enteral vs parenteral nutrition after major abdominal surgery

8/13/2019 enteral vs parenteral nutrition after major abdominal surgery

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ceived1665 72.8 kcal/d. The mean SD amount of nitro-gen infused per day was 10.30.2g and 12.80.1g for theEN and TPN groups, respectively.

Seven (5.9%) of the 119 patients assigned to the ENgroup and 3 (2.5%) of the 122 patients assigned to theTPN group died during the postoperative period. The dif-ference was not statistically significant.

The rates of major postoperative complications weresimilar in the 2 groups: 45 (37.8%) of the 119 patients

receiving EN and 48 (39.3%) of the 122 patients of theTPN group had such complications.

The rates of major infectious complications weresimilar in the 2 groups: 17 (14.3%) of the 119 patientsreceiving EN and 14 (10.7%) of the 122 receiving TPNhad such complications. Similarly, there were no differ-ences between the EN and TPN groups considering non-infectiouscomplications; the rates being 23.5% and27.9%,respectively.

The rates of minor postoperative infectious compli-cations and noninfectious complications were compa-

rable in the EN and TPN groups. The rates of individualcomplications and the relative risk and confidence in-tervals are presented inTable 4.

Duration of postoperative hospital stay was 15.23.6daysin the ENgroupand 16.14.5days inthe TPN group.The most common treatment-related complications in theEN group were abdominal bloating (3 cases), diarrhea(4 cases), and occlusion or displacement of the enteraltube (4 cases). Chylous fistula (2 cases) and hemor-

rhage from jejunostomy (1 case) were also observed.Among patients in the TPN group, 5 experienced mildmetabolic complications (transient hypoglycemia in allcases), and 2 had central venous catheter sepsis.

No patients from TPN group required interruptionof parenteral feeding due to nutrition-related complica-tions,whereasEN wasstopped in14patients(11.8%).These14 patients were crossed over to TPN by a peripheral orcentral route in 9 and 5 cases, respectively; however, forthe analysis of postoperative complications, they wereincluded in the EN group.

PATIENTS AND METHODS

The protocol of thestudywas approved by theethical com-mittees of the participating centers. Informed consent wasobtained from the patients before entering the study.

All patients between the ages of 18 and 80 years whowere admitted to surgical units of the participating cen-ters from January 1996 to June 1998 and who were candi-dates for nonemergency abdominal surgery (excludingappendectomy, cholecystectomy, and viscerolysis) werescreened for the presence of malnutrition according to theNutritional Risk Index: [1.519 serum albumin level(grams per deciliter)] + [0.417 (actual weight/usualweight)] 100.14,15 All patients with an index less than90% were potentially eligible for the study. The patientswho entered the study were assigned by computer-generated random numbers to the EN group or to theTPN group. All patients in the TPN group had a centralvenous catheter inserted at the time of surgery; by con-trast, in the EN group, a central venous catheter was notrequired by protocol. However, if a central venous cath-eter had been positioned immediately before or during theoperation for monitoring or fluid administration or both,

it also was used during the postoperative course in the ENgroup. In patients randomized to receive EN, a needle-catheter jejunostomy or a nasojejunal tube was insertedintraoperatively in the proximal jejunum. Feeding wasinitiated at 9 AM on the first postoperative day in bothgroups. The parenteral formula contained 0.2 g/kg perday of nitrogen and 25 nonprotein kcal/kg per day (30%lipids), with supplemental vitamins and minerals.

The enteral feed used was Nutrison (Nutricia, Zoe-termeer, the Netherlands),providing 1 kcal/mL,40 g of pro-teins per liter, 123 g of carbohydrates per liter, 38.9 g oflipids per liter, plus supplemental vitamins and minerals.The enteral feed began with a full-strength formula intro-duced at 30 mL/h, and increased gradually, depending ontolerance, up to a goal of 25 kcal/kg per day, comparable

with that of the TPN group. During the induction time of

EN (up to 3 days), TPN was added to achieve the samecaloric intake of the TPN group. According to protocol, allpatients in both the TPN and EN groups continued theirnutritional regimens until oral intake was resumed, with atarget of 1000 mL of fluids per day. If oral intake was notresumed after 10 days or if a complication occurred por-tending prolonged restriction of oral intake, either EN orTPN could be instituted by the surgeons of the participat-ing centers according to the availability of access and thetype of complication.

All patients received short-term perioperative anti-biotic prophylaxis and a subcutaneous injection of low-molecular-weight heparin sodium (3000 IU/d) as deepvenous thrombosis prophylaxis.

The patients were monitored for postoperative com-plications and mortality by physicians not associated withthe surgical teams. Complications were classified by ob-

jective criteria as major or minor, and as infectious or non-infectious (Table 1) according to a previously describedclassification.16

The primary objective for comparison was the inci-dence of major postoperative complications. Based on pre-vious studies performed on our surgical population,17 weanticipated a 40% incidencerate of major postoperative com-

plications in theTPN group. A reductionof this rate by half(to 20%) in the EN group would be considered clinicallyimportant.

Detectinga difference of this magnitudeor greater, witha level of statistical significance ofP =.05 and a power of0.90 with a 2-tailed test of proportions, would require atotal of 118 patients in each group. Thus, the goal total forthe accrual of patients was 240 patients for the final out-come analysis.

Continuous variables were compared by analysis ofvariance and categorical variables by the Fisher exact test.Analysis of categorical covariates was performed using theMantel-Haenzsel technique. All statistical analyses were2-tailed andbasedon theintention-to-treat concept (ie, pa-tients randomized to receive EN who crossed over to TPN

were analyzed in the EN group).

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2001 American Medical Association. All rights reserved.

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COMMENT

Although it has been demonstrated for many years18 thatthe interruption of the natural nutrition mechanism (asobserved after surgery of the digestive tract) quickly ex-hausts the carbohydrate store, leading to use of the pro-tein compartment as an alternative source of energy, therole of postoperative nutritional support has not yet been

completely investigated.19As far as the efficacy of postoperative nutritional sup-

port is concerned, no study to date clearly shows that thisprocedure reduces postoperative complications whencompared with controls (this includes not only controlsin normonourished patients, as we have previously dem-onstrated,16 but also in the malnourished ones19).

As far as the route of feeding is concerned, many ar-guments are still open for debate.1

First, the role of the enteral route in modifying theintestinal barrier function, and therefore the clinical out-

come in patients undergoing major digestive surgery, hasbeen questioned.13-20 Second, the efficacy of immune-enhanced EN, although suggested by many recent stud-ies,21 has not yet been confirmed from either the statisti-cal or clinical points of view.21,22 Third, the majority of the

studies concerning this topic are characterized by inad-equate patient selection in consequence of the inclusionof normonourished patients,23,24 small size,7,25-27 and in-sufficient definition of complications.19 The present studywasthereforedesignedwith theaimof overcomingalltheseproblems through adequate statistical power, a clear defi-nition of patient population, and precise outcome mea-sures. Theresults showedno significant reduction of mor-bidity andmortality when postoperativeEN wascomparedwith postoperative TPN. Even when subdividing post-operative complications into different types (minor and

Table 1. Classification of Postoperative Complications

Major infectious

Pneumonia

Abdominal abscess

Fasciitis

Bacteremia

Septic shock

Septic coagulopathy

Major noninfectious

Anastomotic leak

Wound dehiscence

Gastrointestinal complications

BleedingPerforation, obstruction, and ischemia

Pancreatitis

Cardiovascular complications

Myocardial infarction

Cardiogenic shock

Cardiopulmonary arrest

Stroke

Pulmonary embolus

Hemoperitoneum

Pulmonary failure

Renal failure

Grade I

Grade II

Minor infectious

Wound infections

Urinary tract infectionMinor noninfectious

Pleural effusion

Hepatic dysfunction

Table 2. Baseline Characteristics of Randomized Patients*

EN TPN

No. of patients 119 122

Age, y 61.5 10.8 61.6 11.8

Sex (M/F) 73/46 72/50

Nutritional status

Body weight, kg 65.1 10.4 67.1 10.7

% Usual weight 85 4.2 85 4.7

Serum albumin level, g/L 36 3.6 36 3.7Diagnosis

Gastric cancer 64 53

Colorectal cancer 20 28

Pancreatic cancer 9 14

Cholangiocarcinoma 6 7

Other GI cancers 11 9

Benign GI disease 9 11

*All data are presented as number of patients or mean SD. EN indicatesenteral nutrition; TPN, total parenteral nutrition; and GI, gastrointestinal.

Indicates diverticular disease, pyloric stenosis, or chronic pancreatitis.

Table 3. Operative Factors*

Type of ProcedureEN

(n = 119)TPN

(n = 122)

Type of procedure

Esophagectomy 9 7

Total gastrectomy 46 30

Distal subtotal gastrectomy 18 24

Anterior resection of rectum 4 6

Colon resection 16 22

Pancreatoduodenectomy 14 15

Biliodigestive anastomosis 4 2

Multiple abdominal organ resection 3 9

Other 5 7

Intraoperative contamination

No contamination 78 74

Mild contamination 37 45

Severe contamination 4 3

Intraoperative blood lossNone 81 78

1 U 5 8

2 U 20 25

3 U 13 11

*All values are presented as number of patients. EN indicates enteralnutrition; TPN, total parenteral nutrition.

The EN-TPN Study Group

The following members participated in patient random-ization and data collection: Messina, Italy: M. L. Ter-ranova, MD.Naples, Italy:M. De Siena, MD.Rome, Italy:G. Capuano, MD. Siena, Italy: N. Calomino, MD. Torino,Italy: P. Cotogni, MD. Velletri, Italy: M. Gravani, MD. Ve-rona,Italy: A. Fontana, MD;G. Motton, MD. Viterbo,Italy:A. Goglia, MD; G. Delle Monache, MD; M. Piciollo, MD.



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major, infectious and noninfectious), we observed no sta-tistically significant differences between the 2 groups.

Moreover, although the study population was com-posed of high-risk malnourished patients affected by can-cer in the majority of cases (91.7%), the high incidenceof postoperative complications in both groups brings toquestion the efficacy of postoperative support in itself.In fact, patients in the present study seemed not to ben-efit from postoperative artificial feeding, confirming that,as millions of years of evolution have shown, in injured

mammals, food is not a top priority.However, because it is difficult from an ethical point

of view to defend starvation as a standard managementof malnourished surgical patients, more well-designedstudies comparing standard EN or TPN with immune en-hancing formulas are now urgently required. In conclu-sion, the present study, according to recently publishedfigures,1 failed to demonstrate that immediate EN withstandard diet following major abdominal surgery re-duces postoperative complications and mortality whencompared with TPN.

Corresponding author and reprints: Fabio Pacelli, MD, De-partment of Digestive Surgery, Istituto di Clinica Chirur-gica, Catholic University School of Medicine, Largo A. Ge-melli, 8, 00168 Rome, Italy (e-mail: [email protected]).

REFERENCES

1. Lipman TO. Grains or veins: is enteral nutrition really better than parenteral nu-trition? A look at the evidence. JPEN J Parenter Enteral Nutr. 1998;22:167-182.

2. Howard L, Ament M, Fleming CR, Shike M, Steiger E. Current use and clinical

outcome of home parenteral andenteralnutritiontherapies in theUnited States.Gastroenterology. 1995;109:355-365.

3. BowerRH,TalaminiMA, SaxHC, HamiltonF, FisherJE. Postoperativeenteralvs par-enteral nutrition: a randomized controlled trial. Arch Surg.1986;121:1040-1045.

4. Adams S, Dellinger EP, Wertz MJ, Oreskovich MR, Simonowitz D, Johansen K.Enteral versus parenteral nutritional support following laparotomy for trauma: arandomized prospective trial. J Trauma. 1986;26:882-891.

5. Moore FA,FelicianoDV, Andrassy RJ,et al.Early enteral feeding,comparedwithparenteral, reduces postoperative septic complications: the results of a meta-analysis.Ann Surg. 1992;216:172-183.

6. Kudsk KA, Croce MA, Fabian TC, et al. Enteral versus parenteral feeding: effectson septicmorbidityafter bluntand penetrating abdominal trauma.AnnSurg. 1992;215:503-513.

7. Muggia-Sullam M, Bower RH, Murphy RF, Joffe SN, Fischer JE. Postoperativeenteralversus parenteral nutritional supportin gastrointestinalsurgery: a matchedprospective study.Am J Surg. 1985;149:106-112.

8. Hamaoui E, Lefkowitz R, Olender L, et al. Enteral nutrition in the early postop-erative period: a new semi-elemental formula versus total parenteral nutrition.JPEN J Parenter Enteral Nutr.1990;14:501-507.

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11. Baigrie RJ, Devitt PG, Watkin DS. Enteral versus parenteral nutrition after oe-sophagogastric surgery: a prospective randomized comparison. AustNZJSurg.1996;66:668-670.

12. Braga M, Vignali A, Gianotti L, Cestari A, Profili M, Carlo VD. Immune and nu-tritionaleffects of early enteral nutrition after major abdominaloperations. Eur JSurg. 1996;162:105-112.

13. Reynolds JV, Kanwar S, Welsh FK, et al. 1997 Harry M. Vars Research Award:does therouteof feeding modifygut barrier functionand clinical outcome inpa-tients after major upper gastrointestinal surgery?JPEN J Parenter Enteral Nutr.1997;21:196-201.

14. Buzby GP, Knox LS, Crosby LO, et al. Study protocol: a randomized clinical trialof total parenteral nutrition in malnourished surgical patients. Am J Clin Nutr.1988;47(suppl 2):366-381.

15. The Veterans Affairs Total Parenteral Nutrition Cooperative Study Group. Peri-operative total parenteral nutrition in surgical patients.N Engl J Med.1991;325:525-532.

16. Doglietto GB, Gallitelli L, Pacelli F, et al. Protein-sparing therapy after major ab-dominal surgery: lack of clinical effects. Ann Surg. 1996;223:357-362.

17. Bellantone R, DogliettoGB, Bossola M, et al. Preoperative parenteralnutritioninthe high risk surgical patient. JPEN J Parenter Enteral Nutr. 1988;12:195-197.

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Table 4. Postoperative Complications*

Type of ComplicationsEN

(n = 119)TPN

(n = 122)

Major infectious

Pneumonia 10 5

Abdominal abscess 5 7

Septic shock 1 2

Bacteremia 1 2

Total 17 16No. (%) of patients affected 17 (14.3) 14 (10.7)

Major noninfectious

Anastomotic leak 10 14

Digestive fistulas 4 3

Wound dehiscence 5 9

Gastrointestinal tract complications 4 2

Hemoperitoneum 3 5

Myocardial infarction 1 . . .

Pulmonary failure 6 4

Renal failure . . . 3

Total 33 40

No. of patients affected (%) 28 (23.5) 34 (27.9)

Minor infectious

Wound infections 8 7

Urinary tract infections 1 2

Fever 14 15Total 23 24


Minor noninfectious

Pleural effusion 12 10

Atelectasis 7 2

Total 19 12


*All data are presented as numbers unless otherwise indicated. EN indicatesenteral nutrition; TPN, total parenteral nutrition; and ellipses, not applicable.The relative risk (95% confidence interval) for major infectious complicationsis 1.14 (0.76-1.71); for major noninfectious, 0.90 (0.68-1.17); for minorinfectious, 1.01 (0.74-1.40); and for minor noninfectious, 1.22 (0.76-1.95).All relative risks were calculated as a ratio of EN:TPN.Pwas not significant.

The total number of patients shown is less than the sum of the patientslisted as having individual complications because many patients had more than

1 complication.Gastrointestinal tract complications include bleeding, obstruction,perforation, ischemia, and acute pancreatitis.



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enteral vs parenteral nutrition after major abdominal surgery

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