.9)
9 (7.6)
Days after surgery
10 (4–30)
16 (7–30)
NS
Rehospitalization
10 (8)
5 (4.2)
NS
Fig. 2 Logistic regression analysis revealed two independent risk factors for increased LOS to 4 days and more: open surgery (p = 0.011) and non-FT procedures (p \ 0.001)
0.026
Data are numbers with percentages or ranges in parentheses unless otherwise indicated NS nonsignificant
hospitalization rate was not significantly different: 8 vs. 4.2 % respectively (Table 5). The main reasons for emergency consultations were similar in the two groups and were primarily due to abdominal pain or surgical site infection. Independent risk factors for increased LOS were identified by multivariate linear regression analysis to be age (p = 0.001) and type of postoperative care program (p \ 0.001). Logistic regression analysis revealed two independent risk factors for increased LOS to 4 days and more: open surgery (p = 0.011) and non-FT procedures (p \ 0.001; Fig. 2). For increased LOS to 5 days and more, identified risk factors were non-FT recovery (\0.001) and age (p = 0.001), with a cutoff point by ROC curve at 69 years (Fig. 3).
Discussion Our study confirms that a postoperative stay of 2 or 3 days can be implemented after FT colon surgery without increased mortality and morbidity [2, 5–14]. Although the FT group had a significantly higher emergency readmission rate, its rehospitalization rate was similar. Independent risk factors for increased length of stay after colon surgery were
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Fig. 3 For increased LOS to 5 days and more, identified risk factors were non-FT recovery (\0.001) and age (p = 0.001), with a cutoff point by ROC curve at 69 years
identified by multivariate analysis to be open surgery, age older than 69 years and non-FT recovery. The scientific basis for the FT program is to minimize the response to stress induced by surgery by applying a set of perioperative interventions. Each individual item, taken separately, has proven to be useful in improving the postoperative course of patients. In a recent meta-analysis, considering six randomized clinical trials in open colon surgery (RCT) the number of items used in FT programs ranged from 4 to 12 with a mean of 9 [8]. In our study, all the FT items proposed by Kehlet were respected [1]. The use of the epidural did not result in problems concerning early ambulation (in fact the improved pain relief from the epidural probably promoted early ambulation). The
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presence of an epidural did not result in a high rate of intervention linked to the return of bladder function. There was no mortality in our FT group. In major series mortality after colonic resection ranges between 1 and 2 % for traditional perioperative care and between 0 and 5 % for FT studies [6, 20, 21]. In a recent meta-analysis, including 1,021 patients, Gouvas et al. [22] showed no difference in mortality following FT or traditional perioperative care. Some studies recently reported a reduction in complication rates after FT programs compared with traditional care [6, 8, 21, 22]. We did not find such a difference in our study. The lack of uniformity between the various studies in the literature makes the comparison of postoperative complication rates difficult, particularly concerning minor complications, and explains their wide range (3.8–33.2 %) [6, 23]. The differences observed between the complications of the FT and the control groups in our study were not statistically significant, whether concerning major complications, i.e., all Dindo–Clavien types 3a, 3b, 4, and 5 (FT vs. controls: 4.8 vs. 8.4 %), minor complications, i.e., all Dindo–Clavien types 1 and 2 (FT vs. controls: 25.8 vs. 30.2 %). Consultations after hospital discharge were significantly more frequent among FT patients, but still well within the 20 % observed in the literature [24]. This result partially reflects our practice to invite patients to come back to the emergency room with any problem they have to diagnose promptly and deal with potentially serious complications. These emergency reassessments could probably have been prevented by a general practitioner visit. Two anastomotic leakages in the FT group and one in the control group occurred after hospital discharge. There was no mortality in this group of patients. In a retrospective study conducted on more than 550 patients undergoing major intestinal surgery, Kiran et al. [25] stated that the hospital readmissions did not correlate with a shorter length of hospital stay. Moreover, complications occurring after patient discharge did not result in worse outcome compared to diagnosis during hospitalization. At present, steroid use is the only predictor of hospital readmission following colon surgery procedures identified in the literature [25]. Similar results were presented by Azimuddin et al. [26] who described 9 % of unplanned related rehospitalization 90 days after colon surgery that could not be predicted from the postoperative course of patients. Delaney et al. [27] showed that readmission and complication rates were low in patients discharged within 72 h after laparoscopic colectomy when using standardized postoperative care protocols and standardized discharge criteria. The introduction of laparoscopic surgery has improved outcome for patients undergoing colon resection with a conventional approach. A point of discussion is to clarify what the introduction of a FT program can actually add to a ‘‘simple’’ laparoscopic approach in terms of
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postoperative recovery and societal benefits. The question also could be: what can laparoscopy still add to an already well-running FT program? Most trials conducted on the subject failed to show an advantage in adopting the laparoscopic compared with the open technique [13, 22, 28]. The recent LAFA-trial, a multicenter, randomized, clinical study, concluded that the optimal treatment for patients requiring segmental colectomy was laparoscopic resection within a FT program, considering laparoscopy the only independent predictive factor to reduce hospital stay and morbidity [29]. Our results confirm the importance of minimal invasive approach to enhance postoperative recovery. According to our results, the FT program needs to be adapted for patients who require a laparotomy, as well as for all those older than age 69 years. These two factors are observed to have an additional effect by multivariate analysis. Only those patients younger than age 69 years undergoing laparoscopy could be offered a 3-day or less postoperative stay, whereas the same age group requiring a laparotomy probably needs to be hospitalized 4 days or more. When a patient is older than age 69 years, 5-day hospitalization or more is probable. The FT program in colon surgery therefore needs to be tailored according to the surgical approach and patient age. Scharfenberg et al. [30] presented the results of a FT program applied to a group of 74 patients older than aged 70 years, describing a median postoperative stay of 5 days and hospital readmissions of 12 %. Similar results were reported by Bardram et al. [31] in a group of 39 elderly patients (mean age: 81 years), who underwent colonic resection within a FT program and for whom the introduction of laparoscopy reduced mean length of hospital stay from 8–10 days to 4–6 days. Our study is not a randomized, controlled trial. The data of FT patients included were collected prospectively and compared with a historical group. By choosing a retrospective study between two different periods of time, before and after the FT era, we avoided a double potential bias. On the one hand, outside a randomized study, patients in the control group would have been the ones excluded from the FT program based on their higher comorbidities. On the other hand, a parallel control group could have an indirect beneficial effect of the implementation of the FT program in the surgical unit.
Conclusions The comparative study of our FT program confirmed the major gain in LOS after colon surgery without increasing mortality and morbidity. The laparoscopic approach seems to add an advantage to this FT program. Finally, the FT program should be softened and tailored, specifically in
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terms of LOS expectations, in accordance to patients’ age and to surgical approach. Acknowledgments The authors thank the whole ‘‘Fast-Track’’ team of the St-Luc Hospital in Brussels for their invaluable assistance and Prof. C. Craddock-de Burbure for revising the manuscript. Disclosures Drs. Luca Pellegrino, Fernande Lois, Christophe Remue, Patrice Forget, Brigitte Crispin, Daniel Leonard, Jacques Jamart, and Alex Kartheuser have no conflicts of interest or financial ties to disclose.
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14.
15.
16.
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