A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes
A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes
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DOI：
10.1016/j.jamcollsurg.2015.02.022
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发表时间：
2015-07-01
影响因子：
5.2
通讯作者：
Sloan, Jeff
中科院分区：
文献类型：
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作者：
Bingener, Juliane;Skaran, Pam;Sloan, Jeff
背景：医学研究所已将微创外科技术的比较列入其研究议程。本研究旨在评估一种利用患者报告的结果来比较微创手术的模型。研究设计：双盲随机对照试验(NCT01489436)。获得基线数据，诱导标准麻醉，并将患者随机分为单孔(SP)或四孔(FP)两组。围手术期护理标准化。结果是术后第1天的疼痛(视觉模拟评分)(主要)和生活质量(患者报告的结果测量信息系统和线性模拟自评)、血清细胞因子和心率变异性(次要)。分析的是意向治疗。使用相同的闭塞敷料，患者和结果评估者直到术后第2天都是盲目的。结果：55名患者被随机分为两组。在人口统计学上没有区别。视觉模拟评分术后第1天各组间比较差异有统计学意义(SP：1.6+/-1.9~4.2+/-2.4，FP：1.8+/-2.3~4.2+/-2.2)，但组间比较差异无统计学意义(P=0.83)。FP组患者术后第7天的疲劳感明显低于SP组患者(3.1vs4.2+-2.2p=0.009)。FP组术后出院前需要口服麻醉药的患者较少(40%对60%；p=0.056)。两组患者的细胞因子水平和心率变异性相似。在随访1年的患者中，脐疝的发生率没有差异。结论：术后早期生活质量数据反映了疲劳感的差异，表明FP术后恢复在对照试验中有所改善。生理指标相似，表明SP和FP之间的差异很小。(C)2015年由美国外科医师学会颁发)
BACKGROUND: The Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda. This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes.STUDY DESIGN: A double-blinded randomized controlled trial (NCT01489436) was conducted. Baseline data were obtained, standardized anesthesia was induced, and patients were randomized to singleport (SP) or 4-port (FP) laparoscopic cholecystectomy. Perioperative care was standardized. The outcomes were pain (Visual Analog Scale) on postoperative day 1 (primary) and quality of life (Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment), serum cytokines, and heart rate variability (secondary). Analysis was intention to treat. Using identical occlusive dressings, patients and the outcomes assessor remained blinded until postoperative day 2.RESULTS: Fifty-five patients were randomized to each arm. There was no difference in demographics. Visual Analog Scale pain score on postoperative day 1 was significantly different from baseline in each group (SP: 1.6 +/- 1.9 to 4.2 +/- 2.4 vs FP: 1.8 +/- 2.3 to 4.2 +/- 2.2), but not different from each other (p = 0.83). Patients in the FP arm reported significantly less fatigue on postoperative day 7 than patients in the SP group (3.1 +/- 2.1 vs 4.2 +/- 2.2; p = 0.009). Fewer patients in the FP group required postoperative oral narcotics before discharge (40% vs 60%; p = 0.056). Cytokines levels and heart rate variability were similar between arms. In patients followed for > 1 year, no difference in umbilical hernia rates was noted.CONCLUSIONS: Early postoperative quality of life data captured differences in fatigue, indicating improved recovery after FP within a controlled trial. Physiologic measures were similar, suggesting that the differences between SP and FP are minimal. (C) 2015 by the American College of Surgeons)