Surg Endosc (2013) 27:1225–1232 DOI 10.1007/s00464-012-2579-7
and Other Interventional Techniques
The safety of a ‘‘fast-track’’ program after laparoscopic colorectal surgery is comparable in older patients as in younger patients Se-Jin Baek • Seon-Hahn Kim • Se-Young Kim Jae-Won Shin • Jung-Myun Kwak • Jin Kim
•
Received: 18 June 2012 / Accepted: 26 August 2012 / Published online: 12 December 2012 Ó Springer Science+Business Media New York 2012
Abstract Introduction Fast-track protocols, introduced in the late 1990s, have been applied in several surgical fields, particularly for colorectal surgery. However, currently many surgical patients are elderly, and discussion about the application of such programs for elderly patients is lacking. The present study was designed to assess the safety of application of a fast-track program after laparoscopic colorectal surgery in elderly patients. Methods From August 2009 to January 2011, we prospectively collected data from patients who underwent laparoscopic colorectal surgery with a perioperative fasttrack program. The data of patients older and younger than 70 years were compared. Results Of a total of 337 patients, the group of patients older than 70 years (OG) totaled 87 (25.8 %) and the younger group (YG) totaled 250 (74.2 %). Ten patients (11.5 %) were excluded in the OG and 24 (9.6 %) in the YG. There were no differences in gender, history of previous surgeries, body mass index, type of operation, operative time, or blood loss between groups. Age (74.8 vs.
This study was presented as a poster at the 6th International Congress of Laparoscopic Colorectal Surgery, Chelmsford, UK, September 5–7, 2011. S.-J. Baek S.-H. Kim (&) J.-W. Shin J.-M. Kwak J. Kim Colorectal Division, Department of Surgery, Korea University Anam Hospital, Korea University College of Medicine, Inchon-ro 73, Seongbuk-gu, Seoul 136-705, Korea e-mail:
[email protected] S.-J. Baek e-mail:
[email protected] S.-Y. Kim Korea University Postgraduate School, Seoul, Korea
56.7 years, p \ 0.001), presence of comorbidities (70.1 vs. 44.7 %, p \ 0.001), and ASA score (I:II:III, 33.8:57.1:9.1 vs. 60.6:33.2:6.2 %, p \ 0.001) were significantly different between the two groups. Postoperative course did not show differences, including return of flatus, stool passage, advancement of diet, removal of urinary catheter, length of usage of IV antibiotics, complications, and length of postoperative stay. Emergency department visits or readmission within a month after discharge were more frequent in the OG (11.7 %) than the YG (4 %; p = 0.013). Conclusions Fast-track after laparoscopic colorectal surgery can be safely applied in carefully selected elderly patients older than age 70 years. Physicians should keep in mind complications that may present after discharge and should actively educate patients about them. Keywords Fast-track Enhanced recovery after surgery (ERAS) Aged patients Colorectal surgery Laparoscopy
The concept of fast-track (enhanced recovery after surgery, ERAS) was introduced to colorectal surgical practice by Kehlet [1]. The main aspects of fast-track programs include preoperative patient education, no routine bowel preparation, minimal perioperative starvation, tailored anesthesia and postoperative analgesia, early postoperative diet intake, and mobilization [2–5]. This multidisciplinary perioperative care strategy requires a team approach involving the surgical, anesthesia, and nursing teams and other ancillary staff, including physiotherapists, dieticians, and stoma therapists. The concept of fast-track rehabilitation has been recently introduced with the intent to improve perioperative management by reducing stress and complications suffered by patients, shortening the length of hospital stay, and reducing costs of resection of colorectal
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cancer. A systematic review that included several randomized, controlled trials examined the evidence for fasttrack protocols compared with traditional care [2–5]. Fast-track programs have been mainly applied to relatively young patients, usually younger than age 65 years [4–7], because being older is associated with a higher number of comorbid conditions, and suitability of surgical candidates based on age has traditionally been debated [8, 9]. In comparison, the incidence of carcinoma of the colon and rectum peaks in the seventh and eighth decades of life, with only 5 % of cases recorded in patients younger than age 40 years [10]. Thus, in the evaluation of elderly patients, physiologic age rather than chronologic age should be carefully considered in the decision-making process before cancer treatment with an effort to avoid ageism currently [11–13]. Based on the evidence that laparoscopic colorectal resection is a safe option for elderly patients in association with more favorable short-term outcomes [14, 15], the traditional perception that a laparoscopic approach using pneumoperitoneum may be harmful to elderly patients who have cardiovascular or respiratory diseases should be reconsidered. However, studies on the application of a fast-track program in older patients are lacking. The purpose of this study was to evaluate the safety and feasibility of utilizing fast-track protocols in elderly patients with colorectal cancer undergoing laparoscopic surgery including robotic surgery.
Materials and methods Patients who underwent laparoscopic or robotic surgery for colorectal cancer with a fast-track protocol at the Korea University Anam Hospital from August 2009 to January 2011 were prospectively enrolled in this study. The study was approved by the institutional review board (IRB). Clinical characteristics and postoperative outcomes were compared between patients age 70 years or older and patients younger than age 70 years. Exclusion criteria for study participation were that the patient underwent an emergency surgery, was an American Society of Anesthesiologists (ASA) class IV, or required postoperative intensive care or conversion to an open procedure. Enhanced recovery program protocol Fast-track protocol was modified for this Korean population on the basis of published protocols described in Table 1. The protocols of fast-track rehabilitation programs typically include no bowel preparation except one or two enemas in cases of rectal surgery, continuation of a normal diet until 8 h before surgery, no routine use of nasogastric tubes, postoperative pain control with intravenous patientcontrolled analgesia (IV PCA), and minimization of opioid
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use except for in patients with a contraindication to nonsteroidal anti-inflammatory medications (NSAIDs). One or two doses of prophylactic antibiotics consisting of a second-generation cephalosporin were used on the day of surgery. On postoperative day (POD) 1, patients were permitted water intake and urinary catheters were removed. Ambulation was encouraged. For rectal cancer patients, the urinary catheter was removed on the second or third postoperative day. Patients were given a soft diet on POD 2. On POD 3, a normal diet was permitted, IV fluid administration was discontinued, and analgesia was changed to oral medicine if appropriate. On the next day, any abdominal drains placed during surgery were removed. Patients without problems were discharged on POD 5. Discharge criteria were as follows: tolerance of a normal diet without nausea or vomiting, adequately controlled pain (pain score \ 4), passage of stool, no surgical complications, being afebrile without tachycardia, having the ability to perform their own activities of daily living (ADLs), and willingness to be discharged. Categorization according to patient postoperative course The flow sheet for categorization according to patient postoperative course is demonstrated in Fig. 1. Patients who were discharged on POD 5 and had no problems after discharge were classified as group 1. Patients who were discharged on POD 5 but visited the emergency room (ER) or were readmitted with any problems within 30 days postoperatively were classified as group 2. Patients who did not meet discharge criteria on POD 5 were classified as group 3. Patients who met discharge criteria but requested to stay longer or those who had a prolonged hospitalization to start adjuvant chemotherapy were classified as group 4. We analyzed the success rate of discharge on POD 5 (groups 1?2/total number of enrolled patients), readmission rate (group 2/total), dropout rate (group 3/total), mean hospital stay, and postoperative overall morbidity. Statistical analysis Statistical analysis was performed with SPSS version 12.0 (Chicago, IL). Student’s t test was used to compare continuous variables. v2 test and Fisher’s exact test were used to compare discrete variables. p \ 0.05 was considered statistically significant.
Results A total of 337 patients were enrolled [87 in the older group (OG) and 250 in the younger group (YG)]. The number of
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Table 1 Protocol characteristics of the utilized enhanced recovery program Time Preoperative
Procedure a. Preoperative assessment of the possibility for enrollment in ERAS b. Patients and their relatives educated in the standard manner and informed about the surgical procedure and postoperative course
Day before surgery
a. No oral bowel preparation (one or two enemas for rectal surgery patients) b. Normal diet until 8 h before surgery
Day of surgery (before surgery)
a. Antibiotic prophylaxis: single-dose, second-generation cephalosporin 1 h before skin incision
Operating room
a. Surgeons: nasogastric tube, if needed, to be removed before extubation b. Anesthetists: Maintenance: oxygen/air with FiO2 [80 % Monitoring: routine. Only use arterial/central catheter if unavoidable Fluids: avoid overloading Temperature: use liquid heater and heating blanket. c. Prophylaxis for pulmonary thromboembolism following the standard practice
Day of surgery (after surgery)
a. Antibiotic prophylaxis: second dose if the operating time exceeds 3 h b. Analgesia: IV PCA and Ketorolac 0.5 mg/kg/6 h IV (restriction of opioid).
Postoperative day 1
a. Water permitted b. Mobilization: patient seated at least 6 h per day c. Remove urinary catheter (except middle/lower rectal cancer patients) d. Analgesia: IV PCA and Ketorolac 0.5 mg/kg/6 h IV
Postoperative day 2
a. Soft diet permitted b. Mobilization: patient ambulated at least 2 h per day, seated at least 6 h per day c. Remove urinary catheter (for patients with low anterior resection)
Postoperative day 3
d. Analgesia: IV PCA and Ketorolac 0.5 mg/kg/8 h IV a. Normal diet permitted b. IV fluid discontinued c. Mobilization on demand d. Remove urinary catheter (for patients with ultralow anterior resection or intersphincteric resection) e. Remove IV PCA and Ketorolac 0.5 mg/kg/8 h IM and acetaminophen 1 g/8 h PO
Postoperative day 4
a. Acetaminophen 1 g every 8 h PO b. Ketorolac 0.5 mg/kg/IM PRN c. Remove drains c. Assessment of discharge criteria
Postoperative day 5
a. Make decision with respect to the assessment
Follow-up
a. Visit outpatient clinic 1 week after discharge
ERAS enhanced recovery after surgery, IV intravenous, PCA patient-controlled analgesia, PO per oral, IM intramuscular, PRN per requested need
patients who needed postoperative intensive care was 6 (6.9 %) in the OG and 14 (5.6 %) in the YG (p = 0.66). After all exclusions, 303 patients were included in the analysis (77 in the OG and 226 in the YG). The relevant characteristics of patients and the types of surgery are shown in Table 2. No significant difference was observed in sex, body mass index (BMI), type of surgery, length of the operation, or estimated blood loss between the two groups. However, age (74.8 vs. 56.7, p \ 0.001), presence of comorbidities (70.1 vs. 44.7 %, p \ 0.001), having more than two comorbidities (23.4 vs. 12.4 %, p \ 0.001), and ASA score (I:II:III, 33.8:57.1:9.1 % vs. 60.6:33.2:6.2 %,
p \ 0.001) were significantly higher in the OG. In particular, cardiovascular disease (61 vs. 33.2 %, p \ 0.001), pulmonary disease (7.8 vs. 0.9 %, p = 0.004), and history of another malignancy (11.7 vs. 3.5 %, p = 0.012) were significantly higher in the OG. The characteristics of the postoperative course are outlined in Table 3. No significant difference was observed in the return of flatus (2 vs. 2 days, p = 0.334), stool passage (3 vs. 3 days, p = 0.415), or feeding (2 vs. 2 days, p = 0.623). There was no significant difference in the time to urinary catheter removal (2 vs. 2 days, p = 0.936). Two patients in the OG and six patients in the YG could not
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Fig. 1 Categorization according to patient postoperative course. POD postoperative day. *Patients who were assessed to meet the discharge criteria but wanted to stay longer or prolonged hospitalization for early starting adjuvant chemotherapy
Application of the Fast-track Protocol
No
Assessment for Dischargeat POD 4
Group 3
Yes Group 4
No*
Discharge Yes Yes Group 2
Necessity of Re-admission No Group 1
Table 2 Patient characteristics and surgical techniques
OG (n = 77)
YG (n = 226)
Sex
p 0.376
Male
55 (71.4 %)
149 (65.9 %)
Female
22 (28.6 %)
77 (34.1 %)
74.8 ± 4.2 (70–88)
56.7 ± 8.9 (28–69)
\0.001 \0.001
Age, mean ± SD (ranges) Comorbidities Yes
54 (70.1 %)
101 (44.7 %)
[2 systemic
18 (23.4 %)
28 (12.4 %)
0.019 \0.001
Cardiovascular
47 (61.0 %)
75 (33.2 %)
Pulmonary
6 (7.8 %)
2 (0.9 %)
0.004
Endocrine
13 (16.9 %)
35 (15.5 %)
0.773
Urinary
6 (7.8 %)
10 (4.4 %)
0.255
Another malignancy
9 (11.7 %)
8 (3.5 %)
0.012
Others
4 (5.2 %)
6 (2.7 %)
I II III 2
BMI (kg/m ), mean ± SD (ranges)
26 (33.8 %) 44 (57.1 %)
137 (60.6 %) 75 (33.2 %)
7 (9.1 %)
14 (6.2 %)
23.2 ± 2.9 (16.3–30)
23.5 ± 3.3 (15.2–33.1)
Operation type Laparoscopy
65 (84.4 %)
167 (73.9 %)
Robot
12 (15.6 %)
59 (26.1 %)
Right-sided colectomy
21 (27.3 %)
46 (20.4 %)
Left-sided colectomy
3 (3.9 %)
10 (4.4 %)
Rectal surgery
53 (68.8 %)
166 (73.5 %)
Others
0
4 (1.7 %)
0.973
Operation time (min), mean ± SD (ranges)
192.9 ± 77.7 (60–515)
205.8 ± 79.9 (60–500)
0.22
EBL (ml), mean ± SD (ranges)
138.2 ± 207.7 (0–800)
145.3 ± 246.8 (0–1500)
0.82
have the urinary catheter successfully removed during the postoperative hospital stay due to urinary retention. These eight patients were able to have the urinary catheter
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0.481 0.06
Operation procedure
OG older group, YG younger group, SD standard deviation, ASA American Society of Anesthesiologists, BMI body mass index, EBL estimated blood loss
0.283 \0.001
ASA score
removed at an outpatient clinic with or without suprapubic catheter insertion. The median number of days for using IV antibiotics during admission was one in each group
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Table 3 Postoperative course
OG (n = 77) 2 (0–7)
2 (0–4)
Stool (day), median (ranges)
3 (0–6)
3 (0–7)
0.415
Feed (day), median (ranges)
2 (1–12)
2 (1–16)
0.623
0.334
Urinary catheter removal (day), median (ranges)
2 (1–14)
2 (1–28)
0.936
IV antibiotics (day), median (ranges)
1 (0–20)
1 (1–39)
0.478
Oral antibiotics (day), median (ranges)
0 (0–13)
0 (0–14)
0.94
Preoperative HS (day), median (ranges)
3 (1–8)
2 (1–13)
0.718
Postoperative HS (day), median (ranges)
8 (4–27)
9 (3–103)
0.211
Total HS (day), median (ranges)
12 (7–31)
12 (5–109)
0.266
Complications during postoperative hospital stay
20 (26.0 %)
72 (31.9 %)
0.334
Anastomotic leakage
2 (2.6 %)
19 (8.4 %)
0.084
Anastomotic bleeding
1 (1.3 %)
7 (3.1 %)
0.397
Intraabdominal abscess
1 (1.3 %)
5 (2.2 %)
0.621
Wound infection
2 (2.6 %)
5 (2.2 %)
0.847
Chyle leakage Ileus
1 (1.3 %) 8 (10.4 %)
1 (0.4 %) 22 (9.7 %)
0.425 0.869
Voiding difficulty
7 (9.1 %)
16 (7.1 %)
0.566
Nephrologic problem
2 (2.6 %)
Others
2 (2.6 %)
(p = 0.478). The incidence of complications during postoperative hospital stay was 26 % in the OG (20 patients) and 31.9 % in the YG (p = 0.334). There was no cardiopulmonary complication or mortality in either group. No significant differences were observed in preoperative (3 vs. 2 days, p = 0.718), postoperative (8 vs. 9 days, p = 0.211), and total hospital stays (12 vs. 12 days, p = 0.266). The number of patients who visited the emergency room (ER) with any problem related to the surgery or who required readmission was significantly higher in the OG (11.7 %) than in the YG (4 %; p = 0.013). The causes of readmission are outlined in Table 4. The number of patients who completed the fast-track protocol without complications (group 1 plus group 4) was 50 (64.9 %) in the OG and 159 (70.4 %) in the YG (Table 5). However, many patients were discharged after POD 5 (group 4), 44
0.999
10 (4.4 %)
YG (n = 226)
p 0.013
0.479
Table 5 Distribution of categorizations YG (n = 226)
Group
Table 4 Readmission rate and cause OG (n = 77)
0
(57.1 %) patients in the OG and 125 (55.3 %) in the YG. The number of patients who had an extended hospitalization for early initiation of adjuvant chemotherapy was 2 (2.6 %) in the OG and 32 (14.1 %) in the YG, and the number of patients with a prolonged hospital stay due to patient request was 42 (54.5 %) in the OG and 93 (41.2 %) in the YG. The rate of discharge on POD 5 (group 1 plus group 2) was 19.5 % in the OG and 19 % in the YG (p = 0.931). The readmission rate (group 2) was 11.7 % in the OG and 4 % in the YG (p = 0.013). The dropout rate (group 3) was 23.4 % in the OG and 25.7 % in the YG (p = 0.782). No significant difference was observed in overall morbidity throughout the periods before and after discharge (35.1 vs. 29.6 %, p = 0.376).
OG (n = 77)
6 (7.8 %)
34 (15 %)
2
9 (11.7 %)
9 (4 %)
3
18 (23.4 %)
58 (25.7 %)
4
44 (57.1 %)
125 (55.3 %)
50 (64.9 %)
159 (70.4 %)
9 (11.7 %)
9 (4 %)
7
6
General weakness
0
1
Gastric ulcer bleeding
1
0
1?4
Hematochezia
1
0
2
Wound dehiscence Intraabdominal abscess
0 0
1 1
Group
3 Overall morbidity
p 0.533
1
Ileus
OG older group, YG younger group
p
Flatus (day), median (ranges)
OG older group, YG younger group, IV intravenous, HS hospital stay
Readmission
YG (n = 226)
0.785 9 (11.7 %) 18 (23.4 %) 27 (35.1 %)
9 (4 %) 58 (25.7 %) 67 (29.6 %)
0.376
OG older group, YG younger group
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Discussion The results of the present study show that older patients (C70 years of age) can safely participate in a fast-track protocol, similar to younger patients (\70 years of age). Fifty patients (64.9 %) in the OG completed the program, which was similar to the success rate of the YG (70.4 %). In particular, there was no significant difference in gastrointestinal function recovery, postoperative hospital stay, or morbidity between groups. These results do not conform to the common thinking that elderly patients develop postoperative complications more frequently, including cardiovascular, pulmonary, and thromboembolic complications, due to underlying diseases and decreased activity. An emphasis on physiologic age versus chronologic age in a patient’s risk/benefit analysis for the prospect of cancer surgery has been supported by previous research [11–13]. This study may reflect the necessity of more widespread application of fast-track programs to elderly patients than younger patients because elderly patients have more comorbidities. According to the fast-track protocol regarding the limitation of fluid administration intra- and postoperatively, patients can avoid the fluid-electrolyte imbalance that can be induced by preoperative prolonged fasting, massive bowel preparation, and overloading of the cardiopulmonary system. Using pneumatic compression stockings intraoperatively and encouraging early ambulation can prevent thromboembolic complications. The restriction of opioids can reduce the incidence of ileus and gastrointestinal symptoms, such as nausea or vomiting, and related complications, such as aspiration. Therefore, the advantages of fast-track may be maximized in the OG compared with the YG. Pneumoperitoneum used in minimally invasive surgery may cause cardiovascular and respiratory complications. During laparoscopic surgery, those changes mostly occur due to increased intra-abdominal pressure and a hemodynamic stress response with activation of the neurohumoral vasoactive system [16, 17]. However, minimally invasive surgery may be regarded as an important component in the successful application of the fast-track protocol to elderly patients [18]. Laparoscopic surgery, including robotic surgery, is significantly less painful than conventional open surgery and facilitates early ambulation. In this study, the patients in both the YG and the OG did not develop any significant cardiopulmonary complications postoperatively, and this might be related with the use of a low-pressure pneumoperitoneum (8 mmHg) in our practice [19]. Although the role of laparoscopic colorectal resection within a fast-track program remains controversial [20–22], the results of recent, large, randomized trials, such as the LAFA study, show an advantage in adopting a laparoscopic method over an open technique [23].
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Despite the lack of a significant difference in the rate of complications during admission or overall morbidity between groups, it is notable that the readmission rate was higher in the OG. Because the threshold for pain is higher in elderly patients, and often these patients lack fever or leukocytosis with infection [24, 25], misjudgment of their readiness for discharge can occur, leading to complications being discovered after discharge. In addition, recovery may be delayed due to the return to a lower level of activity after discharge without the encouragement of physiotherapists and nurses at home. This is an important consideration given that seven of the nine patients who were readmitted had ileus. Therefore, it is particularly important to educate elderly patients on the problems that can occur after discharge and to stress immediate return to the hospital when problems occur. The overall readmission rate in the current study was 5.9 %, which is comparable with the levels in previous studies (3–9.6 %) [4, 26–28]. However, the rate of discharge on POD 5 was only 19.5 % in the OG and 19 % in the YG, despite the fact that the protocol in our study was less strict than some western protocols that aim to discharge at 48 to 72 h postoperatively (Table 1). More than 50 % of the total number of enrolled patients were deemed to be ready for discharge but declined to leave and prolonged the hospital stay. There were several reasons why the hospital stay was somewhat longer in our series despite our fast-track protocol. Some stage III patients received adjuvant chemotherapy during the same hospitalization, which prolonged the hospital stay. However, in the majority of patients, the hospital stay was extended simply due to patient request (54.5 % in the OG and 41.2 % in the YG). This can be attributed to the fact that Korea has government-funded health care, which means that there is little cost to the patients, removing one of the motivators for discharge. This was also why group 4 was classified separately in our study. Other reasons for prolongation of the hospital stay were both patient and doctor anxiety regarding early discharge and a deficiency of pre-education. Preoperative education for patients and their families and changes in physician recognition are necessary. However, the success rate of discharge at some specific postoperative date may not be important, considering that the primary purpose of the fast-track program is minimization of postoperative patient stress and maintenance of homeostasis, not reduction of hospital stay or cost. Closer collaboration of the multidisciplinary team for optimal management is necessary. Certainly every fasttrack protocol is employed in a modified form based on each situation, but, our protocol administration only was mainly led by the surgical team and lacked coordination with other medical team members, such as the anesthesiologist. For example, the collaboration was not satisfactory
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in terms of intraoperative epidural anesthesia or strict fluid restriction. Therefore, additional coordination with other management staff will be necessary to improve the protocol. The matter of safety and effectiveness of the fast-track protocol applied in this study can be further verified by comparison with a standard protocol. However, we are sorry not to be able to provide a comparison data, because data were not collected prospectively in the past when a standard protocol had been applied. Nevertheless, we believe that our study reflects well the safety of fast-track application on elderly patients, by demonstrating similar clinical outcomes between elderly patients and younger patients who were placed on the same protocol. Despite some limitations, our study does provide some helpful conclusions. First, as far as we know, this is the first study on fast-track published from Korea. Fast-track is not yet common in Asian countries, including Korea. Furthermore, the omission of preoperative bowel preparation is performed selectively even in the United States, and our study protocol had no bowel preparation. The fact that bowel preparation does not reduce anastomotic leakage has been demonstrated in several studies [29, 30]. Additionally, it is very uncomfortable for patients and may cause electrolyte disturbances in susceptible patients. Despite this, bowel preparation is still routinely performed in many institutions. Recently, omitting bowel preparation has been established as one of the important steps in fast-track protocols. Second, there have been no previous studies on the feasibility of application of fast-track in elderly patients, although the advantages are well known. Therefore, our study provides evidence that this may be safe to do, which is important especially now, when the number of elderly patients is increasing. Although the result of our study may not be generalized to other countries because of differences in the health care system between each country, such as hospital discharge criteria, this study can be used as a reference when others apply ‘‘fast-track’’ to elderly patients.
Conclusions We confirmed that fast-track can be safely applied to carefully selected patients older than age 70 years with colorectal cancer who undergo successful minimally invasive surgery. Instead of the typical perioperative care, the advantages provided by fast-track can be maximized in this population. Because the readmission rate may be higher in elderly patients, education about potential problems after discharge and the possibility of readmission should be stressed in elderly patients. In this way, the benefits of fast-track can be obtained through the safe application of the protocol.
1231 Conflict of interest There is no potential of actual, personal, political, or financial conflict of interest. Disclosures We have no source of support in the form of equipment, drugs or grants to declare.
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