Extended lymph node dissection

扩大淋巴结清扫术
  • 文章类型: Letter
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  • 文章类型: Journal Article
    目的:本研究的目的是比较在机器人辅助根治性膀胱切除术(RARC)下膀胱切除术前后行扩大盆腔淋巴结清扫术(ePLND)的膀胱癌患者的临床疗效。方法:对348例接受RARC治疗的膀胱癌患者进行回顾性研究。在患者中,152例(42.8%)在根治性膀胱切除术(RC)前进行了ePLND(A组),196例(56.3%)在RC后进行了ePLND(B组)。临床,病态,并比较总生存率。结果:A组的总手术时间和RC手术时间(总计:130.68±29.25分钟,RC:59.45±28.63分钟)均短于B组(总计:154.17±38.18分钟,RC:94.81±41.21分钟)(P<.05)。然而,ePLND时间无显著差异。A组RC部分和总手术(RC+ePLND)的估计失血量(EBL)少于B组(均P<0.05)。而ePLND部分没有显示出意义。两组的血管和神经损伤结果以及手术引流退出时间相似。A组淋巴结总数少于B组(16对26;P<0.05)。此外,A组双侧髂内、骶前淋巴结数目明显少于B组,而双侧外髂的数量,髂总,两组的闭孔淋巴结相似。A组淋巴结密度明显低于B组,中位随访时间为33.0个月。重要的是,B组的生存率优于A组(风险比:1.412;95%置信区间:1.004-1.987;P=.048).结论:在RC之前进行ePLND在手术时间和EBL上显示出更好的效果,while,当EPLND在RC之后,淋巴结清扫总数较多,生存率较好。建议在RC之前执行ePLND,膀胱切除术后有必要重新检查髂内和骶前区域。
    Objective: The purpose of this study was to compare the clinical outcomes of bladder cancer patients treated with extended pelvic lymph node dissection (ePLND) before or after cystectomy under robotic-assisted radical cystectomy (RARC). Methods: A retrospective study to identify 348 patients with bladder cancer who underwent RARC was performed. Of the patients, 152 (42.8%) underwent ePLND before radical cystectomy (RC) (group A) and 196 (56.3%) underwent ePLND after RC (group B). The clinical, pathological, and overall survival were compared. Results: The total and RC operation time in Group A (total: 130.68 ± 29.25 minutes, RC: 59.45 ± 28.63 minutes) were both shorter than Group B (total: 154.17 ± 38.18 minutes, RC: 94.81 ± 41.21 minutes) (P < .05). However, no significant difference in time of ePLND. The estimate blood loss (EBL) of RC part and total operation (RC+ePLND) in group A was less than group B (both P < .05), while the ePLND part did not show significance. The result of vascular and nerve injury and surgical drain withdrawal time were similar in two groups. The total number of lymph nodes in group A was fewer than group B (16 versus 26; P < .05). Moreover, the number of bilateral internal iliac and presacral lymph nodes of group A was fewer than group B significantly, whereas the number of bilateral external iliac, common iliac, and obturator lymph nodes was similar in two groups. The lymph node density of group A was significantly lower than group B. The median follow-up of all patients was 33.0 months. Importantly, the survival of group B was better than group A (hazard ratio: 1.412; 95% confidence interval: 1.004-1.987; P = .048). Conclusions: Performing ePLND before RC reveals better result on operation time and EBL, while, when ePLND after RC, the total number of lymph nodes dissected is more and the survival is better. It recommended ePLND be performed before RC, and it is necessary to recheck the internal iliac and presacral area after cystectomy.
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  • 文章类型: Systematic Review
    大约1%-2%的结直肠癌(CRC)患者发生主动脉旁淋巴结(PALN)转移,通常被认为是全身性疾病的标志,并与不良预后相关。PALN夹层(PALND)在CRC患者中的应用一直存在争议,迄今为止仅发表了关于该主题的小规模回顾性研究。这项系统评价旨在确定切除PALN转移的实用性,主要结果指标是手术切除或不切除这些转移后生存结果的差异。进行了全面系统的搜索,以确定PubMed中有关PALND的所有英文论文,Medline,和谷歌学者数据库。搜索结果确定了总共12项符合条件的研究进行分析。所有研究均为回顾性队列研究或病例系列研究。在这次系统审查中,与非切除相比,发现PALND与生存获益相关。与同步PALND相比,异时性PALND与更好的总生存率相关,发现PALN转移的数量(2个或更少)和术前癌胚抗原水平<5与更好的预后相关。本综述未发现PALND特异性并发症。需要进行大规模的前瞻性研究以明确确定PALND的实用性。就目前而言,PALND应该在CRC患者的多学科方法中考虑,结合已经建立的治疗方案。
    Approximately 1%-2% of patients with colorectal cancer (CRC) develop para-aortic lymph node (PALN) metastases, which are typically considered markers of systemic disease, and are associated with a poor prognosis. The utility of PALN dissection (PALND) in patients with CRC is of ongoing debate and only small-scale retrospective studies have been published on this topic to date. This systematic review aimed to determine the utility of resecting PALN metastases with the primary outcome measure being the difference in survival outcomes following either surgical resection or non-resection of these metastases. A comprehensive systematic search was undertaken to identify all English-language papers on PALND in the PubMed, Medline, and Google Scholar databases. The search results identified a total of 12 eligible studies for analysis. All studies were either retrospective cohort studies or case series. In this systematic review, PALND was found to be associated with a survival benefit when compared to non-resection. Metachronous PALND was found to be associated with better overall survival as compared to synchronous PALND, and the number of PALN metastases (2 or fewer) and a pre-operative carcinoembryonic antigen level of <5 was found to be associated with a better prognosis. No PALND-specific complications were identified in this review. A large-scale prospective study needs to be conducted to definitively determine the utility of PALND. For the present, PALND should be considered within a multidisciplinary approach for patients with CRC, in conjunction with already established treatment regimens.
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  • 文章类型: Journal Article
    The inferior mesenteric artery (IMA) is a blood vessel of great importance in left colon and rectal cancer surgery. We aimed to determine the role of surgeons in computed tomography (CT) based vascular anatomy interpretation.
    Patients with left colon and rectal cancer treated surgically with D3 lymph node dissection and selective vascular ligation were included in this study. All patients (n=250) underwent preoperative CT with intravenous contrast. The IMA anatomy was schematically depicted by surgeon based on CT interpretation. Intraoperatively anatomy was defined by skeletonisation of the IMA. All patients had segmental resection with selective vascular ligation. The concurrence of prospectively obtained results were evaluated by intraclass correlation and Kendall\'s tau-b test. Misinterpretation of IMA anatomy was analysed by CT-specialist.
    The preoperative and intraoperative IMA anatomy features were correctly interpreted in 237 cases (in 94.8%) within skeletonisation extent, which is supported by high level of agreement and concordance of preoperative data regards to intraoperative findings (K=0.926; p<0.001; CC=0.912; p<0.001). As a result of the CT-based evaluation of the IMA, E, K, and H types of branching patterns were proposed. IMV position was mistakenly identified in 2.6% of cases.
    Surgeons are able to evaluate the IMA anatomy accurately with CT and use it in routine preoperative planning. The E, K, and H branching types may be used when defining approach to skeletonisation and level of vascular ligation.
    Определение возможностей хирургов в изучении сосудистой анатомии толстой кишки по данным компьютерной томографии (КТ).
    Данные особенностей сосудистой анатомии у пациентов с раком левой половины ободочной и прямой кишки собрали проспективно. Всем пациентам (n=279) выполнили КТ-исследование с внутривенным контрастированием на предоперационном этапе. Строение нижней брыжеечной артерии (НБА) определяли на предоперационном этапе на основании КТ и фиксировали в виде схемы. Пациентам выполняли резекцию толстой или прямой кишки с D3-лимфодиссекцией и селективной перевязкой ветвей НБА, которую достигали путем ее скелелетизации. Во время операции анатомические особенности строения определяли на выделенном сегменте артерии, после чего производили фотофиксацию. Статистический анализ собранных данных на предоперационном и интраоперационном этапах сравнивали при помощи теста Kendall’stau-b и kappa анализа. Для определения длины проксимальной части НБА и уровня ее отхождения от аорты проведен морфометрический анализ.
    Хирурги определяли строение НБА в 95% наблюдений правильно, что подтверждено высоким уровнем соответствия предоперационных схем при сравнении с интраоперационными данными (K=0,926; p<0,001; CC=0,912; p<0,001). В результате анализа данных предложены следующие варианты строения НБА: Е-, К- и Н-типы. В 5% наблюдений Е-тип ошибочно интерпретирован как К- или Н-тип. Расстояние между основанием НБА и местом отхождения левой ободочной артерии составило 37,7±2,1 мм (IQR 26—51).
    Хирурги могут правильно определять строение НБА при помощи данных КТ и использовать это для предоперационного планирования этапов операции. Предложенные E-, K-, H-типы строения могут быть использованы для планирования уровня пересечения сосудов на предоперационном этапе.
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  • 文章类型: Journal Article
    To test 1) contemporary pelvic lymph node dissection (PLND) trends at radical cystectomy (RC) in variant histology bladder cancer (VHBC) patients and urothelial carcinoma of the urinary bladder (UCUB), as well as 2) to test the effect of PLND extent on cancer specific mortality (CSM) after RC.
    Within the Surveillance, Epidemiology and End Results Registry (SEER, 2004-2016), we identified non-metastatic stage T1-2 or T3-4 VHBC and UCUB patients, who underwent RC. CSM and lymph node invasion (LNI) rates were stratified according to PLND extent, as well as coded continuously in multivariate Cox and logistic regression models.
    Of 19,020 patients, 1736 (9.1%) were coded as having VHBC (46.9% squamous cell carcinoma, 22.5% adenocarcinoma, 18.9% neuroendocrine carcinoma, 11.7% not otherwise specified) vs 17,284 (90.9%) UCUB. PLND was performed in 80.1 of VHBC vs. 83.5% UCUB patients. In both histological groups, PLND rates increased over time (70.9-89.6% and 76.2%-90.1%, both P < .01). PLND extent did not significantly affect CSM in stage T1-2 or T3-4 VHBC patients. Conversely, PLND extent was associated with lower CSM in T1-2, as well as in T3-4 UCUB patients, which was confirmed in multivariate Cox analyses (Hazard ratio [HR] 0.99, P < .001). Rates of LNI increased with extent of PLND in logistic regression analyses in stage T3-4 VHBC (Odds ratio [OR] 1.01, P = .001), stage T1-2 UCUB (OR 1.01, P < .001) and T3-4 UCUB (OR 1.01, P < .001), but not in stage T1-2 VHBC (OR 1.01, P = .3).
    PLND rates do not differ between VHBC and UCUB patients. A potential survival benefit related to more extensive PLND is operational in UCUB patients, but not in VHBC patients.
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  • 文章类型: Journal Article
    目的:探讨前列腺癌根治术(RP)和盆腔淋巴结清扫术(ePLND)患者淋巴结转移负荷的相关临床因素。
    方法:在2014年11月至2019年12月之间,对617例接受RP和ePLND的未接受雄激素剥夺治疗的连续患者进行了ET测量。淋巴结浸润(LNI)编码为不存在(N=0)或具有一个(N=1)或多于一个转移淋巴结(N>1)。通过将其与其他两组(N>1vs.N=0且N>1vs.N=1)。然后,我们评估了ET与淋巴结侵犯之间的关系,以确定标准预测因子,比如PSA,活检阳性核心(BPC)的百分比,肿瘤分期大于1(cT>1)和肿瘤分级组大于2(ISUP>2)。
    结果:总体而言,在70例患者(11.3%)中检测到LNI,其中39例(6.3%)为N=1,31例(5%)为N>1。在多变量分析中,与N=0相比,ET与N>1的风险呈负相关(比值比,OR0.997;CI0.994-1;p=0.027)以及N=1例(OR0.994;95%CI0.989-1.000;p=0.015)。
    结论:在临床PCa中,低ET水平增加mPLNM的风险.随着ET的减少,患者发生mPLNM的可能性增加.由于ET和mPLNM之间的逆关联,较高的ET水平可以预防侵袭性疾病。具有高转移负荷的局部晚期PCa对ET水平的影响需要通过对照试验来探索。
    OBJECTIVE: To investigate clinical factors associated to lymphnodal metastasis load in patients who underwent to radical prostatectomy (RP) and extended pelvic lymph node dissection (ePLND).
    METHODS: Between November 2014 and December 2019, ET was measured in 617 consecutive patients not under androgen deprivation therapy who underwent RP and ePLND. Lymphnode invasion (LNI) was codified as not present (N = 0) or with one (N = 1) or more than one metastatic node (N > 1). The risk of multiple pelvic lymph node metastasis (N > 1, mPLNM) was assessed by comparing it to the other two groups (N > 1 vs. N = 0 and N > 1 vs. N = 1). Then, we assessed the association between ET and lymphnode invasion for standard predictors, such as PSA, percentage of biopsy positive cores (BPC), tumor stage greater than 1 (cT > 1) and tumor grade group greater than two (ISUP > 2).
    RESULTS: Overall, LNI was detected in 70 patients (11.3%) of whom 39 (6.3%) with N = 1 and 31 (5%) with N > 1. On multivariate analysis, ET was inversely associated with the risk of N > 1 when compared to both N = 0 (odds ratio, OR 0.997; CI 0.994-1; p = 0.027) as well as with N = 1 cases (OR 0.994; 95% CI 0.989-1.000; p = 0.015).
    CONCLUSIONS: In clinical PCa, the risk of mPLNM was increased by low ET levels. As ET decreased, patients had an increased likelihood of mPLNM. Because of the inverse association between ET and mPLNM, higher ET levels were protective against aggressive disease. The influence of locally advanced PCa with high metastatic load on ET levels needs to be explored by controlled trials.
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  • 文章类型: Journal Article
    背景:一项前瞻性随机试验(LEAAUOAB25/02)发现,在接受根治性膀胱切除术(RC)的膀胱癌(BCa)患者中,与有限的盆腔淋巴结清扫术(PLND)模板相比,延长的患者没有生存获益。然而,标准模板和扩展模板的淋巴结浸润率(LNI)低于估计.
    目的:评估术前临床和病理参数预测LNI的准确性,并建立模型以术前选择扩展PLND模板的候选者。
    方法:回顾性分析了在单一机构治疗的903例BCa患者。主要结果是确定术前LNI的风险以定制PLND的类型。扩展的PLND模板包括切除盆腔淋巴结和髂总淋巴结,骶前,主动脉腔旁,主动脉腔,和肠系膜下动脉的腔旁部位。
    方法:总共903例BCa患者接受RC和双侧延伸PLND模板治疗。
    使用接收器工作特征曲线下面积(AUC)评估了预测LNI的几种模型,校准图和决策曲线分析。开发并在内部验证了预测扩展模式中的LNI的列线图。
    结论:总体而言,55例患者(6.1%)在RC的扩展PLND模板中有LNI。去除的节点的中位数为19(四分位间距:13-26)。包括年龄在内的模型,临床T分期,临床淋巴结分期,淋巴管浸润,并且在RC发生之前的最后一次经尿道切除术中存在原位癌。该模型的AUC为73%。使用3%的临界值,108个扩展PLND(12%)将被免除,只有两个LNI(3%)将被错过。我们模型的主要局限性是数据的回顾性,缺乏外部验证,和低LNI率。
    结论:这是第一个在扩展的PLND模板中预测LNI的模型。该模型可能有助于泌尿科医师确定哪些患者可能在RC时受益于延长的PLND,为所有其他人保留标准的PLND。
    我们开发了第一个列线图来预测膀胱癌根治性膀胱切除术患者盆腔淋巴结清扫模板的淋巴结侵犯(LNI)。采用我们的模型来确定扩展的盆腔淋巴结清扫模板的候选者可以避免多达12%的这些程序,而只需错过3%的LNI患者。
    BACKGROUND: A prospective randomized trial (LEA AUO AB 25/02) found no survival benefit in extended compared with limited pelvic lymph node dissection (PLND) templates in bladder cancer (BCa) patients treated with radical cystectomy (RC). However, the rate of lymph node invasion (LNI) in the standard and extended templates was lower than estimated.
    OBJECTIVE: To assess the accuracy of preoperative clinical and pathological parameters to predict LNI and to develop a model to preoperatively select candidates for the extended PLND templates.
    METHODS: A total of 903 BCa patients treated at a single institution were retrospectively identified. The primary outcome was to identify preoperatively the risk of LNI to tailor the type of PLND. The extended PLND templates consisted in the removal of pelvic lymph nodes together with the common iliac, presacral, para-aortocaval, interaortocaval, and paracaval sites up to the inferior mesenteric artery.
    METHODS: A total of 903 BCa patients were treated with RC and bilateral extended PLND templates.
    UNASSIGNED: Several models predicting LNI were evaluated using the area under the receiver operating characteristic curve (AUC), calibration plots and decision curve analyses. A nomogram predicting LNI in the extended pattern was developed and validated internally.
    CONCLUSIONS: Overall, 55 patients (6.1%) had LNI in the extended PLND templates at RC. The median number of nodes removed was 19 (interquartile range: 13-26). A model including age, clinical T stage, clinical node stage, lymphovascular invasion, and presence of carcinoma in situ at the last transurethral resection before RC was developed. The AUC of this model is 73%. Using a cutoff of 3%, 108 extended PLNDs (12%) would be spared and only two LNIs (3%) would be missed. The main limitations of our model are the retrospective nature of the data, lack of external validation, and low rate of LNI.
    CONCLUSIONS: This is the first proposed model to predict LNI in the extended PLND templates. This model might help urologists identify which patients might benefit from an extended PLND at the time of RC, reserving a standard PLND for all the others.
    UNASSIGNED: We developed the first nomogram to predict lymph node invasion (LNI) in the extended pelvic lymph node dissection templates in bladder cancer patients treated with radical cystectomy. The adoption of our model to identify candidates for the extended pelvic lymph node dissection templates could avoid up to 12% of these procedures at the cost of missing only 3% of patients with LNI.
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  • 文章类型: Case Reports
    背景:腹膜结核(TB)是肺外结核的一种相对罕见的表现。腹膜结核因其腹痛等非特异性临床表现而难以早期诊断。发烧,或腹水。尤其是腹部或骨盆手术后的早期,这些症状可误诊为脓毒性腹膜炎。很少有报道将腹膜结核作为腹腔镜手术的术后并发症。这里,我们描述了机器人辅助腹腔镜前列腺切除术(RALP)并进行淋巴结清扫后的第一例腹膜结核。病例介绍:一名78岁的男子在手术25天后出现发烧和腹胀。超声和计算机断层扫描(CT)显示大量腹水。腹水样本混浊,白细胞增加和肌酐水平正常。没有发现吻合口漏。考虑了淋巴囊肿的细菌感染,头孢美唑2克/天,共3天。尽管有抗菌治疗,发烧持续。腹水聚合酶链反应检测结核分枝杆菌阳性。患者得到有效的抗结核治疗。结论:这是腹膜结核作为RALP伴淋巴结清扫扩大的术后并发症的首次报道。术前胸部CT显示左上肺有颗粒状阴影,表明他以前无症状的结核病感染.即使在机器人辅助腹腔镜手术后,结核病也可能爆发,这是微创的。特别是当存在无法解释的腹水对抗生素无反应时,必须考虑腹膜结核。
    Background: Peritoneal tuberculosis (TB) is a relatively uncommon presentation of extrapulmonary TB. Early diagnosis of peritoneal TB is difficult because of its nonspecific clinical manifestation such as abdominal pain, fever, or ascites. Especially early after surgery of abdomen or pelvis, these symptoms can be misdiagnosed as septic peritonitis. There are few reports of peritoneal TB as a postoperative complication of laparoscopic surgery. Here, we describe a first case of peritoneal TB after robot-assisted laparoscopic prostatectomy (RALP) with extended lymph node dissection. Case Presentation: A 78-year-old man presented 25 days after this surgery with fever and abdominal distension. Ultrasonography and computed tomography (CT) revealed massive abdominal ascites. Ascites sample was cloudy, with increased white blood cells and normal creatinine level. No anastomotic leak was found. Bacterial infection of a lymphocele was considered, and cefmetazole 2 g/day for 3 days was prescribed. Despite antibacterial therapy, fever persisted. Polymerase chain reaction testing of ascitic fluid was positive for Mycobacterium tuberculosis. The patient was effectively treated with anti-TB therapy. Conclusion: This is the first report of peritoneal TB as a postoperative complication of RALP with extended lymph node dissection. His preoperative chest CT showed granular shadows in left upper lung, indicating his old asymptomatic TB infection. Flare-up of TB can happen even after robot-assisted laparoscopic surgery, which is minimally invasive. Peritoneal TB must be considered especially when there is unexplained ascites unresponsive to antibiotics.
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  • 文章类型: Journal Article
    前列腺切除术后淋巴结阳性前列腺癌患者的最佳管理仍然是一个挑战。我们评估了显示淋巴结阳性的临床局部患者,并确定了二次治疗的预测因素。从2010年到2015年,在病理分析上确定了接受机器人前列腺切除术和扩大淋巴结清扫术的临床局限性前列腺癌患者。排除临床N1、M1或抢救病例。根据二次治疗对患者进行分层。使用Kaplan-Meier方法确定生化和转移性复发的时间。多变量逻辑回归用于确定额外治疗的预测因子。145名患者(45名没有额外治疗,47佐剂,53挽救)的中位随访时间为31.2个月。抢救患者术前前列腺特异性抗原中位数较高(10.8vs.9.7vs.8.2,p=0.1),病理性格里森≥8的百分比更高(50.9vs.38.3%和22.2%,p<0.01),和更高的中值阳性节点(3vs.1和1,p<0.0001)与辅助和无治疗组相比,分别。病理性Gleason≥8(OR=3.5,p=0.007)和阳性节点≥2(OR=3.3,p=0.006)与其他治疗相关。在不治疗组中,两年期估计BCRFS为74.3%。没有治疗的两年无转移复发率,辅助和救助组分别为100%,87.5%和80.9%,分别(p=0.01)。观察是低转移负担患者的可行替代方案。在机器人前列腺切除术和扩展淋巴结清扫术中最大的淋巴结阳性患者系列中,病理性Gleason≥8例且淋巴结阳性≥2例的患者更有可能接受额外治疗.
    Optimal management of node-positive prostate cancer patients after prostatectomy remains a challenge. We evaluated clinically localized patients who demonstrated node positivity and identified predictors for secondary treatment. From 2010 to 2015, clinically localized prostate cancer patients who underwent robot prostatectomy with extended lymphadenectomy and node-positive disease on pathologic analysis were identified. Clinical N1, M1 or salvage cases were excluded. Patients were stratified based on secondary treatments. Kaplan-Meier method was used to determine the time to biochemical and metastatic recurrence. Multivariate logistic regression was used to identify predictors for additional treatment. 145 patients (45 no additional therapy, 47 adjuvant, 53 salvage) had a median follow-up of 31.2 months. Salvage patients had higher median pre-operative prostate-specific antigen (10.8 vs. 9.7 vs. 8.2, p = 0.1), higher percentage of pathologic Gleason ≥8 (50.9 vs. 38.3% and 22.2%, p < 0.01), and higher median-positive nodes (3 vs. 1 and 1, p < 0.0001) compared to adjuvant and no treatment groups, respectively. Pathologic Gleason ≥8 (OR = 3.5, p = 0.007) and positive nodes ≥2 (OR = 3.3, p = 0.006) were associated with additional therapy. In the no treatment group, two-year estimated BCRFS was 74.3%. Two-year metastatic recurrence-free rates for no treatment, adjuvant and salvage groups were 100, 87.5, and 80.9%, respectively (p = 0.01). Observation is a viable alternative for low metastatic burden patients. In the largest series of node-positive patients from robotic prostatectomy and extended lymphadenectomy, those with pathologic Gleason ≥8 and positive lymph nodes ≥2 were more likely to receive additional treatment.
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  • 文章类型: Comparative Study
    To determine if eliminating the prophylactic placement of a pelvic drain (PD) after robot-assisted radical prostatectomy (RARP) affects the incidence of early (90-day) postoperative adverse events.
    In this parallel-group, blinded, non-inferiority trial, we randomised patients planning to undergo RARP to one of two arms: no drain placement (ND) or PD placement. Patients with demonstrable intraoperative leakage upon bladder irrigation were excluded. Randomisation sequence was determined a priori using a computer algorithm, and included a stratified design with respect to low vs intermediate/high D\'Amico risk classifications. Surgeons remained blinded to the randomisation arm until final eligibility was verified at the end of the RARP. The primary endpoint was overall incidence of 90-day complications which, based on our standard treatment using PD retrospectively, was estimated at 13%. The non-inferiority margin was set at 10%, and the planned sample size was 312. An interim analysis was planned and conducted when one-third of the planned accrual and follow-up was completed, to rule out futility if the delta margin was in excess of 0.1389.
    From 2012 to 2016, 189 patients were accrued to the study, with 92 patients allocated to the ND group and 97 to the PD group. Due to lower than expected accrual rates, accrual to the study was halted by regulatory entities, and we did not reach the intended accrual goal. The ND and PD groups were comparable for median PSA level (6.2 vs 5.8 ng/mL, P = 0.5), clinical stage (P = 0.8), D\'Amico risk classification (P = 0.4), median lymph nodes dissected (17 vs 18, P = 0.2), and proportion of patients receiving an extended pelvic lymph node dissection (70.7% vs 79.4%, P = 0.3). Incidence of 90-day overall and major (Clavien-Dindo grade >III) complications in the ND group (17.4% and 5.4%, respectively) was not inferior to the PD group (26.8% and 5.2%, respectively; P < 0.001 and P = 0.007 for difference of proportions <10%, respectively). Symptomatic lymphocoele rates (2.2% in the ND group, 4.1% in the PD group) were comparable between the two arms (P = 0.7).
    Incidence of adverse events in the ND group was not inferior to the group who received a PD. In properly selected patients, PD placement after RARP can be safely withheld without significant additional morbidity.
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