Departments of Urology, University of Miami, Miller School of Medicine, Miami, Florida.
Department of Urologic Surgery, Vanderbilt University Medical Center, Tennessee.
J Urol. 2019 Mar;201(3):470-477. doi: 10.1016/j.juro.2018.10.010.
We designed a prospective randomized, controlled pilot trial to investigate the effects of an enriched oral nutrition supplement on body composition and clinical outcomes following radical cystectomy.
A total of 61 patients were randomized to an oral nutrition supplement or a multivitamin multimineral supplement twice daily during an 8-week perioperative period. Body composition was determined by analyzing abdominal computerized tomography images at the L3 vertebra. Sarcopenia was defined as a skeletal muscle index of less than 55 cm/m in males and less than 39 cm/m in females. The primary outcome was the difference in 30-day hospital free days. Secondary outcomes included hospital length of stay, complications, readmissions and mortality.
The oral nutrition supplement group lost less weight (-5 vs -6.5 kg, p = 0.04) compared to the multivitamin multimineral supplement group. The proportion of patients with sarcopenia did not change in the oral nutrition supplement group but increased 20% in the multivitamin multimineral supplement group (p = 0.01). Mean length of stay and 30-day hospital free days were similar in the groups. The oral nutrition supplement group had a lower rate of overall and major (Clavien grade 3 or greater) complications (48% vs 67% and 19% vs 25%, respectively) and a lower readmission rate (7% vs 17%) but the differences did not reach statistical significance.
Patients who undergo radical cystectomy after consuming an oral nutrition supplement perioperatively have a reduced prevalence of sarcopenia and may also experience fewer and less severe complications and readmissions. A larger blinded, randomized, controlled trial is necessary to determine whether oral nutrition supplement interventions can improve outcomes following radical cystectomy.
我们设计了一项前瞻性随机对照试验,旨在研究富含口服营养补充剂对根治性膀胱切除术患者术后体成分和临床结局的影响。
共 61 例患者随机分为口服营养补充组或每日两次复合维生素/矿物质补充组,在围手术期 8 周内接受治疗。通过分析 L3 椎骨的腹部计算机断层扫描图像来确定体成分。肌肉减少症定义为男性骨骼肌指数<55cm/m,女性<39cm/m。主要终点是 30 天无住院天数的差异。次要终点包括住院时间、并发症、再入院和死亡率。
与复合维生素/矿物质补充组相比,口服营养补充组体重减轻较少(-5 与-6.5kg,p=0.04)。口服营养补充组的肌肉减少症患者比例没有变化,但复合维生素/矿物质补充组增加了 20%(p=0.01)。两组的平均住院时间和 30 天无住院天数相似。口服营养补充组的总并发症和主要并发症(Clavien 分级 3 级或更高级别)发生率以及再入院率均较低(分别为 48%比 67%和 19%比 25%,以及 7%比 17%),但差异无统计学意义。
在根治性膀胱切除术前接受口服营养补充的患者,肌肉减少症的发生率降低,且并发症和再入院的发生率较低、严重程度较轻。需要开展更大规模的、盲法、随机对照试验,以确定口服营养补充干预是否能改善根治性膀胱切除术患者的结局。