Sage Journals: Discover world-class research

Abstract

Background and Aims:

Although some studies have reported the safety of early oral intake after gastrectomy, it still remains controversial. This study focused on the feasibility of a clinical pathway with early oral intake and discharge setting for exclusively laparoscopic distal gastrectomy.

Materials and Methods:

A clinical pathway was applied to 403 patients until December 2014. In the protocol, patients are allowed to take a sip of water and a soft diet on the first and second days after the operation, respectively, and the discharge day is set as the fifth to seventh day after the operation. Clinicopathological variables were prospectively collected, and risk factors for discharge variances were analyzed.

Results:

The completion rate of the clinical pathway was 76.9%. There were five re-admissions (1.2%). The overall morbidity rate was 18% (n = 72), and major complications (Clavien-Dindo IIIa or greater) occurred in 13 patients (3%). Complications were the causes for discharge variances in 68 cases (73%), while the attending surgeons’ judgment was the cause in 25 cases (27%). On multivariate analysis, age (odds ratio = 2.23, 95% confidence interval = 1.38–3.60, p = 0.001) and operative time (odds ratio = 2.38, 95% confidence interval = 1.45–3.98, p = 0.001) were independent risk factors for discharge variances.

Conclusion:

A high completion rate of a clinical pathway with early oral intake and discharge setting for laparoscopic distal gastrectomy was achievable with an acceptably low re-admission rate. Laparoscopic distal gastrectomy is recommended as a first step for a clinical pathway with an early oral intake and discharge protocol.

Keywords

Clinical pathway laparoscopic distal gastrectomy early oral intake early discharge stomach cancer

Introduction

A clinical pathway (CP) is a set of optimal sequencing and timing of interventions by physicians, nurses, and other staff for a particular diagnosis or procedure (1, 2). It is applied to various surgical fields, such as colorectal (2), urological (3), and cardiovascular (4, 5) surgery, and it decreases costs and hospital stays.

Unlike the fields mentioned above, in the gastric field, CPs have not been very frequently applied and reported. The complexity of the procedure and the subsequent hemodynamic changes, as well as the high morbidity rate, are the reasons, and some studies have reported a low CP completion rate in the gastric field (6, 7).

Recently, minimally invasive surgery (MIS), such as laparoscopic surgery and robotic surgery, has been frequently applied for gastric surgery, which results in less postoperative pain, faster recovery, less morbidity, and shorter hospital stays (8 –11). Some studies reported open procedure and total gastrectomy as risk factors for variances in CPs (6, 12 –14). Therefore, laparoscopic distal gastrectomy may be a good candidate for a CP with a high completion rate, but most of the previous articles regarding CPs in gastric surgery included patients with different approaches (open and MIS) and operation types (total and distal gastrectomy) (6, 7, 12, 13).

Although early enteral feeding has recently been encouraged, and some studies already reported its safety, its feasibility and safety still remain controversial (15 –17). The appropriate discharge timing is also an important issue. Early oral intake may lead to early discharge, but it may overlook the latent complications that can be the causes for subsequent re-admission after early discharge.

Thus, in this study, the focus was on the feasibility of a CP with early oral intake and an early discharge protocol for exclusively laparoscopic distal gastrectomy.

Materials and Methods

Patients and Data Collection

From January 2005 to December 2014, 416 patients underwent laparoscopic distal gastrectomy with lymphadenectomy for gastric cancer in the Department of Gastric Surgery of Tokyo Medical and Dental University Hospital. In all, 13 patients with combined colon resection were excluded from the study, and 403 patients were enrolled in this study.

The following information was collected for each patient: age, sex, body mass index, American Society of Anesthesiologists Classification (ASA), clinical stage, extent of lymphadenectomy, operative time, intraoperative estimated blood loss, initial day of water or soft diet intake, postoperative hospital stay, complications, and re-admission rate. T and N stages were classified according to the 7th edition of the Union for International Cancer Control classification system (18). Complications were assessed according to the Clavien-Dindo classification (19). Re-admission was defined as re-hospitalization due to causes related to gastrectomy within 30 days after discharge. This study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Tokyo Medical and Dental University (M2016-251).

CP

Laparoscopic gastrectomy was introduced and launched in our institute in 1999. The CP for laparoscopic distal gastrectomy was implemented in our institute in 2001. After some modifications, the current CP was finally established in 2005, and it has been used continuously without further modification since then (Fig. 1). On postoperative day (POD) 1, the patient is allowed to have a sip of water and is encouraged to ambulate. On POD 2, a step 1 soft diet (750 kcal and 1130 mL of water) is given to the patient. Epidural and urethral catheters are removed. On POD 3, step 2 soft diet (900 kcal and 1160 mL of water) is started, and the abdominal drain is removed after evaluating the color and appearance of the fluid in the drain. Infusion of lactated Ringer’s solution is also stopped. After POD 5, discharge is recommended if there are no specific complications or complaints. Blood tests and X-rays are performed on PODs 1 and 3. Amylase concentration in the drain is examined on POD 3. Dietary education by a nutritionist is given to patients and their family before discharge. There are no exclusion criteria for the CP. Completion of CP is defined as discharge by POD 7. If a patient was assessed to be eligible for discharge within 7 days, but was not discharged for social reasons, the patient was also regarded as having completed the CP in this study.

Fig. 1.

Clinical pathway for laparoscopic distal gastrectomy.

Operative Procedure

Inclusion criteria for laparoscopic distal gastrectomy in our institute are clinical T1-3 and N0-1. The laparoscopic distal gastrectomy was performed as described previously (20, 21). In short, the 5-trocar technique was used. Lymph node dissection was started along the greater curvature of the stomach. After resection of the duodenum, lymph node dissection along the lesser curvature and the suprapancreatic area was performed, followed by resection of the proximal margin of the stomach. Roux-en-Y reconstruction in an isoperistaltic, antecolic manner was performed in all cases. In the early period, a small midline upper abdominal incision 4–5 cm in length was made for reconstruction and removal of the stomach, but after a totally laparoscopic procedure (intracorporeal anastomosis) was adopted, no upper abdominal incision was made, and the stomach was removed via the umbilical incision. A drain was placed through the foramen of Winslow at the end of the operation. A nasogastric tube was inserted at the beginning of the operation and removed before gastric resection by an anesthesiologist.

Statistical methods

Continuous values are shown as means, standard deviations, and ranges. Data were analyzed using independent t-tests when they showed a normal distribution and the Mann–Whitney test when they did not. To identify the risk factors for discharge variances, univariate analyses were performed using logistic regression analyis. Mulitvariate analyses were performed using multiple logistic regression models with the forward likelihood ratio method.

A p value less than 0.05 was regarded as significant for all analyses. Statistical analyses were performed using SPSS version 19.0 software (IBM SPSS, Chicago, IL, USA).

Results

Baseline Characteristics of the Enrolled Population

The baseline characteristics of all (n = 403) patients are shown in Table 1. The mean age was 66 years (range, 29–92 years). A total of 277 patients (69%) were male and 126 patients (31%) were female. Most cases (377 cases; 94%) were diagnosed as clinical stage I. D2 lymph node dissection was performed in 81 patients (20%). No mortality was encountered. The overall morbidity rate was 18% (n = 72), and major complications (Clavien-Dindo IIIa or greater) were seen in 3% (n = 13). There were 262 patients (65%) who were discharged within 7 days, while 141 patients (35%) were discharged after POD 7. Among them, 48 patients (11.9%) were not discharged within 7 days for social reasons (without any complications or complaints). Altogether, CP completion was achieved in 310 patients (76.9%) (Fig. 2). Five patients (1.2%) were re-admitted after discharge, although all of them were discharged by POD 7 following the initial admission. Reasons for re-admissions were as follows: three patients with anastomotic stenosis (one patient needed endoscopic balloon dilatation, and the others recovered with conservative treatment); one with a pancreatic pseudocyst (conservative treatment); and one with duodenal stump leakage (re-operation was performed, and discharged 44 days after second operation).

Table 1

Baseline characteristics and perioperative results of all patients.

Variable
Age (mean ± SD, range) (years)	66 ± 12 (29–92)
Sex	Male	277 (69)
Sex	Female	126 (31)
BMI (mean ± SD, range) (kg/m²)	22.5 ± 3.1 (15.4–34.3)
ASA	1	150 (37)
	2	235 (58)
	3	18 (4)
Clinical stage	I	377 (94)
	II	22 (5)
	III	4 (1)
Extent of lymphadenectomy	D1	9 (2)
	D1+	313 (77)
	D2	81 (20)
Operative time (mean ± SD, range) (min)	303 ± 59.5 (161–515)
Intraoperative EBL (mean ± SD, range) (mL)	66 ± 94.6 (0–620)
Initial day of water intake (mean ± SD, range) (days)	1 ± 1.5 (1–24)
Initial day of soft diet (mean ± SD, range) (days)	2 ± 1.7 (2–32)
Postoperative hospital stay (days) (mean ± SD, range)	7 ± 7.9 (4–116)
Mortality	0 (0)
Morbidity^a	Total	72 (18)
Morbidity^a	Major (>IIIa)	13 (3)
Re-admission	5 (1)

SD: standard deviation, BMI: body mass index, ASA: American Society of Anesthesiologists Classification; EBL: estimated blood loss.

Numbers in parentheses in categorical values are percentages.

Complications for five patients who were re-admitted are not included.

Fig. 2.

Flowchart of completion of the clinical pathway.

Causes of Discharge Variances

Causes of discharge variances are summarized in Table 2. Complications were the causes of discharge variances in 68 cases (73%) (intra-abdominal 60, systemic 8), while the attending surgeons’ judgment was the cause in 25 cases (27%). The most frequent causes among the complications were abdominal discomfort and pancreatic fistula. Among the 68 cases with complications, the severity of complications was: Grade I, 37 cases (54%); Grade II, 18 cases (26%); Grade IIIa, 6 cases (9%); and Grade IIIb, 7 cases (10%).

Table 2

Causes of discharge variances and their severity.

Reason	Number (%)	Clavien-Dindo Classification Grade
Reason	Number (%)	I	II	IIIa	IIIb
Abdominal discomfort	15	15	0	0	0
Pancreatic fistula	15	6	8	0	1
Ileus	7	5	1	0	1
Anastomotic stenosis	7	4	0	2	1
Ascites	5	5	0	0	0
Aspiration pneumonia	3	0	3	0	0
Anastomotic leakage	2	0	1	0	1
Intra-abdominal bleeding	2	0	1	0	1
Intraluminal bleeding	2	0	1	1	0
Intra-abdominal abscess	2	0	0	2	0
Lymphorrhea	1	0	1	0	0
Atelectasis	1	0	1	0	0
Atrial fibrillation	1	0	1	0	0
Internal hernia	1	0	0	0	1
Port-site hernia	1	0	0	0	1
Wound infection	1	1	0	0	0
Deep venous thrombosis	1	0	0	1	0
Urinary retention	1	1	0	0	0
Complication total	68	37	18	6	7
AS’ judgment	25	–	–	–	–
Total	93

AS: attending surgeon.

Categorical values in parentheses are percentages.

Only one factor that affected the hospital stay most for each patient was counted.

Univariate and Multivariate Analyses for Risk Factors

The results of univariate and multivariate Cox analyses are shown in Table 3. Univariate Cox analyses showed that sex (p = 0.022), age (p = 0.001), ASA (p = 0.031), and operative time (p = 0.001) were significant risk factors for discharge variances. These significant values were included in subsequent multivariate analyses that showed that age (odds ratio (OR) = 2.23, 95% confidence interval (CI) = 1.38–3.60, p = 0.001) and operative time (OR = 2.38, 95% CI = 1.45–3.98, p = 0.001) were the independent risk factors for discharge variances.

Table 3

Univariate and multivariate analyses of risk factors for discharge variance.

Variable		n (%)	Univariate		Multivariate
Variable		n (%)	OR (95% CI)	p value	OR (95% CI)	p value
Sex	Male	277 (69)	1	0.022
Sex	Female	126 (31)	0.53 (0.31–0.91)
Age (years)	<70	254 (63)	1	0.001	1	0.001
Age (years)	≥70	149 (37)	2.21 (1.38–3.54)		2.23 (1.38–3.60)
BMI (kg/m²)	<25	101 (27)	1	0.315
BMI (kg/m²)	≥25	302 (68)	1.31 (0.78–2.19)
ASA	1	150 (37)	1	0.031
	2	235 (58)	1.92 (1.14–3.25)	0.014
	3	18 (4)	2.63 (0.90–7.67)	0.078
cStage	I	377 (94)	1	0.138
	II	22 (5)	2.45 (1.01–5.94)	0.047
	III	4 (1)	1.18 (0.12–11.5)	0.886
ELD	D1, D1+	322 (80)	1	0.119
ELD	D2	81 (20)	1.54 (0.89–2.67)
OT (min)	<300	194 (48)	1	0.001	1	0.001
OT (min)	≥300	209 (52)	2.36 (1.45–3.85)		2.38 (1.45–3.98)
IEBL (mL)	<100	258 (64)	1	0.122
IEBL (mL)	≥100	145 (36)	1.45 (0.91–2.33)

Bold values are statistically significant. OR: odds ratio; CI: confidence interval; BMI: body mass index; ASA: American Society of Anesthesiologists classification; ELD: extent of lymph node dissection; OT: operative time; IEBL: intraoperative estimated blood loss.

Discussion

In this study, the CP completion rate was 76.9%, with a re-admission rate of 1.2%. This completion rate is quite satisfactory with an acceptably low re-admission rate compared to the results reported in previous articles (6, 7, 12, 13).

Table 4 summarizes the previous articles regarding CPs for gastrectomy for gastric cancer, all of which were published from Korean institutes. The risk factors for discharge variances in those studies (not shown in the table) included male sex, older age, open approach, total gastrectomy, combined resection, intraoperative event, comorbidities, and high ASA. In this study, older age and longer operation time were the risk factors for discharge variances. These two factors are relatively common risk factors for complications, which may explain their identification in this study (22 –27). Operation time is also a kind of indicator of difficulty and quality of operation and may affect clinical course of patients, even though no complication is identified. In this study, in fact, 29/93 (31%) patients of discharge variances did not experience any complication in the clinical course.

Table 4

Summary of previously published articles on CPs for gastrectomy.

Author	Number of patients	Approach	Operation type	Discharge (days)	CCP (%)	Morbidity rate (%)	Re-admission rate (%)
Kim et al.	4038	O, L	DG, TG	5–8	84	10	1
Kim et al.	252	O, L	DG, TG	8	46	No data	4
Choi et al.	425	O, L, R	DG, TG	No data	62	No data	No data
Jeong et al.	228	O	DG, TG, PG, PPG	7–8	19	18	1
Nakagawa et al.	403	L	DG	5–7	76	18	1

CPs: clinical pathways; CCP: completion of clinical pathway; O: open; L: laparoscopy; R: robot; DG: distal gastrectomy; TG: total gastrectomy; PG: proximal gastrectomy; PPG: pylorus-preserving gastrectomy.

The CP completion rates in the previous articles were quite low, except in the article by Kim et al., in which the CP completion rate was as high as 84% with discharge day-setting of POD 5–8. Unlike this study, the previous studies included various types of approaches and operation types. In this study, only patients who underwent laparoscopic distal gastrectomy were included, and, as we have repeatedly reported, the technique of laparoscopic distal gastrectomy in our institute is well established and standardized (20, 21, 28). That is why the CP completion rate in this study was quite high, although the set discharge day was earlier than in the previous studies.

The morbidity rate is the key for the CP completion rate, because complications are the major factors that affect progress along the CP, since they accounted for 73% of the reasons for discharge variances in this study. The overall morbidity rate in this study was 18%, and major complications over grade IIIa occurred in 3% of the patients. As seen in the results, not only major complications but also minor complications (Clavien-Dindo I and II) can be the reasons for discharge variances.

Recently, enhanced recovery after surgery (ERAS) protocols are becoming popular in the gastric cancer field, and there have been some reports of their safety and feasibility (15, 29, 30). Most of the components of the current CP overlap with those in the ERAS protocol, but there are some components lacking, such as preoperative carbohydrate loading and omission of bowel preparation, which are crucial in the ERAS protocol. The need for epidural catheter and abdominal drain is also controversial and should be reconsidered for the future modification of our clinical path (31, 32). However, one remarkable point about this study is that it was possible to show the safety and feasibility of early oral intake and subsequent early discharge. Thus, these results may encourage more institutes to apply CPs with early oral intake and discharge setting and, consequently, the ERAS protocol in the long run.

This study has several limitations. First, it was a retrospective one-arm study and did not assess the advantages or disadvantages compared to a non-CP group. Second, the cost issue of CP was not investigated and evaluated, and no conclusion about benefits with respect to admission costs can be made based on the results of this study.

In conclusion, a high completion rate of a CP with early oral intake and discharge setting for laparoscopic distal gastrectomy was achievable with an acceptably low re-admission rate. Standardization of surgical technique with a low morbidity rate is the key factor, and laparoscopic distal gastrectomy is recommended as a first step for an early oral intake and discharge protocol.

Footnotes

Author Contribution

All authors contributed to the study concept and design of the study, acquisition and interpretation of data, and final approval. M.N. contributed to data analysis and drafting the article. K.K. contributed to revising the article.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

References

Pearson

Goulart-Fisher

Lee

: Critical pathways as a strategy for improving care: Problems and potential. Ann Intern Med 1995;123:941–948.

Pritts

Nussbaum

Flesch

et al : Implementation of a clinical pathway decreases length of stay and cost for bowel resection. Ann Surg 1999;230:728–733.

Koch

Smith

Jr : Influence of patient age and co-morbidity on outcome of a collaborative care pathway after radical prostatectomy and cystoprostatectomy. J Urol 1996;155:1681–1684.

Cohn

Rosborough

Fernandez

: Reducing costs and length of stay and improving efficiency and quality of care in cardiac surgery. Ann Thorac Surg 1997;64:S58–S60; discussion S80–S82.

Calligaro

Dougherty

Raviola

et al : Impact of clinical pathways on hospital costs and early outcome after major vascular surgery. J Vasc Surg 1995;22:649–657; discussion 657–660.

Kim

Yoo

Kim

et al : Analysis of patient-dropouts from the critical pathways for gastric cancer. Ann Surg Treat Res 2015;88:311–317.

Jeong

Yoo

Yoon

et al : Is the critical pathway effective for the treatment of gastric cancer? J Korean Surg Soc 2011;81:96–103.

Adachi

Suematsu

Shiraishi

et al : Quality of life after laparoscopy-assisted Billroth I gastrectomy. Ann Surg 1999;229:49–54.

Shinohara

Satoh

Kanaya

et al : Laparoscopic versus open D2 gastrectomy for advanced gastric cancer: A retrospective cohort study. Surg Endosc 2013;27:286–294.

10.

Grantcharov

Kehlet

: Laparoscopic gastric surgery in an enhanced recovery programme. Br J Surg 2010;97:1547–1551.

11.

Kim

Han

et al : Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer: Short-term outcomes from a multicenter randomized controlled trial (KLASS-01). Ann Surg 2016;263:28–35.

12.

Choi

Xuan

Hur

et al : Outcomes of critical pathway in laparoscopic and open surgical treatments for gastric cancer patients: Patients selection for fast-track program through retrospective analysis. J Gastric Cancer 2013;13:98–105.

13.

Kim

: Use of a clinical pathway in laparoscopic gastrectomy for gastric cancer. World J Gastroenterol 2015;21:13507–13517.

14.

Degiuli

Sasako

Ponti

et al : Morbidity and mortality after D2 gastrectomy for gastric cancer: results of the Italian Gastric Cancer Study Group prospective multicenter surgical study. J Clin Oncol 1998;16:1490–1493.

15.

Yamada

Hayashi

Cho

et al : Usefulness of enhanced recovery after surgery protocol as compared with conventional perioperative care in gastric surgery. Gastric Cancer 2012;15:34–41.

16.

Yamada

Hayashi

Aoyama

et al : Feasibility of enhanced recovery after surgery in gastric surgery: A retrospective study. BMC Surg 2014;14:41.

17.

Wang

Kong

Zhong

et al : Fast-track surgery improves postoperative recovery in patients with gastric cancer: A randomized comparison with conventional postoperative care. J Gastrointest Surg 2010;14:620–627.

18.

Sobin

Gospodarowicz

Wittekind

: International Union Against Cancer (UICC) TNM Classification of Malignant Tumours, 7th ed. Wiley-Liss, New York, 2010.

19.

Dindo

Demartines

Clavien

: Classification of surgical complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–213.

20.

Nakagawa

Kojima

Inokuchi

et al : Patterns, timing and risk factors of recurrence of gastric cancer after laparoscopic gastrectomy: Reliable results following long-term follow-up. Eur J Surg Oncol 2014;40:1376–1382.

21.

Motoyama

Kojima

Hayashi

et al : Beta-shaped intracorporeal Roux-en-Y reconstruction after totally laparoscopic distal gastrectomy. Gastric Cancer 2014;17:588–593.

22.

Park

Lee

Kim

et al : Predictors of operative morbidity and mortality in gastric cancer surgery. Br J Surg 2005;92:1099–1102.

23.

Yang

Lee

Kim

et al : Short- and long-term outcomes after gastrectomy in elderly gastric cancer patients. Ann Surg Oncol 2016;24:469–477.

24.

Hayashi

Yoshikawa

Aoyama

et al : Severity of complications after gastrectomy in elderly patients with gastric cancer. World J Surg 2012;36:2139–2145.

25.

Hamel

Henderson

Khuri

et al : Surgical outcomes for patients aged 80 and older: Morbidity and mortality from major noncardiac surgery. J Am Geriatr Soc 2005;53:424–429.

26.

Kim

et al : Surgical complications in gastric cancer patients preoperatively treated with chemotherapy: Their risk factors and clinical relevance. Ann Surg Oncol 2012;19:2452–2458.

27.

Kim

Lee

Kim

: Comparison of the major postoperative complications between laparoscopic distal and total gastrectomies for gastric cancer using Clavien-Dindo classification. Surg Endosc 2015;29:3196–3204.

28.

Gordon

Kojima

Inokuchi

et al : Long-term comparison of laparoscopy-assisted distal gastrectomy and open distal gastrectomy in advanced gastric cancer. Surg Endosc 2013;27:462–470.

29.

Sugisawa

Tokunaga

Makuuchi

et al : A phase II study of an enhanced recovery after surgery protocol in gastric cancer surgery. Gastric Cancer 2016;19:961–967.

30.

Makuuchi

Sugisawa

Kaji

et al : Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol 2016;43:210–217.

31.

Lee

Choi

et al : Do all patients require prophylactic drainage after gastrectomy for gastric cancer? The experience of a high-volume center. Ann Surg Oncol 2015;22:3929–3937.

32.

Grantcharov

Kehiet

: Laparoscopic gastric surgery in an enhanced recovery programme. Br J Surg 2010;97:1547–1551.

Feasibility of a Clinical Pathway With Early Oral Intake and Discharge for Laparoscopic Gastrectomy

Abstract

Background and Aims:

Materials and Methods:

Results:

Conclusion:

Keywords

Introduction

Materials and Methods

Patients and Data Collection

CP

Operative Procedure

Statistical methods

Results

Baseline Characteristics of the Enrolled Population

Causes of Discharge Variances

Univariate and Multivariate Analyses for Risk Factors

Discussion

Footnotes

Author Contribution

Declaration of Conflicting Interests

Funding

References