The impact of enteral nutrition for post-operative patients on nitrogen balance, gut permeability and cost/effect(60 cases randomized, controlled, multi-center clinical trial)

Abstract

Objective To evaluate the impact of enteral nutrition forpost-operative patients on nitrogen balance, gut permeability and cost/effect with the control group.60 consecutive patients undergoing the esophagus or gastrointestinal tract operation were randomized into the study group or the control group. Methods Standard traditional parenteral nutrition were used in the control group. Enteral nutrition (Harmonic-M, Nutrichem, Germany) was used in the study group. The nitrogen and calorie intake in both groups were same. Results Safety: no important adverse event in both groups.There were two patients in the control group having liver function impaired(6.6%). Surrogate end point and clinical outcome:(1)Nitrogen balance:study group: Cumulative nitrogen balance (108.3±107.4)mg.kg-1.6d-1 Control group: Cumulative nitrogen balance (94.6±143.3) mg.kg-1.6d-1. No statistical significance, P=0.675.(2)The pre-and poststudy difference of the serum GLN (delta):Study group: GLN(-20±60) mol/L；Control group:GLN(-106±79)mol/L；reaching the statistical significance, P=0.006.(3) Gut mucosa permeability: The pre-and poststudy difference of the lactofrucotose/mannitol (delta):Study group:increased by(0.020±0.012);Control group:increased by (0.040±0.017);reaching the statistical significance,P=0.001.(4)The total hospitalization cost:study group:(17 716±11 024)RMB,Control group:(21 453±7 999)RMB,no statistical significance,P=0.138.(5)The cost of nutritional drugs:Study group:(1 016±110) RMB,Control group:(3 135±463) RMB,reaching the statistical significance, P=0.0001.(6)No infective complication was observed in both groups during the therapy. (7)No difference of the postoperative hospitalizing days between the groups，P=0.925. Conclusions Enteral nutrition for post-operative patients had better nitrogen balance, less increasing gut permeability and lower cost in this randomized controlled muti-center clinical trial.