Goßler Christopher, May Matthias, Weikert Steffen, Lenart Sebastian, Ponholzer Anton, Dreissig Christina, Stojanoski Gjoko, Anzinger Isabel, Riester Josef, Burger Maximilian, Gilfrich Christian, Mayr Roman, Bründl Johannes
Department of Urology, Caritas St. Josef Medical Centre, University of Regensburg, 93053 Regensburg, Germany.
Department of Urology, St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital, 94315 Straubing, Germany.
Cancers (Basel). 2024 May 19;16(10):1932. doi: 10.3390/cancers16101932.
The available randomised controlled trials (RCTs) assessing the influence of peritoneal interposition flaps (PIF) on the reduction of symptomatic lymphoceles (sLCs) post robot-assisted radical prostatectomy (RARP) do not constitute a sufficient follow-up (FU) to assess the long-term effects. The PIANOFORTE trial was the first of these RCTs, showing no sLC reduction at the 3-month FU. Therefore, all 232 patients from the PIANOFORTE trial were invited for long-term FU. One hundred seventy-six patients (76%) presented themselves for FU and constituted the study group (SG). The median FU duration was 43 months. No significant differences in group allocation or LC endpoints at 90 days were observed between SG patients and patients not presenting themselves for the FU. During the FU period, four patients (2.3%) in the SG developed sLCs, and six patients (3.4%) developed asymptomatic lymphoceles (aLCs), which persisted in five patients (2.9%). There were no significant differences between PIF and non-PIF regarding sLC/aLC formation or persistence, newly developed complications, stress urinary incontinence or biochemical/clinical tumour recurrence. Therefore, this long-term FU confirms the primary outcomes of the PIANOFORTE trial that, while PIF does not impact complications or functionality, it does not reduce sLC/aLC rates. Furthermore, it shows the potential occurrence of LC after the third postoperative month.
评估腹膜置入皮瓣（PIF）对机器人辅助根治性前列腺切除术（RARP）后症状性淋巴囊肿（sLCs）减少影响的现有随机对照试验（RCTs），其随访时间不足以评估长期效果。PIANOFORTE试验是这些RCTs中的首个试验，结果显示在3个月随访期内sLCs没有减少。因此，PIANOFORTE试验的所有232名患者均被邀请进行长期随访。176名患者（76%）前来接受随访并构成研究组（SG）。随访时间中位数为43个月。在SG患者和未前来接受随访的患者之间，未观察到90天时在分组或淋巴囊肿终点方面存在显著差异。在随访期间，SG组中有4名患者（2.3%）出现了sLCs，6名患者（3.4%）出现了无症状性淋巴囊肿（aLCs），其中5名患者（2.9%）的aLCs持续存在。在sLC/aLC的形成或持续存在、新出现的并发症、压力性尿失禁或生化/临床肿瘤复发方面，PIF组和非PIF组之间没有显著差异。因此，这项长期随访证实了PIANOFORTE试验的主要结果，即虽然PIF对并发症或功能没有影响，但它并不能降低sLC/aLC的发生率。此外，它还显示了术后第三个月后淋巴囊肿可能出现。
