Department of Urology, University of Regensburg, Caritas St. Josef Medical Center, Regensburg, Germany; Department of Urology and Andrology, Hospital of St. John of God (Krankenhaus der Barmherzigen Brüder Wien), Vienna, Austria; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, St. Elisabeth Hospital Straubing, Straubing, Germany; Department of Urology, Vivantes Humboldt Hospital Berlin, Berlin Germany; These two authors are co-first authors.
Dtsch Arztebl Int. 2020 Apr 3;117(14):243-250. doi: 10.3238/arztebl.2020.0243.
Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired.
A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115.
The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486).
A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment.
在机器人辅助根治性前列腺切除术（RARP）中，淋巴结切除术后发生淋巴囊肿是最常见的并发症。目前，唯一可用于评估腹膜瓣预防淋巴囊肿效果的数据是回顾性获得的。
对 232 例接受 RARP 联合 PLND 的前列腺癌患者进行了一项随机、对照、多中心、终点盲法评估试验。干预组患者给予腹膜瓣；对照组患者则不进行这种改良。两个主要联合终点为手术期间（iT1）和术后 90 天内（iT2）出现症状性淋巴囊肿的发生率。次要终点为淋巴囊肿体积、淋巴囊肿治疗需求、需要干预的并发症以及术后压力性尿失禁程度。德国临床试验注册编号：DRKS00011115。
数据采用意向治疗分析进行评估，在本试验中，意向治疗分析与实际治疗分析相同。108 例患者（46.6%）被分配到干预组。两组在任何临床或组织病理学标准方面均无统计学显著差异。中位数切除 16 个淋巴结（四分位距 11-21）。1.3%（iT1）和 9.1%（iT2）的患者出现症状性淋巴囊肿，两组间无统计学显著差异（分别为 p = 0.599 和 p = 0.820）。两组间在淋巴囊肿体积方面也无显著差异（T1 时出院时 p = 0.670，T2 时术后 90 天 p = 0.650）或后续手术干预的类型和频率（p = 0.535；iT2）。所有患者中有 81.5%（n = 189）在术后 3 个月内完全没有并发症。在术后 90 天时，两组在压力性尿失禁程度（p = 0.306）或并发症（p = 0.486）方面也无差异。
RARP 后腹膜瓣并未发现影响术后淋巴囊肿的发生率，无论是无症状还是需要治疗的。
