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提高复杂腹部手术后的患者转归并控制成本:Whipple 加速康复路径的随机对照试验。

Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation: A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway.

机构信息

Department of Surgery and the Jefferson Pancreas, Biliary and Related Cancer Center, Thomas Jefferson University, Philadelphia, PA.

Department of Surgery and the Jefferson Pancreas, Biliary and Related Cancer Center, Thomas Jefferson University, Philadelphia, PA.

出版信息

J Am Coll Surg. 2019 Apr;228(4):415-424. doi: 10.1016/j.jamcollsurg.2018.12.032. Epub 2019 Jan 17.

Abstract

BACKGROUND

This study was designed to determine whether a standardized recovery pathway could reduce post-pancreaticoduodenectomy hospital length of stay to 5 days without increasing complication or readmission rates.

STUDY DESIGN

Pancreaticoduodenectomy patients (high-risk patients excluded) were enrolled in an IRB-approved, prospective, randomized controlled trial (NCT02517268) comparing a 5-day Whipple accelerated recovery pathway (WARP) with our traditional 7-day pathway (control). Whipple accelerated recovery pathway interventions included early discharge planning, shortened ICU stay, modified postoperative dietary and drain management algorithm, rigorous physical therapy with in-hospital gym visit, standardized rectal suppository administration, and close telehealth follow-up post discharge. The trial was powered to detect an increase in postoperative day 5 discharge from 10% to 30% (80% power, α = 0.05, 2-sided Fisher's exact test, target accrual: 142 patients).

RESULTS

Seventy-six patients (37 WARP, 39 control) were randomized from June 2015 to September 2017. A planned interim analysis was conducted at 50% trial accrual resulting in mandatory early stoppage, as the predefined efficacy end point was met. Demographic variables between groups were similar. The WARP significantly increased the number of patients discharged to home by postoperative day 5 compared with controls (75.7% vs 12.8%; p < 0.001) without increasing readmission rates (8.1% vs 10.3%; p = 1.0). Overall complication rates did not differ between groups (29.7% vs 43.6%; p = 0.24), but the WARP significantly reduced the time from operation to adjuvant therapy initiation (51 days vs 66 days; p = 0.005) and hospital cost ($26,563 vs $31,845; p = 0.011).

CONCLUSIONS

The WARP can safely reduce hospital length of stay, time to adjuvant therapy, and cost in selected pancreaticoduodenectomy patients without increasing readmission risk.

摘要

背景

本研究旨在确定标准化康复路径是否可以将胰十二指肠切除术后的住院时间减少到 5 天而不增加并发症或再入院率。

研究设计

入选的胰十二指肠切除术患者(排除高危患者)参加了一项经机构审查委员会批准的前瞻性随机对照试验(NCT02517268),比较 5 天 Whipple 加速康复路径(WARP)与我们传统的 7 天路径(对照组)。Whipple 加速康复路径干预措施包括早期出院计划、缩短 ICU 住院时间、修改术后饮食和引流管理算法、在院内健身房进行严格的物理治疗、标准化直肠栓剂给药以及密切的远程医疗随访。该试验旨在检测术后第 5 天出院率从 10%增加到 30%(80%的功效,α=0.05,双侧 Fisher 精确检验,目标入组:142 例)。

结果

2015 年 6 月至 2017 年 9 月,76 例患者(37 例 WARP,39 例对照组)被随机分配。在试验进行到 50%时进行了计划中的中期分析,由于达到了预设的疗效终点,因此强制提前停止。两组患者的人口统计学变量相似。与对照组相比,WARP 显著增加了术后第 5 天出院回家的患者数量(75.7%比 12.8%;p<0.001),而不增加再入院率(8.1%比 10.3%;p=1.0)。两组总体并发症发生率无差异(29.7%比 43.6%;p=0.24),但 WARP 显著缩短了从手术到辅助治疗开始的时间(51 天比 66 天;p=0.005)和住院费用(26563 美元比 31845 美元;p=0.011)。

结论

在选择的胰十二指肠切除术患者中,WARP 可安全减少住院时间、辅助治疗时间和成本,而不会增加再入院风险。

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