Postoperative enteral versus parenteral nutrition in malnourished patients with gastrointestinal cancer: a randomised multicentre trial

doi:10.1016/S0140-6736(01)06578-3

The Lancet

Volume 358, Issue 9292, 3 November 2001, Pages 1487-1492

https://doi.org/10.1016/S0140-6736(01)06578-3 Get rights and content

Summary

Background

Although current opinion favours the use of enteral over parenteral nutrition, the clinical benefits of early postoperative nutrition in patients undergoing elective surgery have never been clearly shown. We aimed to test the hypothesis that postoperative enteral nutrition is better (fewer postoperative complications) than parenteral nutrition containing similar energy and nitrogen amounts (112 kJ kg⁻¹day⁻¹ and 1·4 g aminoacid kg⁻¹day⁻¹).

Methods

We did a randomised multicentre clinical trial in patients with gastrointestinal cancer who were malnourished and candidates for major elective surgery. 159 patients were assigned to enteral nutrition and 158 to parenteral nutrition. The primary endpoint was the occurrence of postoperative complications, and secondary endpoints were length of postoperative hospital stay, adverse effects, and treatment crossover. Analysis was by intention to treat.

Findings

Postoperative complications occurred in 54 (34%) patients fed enterally versus 78 (49%) fed parenterally (relative risk 0·69, 95% Cl 0·53–0·90, p=0·005). Length of postoperative stay was 13·4 days and 15·0 days in the enteral nutrition and parenteral nutrition groups, respectively (p=0·009). Adverse effects occurred in 56 (35%) patients fed enterally versus 22 (14%) patients fed parenterally (2·50, 1·61–3·86, p>0·0001). 14 (9%) patients on enteral nutrition had to switch to parenteral nutrition, whereas none of those fed parenterally crossed over to enteral feeding.

Interpretation

We conclude that early enteral nutrition significantly reduces the complication rate and duration of postoperative stay compared with parenteral nutrition, although parenteral nutrition is better tolerated than enteral nutrition.

Introduction

A compelling scientific and clinical rationale lends support to the use of enteral nutrition rather than intravenous nutrition and bowel rest in patients after injuries such as major surgery. In human beings, total parenteral nutrition is associated with an exaggerated acute phase and metabolic response after injury or endotoxin challenge, effects which are blunted by enteral nutrition.1, 2, 3, 4 Furthermore, Harrison and colleagues⁵ recently reported that early postoperative enteral nutrition in patients with upper gastrointestinal cancer undergoing curative resection results in an improvement in protein kinetics, net balance, and aminoacid flux across peripheral tissue compared with intravenous nutrition.

However, the clinical benefits of postoperative enteral nutrition over parenteral nutrition in malnourished patients undergoing surgery have never been consistently substantiated by clinical trials. In fact, only five small comparative trials6, 7, 8, 9, 10 have shown a benefit of enteral nutrition, namely a lower infection rate6, 10 and a shorter postoperative stay,7, 8, 9 whereas Smith and colleagues¹¹ reported a longer postoperative stay in 50 patients randomised to jejunostomy nutrition versus intravenous therapy.

With the exception of some metabolic studies, most clinical studies11, 12, 13, 14, 15, 16, 17, 18, 19, 20 have failed to show any difference in infectious complications between patients fed enterally or parenterally. Many of these trials had limitations such as low power, inclusion of a large proportion of well nourished patients, heterogeneity for primary disease and nutritional status, and imbalance between parenteral and enteral regimens in terms of energy and nitrogen content.

In an attempt to clarify this issue, the Italian Society for Parenteral and Enteral Nutrition launched a prospective randomised multicentre trial to compare the efficacy and tolerability of enteral nutrition with that of parenteral nutrition in malnourished patients undergoing surgery for gastrointestinal cancer.

Section snippets

Patients

We did a prospective randomised clinical trial in ten Italian institutions. Inclusion criteria were weight loss greater than or equal to 10% of the usual bodyweight in the past 6 months, histologically proven cancer, and major planned elective surgery. Patients were excluded if they were less than 18 years old; had hepatic dysfunction (Child-Pugh >2), renal dysfunction (serum creatinine concentration >265·2 μmol/L, haemodialysis, or both), or cardiac dysfunction (New York Heart Association

Results

Between January, 1997, and March, 1999, 411 patients were registered (figure 1). Of these, 317 were judged eligible for the study and randomly assigned enteral nutrition or parenteral nutrition. Study groups were well balanced for baseline characteristics (table 2) and risk factors (table 3). The mean duration of artificial nutrition was 8·4 days (SD 2·5, range 3–21) in the enteral nutrition group and 9·6 (4·3, 7–39) in the parenteral nutrition group.

In the enteral nutrition group, 125 patients

Discussion

Studley,²² and Rhoads and Alexander,²³ made pioneering observations that related malnutrition to a poor postoperative outcome, and extensive work has since confirmed these findings. As a result, members of national societies for parenteral and enteral nutrition24, 25 have recommended the use of nutritional support if there is continual weight loss greater than 10%, involuntary weight loss greater than 10% of the usual bodyweight within the past 6 months, or weight loss greater than 10% in the

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ArticlesPostoperative enteral versus parenteral nutrition in malnourished patients with gastrointestinal cancer: a randomised multicentre trial

Summary

Background

Methods

Findings

Interpretation

Introduction

Section snippets

Patients

Results

Discussion

Clin Nutr

Clin Nutr

Total parenteral nutrition and bowel rest modify the metabolic response to endotoxin in humans

Ann Surg

Visceral protein response to enteral versus parenteral nutrition and sepsis in patients with trauma

Surgery

The route of feeding influences injury responses

J Trauma

Total enteral nutrition versus total parenteral nutrition after major torso injury: attenuation of hepatic protein reprioritization

Surgery

Early postoperative enteral nutrition improves peripheral protein kinetics in upper gastrointestinal cancer patients undergoing complete resection: a randomized trial

JPEN J Parenter Enteral Nutr

Randomised trial of safety and efficacy of immediate postoperative enteral feeding in patients undergoing gastrointestinal resection

BMJ

Nutritional support after total laryngectomy