OBJECTIVES/HYPOTHESIS: Malnutrition is a significant risk factor for postoperative infections in patients undergoing oncologic surgery. This study was undertaken to determine if perioperative nutritional supplementation with an immune-enhancing formula is superior to standard formula in the prevention of postoperative infectious complications. STUDY DESIGN: This was a prospective, randomized, double-blind trial comparing perioperative nutritional supplementation with Impact and standard nutritional formulas. METHODS: Following stratification, 136 patients undergoing oncologic head and neck surgery were randomly assigned to one of four treatment groups: preoperative/postoperative Impact, postoperative Impact, preoperative/postoperative standard formula, and postoperative standard formula. Outcome measures included laboratory evaluations of nutritional status, infectious and wound healing complications, and duration of hospitalization. Statistical analysis was performed using chi2 or two-tailed Fisher Exact Tests, when appropriate. RESULTS: Intent-to-treat (P = .02) and actual therapy (P = .04) analyses revealed a significant decrease in the incidence of postoperative infectious complications (all sites) in patients who received Impact. There was no significant difference in wound healing problems or duration of hospitalization. Postoperative measures of nutrition status demonstrated a higher serum albumin (P = .05) in patients who received Impact compared with standard formula. CONCLUSIONS: Compared with standard formula, perioperative nutritional supplementation with Impact significantly reduced the incidence of infectious complications. The length of hospitalization was significantly prolonged in patients with postoperative infections, suggesting potential cost savings with the use of immune-enhancing formulas such as Impact.
RCT Entities:
OBJECTIVES/HYPOTHESIS: Malnutrition is a significant risk factor for postoperative infections in patients undergoing oncologic surgery. This study was undertaken to determine if perioperative nutritional supplementation with an immune-enhancing formula is superior to standard formula in the prevention of postoperative infectious complications. STUDY DESIGN: This was a prospective, randomized, double-blind trial comparing perioperative nutritional supplementation with Impact and standard nutritional formulas. METHODS: Following stratification, 136 patients undergoing oncologic head and neck surgery were randomly assigned to one of four treatment groups: preoperative/postoperative Impact, postoperative Impact, preoperative/postoperative standard formula, and postoperative standard formula. Outcome measures included laboratory evaluations of nutritional status, infectious and wound healing complications, and duration of hospitalization. Statistical analysis was performed using chi2 or two-tailed Fisher Exact Tests, when appropriate. RESULTS: Intent-to-treat (P = .02) and actual therapy (P = .04) analyses revealed a significant decrease in the incidence of postoperative infectious complications (all sites) in patients who received Impact. There was no significant difference in wound healing problems or duration of hospitalization. Postoperative measures of nutrition status demonstrated a higher serum albumin (P = .05) in patients who received Impact compared with standard formula. CONCLUSIONS: Compared with standard formula, perioperative nutritional supplementation with Impact significantly reduced the incidence of infectious complications. The length of hospitalization was significantly prolonged in patients with postoperative infections, suggesting potential cost savings with the use of immune-enhancing formulas such as Impact.
Authors: Dan L Waitzberg; Hideaki Saito; Lindsay D Plank; Glyn G Jamieson; Palepu Jagannath; Tsann-Long Hwang; Juan M Mijares; David Bihari Journal: World J Surg Date: 2006-08 Impact factor: 3.352
Authors: Lucas W Thornblade; Thomas K Varghese; Xu Shi; Eric K Johnson; Amir Bastawrous; Richard P Billingham; Richard Thirlby; Alessandro Fichera; David R Flum Journal: Dis Colon Rectum Date: 2017-01 Impact factor: 4.585
Authors: Christelle Machon; Simon Thezenas; Anne-Marie Dupuy; Eric Assenat; Françoise Michel; Emilie Mas; Pierre Senesse; Jean-Paul Cristol Journal: Support Care Cancer Date: 2012-03-28 Impact factor: 3.603
Authors: Paolo Boscolo-Rizzo; Giuseppe De Cillis; Carlo Marchiori; Silvia Carpenè; Maria Cristina Da Mosto Journal: Eur Arch Otorhinolaryngol Date: 2008-02-05 Impact factor: 3.236