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一项比较开放与腹腔镜部分肾切除术疗效的前瞻性、随机试验。

A Prospective, Randomized Trial Comparing the Outcomes of Open vs Laparoscopic Partial Nephrectomy.

机构信息

Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.

出版信息

J Urol. 2022 Aug;208(2):259-267. doi: 10.1097/JU.0000000000002695. Epub 2022 Apr 11.

Abstract

PURPOSE

Partial nephrectomy is the standard treatment for renal tumors <7 cm, and the trend toward minimally invasive surgery has increased. However, data that could support its use and benefits are still lacking.

MATERIALS AND METHODS

We conducted a prospective, randomized controlled trial comparing surgical, functional and oncologic outcomes in patients undergoing open partial nephrectomy (OPN) or laparoscopic partial nephrectomy (LPN). Randomization was 1:1 to OPN or LPN for the treatment of renal tumors <7 cm. The primary endpoint was surgical complications up to 90 days after surgery. Secondary outcomes were comparison of surgical, oncologic and functional results.

RESULTS

We randomized 208 patients between 2012 and 2020 (110 with OPN vs 98 with LPN). Operative data showed no differences in operative time, warm ischemia time, estimated blood loss, transfusions or length of hospital stay. Zero ischemia was more frequent in the OPN (35.4% vs 15.5%, p=0.02). OPN was associated with more abdominal wall complications (31.2% vs 13.1%, p=0.004). Regarding oncologic outcomes, no differences were noted. The LPN group had less kidney function reduction at 3 (-5.2% vs -10%, p=0.04; CI 0.09 to 9.46) and 12 months after surgery (-0.8% vs -6.3%, p=0.02; CI 1.18 to 12.95), and a lower rate of downstaging on the chronic kidney disease classification at 12 months (14.1% vs 32.6%, p=0.006).

CONCLUSIONS

Surgical and oncologic outcomes of LPN were similar to OPN. Minimally invasive surgery may provide better preservation of kidney function. More studies, especially those involving robotic surgery, are necessary to confirm our findings.

摘要

目的

部分肾切除术是治疗<7cm 肾肿瘤的标准治疗方法,微创手术的趋势有所增加。然而,支持其使用和获益的数据仍然缺乏。

材料和方法

我们进行了一项前瞻性、随机对照试验,比较了接受开放性部分肾切除术(OPN)或腹腔镜部分肾切除术(LPN)的患者的手术、功能和肿瘤学结果。OPN 或 LPN 治疗<7cm 肾肿瘤的患者按 1:1 随机分组。主要终点是手术后 90 天内的手术并发症。次要结局是比较手术、肿瘤学和功能结果。

结果

我们在 2012 年至 2020 年间随机分配了 208 例患者(OPN 组 110 例,LPN 组 98 例)。手术数据显示手术时间、热缺血时间、估计失血量、输血或住院时间无差异。OPN 组零缺血更为常见(35.4%比 15.5%,p=0.02)。OPN 组更常见腹壁并发症(31.2%比 13.1%,p=0.004)。关于肿瘤学结果,无差异。LPN 组术后 3 个月(-5.2%比-10%,p=0.04;CI 0.09 至 9.46)和 12 个月(-0.8%比-6.3%,p=0.02;CI 1.18 至 12.95)时肾功能下降更少,12 个月时慢性肾脏病分级降级率更低(14.1%比 32.6%,p=0.006)。

结论

LPN 的手术和肿瘤学结果与 OPN 相似。微创手术可能更好地保留肾功能。需要更多的研究,特别是涉及机器人手术的研究,以证实我们的发现。

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