Enteral Nutrition in the Early Postoperative Period: A New Semi-Elemental Formula Versus Total Parenteral Nutrition ELIE HAMAOUI, M.D., ROSE LEFKOWITZ, R.P.A.-C., LYNDA OLENDER. R.N., B.S.N., C.N.S.N., ELISSA KRASNOPOLSKY-LEVINE, M.S., R.D., MARIA FAVALE, R.PH., HUELDINE WEBB, M.D., AND EDDIE L. HOOVER, M.D. From the Nutrition Section and

Surgical Service, Veterans Administration Medical Center, Brooklyn,

ABSTRACT. Several studies have reported that gastrointestinal (GI) intolerance symptoms are the limiting factor to enteral alimentation in the immediate postoperative period and often the reason for resorting to total parenteral nutrition (TPN). We postulated that Reabilan HN (a recently developed small peptide-based formula, in part obtained by enzyme hydrolysis of proteins) might be better absorbed and better tolerated so as to avoid the need for TPN. Accordingly, 19 patients

undergoing major abdominal

were randomly assigned jejunostomy or an equicaloric isonitrogenous TPN regimen. Both were begun 6 hr postoperatively at 25 ml/hr and increased by 25 ml/hr at 12-hr intervals up to the rate providing 1.5 times the calculated REE. GI tolerance to enteral feeding was excellent during the first three postoperative days, allowing the progression of the feeding rate to 99% of goal. During the next 3 days (starting on average 1.7

surgery

to receive Reabilan HN via

Parenteral nutritional support is utilized in patients whose gastrointestinal (GI) tract cannot or should not be used.’ Patients who have undergone major abdominal surgical procedures often receive parenteral nutritional support pending return of adequate GI function, the obstacles being the presence of postoperative intestinal ileus or the desire on the part of the surgeon to delay enteric flow through an anastomotic site or to reduce the output of an enterocutaneous fistula and facilitate its closure.’ In addition, the patient who is already malnourished may have a prolonged period of postoperative ileus3°4 and may also have impaired digestion and absorption.5 In such cases usage of parenteral nutrition can prevent the development or exacerbation of malnutrition and can thereby reduce postoperative morbidity and

mortality significantly.66 However, although total parenteral nutrition (TPN) can be life-saving, it can itself generate a wide array of complications (mechanical, septic, and metabolic) .7 It also adds substantially to hospital costs.’ For these reato utilize the gut in such patients.9-14 Most of the recent trials 15-17 have generally used elemental or semi-elemental formulas infused into the jejunum and have met with variable success, with GI intolerance symptoms being the main limiting factor. We report here a prospective randomized study comsons

New York

after the return of bowel sounds), GI intolerance symprequired a reduction in feeding rate to 52% on average. Subsequently, the symptoms resolved and the feeding rate reached 96% of goal. Although overall mean daily calorie and nitrogen intakes were lower for the enteral than for the TPN group (79.6 ± 10.2% vs 94.6 ± 3.8% of goal; p < 0.01), the enteral group was nevertheless in positive caloric and nitrogen balance, and maintained similar serum albumin, prealbumin, and plasma transferrin levels. Average daily cost of supplies was $44.36 for enteral us $102.10 for parenteral nutrition (p < 0.001). We conclude that enteral feeding using this formula is well tolerated and cost-effective in the immediate postoperative period. Further studies of GI motility in the postoperative period, specifically during the 2 to 3 days following the return of bowel sounds, seem crucial to achieving further progress in postoperative enteral feeding. (Journal of Parenteral and Enteral Nutrition 14: 501-507, 1990)

days

toms

paring a new small peptide-based formula, Reabilan HN (see Table I) with TPN in the early postoperative period. The most unique feature of this semi-elemental formula is that its protein content is in the form of small peptides obtained by enzyme hydrolysis (trypsin and chymotrypsin). The presumed advantage of this process is that it duplicates normal protein digestion by upper gut enzymes. The result would be small peptides similar (in length and in C- and N-terminal amino acids) to those produced by normal digestion and hence presumably ideally suited for immediate absorption in the small intestine. We postulated that this feature, together with its low osmolarity (390 mOsm/liter) and the fact that most of its fat is in the form of medium chain triglycerides, should greatly facilitate absorption and thereby minimize the occurrence of GI intolerance symptoms. Our aims were (1) to study the tolerance to this formulation in the immediate postoperative period and (2) to compare it to TPN in nutritional efficacy and in cost. MATERIALS AND METHODS

attempts have been made

All patients about to undergo a major abdominal surgical procedure such that oral intake would expectedly be precluded for a week or longer postoperatively were eligible for inclusion in the study provided they had no disease requiring fluid or protein restriction such as would interfere with nutritional regimen. and provided they agreed to participate in the study. The patients were

randomized to receive Reabilan HEX (enteral group) or TPN according to a randomization table, except that. in

Reprint requests: Dr. Elie Hamaoui. Chief, Nutrition Section (111G), VA Medical Center, 800 Poly Place, Brooklyn, NY 11209. 501 501

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502 ensure sufficient data to answer the question on postoperative tolerance to this new formula, the decision was made midway through the study to prospectively

order to

enroll the next four available subjects in the enteral group and subsequent patients into the TPN group to attempt equalization of group size. The enteral group received Reabilan HN into the jejunum via a percutaneous temporary feeding jejunostomy performed during to the main surgical procedure or via a transgastrostomy tube. The TPN group received a TPN formulation consisting of amino acids 8.5% (Freamine III) and 70% dextrose in a proportion that duplicated the caloric contribution of protein (17.5%) and carbohydrate (47.5%) in the enteral formula. Intralipid 10% or 20% in units of 250 or 500 ml was used separately to supply the remaining 35% of calories. Multivitamins (MVI-12) and trace elements (MTE) were added in standard amounts. Electrolytes were added in standard or modified amounts as required. Both feeding regimens were begun 6 hr postoperatively at a pump-controlled rate of 25 ml/hr and increased by 25 ml/hr every 12 hr up to a caloric intake of 1.5 times the calculated resting energy expenditure (REE), except that for the TPN patients, fat was provided as a separate daily 6 hr infusion. REE was calculated using the HarrisBenedict equation with an added factor of 15% for operative stress. This nutritional support was continued until oral intake could be resumed or a complication occurred requiring its discontinuation. All patients were monitored clinically daily for postoperative complications as well as for complications of enteral or parenteral feeding. Monitored parameters included a complete blood count and white cell differential,

aration and administration (Table II) was monitored and daily cost of these supplies to the hospital was computed based on the purchase price. (This cost does not include labor cost or indirect hospital costs and is not to be equated with charges that might appear on a patient’s

hospital bill). Results were reported as a mean ± SD and compared for statistical significance by the Student’s t test. Data pertaining to nutritional effectiveness (e.g. serum protein changes, N balance) were included in the analysis only if the patient remained in the study for 7 or more days. Data pertaining to formula tolerance or cost of nutritional support were included regardless of the length of time spent in the study. The study protocol was approved by the Subcommittee on Human Studies of the Veterans Administration Medical Center, Brooklyn, New York. Informed signed consent was obtained from all subjects prior to enrollment in the study. RESULTS

A total of 19 patients were enrolled into the study, 11 in the enteral group and 8 in the TPN group. As shown in Table III, the two groups of patients were similar in age, degree of weight loss, and initial serum albumin, prealbumin and transferrin levels. Their primary diagnoses (mostly GI neoplasms) were also similar (Table

IV). Three patients from each group were studied for less than 7 days. In the enteral group the reasons for discontinuation from the study were dislodgment of a jejunostomy tube on day 2 (1 patient), death on day 3 due to heart disease (1 patient), and development of multiple

glucose, electrolytes, urea, creatinine, calcium, postoperative septic complications-including empyema phosphorus, magnesium, transaminases, alkaline phos- and wound infection on day 2 (1 patient). None of these phatase, bilirubin, total proteins, albumin, prealbumin was considered a complication of the tube-feeding. and plasma transferrin. Urine was collected daily and In the TPN group, reasons for early discontinuation analyzed for urea and creatinine. Stools produced during of TPN included resumption of oral alimentation on day the study period were weighed, and an average output in 4 (1 patient) or day 5 (1 patient) and inability to achieve g/day was calculated. Total nitrogen excretion was de- glucose control by day 5 (1 patient). rived from the 24-hr urine urea nitrogen (in grams) + 2, plus 0.012 g/kg of ideal body weight for GI losses and Enteral Intake and Tolerance 0.005 gm/kg for insensible nitrogen losses .2’ Because of the variability in stool output (especially when comparFigure 1 shows the daily intake of each of the enterally ing patients fed enterally us those fed parenterally), the fed patients as a percentage of his nutritional goal. empirically calculated stool nitrogen (12 mg/kg ideal During the first three days of feeding there were few GII body weight) was adjusted using the ratio of measured intolerance symptoms. This allowed the planned prostool output over the accepted upper limit of normal for gression of the feeding rate by day 2, up to 85 to 116% daily stools weight (200 g).29 Nitrogen balance was ob- of the daily caloric goal (mean 99.25 ± 11.6%) in all tained by subtracting total nitrogen excretion from the available patients except one in whom the feeding pronitrogen in the enteral or parenteral fluids. gression was delayed due to a misunderstanding of orUtilization of all supplies pertaining to nutrient prep- ders. serum

TABLE I

Protein/calorie composition of Reabilan

*

Obtained

by trypsin

and

chymotrypsin hydrolysis

of

HN

whey and casein.

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503 TABLE II Nutritional support supplies monitored

TABLE III

Comparison of initial data (mean -L SD) between TPN group*

*

None of the differences

are

the enteral and the

statistically significant. TABLE IV

of the study (days 6-8). As expected, the mean daily stool output was greater in the enteral than in the TPN group (93.1 ± 68.5 g/day us 22.2 ± 35.3 g/day, p < 0.05), although less than half of the accepted upper limit of normal, 200 g/day. The mean daily intake for all 11 patients was 76.3 ± 14.9% of the planned goal. If data from the three patients who were discontinued early from the study are discounted, the mean daily intake is 79.6 ± 10.2%. Interestingly and unexpectedly, no GI symptoms were noted during the period of postoperative ileus. In fact, the above noted reductions in feeding rate occurred on average 1.7 days after the return of bowel sounds.

days

Diagnoses

TPN Intake and Tolerance

Except for the patient whose high blood glucose level prevented his TPN rate progression, the patients on TPN achieved 94 to 107% of their target rate by day 2 or 3 (mean 99.7 ± 5.1%). Individual day to day calorie intake fluctuated because the fat component of their diet given as a variable number of units of 550, 500, or 1000 kcal each day, calculated to average, over the study period, 35% of their caloric goal. The average daily intake for all 8 TPN patients was 87.3%. Discounting the data of the 3 patients studied for less than 7 days, the mean daily intake is 94.6 ± 3.8’c, which is significantly greater than the mean daily intake achieved in the enteral group

was

In contrast, during the next three days of the study each of the 8 patients in the enteral group experienced at some point abdominal distention, cramps, or diarrhea which led to the reduction of the feeding rate to 22 to 76% of the daily caloric goal (mean 52.5 ± 17.5%) during one of these 3 days. No patient required total discontinuation of the feeding. Subsequently, however, the GI symptoms abated and the feeding rate was again increased, reaching 80 to 111 % of goal (mean 96 ± 12.5%) during the next two to three

(days 3-5),

(p
0.10), it might be argued that with a larger sample, statistical significance might be achieved. However, in view of the large variance within groups, it is also possible for the difference in means to shrink or even be reversed if a larger sample were used. From a clinical standpoint, there is little difference between 0.9 and 0.4 abnormalities per day-both indicate a need for daily monitoring. Such frequency of monitoring is probably more related to the fact that our patients were acutely ill postoperative patients than to their receiving nutritional support, whether enteral or parenteral. Since no one has ever found enteral feeding to be as expensive as TP~T, we were not surprised by our lower cost for enteral feeding. In fact, hot~~e~-er. the difference in cost would have been greater if our cost analysis had

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506

included labor costs and incidental costs. Comparison of the number of items required for TPN preparation and administration us that needed for enteral feeding ( 60 items us 11 items, as shown in Table VI) suggests that handling costs alone must be severalfold greater for TPN than for enteral nutrition. It is notable that the cost of non-nutrient supplies required for TPN preparation and administration is by itself greater than tine entire cost of enteral feeding. Finally, and perhaps most worrisome, is the fact that the need to focus on so many more details in TPN than in enteral therapy increases the chance of human error. This can lead to greater wastage of the already more expensive TPN supplies and more frequent clinical complications. Such complications carry the potential for more serious consequence, because TPN is much more invasive than enteral feeding. The fact that in a carefully conducted and relatively small study such as this one we did not observe more complications in the TPN group does not negate that risk, particularly when TPN is provided in a non-study setting. Thus the potential cost of TPN may be much larger than would appear from cost analysis of labor, supplies and incidental costs. This means that the actual cost saving achieved by using enteral nutritional support instead of TPN is greater than would appear from a comparison of cost of supplies for the two therapies. The potential saving may be even greater because of the avoidance of the more costly errors of TPN. We conclude that enteral feeding using this new semielemental forrnula is sufficiently well tolerated even during the immediate postoperative period to achieve nutritional results comparable to those of TPN, though at a much lower cost. The transient GI intolerance noted in all patients following the return of bowel sounds appears to represent a passing stage during the recovery from postoperative ileus rather than a true adverse effect of this formulation. Further studies of GI motility in the postoperative period are indicated in order to allow even more effective enteral nutritional support and less dependence on TPN. ACKNOWLEDGMENTS

The help of Ann Sellitti in manuscript preparation is

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Enteral nutrition in the early postoperative period: a new semi-elemental formula versus total parenteral nutrition.

Several studies have reported that gastrointestinal (GI) intolerance symptoms are the limiting factor to enteral alimentation in the immediate postope...
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