Clinic for Urology, University Medical Center Freiburg, Freiburg im Breisgau, Germany.
UroEvidence@Deutsche Gesellschaft für Urologie, Berlin, Germany.
Cochrane Database Syst Rev. 2023 Jul 28;7(7):CD012607. doi: 10.1002/14651858.CD012607.pub2.
Percutaneous nephrolithotomy (PNL) is the standard of care for removing large kidney stones (> 2 cm). Once the procedure is complete, different exiting strategies exist to manage the percutaneous tract opening, including placement of an external nephrostomy tube, placement of an internal ureteral stent, or no external or internal tube. The decision to place or not place a tube is handled differently among clinicians and may affect patient outcomes.
To assess the effects of tubeless PNL (with ureteral stenting), totally tubeless PNL (without ureteral stenting or nephrostomy), and standard PNL (nephrostomy only) for the treatment of kidney stones in adults.
We performed a systematic literature search in multiple biomedical databases (CENTRAL, MEDLINE, Embase, Web of Science), as well as in two clinical trial registries. We also handsearched reference lists of relevant publications and conference proceedings. We applied no language restrictions. The latest search update was conducted in September 2022.
We included randomized controlled and quasi-randomized controlled trials of adult patients who received tubeless, totally tubeless, or standard PNL for treating kidney stones. We defined tubeless PNL as no nephrostomy tube, but ureteral stenting, while totally tubeless PNL meant no nephrostomy tube or ureteral stenting. Both interventions were compared to standard PNL with placement of a nephrostomy tube (only). We considered access tubes of any sizes. We only considered unilateral PNL with single-tract access. There were no exclusions on stone composition, size, or location.
Two review authors independently screened the literature, extracted data, assessed risk of bias, and rated the certainty of evidence using GRADE. Primary outcomes were severe adverse events and postoperative pain, and secondary outcomes were operating time, length of hospital stay, and stone-free rate. We used the random-effects model for meta-analysis.
We included 10 studies in the review. Participant age varied among studies, ranging from 20 to 60 years. Detailed information on stone characteristics was rarely presented. Tubeless PNL versus standard PNL We are very uncertain whether there is a difference in severe adverse events (SAEs) between tubeless PNL and standard PNL (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.14 to 16.46; I = 42%; 2 studies, 46 participants; very low-certainty evidence). Tubeless PNL may have little to no effect on pain on postoperative day one (mean difference (MD) 0.56 lower, 95% CI 1.34 lower to 0.21 higher; I = 84%; 4 studies, 186 participants; low-certainty evidence), and probably results in little to no difference in operating room time (MD 0.40 longer (in minutes), 95% CI 4.82 shorter to 5.62 longer; I = 0%; 3 studies, 81 participants; moderate-certainty evidence). Tubeless PNL may reduce length of hospital stay (MD 0.90 shorter, 95% CI 1.45 shorter to 0.35 shorter; I = 84%; 6 studies, 238 participants; low-certainty evidence). We are very uncertain of the effect of tubeless PNL on blood transfusions (RR 0.64, 95% CI 0.16 to 2.52; I = 0%; 4 studies, 161 participants; very low-certainty evidence), sepsis or fever (RR 0.50, 95% CI 0.05 to 4.75; I = not applicable; 2 studies, 82 participants; very low-certainty evidence), or readmissions (RR 1.00, 95% CI 0.07 to 14.21; I = not applicable, 1 study, 24 participants; very low-certainty evidence). Totally tubeless versus standard PNL Totally tubeless PNL may result in lower SAE rates (RR 0.49, 95% CI 0.19 to 1.25; I = 0%; 2 studies, 174 participants; low-certainty evidence) and pain on postoperative day one (MD 3.60 lower, 95% CI 4.24 lower to 2.96 lower; I = Not applicable; 1 study, 50 participants; low-certainty evidence). Totally tubeless PNL may result in little to no difference in operating room time (MD 6.23 shorter (in minutes), 95% CI 14.29 shorter to 1.84 longer; I = 72%; 2 studies, 174 participants; moderate-certainty evidence) and sepsis or fever (RR 0.33, 95% CI 0.01 to 7.97; I = not applicable; 1 study, 90 participants; low-certainty evidence). Totally tubeless PNL likely shortens the length of hospital stay (MD 1.55 shorter, 95% CI 1.82 shorter to 1.29 shorter; I = 0%; 4 studies, 274 participants; moderate-certainty evidence). We are very uncertain of the effect of totally tubeless PNL on blood transfusions (RR 0.62, 95% CI 0.26 to 1.48; I = 0%; 4 studies, 274 participants; very low-certainty evidence) or readmissions (RR not estimable, 95% CI not estimable; I = not applicable; 1 study, 50 participants; very low-certainty evidence). We found no studies comparing tubeless mini versus standard mini-PNL or totally tubeless mini versus standard mini-PNL.
AUTHORS' CONCLUSIONS: When comparing tubeless to standard PNL with regard to the predefined primary outcomes of this review, there may be little difference in early postoperative pain, while we are very uncertain of the effect on SAEs. People treated with tubeless PNL may benefit from a reduced length of stay compared to standard PNL. When comparing totally tubeless to standard PNL, early postoperative pain and severe adverse events may be reduced with totally tubeless PNL. The certainty of evidence by outcome was mostly very low (range: moderate to very low) for the comparison of tubeless to standard PNL and low (range: moderate to very low) for the comparison of totally tubeless to standard PNL. The most common reasons for downgrading the certainty of the evidence were study limitations, inconsistency, and imprecision. We did not find randomized trial evidence for other comparisons. Overall, further and higher-quality studies are needed to inform clinical practice.
经皮肾镜碎石取石术(PNL)是治疗大肾结石(>2 厘米)的标准方法。一旦手术完成,有不同的方法可以管理经皮肾造口术的开口,包括放置外部肾造瘘管、放置内部输尿管支架或不放置外部或内部管。是否放置管的决定在临床医生之间存在差异,可能会影响患者的预后。
评估无管经皮肾镜碎石取石术(带输尿管支架)、完全无管经皮肾镜碎石取石术(不带输尿管支架或肾造瘘管)和标准经皮肾镜碎石取石术(仅肾造瘘管)治疗成人肾结石的效果。
我们在多个生物医学数据库(Cochrane 中心对照试验数据库、MEDLINE、Embase、Web of Science)以及两个临床试验注册处进行了系统文献检索。我们还手工检索了相关出版物和会议论文集的参考文献列表。我们没有语言限制。最新的搜索更新是在 2022 年 9 月进行的。
我们纳入了接受无管、完全无管或标准 PNL 治疗肾结石的成年患者的随机对照试验和准随机对照试验。我们将无管 PNL 定义为无肾造瘘管,但有输尿管支架,而完全无管 PNL 意味着无肾造瘘管或输尿管支架。这两种干预措施均与仅放置肾造瘘管的标准 PNL(仅)进行比较。我们考虑了任何尺寸的通道管。我们只考虑单侧 PNL 采用单通道入路。结石成分、大小或位置没有排除在外。
两名综述作者独立筛选文献、提取数据、评估偏倚风险,并使用 GRADE 评估证据确定性。主要结局是严重不良事件和术后疼痛,次要结局是手术时间、住院时间和结石清除率。我们使用随机效应模型进行荟萃分析。
我们纳入了 10 项研究。参与者的年龄在研究之间有所不同,范围从 20 岁到 60 岁。详细的结石特征信息很少报道。无管 PNL 与标准 PNL 相比:无管 PNL 与标准 PNL 相比,严重不良事件(RR 1.53,95%CI 0.14 至 16.46;I = 42%;2 项研究,46 名参与者;极低确定性证据)可能存在差异。无管 PNL 可能对术后第 1 天的疼痛影响较小(MD 0.56 更低,95%CI 1.34 更低至 0.21 更高;I = 84%;4 项研究,186 名参与者;低确定性证据),并且可能对手术时间(MD 4.82 更短至 5.62 更长,4 项研究,81 名参与者;中度确定性证据)的影响较小。无管 PNL 可能会缩短住院时间(MD 0.90 更短,95%CI 1.45 更短至 0.35 更短;I = 84%;6 项研究,238 名参与者;低确定性证据)。无管 PNL 对输血(RR 0.64,95%CI 0.16 至 2.52;I = 0%;4 项研究,161 名参与者;极低确定性证据)、脓毒症或发热(RR 0.50,95%CI 0.05 至 4.75;I = 不适用;2 项研究,82 名参与者;极低确定性证据)或再入院(RR 1.00,95%CI 0.07 至 14.21;I = 不适用,1 项研究,24 名参与者;极低确定性证据)的影响我们不确定。完全无管与标准 PNL 完全无管 PNL 可能会降低严重不良事件的发生率(RR 0.49,95%CI 0.19 至 1.25;I = 0%;2 项研究,174 名参与者;低确定性证据)和术后第 1 天的疼痛(MD 3.60 更低,95%CI 4.24 更低至 2.96 更低;I = 不适用;1 项研究,50 名参与者;低确定性证据)。完全无管 PNL 可能对手术时间(MD 6.23 更短,95%CI 14.29 更短至 1.84 更长;I = 72%;2 项研究,174 名参与者;中度确定性证据)和脓毒症或发热(RR 0.33,95%CI 0.01 至 7.97;I = 不适用;1 项研究,90 名参与者;低确定性证据)的影响不大。完全无管 PNL 可能会缩短住院时间(MD 1.55 更短,95%CI 1.82 更短至 1.29 更短;I = 0%;4 项研究,274 名参与者;中度确定性证据)。我们不确定完全无管 PNL 对输血(RR 0.62,95%CI 0.26 至 1.48;I = 0%;4 项研究,274 名参与者;极低确定性证据)或再入院(RR 不可估计,95%CI 不可估计;I = 不适用;1 项研究,50 名参与者;极低确定性证据)的影响。我们没有发现比较无管微通道与标准微通道 PNL 或完全无管微通道与标准微通道 PNL 的研究。
当比较无管与标准 PNL 时,在本综述的预先确定的主要结局方面,术后早期疼痛可能没有差异,而我们对严重不良事件的影响非常不确定。与标准 PNL 相比,接受无管 PNL 治疗的人可能受益于缩短住院时间。与标准 PNL 相比,完全无管 PNL 可能会降低术后早期疼痛和严重不良事件的发生率。比较无管与标准 PNL 和完全无管与标准 PNL 的结局的证据确定性,大多数情况下为非常低(范围:中度至非常低)。最常见的降低证据确定性等级的原因是研究局限性、不一致性和不精确性。我们没有发现针对其他比较的随机试验证据。总的来说,需要进一步和更高质量的研究来为临床实践提供信息。