Download Effect of Immunonutrition on Postoperative Complications of

Effect of Immunonutrition on Postoperative Complications of Gastrointestinal
Tract Cancer Surgery among Patients at South Egypt Cancer Institute, Assiut
University
Wafaa Taha Salem1, Mostafa Galal Mostafa2, Mohamed A.M. Mostafa2, Mohamad
Farouk Mohamad2, Hosny Badrawy Hamed3, Asmaa M. Zahran3, Rania Mohammed
Abd Elemam2
1
Anesthesia, ICU and Pain Relief Department, National Cancer Institute, Cairo
University.
2
Anesthesia, ICU and Pain Relief Department, South Egypt Cancer Institute, Assiut
University.
3
Clinical Pathology Department, South Egypt Cancer Institute, Assiut University.
Correspondence should be addressed to Rania Mohammed Abd Elemam, Assistant lecturer of
Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University.
[email protected]
Abstract
Background: Immunonutrition not only a nutritional supply for patients but it is a therapy
which should be started as early as possible especially in expected malnutrition following
gastrointestinal cancer surgery. Objectives: Evaluation the effect of imunonutrition in
gastrointestinal tract cancer surgery patients on postoperative complications. Patient and
Methods: A prospective randomized trial was carried out on 45 patients who were chosen
and classified randomly into three groups each of them included 15 patients as the followings:
Group I received total parenteral nutrition immediately postoperative for 7 days in the form of
carbohydrate, proteins, fat (Intralipid 20%), electrolytes, trace elements and glutamine
intravenous in central venous catheter. Group II received nutrition like group one except that
lipid was administered in a new formula containing soya bean oil, medium chain triglyceride,
olive oil and fish oil. Group III received nutrition in the same formula of group II but it was
started 7 days preoperative and continued for 7 days postoperative. Assessment parameters
such as body weight and complications were recorded. Results: No significant difference
between three groups concerning age and sex. A significant effect of time on body weight
collectively was proved. There is significant group interaction between 3 groups. Body
weight showed a significant drop both in group I and group III, but not in group II.
Concerning postoperative complications there were no statistical significance between three
groups. There was a decrease in the rate of pulmonary tract infection in group III compared to
other groups but the decrease was not statistically significant. Only one case of urinary tract
infection was reported in group II and one case of intra-abdominal infection in group I.
Conclusion: There was positive impact of enteral immunonutrition on reduction of
postoperative complications compare to basic caloric requirements (Intralipid postoperative).
These findings suggest its use as a method of choice during the postoperative period.
Key words: Immunonutrition, Postoperative Complications, Gastrointestinal Tract Cancer
Surgery.
__________________________________________________________________________
1
Introduction:
Cancer is a systemic disease that directly affects the site of onset and can
metastasize to other sites causing a variety of complications and loss of progressive
organ function. The development of the disease may be initially slowly or rapidly
evolving, unavoidably affecting nutritional status [1]. Malnutrition is a possible
complication in patients with cancer and can be the first symptom to reveal the
presence of the disease [2].
Malnutrition can negatively affect the clinical decision to resect the tumor,
which is the main and potentially curative step in the management of cancer. Indeed,
malnutrition can increase the incidence of postoperative complications, such as
delayed wound healing, dehiscence of anastomosis, morbidity and mortality [1].
Increasing evidence has been accumulated during recent years that nutritional
screening and therapy are important adjuncts in modern surgical care since up to 40%
of patients are at nutritional risk preoperatively [8, 9]. Malnourished patients have a
significantly higher morbidity and mortality, a longer length of stay (LOS) and
increased hospital costs [3-7]. In addition, malnutrition is an independent risk factor
for quality of life [2].
Malnutrition impairs the immune status and reduces the body’s defense
against infectious diseases. In light of these possible complications, malnutrition
represents a poor prognostic factor and, as such, should be prevented or detected as
early as possible [2].
Perioperative nutrition has been convincingly shown to improve clinical
outcome in patients undergoing major gastrointestinal surgery and to reduce costs [3,
8]. The mechanism of action seems to be not only an improved nutritional status by
providing a higher caloric intake, but primarily a reinforced immune response;
nutritional formulas containing immune-modulating agents (glutamine, arginine,
omega 3 fatty acids, and ribonucleic acids) are particularly beneficial modulators of
the acute stress response [9,10].
The field of investigation of the role of nutrition in the cancer process is very
broad. It is becoming clearer as research continues that nutrition plays a major role in
cancer [11].Tumor-induced weight loss occurs frequently in patients with solid
tumors of the lung, pancreas, and upper gastrointestinal tract and less often in patients
with breast cancer or lower gastrointestinal cancer [12].
Malnutrition is more common in gastrointestinal (GI), head and neck and lung
than in other types of cancer and it is associated with a poor prognosis [13-15]. Major
abdominal operations lead to post traumatic dysregulation of immune system, which
is characterized by suppression of immune functions [16].
Immunonutrition contain pharmacologic doses of nutrients including arginine
(Arg), ω-3 polyunsaturated fatty acids (ω-3 PUFA), glutamine (Glu) and ribonucleic
acid (RNA). All are proved to enhance immune function in vitro and animal
experiments. Some clinical trials have been reported to affect the risk of postoperative
infection and length of hospital stay in patients underwent operation [24].But the
outcome of these studies is inconsistent and new sufficient clinical evidences is absent
for gastrointestinal surgery [17].
2
Aims of the study:
The present study aims to evaluate the effect of immunonutrition on postoperative
complications after gastrointestinal tract cancer surgery among patients attending
South Egypt Cancer Institute, Assiut University.
Patients and Methods:
Study design:
The randomized controlled clinical trial was conducted in South Egypt Cancer
Institute, Assiut University during??????????.
Inclusion/exclusion criteria
The inclusion criteria included patients with good overall status aged between 18 and
70 years. Patients older than 70 years and younger than 18 years, patients with organ
failure (liver and renal insufficiency) and patients suffered from ongoing infections
and/ or inflammatory bowel diseases were excluded.
Studied patients
A total of 45 patients met the inclusion criteria and who underwent resectional
surgery for gastrointestinal cancer were included in the study . The patients were
divided in to three groups:
Group I: consisting of 15 patients and they were received total parenteral nutrition
immediately postoperative for 7 days. Total parenteral nutrition was administered in
the form of carbohydrate, fat and protein with lipid emulsion in the form of Intralipid
20%, electrolytes and trace elements also added, also glutamine intravenous was
given to the patients in central venous catheter.
Group II: consisting of 15 patients and they were received total parenteral nutrition
immediately postoperative for 7 days. Total parenteral nutrition was administered like
group one except that fat emulsion was administered in a new formula containing
soya bean oil, medium chain triglyceride, olive oil, and fish oil (SMOF).
Group III: consisting of 15 patients and they were received total parenteral nutrition
in the same formula of group II but in this group of patients the nutrition was started 7
days preoperative and was continued for 7 days postoperative.
Normal caloric requirements were calculated by nomograms based on Harris Bendict
equation [18]. this equation is used to predict the basal energy expenditure (BEE)
which is the basal metabolic rate in the resting and fasting states, corrected by
considering both activity and stress factors (+45%) provided that the patients are not
feverish, and accordingly macronutrients (proteins and fats) and micronutrients
(vitamins, trace elements, and electrolytes) was calculated and supplied.
This equation depends on the age, sex, height, ideal body weight.
Male’s BEE (kcal/day)= 66+(13.7×body weight in kg)+ (5×height in cm) – (6.7×age
in years)
3
Females BEE (kcal/day) = 655+(9.6×body weight in kg)+ (1.8×height in cm) –
(4.7×age in years)
These predictive equations (with adjustments for the degree of stress) overestimate
the daily energy needs by 20-60%. Therefore, they are only a guide in the Intensive
Care Unit.
Index of assessment:
Each patient in the first two groups was followed up for 7 days postoperatively except
in the third group follow up was started 7 days preoperative and continued for 7 days
postoperative.
1) Anthropometric measurements: body weight.
2) Complications as: fistula, wound infection, pulmonary tract infection,
urinary tract infection, intra-abdominal infection.
Ethical consideration:
The study was carried out after the approval of the Ethical Committee of the South
Egypt Cancer Institute, Assiut University. Administrative approval of the Dean of the
Institute was obtained. Patient participation was voluntary. The written informed
consent was obtained from each respondent. The aims of the study were explained to
the participants. The participants were informed that their non-compliance would not
in any way influence their clinical services or treatment.
Statistical analysis:
SPSS version 18 was used for data analysis. Mean ± standard deviation described
quantitative data. Qualitative data were expressed as percentages. Mixed model with
repeated measures ANOVA was used for testing time effect and for group interaction.
Pair-wise post-hoc tests were Bonferroni adjusted. For values that were not normally
distributed or with extreme values, non-parametric ANOVA (Friedman test) was
used. P value is significant at 0.05 level.
Results:
The present study included 45 patients 16 were males and 29 were females with aged
ranged from 35 t0 69 years old. As shown in Table (1), there are no statistically
significant differences in both sex and age of the three studied groups.
All p values were Bonferroni adjusted, p value is significant→ 0.05. Repeated
measures ANOVA revealed a significant effect of time on body weight collectively.
This effect was not found for the 3 groups (evident by significant group interaction.
Body weight showed a significant drop both in group A & group C, but not in group
B. In group A significant drop in body weight was only one day after operation but
not afterwards, p = 0.03. In group C highly significant drop in body weight was one
day after operation and continued up to seventh day.
Concerning postoperative complications there were no statistical significance between
three groups. There was a decrease in the rate of pulmonary tract infection in group III
4
compared to other groups. But the decrease was not statistically significant. Only one
case of urinary tract infection was reported in group II and one case of intraabdominal infection in group I.
Discussion:
The field of nutritional support therapy has undergone a lot of transformation since its
conception. Originally, artificial feeding was recommended as a mean of providing
energy, protein, and essential micronutrients to offset muscle wasting and prevent
starvation induced immune depletion. Subsequently, various dietary components have
been used in an attempt to modulate immune function. To this end, specific amino
acids, long chain-fatty acids, and nucleic acids have been studied.
Malnutrition occurs in 40 to 80 percent of cancer patients and is a major cause
of morbidity and mortality in patients with advanced disease. It is particularly
frequent in patients with digestive and upper digestive tract tumors [19].
The place of pre- and postoperative nutrition is no longer in question;
particularly since it has been confirmed that, in severely malnourished individuals
scheduled for major GI surgery, it was advantageous to postpone surgery for up to
10–14 days and to administer nutritional support, preferably with enteral diets. From
the surgical point of view, it was not enough to stop there; for over 10 years the focus
has been on understanding immunologic and inflammatory responses, so as to
enhance host defense mechanisms and improve clinical course [20].
These activities led to the idea of immunonutrition, a type of
pharmaconutrition that has been described as nutritional intervention, not only able to
provide essential nutrients to maintain basic organ functions, but also to augment the
immune system. The use of various biochemical agents, such as non-essential
(glutamine, arginine) or sulfur-containing amino acids, omega-3-polyunsaturated fatty
acids, nucleotides, and anti-oxidants (free radical scavengers), administered
simultaneously, in few, some or alone, was assumed to alter the host immune
response [21].
In the present study, the early administration of nutritional support using micro
and macro nutrients was tailored to complement the primary treatment (surgery).The
purpose was to improve the clinical outcome.
In our study we found that there is a decrease in the rate of complications
(wound infection, pulmonary tract infection, urinary tract infection, and intraabdominal abscess) in the immune enhanced diet group (receiving SMOF) either peri
or postoperative groups to the group who received only basic caloric requirements
(Intralipid postoperative).The decrease was not statistically significant but that could
be attributed to the sample size and the duration of immunonutrition as it could have
been not long enough.
A number of prospective randomized trials employing some combination of
these immunomodulatory agents have been performed to investigate the effect of
immunonutrition on hospitalized patients. It was found that clinical trials on
supplemented enteral feeding showed reduced infection rates and a shorter duration of
hospital stay in critically ill patients who received enteral nutrition supplemented with
key nutrients (glutamine, Arginine,…..).
5
One of these prospective randomized studies done by NabeyaY in 2006
showed that giving preoperative immunonutrition in esophageal cancer patients
(giving immune enhancing diet rich in arginine, omega-3 fatty acid for 6-7 days
preoperatively) decreased significantly the incidence of infectious complications 3/23
in study group versus 11/26 patients in the control group who received normal diet (P
value <0.05) [22].
Nineteen RCTs involving a total of 2331 patients were included in a metaanalysis done byZhang,etal. In 2012 the results showed perioperative IN significantly
reduced length of hospital stay (P < 0.01) and morbidity of postoperative infectious
complication (P < 0.01) compared with standard diet. Moreover, perioperative IN also
significantly decreased morbidity of postoperative non-infectious complication in
comparison with standard diet (P ¼ 0.03). So Perioperative IN is effective and safe to
reduce postoperative infection, non-infection complication and length of hospital stay
[23].
Another study performed by DupertuisY in 2007, showed that the
immunonutrition directly affects gastrointestinal cancer cells either by inducing an
apoptotic or a necrotic process, depending on the cell type [24].
Four hundred and sixty-eight elective moderately or severely malnourished
surgical patients with gastric or colorectal cancers defined by the subjective global
assessment (SGA) were randomly assigned to 7 d preoperative and 7 d postoperative
parenteral or enteral nutrition vs a simple control group. Control patients did not
receive preoperative nutrition but received 600±100 kcal non-protein plus or not plus
62 ± 16 g crystalline amino acids postoperatively. The investigators found that
complications occurred in 18.3% of the patients receiving nutrition and in 33.5% of
the control patients (P = 0.012). Fourteen patients died in the control group and 5 in
those receiving nutrition. There were significant differences in the mortality between
the two groups (2.1% vs 6.0%, P = 0.003). The total length of hospitalization and
postoperative stay of control patients were significantly longer (29 vs 22 d, P = 0.014)
than those of the studied patients (23 vs 12 d，P = 0.000).So they concluded that
Perioperative nutrition support is beneficial for moderately or severely malnourished
gastrointestinal cancer patients and can reduce surgical complications and mortality
[25].
A study by Bragara, et al. in 2002, focused on such a population with weight
loss of >10% of body weight over the preceding 6 months who were randomly
assigned to 3 different treatments: pre- and postoperative immunonutrition,
preoperativeimmunonutrition plus postoperative control solution, and postoperative
control solution only. The group receiving immunonutrition both before and after
surgery had fewer complications than those fed control solution postoperatively.
Although the statistical analysis did not confirm this, use of immunonutrition both
before and after surgery in malnourished patients showed a trend toward being the
best treatment, so perioperative immunonutrition seems to be the best approach to
support malnourished patients with cancer [26].
A prospective clinical trial in 2005 done by Kłek S et al. of a group of 105
patients operated on for gastric carcinoma between 2001–2003.During the
postoperative period, patients were randomly allocated to one of three groups :
standard PN (A), PN + glutamine (B) and PN + omega-3-FA (C). The minimal time
6
of parenteral nutrition in each of three groups was 7 days, and maximal 11 days in
groups A and C, and 10 days in group B. postoperative infection complications were
observed in 11 patients (36.6 per cent) in group A, in 7(23.3 per cent) in B and in 8
(26.6 per cent) in C. The difference between group A and the others was not
significant (A vs. B p = 0.13, A vs. C – p = 0.2) [27].
In 2014 Metry A et al. conducted a prospective randomized double-blinded
study was designed to compare between two groups of postsurgical ICU patients.
Group I and group II. Both the groups were given total parentral nutrition for not less
than 7 days postoperatively. Group I was given Intralipid as a source of fat, and
Group II was given SMOFlipid in substitution of intralipid. In this study, they found
that the clinical outcomes including duration of ventilation, days of ICU stay, days of
hospital stay, 1 week mortality and 1 month mortality showed a non- statistically
significant difference between the two study groups, although it was less in SMOF
lipid group [28].
In 2012 Pradelli L, et al. found that in 23 randomized controlled trials (n =
1,502 patients; n = 762 admitted to the ICU) were included in meta-analysis
comparing ω-3 PUFA-enriched lipid emulsions with standard non-enriched lipid
emulsions (i.e. soybean oil, MCT/LCT or olive/soybean oil emulsions) in surgical and
ICU patients receiving parenteral. No statistically significant difference in mortality
rate was found between patients receiving ω-3 PUFA-enriched lipid emulsions and
those receiving standard lipid emulsions, possibly reflecting a relatively low
underlying mortality risk. However, ω-3 PUFA-enriched emulsions are associated
with a statistically and clinically significant reduction in the infection rate and the
lengths of stay, both in the ICU and in hospital overall nutrition. Pooled data indicate
important and significant positive effects of ω -3 PUFA-enriched parenteral regimens
over a wide range of outcomes in the selected patient populations. Subgroup analysis
shows that the magnitude of these effects for some of the outcomes varied between
ICU patients and elective surgery patients [29].
Another study done by Senkel M, etal.randomized 164 patients with upper GI
cancer to receive postoperative jejunostomy feedings with IMN or control feeding.
This trial started feedings at 20 mL/hr 12–24 hours postoperatively, and advanced to
goal rate by postoperative day 5. The authors reported that overall complications, and
early postoperative complications (up to day 5) were similar between groups, but that
late phase complications (after day 5) were significantly less in the IMN group (5
IMN vs 13 control, p < 0.05). This study has been categorized as a negative study in
some reviews that mention only the lack of significance overall, but the results
demonstrate a significant reduction in complications once patients actually received
reasonable amounts of the IMN formula [30].
One study done by Gianotti L, et al. In 2002 compared the effects of
preoperative IMN with no nutrition support in 305 patients scheduled for elective GI
cancer surgery. Patients with <10% weight loss were randomized to one of three
groups:
1. Oral IMN (1L/day) for 5 days prior to surgery, with no post-op nutrition support,
2. Oral IMN for 5 days, with postoperative jejuna IMN, or
3. No specialized nutrition support before or after surgery.
7
The investigators reported a significant reduction in postoperative infections
and hospital length of stay in both IMN groups compared to those who did not receive
nutrition support [31].
A study was done by Helminen, et al. In 2007one hundred patients with a
planned elective operation for benign or malignant gastrointestinal illness were
randomized into two groups: group 1) oral supplementation for five days before and
five days after surgery with 900 mL/day of a formula enriched with arginine,
glutamine, omega-3-fatty acids and ribonucleic acid (rNA) + liquid diet ad libitum on
one and two postoperative day and then solid food (immunonutrition group; n = 50)
or group 2) no artificial nutrition before and after surgery, on one and two
postoperative day intravenous solution of 5% glucose and electrolytes and then
normal diet (conventional group; n = 50).
The groups were comparable for all key baseline and surgical characteristics.
there were nine (18%) infectious complications in both groups. overall complication
rates were 28% (n = 14) in the immunonutrition group and 24% (n = 12) in the
conventional group. No significant difference between the groups was found in
complication rates, mortality or length of hospital stay. The investigators found that
routine perioperative immunonutrition to the patients undergoing major
gastrointestinal surgery is not beneficial [32]. This result opposite to our results. The
small number of patients studied in a single institution, limiting the generalizability of
our conclusions.
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Table (1): Personal characteristics of the studied groups, South Egypt Cancer
Institute, 2014
Group I
(n= 15)
Group II
(n= 15)
Group III
(n= 15)
No.
%
No.
%
No.
%
Male
5
33.3
8
53.3
3
20.0
Female
10
66.7
7
46.7
12
80.0
P-value
Sex:
0.158
Age: (years)
Mean ± SD
53.60 ± 8.35
50.67 ± 6.22
52.40 ± 7.44
Range
35.0 – 64.0
40.0 – 62.0
42.0 – 69.0
0.118
Table (2): Body weight pre-operatively and 1, 3 and 7 days post-operative of the
studied groups, South Egypt Cancer Institute, 2014
Group I
Time
days
Group II
Group III
Mea
n
SD
Mean
SD
Mean
SD
P-value group
interaction
59.67
7.43
61.67
8.16
67.13
8.55
< 0.001
in
Preoperative
10
Day1 post
58.20
7.26
61.13
7.99
65.13
8.37
Day3 post
58.63
6.97
60.53
7.99
65.33
8.34
Day7 post
58.93
6.97
60.27
7.90
65.67
8.25
P
value
for time
effect in
each
group
P
value
for overall
Time
effect
0.009
0.63
< 0.001
< 0.001
Figure (3): Body weight pre-operatively and 1, 3 and 7 days post-operative.
11
Table (3): Complications.
Complications
Group
(n= 15)
I Group II GroupIII
(n= 15)
(n= 15)
No.
No.
%
Fistula
44
226.7 33
220.0 55
333.3
00.711
Wound infection
44
226.7 55
333.3 44
226.7
00.897
Pulmonary tract infection
22
123.3 33
220.0 11
66.7
00.562
Urinary tract infection
00
0.0
11
66.7
00
00.0
00.360
Intra-abdominal infection
11
66.7
00
00.0
00
00.0
00.360
12
%
No.
P-value
%