World J Surg DOI 10.1007/s00268-014-2548-5
Perioperative Care with Fast-Track Management in Patients Undergoing Pancreaticoduodenectomy Shinjiro Kobayashi • Ryuiti Ooshima • Satoshi Koizumi • Masafumi Katayama • Joe Sakurai • Taiji Watanabe • Hiroshi Nakano • Toshihide Imaizumi • Takehito Otsubo
Ó Socie´te´ Internationale de Chirurgie 2014
Abstract Background It has been considered that allowing patients to return to daily life earlier after surgery helps recovery of physiological function and reduces postoperative complications and hospital stay. We investigated the usefulness of fast-track management in perioperative care of patients undergoing pancreaticoduodenectomy (PD). Methods Patients (n = 90) who received conventional perioperative management from 2005 to 2009 were included as the ‘conventional group’ (historical control group), and patients who received perioperative care with fasttrack management (n = 100) from 2010 to March 2013 were included as the ‘fast-track group’. To evaluate the efficacy of perioperative care with fast-track management, the incidence of postoperative complications and the length of hospital stay were compared between the two groups (comparative study). For statistical analysis, univariate analysis was performed using the v2 test or Fisher’s exact test. Results There was no significant difference between the two groups in sex, mean age, presence/absence of diabetes mellitus, preoperative drainage for jaundice, previous disease, operative procedure, mean duration of operation, or blood loss (p \ 0.01). The incidence of surgical site infection in the conventional group and fast-track group was 28.9 and 14.0 %, respectively, with a significant difference between the two groups (p = 0.019). In addition, the incidence of pancreatic fistula (grade B, C) significantly
S. Kobayashi (&) R. Ooshima S. Koizumi M. Katayama J. Sakurai T. Watanabe H. Nakano T. Imaizumi T. Otsubo Division of Gastroenterological and General Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan e-mail: [email protected]
differed between the two groups (27.8 % in the conventional group, 9.0 % in the fast-track group; p = 0.001). The mean postoperative hospital stay was 36.3 days in the conventional group and 21.9 days in the fast-track group (p \ 0.001). Conclusions Perioperative care with fast-track management may reduce postoperative complications and decrease the length of hospital stay in patients undergoing PD.
Introduction Pancreaticoduodenectomy (PD) has been considered to require cautious postoperative management because of the frequent development of complications. This consequently necessitates patients to be in an inconvenient state, including prohibition of oral intake for approximately 1 week after surgery. However, in recent years, it has been considered that postoperative abnormal daily life (e.g., fasting, use of laxatives, intravenous drip) should be shortened so that patients can go back to usual daily life as early as possible. It is becoming clear that allowing patients to return to daily life earlier after surgery helps recovery of physiological function and reduces postoperative complications and hospital stay [1–3]. Since Cotton [4] first used the term ‘‘fast-track’’ for the procedure to improve recovery from coronary artery bypass graft surgery in the early 1990s, various perioperative management with reported evidence has been undertaken comprehensively to improve recovery from surgery [5, 6]. In 2005, comprehensive evidence-based perioperative management (composed of 21 items) for patients undergoing colonic resection was reported as an Enhanced Recovery After Surgery (ERASÒ) protocol at the European Society for Clinical Nutrition and Metabolism [7].
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Beneficial experiences with clinical pathway programs after PD have been published [8–10], but the reported series employed different protocols or no prospective protocol at all. We therefore investigated whether fasttrack management can also be introduced to PD, and whether perioperative care with fast-track management can contribute to reduction of postoperative complications and length of hospital stay. ERASÒ protocols are multimodal perioperative care pathways, and in order to evaluate their effects properly, the individual pathway must be verified prospectively. However, the number of patients undergoing PD per institution is limited. Therefore, when such an evaluation is to be conducted in a multicenter investigation, it is necessary to standardize the operative procedure and the technology employed, making it difficult to perform proper investigations. Our present study was thus undertaken as a single-center comparative study using an historical control.
Subjects and methods The subjects were 190 consecutive patients who underwent PD between 2005 and 2013. The number of PD surgical cases at our hospital increased from around 2009, and thus, we needed to implement a proper strategy to reduce postoperative complications. Since 2010, therefore, we have reviewed the perioperative management of PD, and changed our conventional management in many respects. A total of 90 patients who received conventional perioperative management in our hospital from 2005 to 2009 were included as the ‘conventional group’ (historical control group), and 100 patients who underwent perioperative care with fast-track management from 2010 to March 2013 were included as the ‘fast-track group’. To evaluate the efficacy of perioperative care with fast-track management, the postoperative course (the day of starting oral intake after surgery and changes in postoperative serum albumin and prealbumin levels), incidence of postoperative complications, including delayed gastric emptying (DGE), surgical site infection (SSI), and pancreatic fistula (PF), and postoperative hospital stay were compared between the conventional group and the fast-track group as a comparative study. Included in the analysis were grade A or more severe DGE as determined by the International Study Group of Pancreatic Surgery (ISGPS) [11], PF (grade B or C) as defined by the International Study Group on Pancreatic Fistula Definition (ISGPF) [12], and grade 1 or more severe SSI or other complications as determined by the Clavien classification [13]. Preoperative biliary drainage was performed by percutaneous transhepatic catheter drainage, endoscopic nasal biliary drainage, or endoscopic retrograde biliary drainage
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when the serum level of total bilirubin was greater than 4 mg/mL. All subjects underwent Child reconstruction. Pancreatic anastomosis after PD was performed by duct-tomucosa and end-to-side pancreaticojejunostomy in all subjects enrolled. In both groups, one 6-mm silicone tube drain (Kaneka Medix Corp., Osaka, Japan) was inserted at the superior border of the site of pancreaticojejunostomy, and one 6.3-mm silicone blake drain (Johnson & Johnson K. K., Tokyo, Japan) was inserted behind the site of cholangiojejunostomy. For postoperative prophylaxis, a sulbactam/cefoperazone sodium agent was given intravenously until the 4th postoperative day (1 g, twice daily) in both groups. Furthermore, octreotide acetate was administered at a dose of 150 lg/day from immediately after surgery until the 7th postoperative day in the conventional group, and until the 4th day in the fast-track group. No anticoagulants were administered to prevent thrombosis. We normally allow patients to leave hospital at 2 weeks after surgery at the shortest if the blood inflammatory response is mild (C-reactive protein \3) after the 14th postoperative day, if the temperature is lower than 37.5 °C for at least 5 days, and if the patient can eat at least 50 % of the food provided.
Conventional perioperative management (2005–2009) On the day before surgery, the subjects could have breakfast and lunch before they were fasted, and were treated with oral magnesium citrate (Magcorol P) as mechanical bowel preparation. After surgery, the subjects were fasted until the 7th postoperative day and received total parenteral nutrition through a central venous catheter. The timing of drain removal was determined at the discretion of each surgeon, and was 9.24 ± 3.09 days postoperatively on average.
Fast-track management in our hospital (from 2010 onwards) During counseling before surgery, patients are frequently informed about the diagnosis, therapeutic strategy, complications, and postoperative course shown on a clinical pathway. Patients with malnutrition receive oral intake with nutritional supplements (Racol, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan) according to preoperative nutritional status. Mechanical bowel preparation before surgery is not performed. For preoperative oral intake, patients can have breakfast, lunch, and dinner on the day before surgery. An arched skin incision is made. The nasogastric tube is removed on the 1st postoperative day. Postoperative water intake is started on the 1st
World J Surg Table 1 List of items for fast-track management 1. Counseling before surgery 2. Management of preoperative nutritional status (patients with malnutrition receive oral intake of low residual diets) 3. Discontinuation of intake of mechanical bowel preparation before surgery 4. Discontinuation of fasting before surgery (patients can have dinner on the day before surgery)
Table 2 Comparison of postoperative results between conventional group and fast-track group Item
Conventional group (n = 90)
Fast-track group (n = 100)
p value
Sex (male/female)
62/28
61/39
0.256
Age (years)
65.4 ± 10.8
67.5 ± 10.7
0.171
45/45
45/55
0.491
6. Removal of nasogastric tube on 1st postoperative day
Disease (pancreatic tumor/non-pancreatic tumora)
7. Water intake starts from 1st postoperative day, elemental diet from 2nd day, and rice porridge from 3rd day
Diabetes mellitus (yes/ no)
28/62
31/69
0.987
8. Discontinuation of central venous nutrition
BMI (kg/m2)
25.0 ± 4.54
21.6 ± 3.54
0.455
9. Early removal of abdominal cavity drains (on postoperative 5th day)
Jaundice requiring biliary drainage (yes/ no)
54/36
57/43
0.675
Diameter of pancreatic duct (mm)
3.71 ± 2.46
4.10 ± 2.15
0.288
Operative procedure (PD/PPPD/SSPD)
12/76/2
5/85/10
0.016
Stenting of pancreatic duct (external/ internal/no stent)
90/0/0
78/14/8
\0.001
With portal vein resection (yes/no)
15/75
13/87
0.477
Duration of operation (min)
438.2 ± 103.9
457.9 ± 119.6
0.243
Blood loss (mL)
1088.8 ± 590.1
949.6 ± 724.4
0.162
5. Skin incision is performed in the form of arch
postoperative day, and an elemental diet (Elental, Ajinomoto Pharmaceuticals Co., Ltd., Tokyo, Japan) on the 2nd postoperative day. Intake of rice porridge is started on the 3rd postoperative day in parallel with Elental. Central venous nutrition is not performed as perioperative management. Abdominal drains are removed on the 5th postoperative day in principle (Table 1). Since 2010, all patients have received care according to the above-mentioned standardized postoperative management. Statistical analysis Data are expressed as mean ± standard deviation (SD). Patient characteristics and perioperative and postoperative factors were compared between the two groups using the v2 test, Fisher’s exact test, and Mann–Whitney’s U test. Statistical significance was defined as p \ 0.05.
Results There was no significant difference between the conventional group and fast-track group in terms of sex, mean age, presence/absence of diabetes mellitus, body mass index (BMI), previous disease, preoperative drainage for jaundice, diameter of the pancreatic duct, duration of operation, and blood loss (Table 2). PD predominated in the operative procedures performed from 2005 to 2009 (conventional group), whereas subtotal stomach-preserving (SSPD) predominated from 2010 onwards (fast-track group). This is based on the concept that the nutritional status following PD is maintained in cases in which the stomach can be retained. In the conventional group, all patients received an external pancreatic duct stent, whereas in the fast-track group 14 patients received an internal pancreatic duct stent and eight patients received no stent.
Data are presented as mean ± SD unless otherwise indicated BMI body mass index, PD pancreaticoduodenectomy, PPPD pyloruspreserving PD, SD standard deviation, SSPD subtotal stomach-preserving PD a
Pancreatic tumor: pancreatic cancer or intraductal papillary mucinous neoplasm
Until 2009 (conventional group), the amylase level in drainage fluid had been measured on postoperative days 1, 3, and 7, and the drain was not removed if the value obtained on postoperative day 7 was not lower than 400 IU/L. From 2010 onwards (fast-track group), on the other hand, the drain was, in principle, removed on postoperative day 5 regardless of the amylase level in drainage fluid (measurements were made on postoperative days 1, 3, and 5). Of the items for fast-track management listed in Table 1, early removal of abdominal cavity drains (on the 5th postoperative day) was impossible in nine patients in the fast-track group who developed PF (Grade B or C), but was possible in the remaining 91 of 100 patients (91 %). In this group, 88 patients (88 %) were able to start oral intake early after surgery during fast-track management. Of the remaining 12 patients, nine had PF (grade B or C), and one each had DGE, ileus, pneumonia, and heart failure. In the conventional group, drains were removed on postoperative
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World J Surg Table 3 Postoperative course of patients
Data are presented as mean ± standard deviation
Item
Conventional group (n = 90)
p value \0.001
Day of starting oral intake (days after surgery)
8.3 ± 4.9
2.9 ± 1.9
Change in albumin level on postoperative day 7 (%)
84.1 ± 12.4
84.5 ± 12.4
0.851
Change in albumin level on postoperative day 14 (%) Change in prealbumin level on postoperative day 7 (%)
85.5 ± 11.5
88.9 ± 12.9
0.079
59.6 ± 23.6
62.2 ± 22.3
0.541
Change in prealbumin level on postoperative day 14 (%)
63.4 ± 22.6
69.5 ± 31.9
0.337
Day of drain removal in patients without Grade B or C pancreatic fistula (days after surgery)
9.24 ± 3.09 (n = 65)
Table 4 Postoperative complications in conventional group and fast-track group Complication
Conventional group (n = 90)
Fast-track group (n = 100)
p value
Delayed gastric emptying
10.0 (9/81)
2.0 (2/98)
0.040
Surgical site infection (incisional)
28.9 (26/64)
14.0 (14/86)
0.019
Pancreatic fistula
27.8 (25/65)
9.0 (9/91)
0.001
Surgical site infection (organ/space)
5.6 (5/85)
5.0 (5/95)
0.878
Intra-abdominal hemorrhage
8.9 (8/82)
3.0 (3/97)
0.154
Bile leak
2.2 (2/88)
4.0 (4/96)
0.776
Cholangitis
11.1 (10/80)
4.0 (4/96)
0.111
Ileus
2.2 (2/88)
1.0 (1/99)
0.927
Lymphorrhea
1.1 (1/89)
2.0 (2/98)
0.927
Pneumonia
2.2 (2/88)
1.0 (1/99)
0.927
Heart failure
1.1 (1/89)
1.0 (1/99)
0.524
Number of patients with complications (%)
54 (60)
39 (39)
0.004
Mortality
1.1 (1/89)
0.0
0.957
Values are percentages presented as ‘yes/no’
day 9.24, on average, in the 65 patients who did not develop PF (Grade B or C) (Table 3). The mean starting day of oral intake in the conventional group and fast-track group was 8.3 (± 4.9) (median 7) and 2.9 days (± 1.9) (median 2) postoperatively, respectively (Table 3). When the preoperative serum albumin level was taken as 100 %, the serum albumin level on the 7th and 14th postoperative days was 84.1 ± 12.4 % and 85.5 ± 11.5 %, respectively, in the conventional group, and 84.5 ± 12.4 % and 88.9 ± 12.9 %, respectively, in
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Fast-track group (n = 100)
5 ± 0.0 (n = 91)
\0.001
Table 5 Length of postoperative hospital stay and percentage of rehospitalization in conventional group and fast-track group Conventional group (n = 90)
Fast-track group (n = 100)
p value
Length of postoperative hospital stay (days)
36.3 ± 23.8
21.9 ± 11.9
\0.001
Length of postoperative hospital stay in patients without complications (days) Rehospitalization rate within 90 days after discharge (%)
21.6 ± 5.4 (n = 36)
18.1 ± 4.9 (n = 61)
\0.001
2 (2/90)
2 (2/100)
0.689
the fast-track group. When the prealbumin level was compared in the same manner, that on the 7th and 14th postoperative days was 59.6 ± 23.6 % and 63.4 ± 22.6 %, respectively, in the conventional group, and 62.2 ± 22.3 % and 69.5 ± 31.9 %, respectively, in the fast-track group, with no significant difference in these parameters (Table 3). The incidence of postoperative DGE was 10.0 % in the conventional group and 2.0 % in the fast-track group (p = 0.04). The incidence of incisional SSI was 28.9 % in the conventional group and 14 % in the fast-track group (p = 0.019). The incidence of PF (grade B or C) was 27.8 % in the conventional group and 9.0 % in the fasttrack group (p = 0.0014). There were significant differences in the incidence of these postoperative complications (Table 4). Further, there was a significant difference in mean length of hospital stay between the conventional group (36.3 days) and fast-track group (21.9 days) (p \ 0.001). Even if subjects with postoperative complications were excluded from the analysis, the mean length of
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postoperative hospital stay was 21.6 days in the conventional group and 18.1 days in the fast-track group, with a significant difference between the two groups (p \ 0.001). Within 90 days of discharge, two of the 90 patients in the conventional group were re-hospitalized (both because of cholangitis), while two of the 100 patients in the fast-track group were re-hospitalized (one because of PF, and the other because of cholangitis) (p = 0.689) (Table 5).
Discussion The basic concept of the fast-track protocol and ERASÒ protocol is to reduce mental and physical stress, and to prevent deterioration of organ function so that patients can return to daily life by expediting recovery after surgery. The ERASÒ protocol, originally prepared as a consensus review of clinical care for patients undergoing colonic surgery, is now applied to a variety of surgeries [14–16]. Meanwhile, since PD has a high incidence (about 40 %) of postoperative complications, even in high-volume medical centers, careful perioperative management is required [17–20]. Therefore, comprehensive medical care, such as fast-track management or ERASÒ, tends to be considered unsuitable for PD. However, the more invasive an operation, the more significance a protocol such as ERASÒ has in perioperative management of PD [21]. The ERASÒ guidelines for PD [22] were formulated in 2012, and the usefulness of the program for early recovery from surgery has attracted attention. The results of our present study indicated that 91 % of the patients could achieve early drain removal, and 88 % could restart oral intake from the early stage after surgery, suggesting that fast-track management can be safely introduced in PD. Preoperative counseling with various information eliminates patients’ preoperative anxiety, and enhances postoperative recovery, resulting in a shortened hospital stay [23, 24]. It was reported that there was no significant difference in the incidence of perioperative infection in colorectal surgery between patients with and without preoperative mechanical bowel preparation; but that the preparation significantly increased the incidence of anastomotic insufficiency [25]. In addition, mechanical bowel preparation was reported to cause dehydration and electrolyte imbalance due to diarrhea, and induce subsequent intestinal edema caused by intraoperative infusion [26]. Shortening of the perioperative fasting period may lead to improvement of insulin resistance and postoperative hyperglycemia, resulting in improvement of perioperative quality of life [27]. Oral intake could reportedly be allowed as late as 6 h prior to the induction of anesthesia [28, 29]. Regarding the direction of the skin incision, a longitudinal or arcuate incision has been reported to cause much
less postoperative pain and improved decreased postoperative lung function than a lateral incision [30]. Abdominal cavity drainage was reported not to improve the incidence and severity of postoperative complications (such as anastomotic leakage) in colorectal surgery [31]. It was also reported that there was no significant difference in the incidence of complications and operative mortality between pancreatectomy patients with and without abdominal cavity drainage [32]. However, in the case of pancreatectomy, in which PF can be a fatal complication, placement of an abdominal drain may be acceptable. The guidelines for the Prevention of SSI formulated by the Centers for Disease Control and Prevention recommend the employment of closed drainage tubes and to remove them as early as possible [33]. Further, it has been often reported that early removal of a drain in pancreatectomy reduces the incidence of postoperative infectious complications [17, 18]. Thus, a drainage tube should be removed at an early stage in cases where the amylase level in drainage fluid on postoperative day 1 is not very high [34]. In our hospital, before the initiation of fast-track management, drains were, on average, usually removed on the 9th postoperative day. Surgeons were disinclined to drastically reduce the number of days to less than half. Therefore, we decided that drains should be removed on the 5th postoperative day in fast-track management in this study. Kawai et al. [17] and Bassi et al. [18] reported that drain removal on the 3rd or 4th postoperative day significantly reduced postoperative complications. We should consider reducing the duration of drainage further in our hospital. It has been reported that early postoperative oral intake does not worsen anastomotic leakage in colorectal surgery [35]. Early postoperative oral intake has been avoided in patients undergoing PD with the concern that PD is associated with a high incidence of postoperative DGE [36, 37] and that early oral intake might stimulate pancreatic exocrine secretion, resulting in an increased incidence of PF. However, recently, Balzano et al. [38] reported that early postoperative oral intake decreased the incidence of DGE and the length of hospital stay without increasing the incidence of PF. In the present study, oral intake was allowed from the 1st postoperative day on the condition that vital signs were stable and abdominal X-ray revealed a normal pattern of bowel gas. Since oral intake was delayed in some patients owing to the occurrence of a complication, such as DGE, ileus, pneumonia, or heart failure, oral intake was started a mean of 2.9 days after surgery. However, in many patients, it was feasible to start oral intake on the 1st postoperative day. The nutritional supplement used in our hospital for preoperative nutritional care (Racol) contains omega-3 fatty acids and medium-chain triglycerides [39, 40]. These
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specific nutrients have been reported to enhance the body’s natural defenses. In many randomized controlled trials, postoperative infectious complications were shown to be decreased by nutrients [41]. The elemental diet (Elental) used for early postoperative oral feeding in our hospital is characterized by a low-fat composition with a combination of four major nutrients (amino acids, carbohydrates, vitamins, and minerals) and is considered to contribute to improvement of nutritional status without stimulating pancreatic exocrine secretion [42, 43]. The present study clearly indicated that the incidence of DGE, SSI, and PF in the fast-track group was significantly reduced as compared with that in the conventional group. In the present study, there were differences in the proportion of patients undergoing different operative procedures [PD, pylorus-preserving PD (PPPD), and SSPD]. Whether PD was pylorus-preserving or not could cause a bias in the incidence of DGE. Loss of vagal control may cause a decrease in function of the pyloric ring, thereby leading to the development of DGE [44]. From this perspective, the proportion of patients undergoing PPPD and non-PPPD (PD?SSPD) was found to be 76:14 in the conventional group and 85:15 in the fast-track group, with no significant difference (p = 0.915). This finding indicates that there was no correlation between the preservation of the pyloric ring and the occurrence of DGE. Regarding PF, there was no significant difference between the two groups in terms of presence/absence of diabetes mellitus (which could be related to the development of PF), BMI, diameter of the pancreatic duct, duration of operation, and blood loss. A stent is commonly placed in a pancreato-enteroanastomosis in Japan. Also in our hospital, external or internal pancreatic duct stenting has been performed in principle. Although no significant difference in the incidence of PF was found between internal and external drainage [45], it has been reported that the incidence of PF is significantly higher in patients without a stent than in those with external drainage [46]. With respect to the difference between internal and external drainage, we consider that PF, once it occurs, is unlikely to develop into a serious condition (e.g., intra-abdominal hemorrhage) in the presence of external drainage because pancreatic juice can be deliberately drained via this route. As for stenting of the pancreatic duct, the proportion of patients with ‘no stent’, which may lead to a risk of PF development, was higher in the fast-track group. However, the incidence of PF was significantly lower in the fast-track group, showing that the perioperative management might have been effective. Among the patients who did not experience postoperative complications, the length of hospital stay was significantly shorter in the fast-track group than in the
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conventional group. However, the length of hospital stay was 18 days even in the fast-track group, which was not a short period. Since our hospital plays a central role in this region, most of our patients are referred from clinics without beds. Therefore, most of them are discharged from hospital directly to home. In recent years, many elderly patients live alone or as a couple only at home, and thus wish to be hospitalized for 2 weeks or more even if they do not have any complications. It is not our policy to discharge patients from hospital if they wish to prolong their hospitalization. Since the rehospitalization rate within 90 days after discharge was as low as 2 % during the present study, we consider the hospital stay to be satisfactory if the mean length was within 3 weeks after surgery. It is possible that improvement of surgical skill might have favorably influenced the incidence of postoperative complications, because this was a historical control study. However, the reduction of incidence of SSI may not solely be attributable to improvement of surgical skill. In order to confirm the postoperative nutritional status, albumin and prealbumin levels were compared, and the results indicated no significant difference between the two groups. We consider the purpose and significance of early restarting of oral intake after surgery to be that patients’ immune systems are not compromised while leading an ‘abnormal daily life’, and not that patients’ nutritional status is promptly improved. Among the patients who did not experience postoperative complications, the length of hospital stay was significantly shorter in the fast-track group than in the conventional group. One care pathway alone may not produce a major improvement in the outcome of perioperative management of patients undergoing a highly invasive operative procedure such as PD. However, a multimodal approach is considered likely to reduce postoperative complications. Furthermore, the findings of the present study suggested that the relevant pathways were also associated with reduced length of hospital stay. Nevertheless, multicenter, randomized clinical trials may be further needed to demonstrate the true significance of fast-track management. Grant Support
None.
Conflict of interest of interest.
The authors declare that they have no conflicts
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24. Kiecolt-Glaser JK, Page GG, Marucha PT et al (1998) Psychological influences on surgical recovery. Perspectives from psychoneuroimmunology. Am Psychol 53:1209–1218 25. Slim K, Vicaut E, Panis Y et al (2004) Meta-analysis of randomized clinical trials of colorectal surgery with or without mechanical bowel preparation. Br J Surg 91:1125–1130 26. Sanders G, Mercer SJ, Saeb-Parsey K et al (2001) Randomized clinical trial of intravenous fluid replacement during bowel preparation for surgery. Br J Surg 88:1363–1365 27. Eriksson LI, Sandin R (1996) Fasting guidelines in different countries. Acta Anaesthesiol Scand 40:971–974 28. Søreide E, Fasting S, Raeder J (1997) New preoperative fasting guidelines in Norway. Acta Anaesthesiol Scand 41:799 29. No authors listed (1999) Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anesthesiologist Task Force on Preoperative Fasting. Anesthesiology 90:896–905 30. Grantcharov TP, Rosenberg J (2001) Vertical compared with transverse incisions in abdominal surgery. Eur J Surg 167:260–267 31. Urbach DR, Kennedy ED, Cohen MM (1999) Colon and rectal anastomoses do not require routine drainage: a systematic review and meta-analysis. Ann Surg 229:174–180 32. Conlon KC, Labow D, Leung D et al (2001) Prospective randomized clinical trial of the value of intraperitoneal drainage after pancreatic resection. Ann Surg 234:487–493 33. Mangram AJ, Horan TC, Pearson ML et al (1999) Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 20:250–278 34. Kawai M, Kondo S, Yamaue H et al (2011) Predictive risk factors for clinically relevant pancreatic fistula analyzed in 1,239 patients with pancreaticoduodenectomy: multicenter data collection as a project study of pancreatic surgery by the Japanese Society of Hepato-Biliary-Pancreatic Surgery. J Hepatobiliary Pancreat Sci 18:601–608 35. Wind J, Hofland J, Preckel B et al (2006) Perioperative strategy in colonic surgery: laparoscopy and/or fast track multimodal management versus standard care (LAFA trial). BMC Surg 6:16 36. CarloV Di, Zerbi A, Balzano G et al (1999) Pylorus-preserving pancreaticoduodenectomy versus conventional whipple operation. World J Surg 23:920–925 37. Hirata K, Sato T, Mukaiya M et al (1997) Results of 1001 pancreatic resections for invasive ductal adenocarcinoma of the pancreas. Arch Surg 132:771–776 38. Balzano G, Zerbi A, Braga M et al (2008) Fast-track recovery programme after pancreatico-duodenectomy reduces delayed gastric emptying. Br J Surg 95:1387–1393 39. Miyata H, Yano M, Yasuda T et al (2012) Randomized study of clinical effect of enteral nutrition support during neoadjuvant chemotherapy on chemotherapy-related toxicity in patients with esophageal cancer. Clin Nutr 31:330–336 40. Aiko S, Yoshizumi Y, Tsuwano S et al (2005) The effects of immediate enteral feeding with a formula containing high levels of omega-3 fatty acids in patients after surgery for esophageal cancer. JPEN J Parenter Enteral Nutr 29:141–147 41. Heys SD, Walker LG, Smith I et al (1999) Enteral nutritional supplementation with key nutrients in patients with critical illness and cancer: a meta-analysis of randomized controlled clinical trials. Ann Surg 229:467–477 42. Watanabe S, Shiratori K, Takeuchi T et al (1986) Release of cholecystokinin and exocrine pancreatic secretion in response to an elemental diet in human subjects. Dig Dis Sci 31:919–924
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World J Surg 43. Novis BH, Bank S, Marks IN (1972) Exocrine pancreatic function in intestinal malabsorption and small bowel disease. Am J Dig Dis 17:489–494 44. Srinarmwong C, Luechakiettisak P, Prasitvilai W (2008) Standard Whipple’s operation versus pylorus preserving pancreaticoduodenectomy: a randomized controlled trial study. J Med Assoc Thai 91:693–698 45. Winter JM, Cameron JL, Campbell KA et al (2006) Does pancreatic duct stenting decrease the rate of pancreatic fistula
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following pancreaticoduodenectomy? Results of a prospective randomized trial. J Gastrointest Surg 10:1280–1290 46. Tani M, Kawai M, Hirono S et al (2010) A prospective randomized controlled trial of internal versus external drainage with pancreaticojejunostomy for pancreaticoduodenectomy. Am J Surg 199:759–764
Perioperative Care with Fast-Track Management in Patients Undergoing Pancreaticoduodenectomy Shinjiro Kobayashi • Ryuiti Ooshima • Satoshi Koizumi • Masafumi Katayama • Joe Sakurai • Taiji Watanabe • Hiroshi Nakano • Toshihide Imaizumi • Takehito Otsubo
Ó Socie´te´ Internationale de Chirurgie 2014
Abstract Background It has been considered that allowing patients to return to daily life earlier after surgery helps recovery of physiological function and reduces postoperative complications and hospital stay. We investigated the usefulness of fast-track management in perioperative care of patients undergoing pancreaticoduodenectomy (PD). Methods Patients (n = 90) who received conventional perioperative management from 2005 to 2009 were included as the ‘conventional group’ (historical control group), and patients who received perioperative care with fasttrack management (n = 100) from 2010 to March 2013 were included as the ‘fast-track group’. To evaluate the efficacy of perioperative care with fast-track management, the incidence of postoperative complications and the length of hospital stay were compared between the two groups (comparative study). For statistical analysis, univariate analysis was performed using the v2 test or Fisher’s exact test. Results There was no significant difference between the two groups in sex, mean age, presence/absence of diabetes mellitus, preoperative drainage for jaundice, previous disease, operative procedure, mean duration of operation, or blood loss (p \ 0.01). The incidence of surgical site infection in the conventional group and fast-track group was 28.9 and 14.0 %, respectively, with a significant difference between the two groups (p = 0.019). In addition, the incidence of pancreatic fistula (grade B, C) significantly
S. Kobayashi (&) R. Ooshima S. Koizumi M. Katayama J. Sakurai T. Watanabe H. Nakano T. Imaizumi T. Otsubo Division of Gastroenterological and General Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan e-mail: [email protected]
differed between the two groups (27.8 % in the conventional group, 9.0 % in the fast-track group; p = 0.001). The mean postoperative hospital stay was 36.3 days in the conventional group and 21.9 days in the fast-track group (p \ 0.001). Conclusions Perioperative care with fast-track management may reduce postoperative complications and decrease the length of hospital stay in patients undergoing PD.
Introduction Pancreaticoduodenectomy (PD) has been considered to require cautious postoperative management because of the frequent development of complications. This consequently necessitates patients to be in an inconvenient state, including prohibition of oral intake for approximately 1 week after surgery. However, in recent years, it has been considered that postoperative abnormal daily life (e.g., fasting, use of laxatives, intravenous drip) should be shortened so that patients can go back to usual daily life as early as possible. It is becoming clear that allowing patients to return to daily life earlier after surgery helps recovery of physiological function and reduces postoperative complications and hospital stay [1–3]. Since Cotton [4] first used the term ‘‘fast-track’’ for the procedure to improve recovery from coronary artery bypass graft surgery in the early 1990s, various perioperative management with reported evidence has been undertaken comprehensively to improve recovery from surgery [5, 6]. In 2005, comprehensive evidence-based perioperative management (composed of 21 items) for patients undergoing colonic resection was reported as an Enhanced Recovery After Surgery (ERASÒ) protocol at the European Society for Clinical Nutrition and Metabolism [7].
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Beneficial experiences with clinical pathway programs after PD have been published [8–10], but the reported series employed different protocols or no prospective protocol at all. We therefore investigated whether fasttrack management can also be introduced to PD, and whether perioperative care with fast-track management can contribute to reduction of postoperative complications and length of hospital stay. ERASÒ protocols are multimodal perioperative care pathways, and in order to evaluate their effects properly, the individual pathway must be verified prospectively. However, the number of patients undergoing PD per institution is limited. Therefore, when such an evaluation is to be conducted in a multicenter investigation, it is necessary to standardize the operative procedure and the technology employed, making it difficult to perform proper investigations. Our present study was thus undertaken as a single-center comparative study using an historical control.
Subjects and methods The subjects were 190 consecutive patients who underwent PD between 2005 and 2013. The number of PD surgical cases at our hospital increased from around 2009, and thus, we needed to implement a proper strategy to reduce postoperative complications. Since 2010, therefore, we have reviewed the perioperative management of PD, and changed our conventional management in many respects. A total of 90 patients who received conventional perioperative management in our hospital from 2005 to 2009 were included as the ‘conventional group’ (historical control group), and 100 patients who underwent perioperative care with fast-track management from 2010 to March 2013 were included as the ‘fast-track group’. To evaluate the efficacy of perioperative care with fast-track management, the postoperative course (the day of starting oral intake after surgery and changes in postoperative serum albumin and prealbumin levels), incidence of postoperative complications, including delayed gastric emptying (DGE), surgical site infection (SSI), and pancreatic fistula (PF), and postoperative hospital stay were compared between the conventional group and the fast-track group as a comparative study. Included in the analysis were grade A or more severe DGE as determined by the International Study Group of Pancreatic Surgery (ISGPS) [11], PF (grade B or C) as defined by the International Study Group on Pancreatic Fistula Definition (ISGPF) [12], and grade 1 or more severe SSI or other complications as determined by the Clavien classification [13]. Preoperative biliary drainage was performed by percutaneous transhepatic catheter drainage, endoscopic nasal biliary drainage, or endoscopic retrograde biliary drainage
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when the serum level of total bilirubin was greater than 4 mg/mL. All subjects underwent Child reconstruction. Pancreatic anastomosis after PD was performed by duct-tomucosa and end-to-side pancreaticojejunostomy in all subjects enrolled. In both groups, one 6-mm silicone tube drain (Kaneka Medix Corp., Osaka, Japan) was inserted at the superior border of the site of pancreaticojejunostomy, and one 6.3-mm silicone blake drain (Johnson & Johnson K. K., Tokyo, Japan) was inserted behind the site of cholangiojejunostomy. For postoperative prophylaxis, a sulbactam/cefoperazone sodium agent was given intravenously until the 4th postoperative day (1 g, twice daily) in both groups. Furthermore, octreotide acetate was administered at a dose of 150 lg/day from immediately after surgery until the 7th postoperative day in the conventional group, and until the 4th day in the fast-track group. No anticoagulants were administered to prevent thrombosis. We normally allow patients to leave hospital at 2 weeks after surgery at the shortest if the blood inflammatory response is mild (C-reactive protein \3) after the 14th postoperative day, if the temperature is lower than 37.5 °C for at least 5 days, and if the patient can eat at least 50 % of the food provided.
Conventional perioperative management (2005–2009) On the day before surgery, the subjects could have breakfast and lunch before they were fasted, and were treated with oral magnesium citrate (Magcorol P) as mechanical bowel preparation. After surgery, the subjects were fasted until the 7th postoperative day and received total parenteral nutrition through a central venous catheter. The timing of drain removal was determined at the discretion of each surgeon, and was 9.24 ± 3.09 days postoperatively on average.
Fast-track management in our hospital (from 2010 onwards) During counseling before surgery, patients are frequently informed about the diagnosis, therapeutic strategy, complications, and postoperative course shown on a clinical pathway. Patients with malnutrition receive oral intake with nutritional supplements (Racol, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan) according to preoperative nutritional status. Mechanical bowel preparation before surgery is not performed. For preoperative oral intake, patients can have breakfast, lunch, and dinner on the day before surgery. An arched skin incision is made. The nasogastric tube is removed on the 1st postoperative day. Postoperative water intake is started on the 1st
World J Surg Table 1 List of items for fast-track management 1. Counseling before surgery 2. Management of preoperative nutritional status (patients with malnutrition receive oral intake of low residual diets) 3. Discontinuation of intake of mechanical bowel preparation before surgery 4. Discontinuation of fasting before surgery (patients can have dinner on the day before surgery)
Table 2 Comparison of postoperative results between conventional group and fast-track group Item
Conventional group (n = 90)
Fast-track group (n = 100)
p value
Sex (male/female)
62/28
61/39
0.256
Age (years)
65.4 ± 10.8
67.5 ± 10.7
0.171
45/45
45/55
0.491
6. Removal of nasogastric tube on 1st postoperative day
Disease (pancreatic tumor/non-pancreatic tumora)
7. Water intake starts from 1st postoperative day, elemental diet from 2nd day, and rice porridge from 3rd day
Diabetes mellitus (yes/ no)
28/62
31/69
0.987
8. Discontinuation of central venous nutrition
BMI (kg/m2)
25.0 ± 4.54
21.6 ± 3.54
0.455
9. Early removal of abdominal cavity drains (on postoperative 5th day)
Jaundice requiring biliary drainage (yes/ no)
54/36
57/43
0.675
Diameter of pancreatic duct (mm)
3.71 ± 2.46
4.10 ± 2.15
0.288
Operative procedure (PD/PPPD/SSPD)
12/76/2
5/85/10
0.016
Stenting of pancreatic duct (external/ internal/no stent)
90/0/0
78/14/8
\0.001
With portal vein resection (yes/no)
15/75
13/87
0.477
Duration of operation (min)
438.2 ± 103.9
457.9 ± 119.6
0.243
Blood loss (mL)
1088.8 ± 590.1
949.6 ± 724.4
0.162
5. Skin incision is performed in the form of arch
postoperative day, and an elemental diet (Elental, Ajinomoto Pharmaceuticals Co., Ltd., Tokyo, Japan) on the 2nd postoperative day. Intake of rice porridge is started on the 3rd postoperative day in parallel with Elental. Central venous nutrition is not performed as perioperative management. Abdominal drains are removed on the 5th postoperative day in principle (Table 1). Since 2010, all patients have received care according to the above-mentioned standardized postoperative management. Statistical analysis Data are expressed as mean ± standard deviation (SD). Patient characteristics and perioperative and postoperative factors were compared between the two groups using the v2 test, Fisher’s exact test, and Mann–Whitney’s U test. Statistical significance was defined as p \ 0.05.
Results There was no significant difference between the conventional group and fast-track group in terms of sex, mean age, presence/absence of diabetes mellitus, body mass index (BMI), previous disease, preoperative drainage for jaundice, diameter of the pancreatic duct, duration of operation, and blood loss (Table 2). PD predominated in the operative procedures performed from 2005 to 2009 (conventional group), whereas subtotal stomach-preserving (SSPD) predominated from 2010 onwards (fast-track group). This is based on the concept that the nutritional status following PD is maintained in cases in which the stomach can be retained. In the conventional group, all patients received an external pancreatic duct stent, whereas in the fast-track group 14 patients received an internal pancreatic duct stent and eight patients received no stent.
Data are presented as mean ± SD unless otherwise indicated BMI body mass index, PD pancreaticoduodenectomy, PPPD pyloruspreserving PD, SD standard deviation, SSPD subtotal stomach-preserving PD a
Pancreatic tumor: pancreatic cancer or intraductal papillary mucinous neoplasm
Until 2009 (conventional group), the amylase level in drainage fluid had been measured on postoperative days 1, 3, and 7, and the drain was not removed if the value obtained on postoperative day 7 was not lower than 400 IU/L. From 2010 onwards (fast-track group), on the other hand, the drain was, in principle, removed on postoperative day 5 regardless of the amylase level in drainage fluid (measurements were made on postoperative days 1, 3, and 5). Of the items for fast-track management listed in Table 1, early removal of abdominal cavity drains (on the 5th postoperative day) was impossible in nine patients in the fast-track group who developed PF (Grade B or C), but was possible in the remaining 91 of 100 patients (91 %). In this group, 88 patients (88 %) were able to start oral intake early after surgery during fast-track management. Of the remaining 12 patients, nine had PF (grade B or C), and one each had DGE, ileus, pneumonia, and heart failure. In the conventional group, drains were removed on postoperative
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World J Surg Table 3 Postoperative course of patients
Data are presented as mean ± standard deviation
Item
Conventional group (n = 90)
p value \0.001
Day of starting oral intake (days after surgery)
8.3 ± 4.9
2.9 ± 1.9
Change in albumin level on postoperative day 7 (%)
84.1 ± 12.4
84.5 ± 12.4
0.851
Change in albumin level on postoperative day 14 (%) Change in prealbumin level on postoperative day 7 (%)
85.5 ± 11.5
88.9 ± 12.9
0.079
59.6 ± 23.6
62.2 ± 22.3
0.541
Change in prealbumin level on postoperative day 14 (%)
63.4 ± 22.6
69.5 ± 31.9
0.337
Day of drain removal in patients without Grade B or C pancreatic fistula (days after surgery)
9.24 ± 3.09 (n = 65)
Table 4 Postoperative complications in conventional group and fast-track group Complication
Conventional group (n = 90)
Fast-track group (n = 100)
p value
Delayed gastric emptying
10.0 (9/81)
2.0 (2/98)
0.040
Surgical site infection (incisional)
28.9 (26/64)
14.0 (14/86)
0.019
Pancreatic fistula
27.8 (25/65)
9.0 (9/91)
0.001
Surgical site infection (organ/space)
5.6 (5/85)
5.0 (5/95)
0.878
Intra-abdominal hemorrhage
8.9 (8/82)
3.0 (3/97)
0.154
Bile leak
2.2 (2/88)
4.0 (4/96)
0.776
Cholangitis
11.1 (10/80)
4.0 (4/96)
0.111
Ileus
2.2 (2/88)
1.0 (1/99)
0.927
Lymphorrhea
1.1 (1/89)
2.0 (2/98)
0.927
Pneumonia
2.2 (2/88)
1.0 (1/99)
0.927
Heart failure
1.1 (1/89)
1.0 (1/99)
0.524
Number of patients with complications (%)
54 (60)
39 (39)
0.004
Mortality
1.1 (1/89)
0.0
0.957
Values are percentages presented as ‘yes/no’
day 9.24, on average, in the 65 patients who did not develop PF (Grade B or C) (Table 3). The mean starting day of oral intake in the conventional group and fast-track group was 8.3 (± 4.9) (median 7) and 2.9 days (± 1.9) (median 2) postoperatively, respectively (Table 3). When the preoperative serum albumin level was taken as 100 %, the serum albumin level on the 7th and 14th postoperative days was 84.1 ± 12.4 % and 85.5 ± 11.5 %, respectively, in the conventional group, and 84.5 ± 12.4 % and 88.9 ± 12.9 %, respectively, in
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Fast-track group (n = 100)
5 ± 0.0 (n = 91)
\0.001
Table 5 Length of postoperative hospital stay and percentage of rehospitalization in conventional group and fast-track group Conventional group (n = 90)
Fast-track group (n = 100)
p value
Length of postoperative hospital stay (days)
36.3 ± 23.8
21.9 ± 11.9
\0.001
Length of postoperative hospital stay in patients without complications (days) Rehospitalization rate within 90 days after discharge (%)
21.6 ± 5.4 (n = 36)
18.1 ± 4.9 (n = 61)
\0.001
2 (2/90)
2 (2/100)
0.689
the fast-track group. When the prealbumin level was compared in the same manner, that on the 7th and 14th postoperative days was 59.6 ± 23.6 % and 63.4 ± 22.6 %, respectively, in the conventional group, and 62.2 ± 22.3 % and 69.5 ± 31.9 %, respectively, in the fast-track group, with no significant difference in these parameters (Table 3). The incidence of postoperative DGE was 10.0 % in the conventional group and 2.0 % in the fast-track group (p = 0.04). The incidence of incisional SSI was 28.9 % in the conventional group and 14 % in the fast-track group (p = 0.019). The incidence of PF (grade B or C) was 27.8 % in the conventional group and 9.0 % in the fasttrack group (p = 0.0014). There were significant differences in the incidence of these postoperative complications (Table 4). Further, there was a significant difference in mean length of hospital stay between the conventional group (36.3 days) and fast-track group (21.9 days) (p \ 0.001). Even if subjects with postoperative complications were excluded from the analysis, the mean length of
World J Surg
postoperative hospital stay was 21.6 days in the conventional group and 18.1 days in the fast-track group, with a significant difference between the two groups (p \ 0.001). Within 90 days of discharge, two of the 90 patients in the conventional group were re-hospitalized (both because of cholangitis), while two of the 100 patients in the fast-track group were re-hospitalized (one because of PF, and the other because of cholangitis) (p = 0.689) (Table 5).
Discussion The basic concept of the fast-track protocol and ERASÒ protocol is to reduce mental and physical stress, and to prevent deterioration of organ function so that patients can return to daily life by expediting recovery after surgery. The ERASÒ protocol, originally prepared as a consensus review of clinical care for patients undergoing colonic surgery, is now applied to a variety of surgeries [14–16]. Meanwhile, since PD has a high incidence (about 40 %) of postoperative complications, even in high-volume medical centers, careful perioperative management is required [17–20]. Therefore, comprehensive medical care, such as fast-track management or ERASÒ, tends to be considered unsuitable for PD. However, the more invasive an operation, the more significance a protocol such as ERASÒ has in perioperative management of PD [21]. The ERASÒ guidelines for PD [22] were formulated in 2012, and the usefulness of the program for early recovery from surgery has attracted attention. The results of our present study indicated that 91 % of the patients could achieve early drain removal, and 88 % could restart oral intake from the early stage after surgery, suggesting that fast-track management can be safely introduced in PD. Preoperative counseling with various information eliminates patients’ preoperative anxiety, and enhances postoperative recovery, resulting in a shortened hospital stay [23, 24]. It was reported that there was no significant difference in the incidence of perioperative infection in colorectal surgery between patients with and without preoperative mechanical bowel preparation; but that the preparation significantly increased the incidence of anastomotic insufficiency [25]. In addition, mechanical bowel preparation was reported to cause dehydration and electrolyte imbalance due to diarrhea, and induce subsequent intestinal edema caused by intraoperative infusion [26]. Shortening of the perioperative fasting period may lead to improvement of insulin resistance and postoperative hyperglycemia, resulting in improvement of perioperative quality of life [27]. Oral intake could reportedly be allowed as late as 6 h prior to the induction of anesthesia [28, 29]. Regarding the direction of the skin incision, a longitudinal or arcuate incision has been reported to cause much
less postoperative pain and improved decreased postoperative lung function than a lateral incision [30]. Abdominal cavity drainage was reported not to improve the incidence and severity of postoperative complications (such as anastomotic leakage) in colorectal surgery [31]. It was also reported that there was no significant difference in the incidence of complications and operative mortality between pancreatectomy patients with and without abdominal cavity drainage [32]. However, in the case of pancreatectomy, in which PF can be a fatal complication, placement of an abdominal drain may be acceptable. The guidelines for the Prevention of SSI formulated by the Centers for Disease Control and Prevention recommend the employment of closed drainage tubes and to remove them as early as possible [33]. Further, it has been often reported that early removal of a drain in pancreatectomy reduces the incidence of postoperative infectious complications [17, 18]. Thus, a drainage tube should be removed at an early stage in cases where the amylase level in drainage fluid on postoperative day 1 is not very high [34]. In our hospital, before the initiation of fast-track management, drains were, on average, usually removed on the 9th postoperative day. Surgeons were disinclined to drastically reduce the number of days to less than half. Therefore, we decided that drains should be removed on the 5th postoperative day in fast-track management in this study. Kawai et al. [17] and Bassi et al. [18] reported that drain removal on the 3rd or 4th postoperative day significantly reduced postoperative complications. We should consider reducing the duration of drainage further in our hospital. It has been reported that early postoperative oral intake does not worsen anastomotic leakage in colorectal surgery [35]. Early postoperative oral intake has been avoided in patients undergoing PD with the concern that PD is associated with a high incidence of postoperative DGE [36, 37] and that early oral intake might stimulate pancreatic exocrine secretion, resulting in an increased incidence of PF. However, recently, Balzano et al. [38] reported that early postoperative oral intake decreased the incidence of DGE and the length of hospital stay without increasing the incidence of PF. In the present study, oral intake was allowed from the 1st postoperative day on the condition that vital signs were stable and abdominal X-ray revealed a normal pattern of bowel gas. Since oral intake was delayed in some patients owing to the occurrence of a complication, such as DGE, ileus, pneumonia, or heart failure, oral intake was started a mean of 2.9 days after surgery. However, in many patients, it was feasible to start oral intake on the 1st postoperative day. The nutritional supplement used in our hospital for preoperative nutritional care (Racol) contains omega-3 fatty acids and medium-chain triglycerides [39, 40]. These
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specific nutrients have been reported to enhance the body’s natural defenses. In many randomized controlled trials, postoperative infectious complications were shown to be decreased by nutrients [41]. The elemental diet (Elental) used for early postoperative oral feeding in our hospital is characterized by a low-fat composition with a combination of four major nutrients (amino acids, carbohydrates, vitamins, and minerals) and is considered to contribute to improvement of nutritional status without stimulating pancreatic exocrine secretion [42, 43]. The present study clearly indicated that the incidence of DGE, SSI, and PF in the fast-track group was significantly reduced as compared with that in the conventional group. In the present study, there were differences in the proportion of patients undergoing different operative procedures [PD, pylorus-preserving PD (PPPD), and SSPD]. Whether PD was pylorus-preserving or not could cause a bias in the incidence of DGE. Loss of vagal control may cause a decrease in function of the pyloric ring, thereby leading to the development of DGE [44]. From this perspective, the proportion of patients undergoing PPPD and non-PPPD (PD?SSPD) was found to be 76:14 in the conventional group and 85:15 in the fast-track group, with no significant difference (p = 0.915). This finding indicates that there was no correlation between the preservation of the pyloric ring and the occurrence of DGE. Regarding PF, there was no significant difference between the two groups in terms of presence/absence of diabetes mellitus (which could be related to the development of PF), BMI, diameter of the pancreatic duct, duration of operation, and blood loss. A stent is commonly placed in a pancreato-enteroanastomosis in Japan. Also in our hospital, external or internal pancreatic duct stenting has been performed in principle. Although no significant difference in the incidence of PF was found between internal and external drainage [45], it has been reported that the incidence of PF is significantly higher in patients without a stent than in those with external drainage [46]. With respect to the difference between internal and external drainage, we consider that PF, once it occurs, is unlikely to develop into a serious condition (e.g., intra-abdominal hemorrhage) in the presence of external drainage because pancreatic juice can be deliberately drained via this route. As for stenting of the pancreatic duct, the proportion of patients with ‘no stent’, which may lead to a risk of PF development, was higher in the fast-track group. However, the incidence of PF was significantly lower in the fast-track group, showing that the perioperative management might have been effective. Among the patients who did not experience postoperative complications, the length of hospital stay was significantly shorter in the fast-track group than in the
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conventional group. However, the length of hospital stay was 18 days even in the fast-track group, which was not a short period. Since our hospital plays a central role in this region, most of our patients are referred from clinics without beds. Therefore, most of them are discharged from hospital directly to home. In recent years, many elderly patients live alone or as a couple only at home, and thus wish to be hospitalized for 2 weeks or more even if they do not have any complications. It is not our policy to discharge patients from hospital if they wish to prolong their hospitalization. Since the rehospitalization rate within 90 days after discharge was as low as 2 % during the present study, we consider the hospital stay to be satisfactory if the mean length was within 3 weeks after surgery. It is possible that improvement of surgical skill might have favorably influenced the incidence of postoperative complications, because this was a historical control study. However, the reduction of incidence of SSI may not solely be attributable to improvement of surgical skill. In order to confirm the postoperative nutritional status, albumin and prealbumin levels were compared, and the results indicated no significant difference between the two groups. We consider the purpose and significance of early restarting of oral intake after surgery to be that patients’ immune systems are not compromised while leading an ‘abnormal daily life’, and not that patients’ nutritional status is promptly improved. Among the patients who did not experience postoperative complications, the length of hospital stay was significantly shorter in the fast-track group than in the conventional group. One care pathway alone may not produce a major improvement in the outcome of perioperative management of patients undergoing a highly invasive operative procedure such as PD. However, a multimodal approach is considered likely to reduce postoperative complications. Furthermore, the findings of the present study suggested that the relevant pathways were also associated with reduced length of hospital stay. Nevertheless, multicenter, randomized clinical trials may be further needed to demonstrate the true significance of fast-track management. Grant Support
None.
Conflict of interest of interest.
The authors declare that they have no conflicts
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