A 6-day clinical pathway after a pancreaticoduodenectomy is feasible, safe and efficient

Abstract

Background: The utilization of post-operative clinical pathways leads to shorter hospital stays and decreased healthcare costs. This study evaluated patient outcomes after implementation of a 6-day discharge pathway after a pancreaticoduodenectomy.

Methods: A post-operative clinical pathway was developed and implemented for patients undergoing a pancreaticoduodenectomy at the present institution aimed at discharge by post-operative day six. Patient charts were retrospectively reviewed to determine the rates of adherence to the pathway at each step, readmission and post-operative complications.

Results: In total, 113 consecutive patients underwent a pancreaticoduodenectomy, receiving post-operative care under the clinical pathway guidelines. The median length of stay was 7 days (mode 6 days); 41% of patients were discharged by post-operative day six, 62% by day seven and 79% by day eight. In univariate analysis, delayed gastric emptying was associated with a delayed discharge after post-operative day six (P = 0.002). There were no post-operative deaths and 16% of patients required readmission within 30 days of discharge. In univariate analysis, obesity was the only variable associated with an increased rate of readmission (P < 0.001).

Discussion: Clinical pathway utilization after a pancreaticoduodenectomy allows a high percentage of patients to be discharged within a week and is associated with a low rate of readmission. Clinical pathway implementation allows for safe and efficient patient care.

Introduction

A systemized approach to medicine, with the use of checklists, protocols and algorithms, provides a standardized basis for care, with improved efficiency and a reduction in errors.¹ Such an approach has been utilized in various surgical fields to improve the efficiency of post-operative recovery. So-called ‘fast-track’ recovery has been shown to decrease hospital length of stay without increasing complications after various surgical procedures.^2–4

A pancreaticoduodenectomy, since its inception and refinement by Whipple and colleagues in 1935, has historically been associated with high peri-operative morbidity and mortality. Even by the 1960s and 1970s, hospital mortality was roughly 25%.⁵ Surgical specialization and the emergence of high volume tertiary care centres paved the way for a great reduction in the peri-operative risk of a pancreaticoduodenectomy. In the most recent decade, peri-operative mortality at many tertiary care centres has decreased to 1–2%.⁶ Morbidity has followed a similar trend, but still remains high after a pancreaticoduodenectomy. Grobmyer et al. compiled outcomes data from 11 series totalling 2630 patients; in the 1990s, morbidity ranged from 27–47% and hospital length of stay ranged from 12–15 days.⁷

The application of a ‘fast-track’ recovery after pancreatic surgery has been shown to further decrease the hospital length of stay without jeopardizing morbidity or mortality. Montiel Casado et al. demonstrated that instituting a post-operative pathway reduced the hospital length of stay at their centre to a median total stay of 11 days.⁸ Similarly, Berberat et al. reported a reduced hospital length of stay from 14–16 days to a median of 10 days after implementing three main fast-track parameters: early return to a normal ward, early return of gastrointestinal function and early ambulation. Surgical morbidity and mortality was unchanged.⁹ Balzano et al. demonstrated a reduced incidence of delayed gastric emptying after implementing a ‘fast-track’ programme. Morbidity and mortality did not increase, and hospital length of stay decreased from a median 15 to 13 days.¹⁰

At the present institution, a post-operative clinical pathway for patients undergoing a pancreaticoduodenectomy aimed at discharge by post-operative day six, with well-defined daily parameters and goals was developed. The purpose of this study was to determine adherence to the clinical pathway and determine whether an aggressive early discharge pathway was associated with acceptable readmission and post-operative complication rates.

Methods

Patients, pathway description, and definitions

This study was conducted with approval from the Institutional Review Board at the University of Virginia, including a waiver for the need to obtain consent. Patient data from a prospectively collected database of all patients who underwent a pancreaticoduodenectomy between September 2005 and September 2011 by a single surgeon (T.W.B.) were retrospectively reviewed. Demographic, operative and postoperative data were collected for each patient, including dietary, discharge and readmission data.

All patients underwent a standard pancreaticoduodenectomy. No pylorus-preserving pancreaticoduodenectomies were performed. Patients with borderline resectable disease as defined by the MD Anderson criteria¹¹ underwent neoadjuvant chemoradiation and all patients were nutritionally optimized pre-operatively. Patients routinely underwent epidural catheter placement pre-operatively to assist with post-operative analgesia. Nasogastric tubes were placed intra-operatively in all patients and constant suction continued in the post-operative period. No drains were left at the time of surgery and no feeding jejunostomy or gastrostomy tubes were placed. In the post-operative period, each patient was placed on a clinical pathway (Fig. 1) aimed at discharge by post-operative day six. Discharge requirements included tolerance of a solid diet, pain control with oral analgesia, a return to pre-operative ambulatory status, attending physician approval and patient comfort with discharge. Prokinetic agents were used selectively for patients with symptoms of delayed gastric emptying and patients who were taking those medications pre-operatively. Pancreatic enzymes were given in selective cases when post-operative malabsorption occurred. Patients were routinely monitored after discharge, including a follow-up visit 3–4 weeks post-operatively and subsequent follow-up visits as indicated.

Figure 1.

Details of the clinical pathway

In this study, the day of surgery was referred to as post-operative day (POD) no. 0, with subsequent days listed as POD no. 1, no. 2, etc. The International Study Group definitions for delayed gastric emptying¹² and post-operative pancreatic fistula¹³ were used.

Outcomes measures and statistical methods

Primary outcomes were length of hospital stay and rate of readmission within 30 days. Secondary outcomes included adherence to each step of the pathway and post-operative complications, which were graded using the Clavien–Dindo grading system.¹⁴ Additionally, a univariate analysis was performed to assess the relationship between pre-/intra-operative variables and primary outcomes.

All group comparisons in this study were unpaired. Categorical variables were compared using either Fischer's exact or Pearson's chi-square tests where appropriate. All categorical variables were expressed as a percentage of the group of origin, and continuous variables were expressed by means ± standard error (SE). All P-values reported were two-tailed, and statistical significance was indicated by P-values of < 0.05. GraphPad Prism (version 5) software (La Jolla, CA, USA) was used for statistical analyses.

Results

During the study period, 113 consecutive patients underwent a pancreaticoduodenectomy. All patients underwent a standard pancreaticoduodenectomy with a 9-cm gastrojejunostomy by a single surgeon (T.W.B.). The demographic data are shown in Table 1, including comorbid conditions. Two-thirds of patients underwent surgery for malignant disease, 38% for pancreatic adenocarcinoma. One-third of the patients had benign disease at surgery, the majority of whom had cystic neoplasms (n = 18), pancreatitis (n = 11) and ampullary adenomas (n = 6). Eleven patients had borderline resectable disease at the time of diagnosis and underwent neoadjuvant chemoradiation as per protocol with subsequent restaging and resection. The mean operative blood loss was 267 cc and only three patients (2.7%) required a transfusion.

Table 1.

Patient demographics and operative characteristics

Total number of patients, n	113
Gender (%)
Male	54
Female	46
Age (years ± SE)	63.5 ± 1.1
Body mass index (mean ± SE)	26.7 ± 0.5
Comorbidities (%)
Obesity (BMI ≥ 30)	24
Diabetes mellitus	32
Gastroesophageal reflux disease	27
Smoker	52
Pre-operative radiation (%)	10
ASA score (mean ± SE)	2.5 ± 0.05
Type of pancreaticoduodenectomy (%)
Standard	100
Pylorus-preserving	0
Indication (%)
Pancreatic adenocarcinoma	38
Other carcinoma (ampullary, etc.)	29
Benign disease	33
Operative blood loss (ml ± SE)	267 ± 19
Transfusion (%)	2.7

BMI, body mass index; ASA, American Society of Anesthesiologists.

A primary outcome of this study was adherence to the goal of discharge by POD no. 6. In all, 40.7% of patients were discharged by POD no. 6 over the course of the study period. This goal was increasingly met throughout the study period with 37.9%, 35.7%, 42.9% and 46.4% discharged by POD no. 6 by sequential quartiles (data not shown). 61.9% and 78.7% of patients were discharged by POD no. 7 and POD no. 8, respectively. Table 2 shows adherence to the major dietary and discharge parameters of the pathway and Fig. 2 graphically depicts the post-operative days of discharge for every patient in the study. As shown, the NGT was removed by POD no. 3 in 93.0% of patients; 83.2% of patients tolerated a clear diet by POD no. 4 and 63.7% of patients tolerated a solid diet by POD no. 5.

Table 2.

Pathway parameters

NGT
Day of NGT removal (POD ± SE)	3.0 ± 0.1
NGT Removal by POD no. 3 (%)	93.0
Required reinsertion of NGT (%)	6.2
Dietary parameters
POD tolerating clear diet (POD ± SE)	4.9 ± 0.5
Tolerating clear diet by POD no. 4 (%)	83.2
POD tolerating solid diet (POD ± SE)	6.5 ± 0.5
Tolerating solid diet by POD no. 5 (%)	63.7
Discharge day (%)
POD no. 5	5.3
POD no. 6	35.4
POD no. 7	21.2
POD no. 8	16.8
POD no. 9–10	6.2
POD no. 10–14	9.7
After POD no. 14	5.3

NGT, nasogastric tube; POD, post-operative day.

Figure 2.

A graph of all patients who underwent a pancreaticoduodenectomy during the study period and the post-operative day of discharge

Overall 30-day follow-up was excellent for this study (98.2%). There were no deaths within 30 days of surgery. Overall morbidity was 48.7% (55/113 patients). Most of these complications were Clavien grade I/II (38 patients), the majority of which were wound infections and delayed gastric emptying. Fifteen patients experienced Clavien grade III complications, consisting mainly of pancreatic fistulae, abdominal fluid collections and wound infections requiring radiographic or operative intervention. There were two Clavien grade IV complications, including a patient who developed post-operative pneumonia and another who developed post-operative pancreatitis. The most common complication was delayed gastric emptying, which occurred in 17.7% of patients, the vast majority of which were classified as grade A using the ISGPS definition. 15.9% of patients required readmission to the hospital within 30 days and the reasons for readmission are detailed in Table 3. Only one patient required readmission for dehydration and no patients required readmission for failure to thrive or delayed gastric emptying. The vast majority of readmissions were because of wound-related or other infectious complications. Patients discharged by POD no. 6 were less likely to require readmission than those patients discharged on POD no. 7 or later, but this was not statistically significant.

Table 3.

Post-operative and readmission outcomes

30-day follow-up	98.2
30-day mortality (%)	0.0
Total post-operative morbidity (%)	48.7
Clavian grade I/II	33.6
Clavian grade III	13.3
Clavian grade IV/V	1.8
Delayed gastric emptying (%)
Total	17.7
Grade A	15.9
Grade B	0
Grade C	1.8
30-day readmission rate (%)
Total	15.9	P = 0.49
Patients discharged by POD no. 6	13.0
Patients discharged on or after POD no. 7	17.9
Reasons for readmission, n
Wound-related complications	5
Pancreatic fistula	3
Intra-abdominal abscess	3
Other infectious complications	3
Biliary leak	2
Gastrojejunostomy leak	1
Dehydration	1
Failure to thrive/delayed gastric emptying	0

Terms in bold are taken from the Clavien—Dindo Classification of Surgical Complications.¹⁴

POD, post-operative day.

We next performed univariate analyses to determine which variables were associated with delayed discharge or readmission (Table 4). For patients less than 65 years of age, there was a trend towards discharge by POD no. 6 compared with patients 65 years or older, but this did not reach statistical significance. Patients who experienced delayed gastric emptying were significantly more likely to be discharged after POD no. 6 than those patients without delayed gastric emptying (P = 0.002). Delayed gastric emptying had no significant impact on the readmission rate. In our univariate analysis, the only factor significantly associated with increased readmission was obesity (P < 0.001). There was a trend towards increased readmission for patients with benign disease; however, this did not reach statistical significance (P = 0.09).

Table 4.

Univariate analyses of factors associated with discharge and readmission

	n (%)	P-value
Factors associated with discharge by day 6
Age < 65 years	62 (48.4)	0.07
Age ≥ 65 years	51 (31.4)
Pre-operative radiation	11 (27.3)	0.34
No pre-operative radiation	102 (42.2)
Diabetes mellitus	36 (38.9)	0.79
No diabetes mellitus	77 (41.6)
Smoker	59 (40.7)	0.99
Non-smoker	54 (40.7)
Gastroesophageal reflux disease	30 (30)	0.16
No gastroesophageal reflux disease	83 (44.6)
Obesity	27 (33.3)	0.37
Non-obese	86 (43.0)
EBL < 250 cc	58 (37.9)	0.54
EBL ≥ 250 cc	55 (43.6)
Diagnosis of cancer	76 (40.8)	0.98
Benign disease	37 (40.5)
Delayed gastric emptying	20 (10)	0.002
No delayed gastric emptying	93 (47.3)
Factors associated with readmission
Age < 65 years	62 (16.1)	0.95
Age ≥ 65 years	51 (15.7)
Pre-operative radiation	11 (9.1)	0.51
No pre-operative radiation	102 (16.7)
Diabetes mellitus	36 (11.1)	0.34
No diabetes mellitus	77 (18.2)
Smoker	59 (16.9)	0.76
Non-smoker	54 (14.8)
Gastroesophageal reflux disease	30 (23.3)	0.20
No gastroesophageal reflux disease	83 (13.3)
Obesity	27 (37.0)	<0.001
Non-obese	86 (9.3)
EBL < 250 cc	58 (19.0)	0.37
EBL ≥ 250 cc	55 (12.7)
Diagnosis of cancer	96 (11.8)	0.09
Benign disease	37 (24.3)
Delayed gastric emptying	20 (15)	0.90
No delayed gastric emptying	93 (16.1)

EBL, estimated blood loss.

Discussion

Clinical pathways have been shown to reduce the length of hospital stay and decrease healthcare costs in a number of complicated surgical procedures, including pancreatic surgery.^3,4,15 A clinical pathway has been implemented for patients undergoing a pancreaticoduodenectomy aimed at discharge by POD no. 6. Using this pathway, we successfully discharged 41% of patients by POD no. 6, 62% by POD no. 7, and 79% by POD no. 8. The median length of stay in our study was 7 days and the mode was 6 days. While these data do not demonstrate strict adherence to the goal of discharge by POD no. 6 in all patients, our median length of stay of 7 days compares favourably to other published series. Berberat et al. demonstrated a median length of stay of 10 days after implementation of a ‘fast-track’ pathway for patients undergoing all types of pancreatic surgery.⁹ Balzano et al. reported a decreased median length of stay from 15 to 13 days for patients undergoing a pancreaticoduodenectomy after utilization of a ‘fast-track’ pathway.¹⁰ Kennedy et al. investigated the effects of a similar pathway to this one, aimed at discharge by POD no. 6 or 7, and reported a decreased length of stay from 13 to 7 days, as well as a nearly 50% reduction in healthcare costs.¹⁵ In our univariate analyses, delayed gastric emptying was associated with failure to discharge by POD no. 6. There were trends towards failure of discharge by POD no. 6 for elderly patients (≥65 years) and patients with a diagnosis of gastroesophageal reflux disease, but neither reached statistical significance.

Our pathway essentially consists of a checklist, with specific goals for each post-operative day. As expected, with each step of the pathway, there is a slight decrease in adherence; however, overall a high percentage of patients are able to remain fully on the pathway for the duration of the post-operative period. For patients who successfully remained on the pathway and were discharged by POD no. 6, the rate of readmission to the hospital was 13%, compared with 18% for those discharged on or after POD no. 7. While this did not meet statistical significance, it does indicate that early discharge is not associated with an increased rate of readmission and implies that successful discharge by POD no. 6 is likely not owing to discharging patients before they are ready to leave the hospital.

When establishing a pathway that advocates for early discharge, there are two critical issues. First, the pathway must be safe. Our series demonstrated a 0% 30-day mortality rate and a low rate of major complications such as an anastomotic leak. Second, the pathway should be associated with a low rate of readmissions. The overall rate of readmissions within 30 days in our series was 16% and was 13% for patients discharged by POD no. 6. This rate compares favourably to other published series showing overall readmission rates of 21–59%^16–19 and the series by Grewal et al. reporting a 30-day readmission rate of 15% after a pancreaticoduodenectomy.²⁰ Data on 90-day readmission rates were not collected, but Kent et al. demonstrated a low (2%) rate of readmissions between 31 and 90 days after major pancreatic surgery¹⁹ and we believe that the majority of readmissions related to premature discharge will generally present for readmission within 30 days of discharge. In the present series, the majority of the 18 readmissions were because of infectious complications, predominantly wound-related (n = 5) or intraabdominal abscess (n = 3) and anastomotic leaks (3 pancreatic, 2 biliary and 1 gastrojejunostomy). Only one patient was readmitted for dehydration and no other patients were readmitted for failure to thrive or delayed gastric emptying. The only variable associated with increased rates of readmission by univariate analysis in our series was obesity.

An unintended positive consequence of the clinical pathway that we have observed is that it allows for team building, integrating multiple healthcare providers, including physicians, nurses, dieticians, therapists and social workers, all working to achieve a common goal. While we do not have an objective method for evaluating this, establishment of a clinical pathway has assigned each member of the team important and defined roles in the care of each patient and we believe this increases team morale and consequently better patient care.

In order for an aggressive discharge pathway to be successful, several factors are absolutely critical. There must be an effort to educate each patient on what to expect during the post-operative period, including a thorough explanation of the steps of the pathway. Understanding the pathway establishes daily goals for the patient and likely contributes to patient satisfaction and successful pathway implementation. At the present institution, patient education begins in the clinic pre-operatively and continues in the pre-operative area on the day of surgery and into the post-operative period. Educating the clinical team is also critical, particularly in an academic setting, where the composition of the healthcare team is constantly in flux. We find that this is best done through face-to-face orientation as well as written guidelines each time a new member joins the team. Finally, and most importantly, in order for a clinical pathway to be successful, the operation must be technically sound and associated with a relatively low rate of complications. Other studies have shown that lower blood loss, blood transfusion and infectious complications contribute to lower rates of readmission.^16,20 In this study, operative blood loss was very low and only 2.7% of patients required a blood product transfusion. The overall complication rate was low, including the incidence of delayed gastric emptying (18%), compared with other studies using the ISGPS definition for delayed gastric emptying, with rates of 33–59%.^21–23

In summary, clinical pathway utilization after a pancreaticoduodenectomy allows a high percentage of patients to be discharged within a week of surgery, is associated with safe and efficient patient care and low rates of readmission. In order to successfully implement such a pathway, education of the patient and the healthcare team is critical, as well as meticulous surgery with low operative blood loss and low rates of post-operative complications, including delayed gastric emptying and anastomotic leak.

Conflicts of interest

None declared.