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CONSORT: Different End-Points of Preoperative Nutrition and Outcome of Bowel Resection of Crohn Disease: A Randomized Clinical Trial.

ABSTRACT: Nutritional therapy cannot only improve nutritional status but also reduce bowel inflammation in Crohn disease (CD). The benefits of preoperative nutritional therapy on outcomes of surgery for CD have been demonstrated. However, the ideal end-points of preoperative nutrition in CD remain elusive. We conducted this study to figure out whether improvement of malnutrition or reduction of inflammation is the better end-point of preoperative nutrition for CD. This was a prospective, randomized study. All patients enrolled received preoperative nutrition with different end-points (improvement of malnutrition, IOM, or reduction of inflammation, ROI). The end-points were defined using serum albumin and body weight gain, and serum C-reactive protein (CRP), respectively. Postoperative complications, rate of fecal diversion, and postoperative recurrence of the disease were compared. A total of 108 patients were randomized and 91 patients (44 in IOM group and 47 in ROI group) completed this study. It took 25.57 ± 11.68 days to achieve ROI and 45.29 ± 18.47 days for IOM (P = 0.0023). After nutritional therapy, serum CRP, CDAI, and serum albumin in both groups improved significantly. But patients in the IOM group had a higher albumin level and body weight gain compared with ROI group (P = 0.0026, P < 0.0001). When comparing postoperative complications, rate of fecal diversion, and postoperative recurrence, no significant differences were noted. Compared with IOM, ROI as the end-point of preoperative nutrition had the same benefits on operative outcomes in CD patients undergoing resection, but could be achieved in a shorter time (NCT01540942).

SUBMITTER: Zhu W

PROVIDER: S-EPMC4603011 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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CONSORT: Different End-Points of Preoperative Nutrition and Outcome of Bowel Resection of Crohn Disease: A Randomized Clinical Trial.

Zhu Weiming W Guo Zhen Z Zuo Lugen L Gong Jianfeng J Li Yi Y Gu Lili L Cao Lei L Li Ning N Li Jieshou J

Medicine 20150701 29

Nutritional therapy cannot only improve nutritional status but also reduce bowel inflammation in Crohn disease (CD). The benefits of preoperative nutritional therapy on outcomes of surgery for CD have been demonstrated. However, the ideal end-points of preoperative nutrition in CD remain elusive. We conducted this study to figure out whether improvement of malnutrition or reduction of inflammation is the better end-point of preoperative nutrition for CD. This was a prospective, randomized study. ...[more]

PMID: 26200619

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Project description:Background Cardio/kidney composite end points are clinically relevant but rarely analyzed in cardiovascular trials. This post hoc analysis of the EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial evaluated cardio/kidney composite end points by 2 statistical approaches. Methods and Results A total of 7020 patients with type 2 diabetes mellitus and established cardiovascular disease were treated with empagliflozin 10 or 25 mg (n=4687) or placebo (n=2333) on top of standard care. Cardio/kidney composite end points studied were: (1) cardiac or kidney death, kidney failure, hospitalization for heart failure, sustained decline in estimated glomerular filtration rate ≥40% from baseline, or sustained progression to macroalbuminuria; (2) cardiac or kidney death, kidney failure, hospitalization for heart failure, or sustained estimated glomerular filtration rate decline ≥40% from baseline; and (3) cardiac or kidney death, kidney failure, hospitalization for heart failure, or sustained doubling in serum creatinine from baseline. Cox regression using time-to-first-event analysis and win ratio (WR) using hierarchical order of events were applied. Empagliflozin reduced the risk of all cardio/kidney composites. The results varied only slightly between Cox and WR (eg, composite 1: hazard ratio, 0.56 [95% CI, 0.49-0.64]; WR, 1.76 [95% CI, 1.53-2.02]. WR prioritizes events by clinical importance; in particular, all fatal events are evaluated, whereas Cox regression ignores deaths when preceded by nonfatal events. Of the 285 cardio/kidney deaths in the analysis, 44 to 56 (15%-20%), depending on the composite, occurred after a nonfatal event and were not evaluated in Cox regression but evaluated by the WR. Conclusions By considering the clinical relevance of different event types, the WR represents an appropriate method to complement the traditional time-to-first-event analysis in cardio/kidney outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01131676.

Project description:Preoperative nutrition intervention is recommended prior to upper gastrointestinal (UGI) cancer resection; however, there is limited understanding of interventions received in current clinical practice. This study investigated type and frequency of preoperative dietetics intervention and nutrition support received and clinical and demographic factors associated with receipt of intervention. Associations between intervention and preoperative weight loss, surgical length of stay (LOS), and complications were also investigated. The NOURISH Point Prevalence Study was conducted between September 2019 and May 2020 across 27 Australian tertiary centres. Subjective global assessment and weight were performed within 7 days of admission. Patients reported on preoperative dietetics and nutrition intervention, and surgical LOS and complications were recorded. Two-hundred patients participated (59% male, mean (standard deviation) age 67 (10)). Sixty percent had seen a dietitian preoperatively, whilst 50% were receiving nutrition support (92% oral nutrition support (ONS)). Patients undergoing pancreatic surgery were less likely to receive dietetics intervention and nutrition support than oesophageal or gastric surgeries (p < 0.001 and p = 0.029, respectively). Neoadjuvant therapy (p = 0.003) and malnutrition (p = 0.046) remained independently associated with receiving dietetics intervention; however, 31.3% of malnourished patients had not seen a dietitian. Patients who received ≥3 dietetics appointments had lower mean (SD) percentage weight loss at the 1-month preoperative timeframe compared with patients who received 0-2 appointments (1.2 (2.0) vs. 3.1 (3.3), p = 0.001). Patients who received ONS for >2 weeks had lower mean (SD) percentage weight loss than those who did not (1.2 (1.8) vs. 2.9 (3.4), p = 0.001). In malnourished patients, total dietetics appointments ≥3 was independently associated with reduced surgical complications (odds ratio 0.2, 95% confidence interval (CI) 0.1, 0.9, p = 0.04), and ONS >2 weeks was associated with reduced LOS (regression coefficient -7.3, 95% CI -14.3, -0.3, p = 0.04). Despite recommendations, there are low rates of preoperative dietetics consultation and nutrition support in this population, which are associated with increased preoperative weight loss and risk of increased LOS and complications in malnourished patients. The results of this study provide insights into evidence-practice gaps for improvement and data to support further research regarding optimal methods of preoperative nutrition support.

Dataset Information

CONSORT: Different End-Points of Preoperative Nutrition and Outcome of Bowel Resection of Crohn Disease: A Randomized Clinical Trial.

Publications

CONSORT: Different End-Points of Preoperative Nutrition and Outcome of Bowel Resection of Crohn Disease: A Randomized Clinical Trial.

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