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经皮导管插入技术改善腹膜透析患者导管功能和临床结局的应用。

Catheter insertion techniques for improving catheter function and clinical outcomes in peritoneal dialysis patients.

机构信息

Department of Nephrology, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, UK.

School of Health and Related Research, University of Sheffield, Sheffield, UK.

出版信息

Cochrane Database Syst Rev. 2023 Feb 22;2(2):CD012478. doi: 10.1002/14651858.CD012478.pub2.

Abstract

BACKGROUND

Peritoneal dialysis (PD) relies on the optimal functionality of the flexible plastic PD catheter present within the peritoneal cavity to enable effective treatment. As a result of limited evidence, it is uncertain if the PD catheter's insertion method influences the rate of catheter dysfunction and, thus, the quality of dialysis therapy. Numerous variations of four basic techniques have been adopted in an attempt to improve and maintain PD catheter function. This review evaluates the association between PD catheter insertion technique and associated differences in  PD catheter function and post-PD catheter insertion complications OBJECTIVES: Our aims were to 1) evaluate if a specific technique used for PD catheter insertion has lower rates of PD catheter dysfunction (early and late) and technique failure; and 2) examine if any of the available techniques results in a reduction in post-procedure complication rates including postoperative haemorrhage, exit-site infection and peritonitis.

SEARCH METHODS

We searched the Cochrane Kidney and Transplant Register of Studies up to 24 November 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) examining adults and children undergoing PD catheter insertion. The studies examined any two PD catheter insertion techniques, including laparoscopic, open-surgical, percutaneous and peritoneoscopic insertion. Primary outcomes of interest were PD catheter function and technique survival.  DATA COLLECTION AND ANALYSIS: Two authors independently performed data extraction and assessed the risk of bias for all included studies. Main outcomes in the Summary of Findings tables include primary outcomes - early PD catheter function, long-term PD catheter function, technique failure and postoperative complications. A random effects model was used to perform meta-analyses; risk ratios (RRs) were calculated for dichotomous outcomes, and mean differences (MD) were calculated for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. The certainty of the evidence was evaluated using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.  MAIN RESULTS: Seventeen studies were included in this review. Nine studies were suitable for inclusion in quantitative meta-analysis (670 randomised participants). Five studies compared laparoscopic with open PD catheter insertion, and four studies compared a 'medical' insertion technique with open surgical PD catheter insertion: percutaneous (2) and peritoneoscopic (2). Random sequence generation was judged to be at low risk of bias in eight studies. Allocation concealment was reported poorly, with only five studies judged to be at low risk of selection bias. Performance bias was judged to be high risk in 10 studies. Attrition bias and reporting bias were judged to be low in 14 and 12 studies, respectively. Six studies compared laparoscopic PD catheter insertion with open surgical insertion. Five studies could be meta-analysed (394 participants). For our primary outcomes, data were either not reported in a format that could be meta-analysed (early PD catheter function, long-term catheter function) or not reported at all (technique failure). One death was reported in the laparoscopic group and none in the open surgical group. In low certainty evidence, laparoscopic PD catheter insertion may make little or no difference to the risk of peritonitis (4 studies, 288 participants: RR 0.97, 95% CI 0.63 to 1.48; I² = 7%), PD catheter removal (4 studies, 257 participants: RR 1.15, 95% CI 0.80 to 1.64; I² = 0%), and dialysate leakage (4 studies, 330 participants: RR 1.40, 95% CI 0.49 to 4.02; I² = 0%), but may reduce the risk of haemorrhage (2 studies, 167 participants: RR 1.68, 95% CI 0.28 to 10.31; I² = 33%) and catheter tip migration (4 studies, 333 participants: RR 0.43, 95% CI 0.20 to 0.92; I² = 12%). Four studies compared a medical insertion technique with open surgical insertion (276 participants). Technique failure was not reported, and no deaths were reported (2 studies, 64 participants). In low certainty evidence, medical insertion may make little or no difference to early PD catheter function (3 studies, 212 participants: RR 0.73, 95% CI 0.29 to 1.83; I² = 0%), while one study reported long-term PD function may improve with peritoneoscopic insertion (116 participants: RR 0.59, 95% CI 0.38 to 0.92). Peritoneoscopic catheter insertion may reduce the episodes of early peritonitis (2 studies, 177 participants: RR 0.21, 95% CI 0.06 to 0.71; I² = 0%) and dialysate leakage (2 studies, 177 participants: RR 0.13, 95% CI 0.02 to 0.71; I² = 0%). Medical insertion had uncertain effects on catheter tip migration (2 studies, 90 participants: RR 0.74, 95% CI 0.15 to 3.73; I² = 0%). Most of the studies examined were small and of poor quality, increasing the risk of imprecision. There was also a significant risk of bias therefore cautious interpretation of results is advised.

AUTHORS' CONCLUSIONS: The available studies show that the evidence needed to guide clinicians in developing their PD catheter insertion service is lacking. No PD catheter insertion technique had lower rates of PD catheter dysfunction. High-quality, evidence-based data are urgently required, utilising multi-centre RCTs or large cohort studies, in order to provide definitive guidance relating to PD catheter insertion modality.

摘要

背景

腹膜透析(PD)依赖于存在于腹腔内的灵活塑料 PD 导管的最佳功能,以实现有效的治疗。由于证据有限,尚不确定 PD 导管的插入方法是否会影响导管功能障碍的发生率,从而影响透析治疗的质量。为了改善和维持 PD 导管的功能,已经采用了四种基本技术的许多变体。本综述评估了 PD 导管插入技术与 PD 导管功能和 PD 导管插入后并发症之间的关联

目的

我们的目的是 1)评估用于 PD 导管插入的特定技术是否具有较低的 PD 导管功能障碍(早期和晚期)和技术失败率;2)检查是否任何现有技术都可以降低术后并发症发生率,包括术后出血、出口部位感染和腹膜炎。

检索方法

我们通过与信息专家联系,使用与本综述相关的搜索词,在截至 2022 年 11 月 24 日之前,在 Cochrane 肾脏和移植登记册中搜索了研究。通过对 CENTRAL、MEDLINE 和 EMBASE 的搜索、会议记录、国际临床试验注册中心(ICTRP)搜索门户和 ClinicalTrials.gov 的搜索来确定登记册中的研究。

选择标准

我们纳入了随机对照试验(RCT),其中包括接受 PD 导管插入术的成年人和儿童。这些研究检查了任何两种 PD 导管插入技术,包括腹腔镜、开放式手术、经皮和腹膜镜插入。主要感兴趣的结果是 PD 导管功能和技术存活率。

数据收集和分析

两名作者独立提取数据,并对所有纳入的研究进行了偏倚风险评估。汇总结果表中的主要结局包括主要结局-早期 PD 导管功能、长期 PD 导管功能、技术失败和术后并发症。使用随机效应模型进行荟萃分析;二分类结局的效应估计采用风险比(RR),连续结局的效应估计采用均数差(MD),置信区间(CI)为 95%。使用 GRADE(推荐、评估、发展和评估)方法评估证据的确定性。

主要结果

本综述纳入了 17 项研究。9 项研究适合进行定量荟萃分析(670 名随机参与者)。5 项研究比较了腹腔镜与开放式 PD 导管插入,4 项研究比较了“医学”插入技术与开放式手术 PD 导管插入:经皮(2)和腹膜镜(2)。8 项研究中,随机序列生成被认为偏倚风险低。只有 5 项研究报告了低选择偏倚风险。10 项研究中,绩效偏倚被认为是高风险。14 项和 12 项研究分别报告了低偏倚风险和低报告偏倚风险。6 项研究比较了腹腔镜 PD 导管插入术与开放式手术插入术。5 项研究(394 名参与者)可进行荟萃分析。对于我们的主要结局,数据要么没有以可进行荟萃分析的格式报告(早期 PD 导管功能、长期导管功能),要么根本没有报告(技术失败)。腹腔镜组报告了 1 例死亡,开放式手术组未报告死亡。在低确定性证据中,腹腔镜 PD 导管插入术可能对腹膜炎(4 项研究,288 名参与者:RR 0.97,95%CI 0.63 至 1.48;I²=7%)、PD 导管移除(4 项研究,257 名参与者:RR 1.15,95%CI 0.80 至 1.64;I²=0%)和透析液渗漏(4 项研究,330 名参与者:RR 1.40,95%CI 0.49 至 4.02;I²=0%)的风险影响不大,但可能降低出血(2 项研究,167 名参与者:RR 1.68,95%CI 0.28 至 10.31;I²=33%)和导管尖端迁移(4 项研究,333 名参与者:RR 0.43,95%CI 0.20 至 0.92;I²=12%)的风险。4 项研究比较了医学插入技术与开放式手术插入(276 名参与者)。未报告技术失败,也未报告死亡(2 项研究,64 名参与者)。在低确定性证据中,医学插入术可能对早期 PD 导管功能(3 项研究,212 名参与者:RR 0.73,95%CI 0.29 至 1.83;I²=0%)影响不大,而一项研究报告说,腹膜镜插入术可能会改善长期 PD 功能(116 名参与者:RR 0.59,95%CI 0.38 至 0.92)。腹膜镜导管插入术可能减少早期腹膜炎(2 项研究,177 名参与者:RR 0.21,95%CI 0.06 至 0.71;I²=0%)和透析液渗漏(2 项研究,177 名参与者:RR 0.13,95%CI 0.02 至 0.71;I²=0%)的发作。医学插入术对导管尖端迁移的影响不确定(2 项研究,90 名参与者:RR 0.74,95%CI 0.15 至 3.73;I²=0%)。大多数研究规模较小且质量较差,增加了不准确性的风险。此外,还存在显著的偏倚风险,因此建议谨慎解释结果。

结论

现有研究表明,指导临床医生开展 PD 导管插入服务所需的证据不足。没有 PD 导管插入技术具有较低的 PD 导管功能障碍发生率。迫切需要高质量的循证数据,利用多中心 RCT 或大型队列研究,为 PD 导管插入方式提供明确的指导。

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