Department of Urology and Urologic Surgery, University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Department of Urology and Urologic Surgery, University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Eur Urol Oncol. 2024 Feb;7(1):53-62. doi: 10.1016/j.euo.2023.07.009. Epub 2023 Aug 4.
Symptomatic lymphoceles (SLCs) after transperitoneal robotic-assisted radical prostatectomy with pelvic lymph node dissection (PLND) are common. Evidence from randomised controlled trials (RCTs) on the impact of peritoneal flaps (PFs) on lymphocele (LC) reduction is inconclusive.
To show that addition of PFs leads to a reduction of postoperative SLCs.
DESIGN, SETTING, AND PARTICIPANTS: An investigator-initiated, prospective, parallel, double-blinded, adaptive, phase 3 RCT was conducted. Recruitment took place from September 2019 until December 2021; 6-month written survey-based follow-up was recorded. Stratification was carried out according to potential LC risk factors (extended PLND, diabetes mellitus, and anticoagulation) and surgeons; 1:1 block randomisation was used. Surgeons were informed about allocation after completion of the last surgical step.
To create PFs, the ventral peritoneum was incised bilaterally and fixated to the pelvic floor.
The primary endpoint was SLCs. Secondary endpoints included asymptomatic lymphoceles (ALCs), perioperative parameters, and postoperative complications.
In total, 860 men were screened and 551 randomised. Significant reductions of SLCs (from 9.1% to 3.7%, p = 0.005) and ALCs (27.2% to 10.3%, p < 0.001) over the follow-up period of 6 mo were observed in the intention-to-treat analysis. Operating time was 11 min longer (p < 0.001) in the intervention group; no significant differences in amount (80 vs 103, p = 0.879) and severity (p = 0.182) of postoperative complications (excluding LCs) were observed. The survey-based follow-up might be a limitation.
This is the largest RCT evaluating PF creation for LC prevention and met its primary endpoint, the reduction of SLCs. The results were consistent among all subgroup analyses including ALCs. Owing to the subsequent reduction of burden for patients and the healthcare system, establishing PFs should become the new standard of care.
A new technique-creation of bilateral peritoneal flaps-was added to the standard procedure of robotic-assisted prostatectomy for lymph node removal. It was safe and decreased lymphocele development, a common postoperative complication and morbidity. Hence, it should become a standard procedure.
经腹腔机器人辅助根治性前列腺切除术联合盆腔淋巴结清扫术（PLND）后，症状性淋巴囊肿（SLC）很常见。随机对照试验（RCT）证据表明，腹膜瓣（PF）对减少淋巴囊肿（LC）的影响尚无定论。
表明添加 PF 可减少术后 SLC。
设计、设置和参与者：一项由研究者发起的前瞻性、平行、双盲、适应性、3 期 RCT。招募于 2019 年 9 月至 2021 年 12 月进行；记录了 6 个月的书面调查随访。根据潜在的 LC 危险因素（广泛的 PLND、糖尿病和抗凝）和外科医生进行分层；使用 1:1 块随机化。在完成最后一步手术步骤后，外科医生会了解到分配情况。
双侧切开腹侧腹膜并固定于骨盆底，以形成 PF。
主要终点是 SLCs。次要终点包括无症状性淋巴囊肿（ALCs）、围手术期参数和术后并发症。
共筛选了 860 名男性，其中 551 名被随机分配。在意向治疗分析中，在 6 个月的随访期间，SLCs（从 9.1%降至 3.7%，p=0.005）和 ALCs（从 27.2%降至 10.3%，p<0.001）显著减少。在干预组中，手术时间延长了 11 分钟（p<0.001）；术后并发症（不包括 LC）的数量（80 比 103，p=0.879）和严重程度（p=0.182）无显著差异。基于调查的随访可能是一个限制。
这是评估 PF 预防 LC 的最大 RCT，达到了减少 SLCs 的主要终点。这些结果在包括 ALCs 在内的所有亚组分析中均一致。由于患者和医疗保健系统的负担随后减少，建立 PF 应该成为新的护理标准。
在机器人辅助前列腺切除术和淋巴结切除的标准手术中增加了一种新技术——双侧腹膜瓣的创建。它是安全的，可以减少常见的术后并发症和发病率——淋巴囊肿。因此，它应该成为一种标准程序。
