Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou City, China.
Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou City, China.
Cochrane Database Syst Rev. 2021 Jun 21;6(6):CD010373. doi: 10.1002/14651858.CD010373.pub3.
There has been extensive debate in the surgical literature regarding the optimum surgical access approach to the infrarenal abdominal aorta during an operation to repair an abdominal aortic aneurysm. The published trials comparing retroperitoneal (RP) and transperitoneal (TP) aortic surgery show conflicting results. This is an update of the review first published in 2016.
To assess the effectiveness and safety of the retroperitoneal versus transperitoneal approach for elective open abdominal aortic aneurysm repair on mortality, complications, hospital stay and blood loss.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials registers to 30 November 2020. The review authors searched the Chinese Biomedical Literature Database and handsearched reference lists of relevant articles to identify additional trials.
We included randomized controlled trials (RCTs) that assessed the RP approach versus the TP approach for elective open abdominal aortic aneurysm (AAA) repair. There were no restrictions on language or publication status.
Two review authors independently extracted data from the included trials. We resolved any disagreements through discussion with a third review author. Two review authors independently assessed the risk of bias in included trials with the Cochrane risk of bias tool. For dichotomous outcomes, we calculated the odds ratio (OR) with the corresponding 95% confidence interval (CI). For continuous data, we calculated a pooled estimate of treatment effect by calculating the mean difference (MD) and standard deviation (SD) with corresponding 95% CIs. We pooled data using a fixed-effect model, unless we identified heterogeneity, in which case we used a random-effects model. We used GRADE to assess the overall certainty of the evidence. We evaluated the outcomes of mortality, complications, intensive care unit (ICU) stay, hospital stay, blood loss, aortic cross-clamp time and operating time.
We identified no new studies from the updated searches. After reassessment, we included one study which had previously been excluded. Five RCTs with a combined total of 152 participants are included. The overall certainty of the evidence ranged from low to very low because of the low methodological quality of the included trials (unclear random sequence generation method and allocation concealment, and no blinding of outcome assessors), small sample sizes, small number of events, high heterogeneity and inconsistency between the included trials, no power calculations and relatively short follow-up. There was no evidence of a difference between the RP approach and the TP approach regarding mortality (odds ratio (OR) 0.32, 95% CI 0.01 to 8.25; 3 studies, 110 participants; very low-certainty evidence). Similarly, there was no evidence of a difference in complications such as hematoma (OR 0.90, 95% CI 0.13 to 6.48; 2 studies, 75 participants; very low-certainty evidence), abdominal wall hernia (OR 10.76, 95% CI 0.55 to 211.78; 1 study, 48 participants; very low-certainty evidence), or chronic wound pain (OR 2.20, 95% CI 0.36 to 13.34; 1 study, 48 participants; very low-certainty evidence) between the RP and TP approaches in participants undergoing elective open AAA repair. The RP approach may reduce ICU stay (mean difference (MD) -19.02 hours, 95% CI -30.83 to -7.21; 3 studies, 106 participants; low-certainty evidence); hospital stay (MD -3.30 days, 95% CI -4.85 to-1.75; 5 studies, 152 participants; low-certainty evidence); and blood loss (MD -504.87 mL, 95% CI -779.19 to -230.56; 4 studies, 129 participants; very low-certainty evidence). There was no evidence of a difference between the RP approach and the TP approach regarding aortic cross-clamp time (MD 0.69 min, 95% CI -7.23 to 8.60; 4 studies, 129 participants; very low-certainty evidence) or operating time (MD -15.94 min, 95% CI -34.76 to 2.88; 4 studies, 129 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS: Very low-certainty evidence from five small RCTs showed no clear evidence of a difference between the RP approach and the TP approach for elective open AAA repair in terms of mortality, or for rates of complications including hematoma (very low-certainty evidence), abdominal wall hernia (very low-certainty evidence), or chronic wound pain (very low-certainty evidence). However, a shorter intensive care unit (ICU) stay and shorter hospital stay was probably indicated following the RP approach compared to the TP approach (both low-certainty evidence). A possible reduction in blood loss was also shown after the RP approach (very low-certainty evidence). There is no clear difference between the RP approach and TP approach in aortic cross-clamp time or operating time. Further well-designed, large-scale RCTs assessing the RP approach versus TP approach for elective open AAA repair are required.
在修复腹主动脉瘤的手术中,关于在肾下腹部主动脉手术中选择最佳手术入路的问题,外科文献中存在广泛的争论。已发表的比较腹膜后(RP)和经腹腔(TP)主动脉手术的试验结果存在矛盾。这是首次发表于 2016 年的综述的更新。
评估在择期开放腹主动脉瘤修复中,腹膜后与经腹腔入路在死亡率、并发症、住院时间和失血量方面的有效性和安全性。
Cochrane 血管专业信息员检索了 Cochrane 血管特刊登记册、CENTRAL、MEDLINE、Embase 和 CINAHL 数据库,以及世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov 试验注册中心,检索时间截至 2020 年 11 月 30 日。综述作者检索了中国生物医学文献数据库,并对相关文章的参考文献进行了手工检索,以确定其他试验。
我们纳入了评估择期开放腹主动脉瘤(AAA)修复中 RP 与 TP 方法的随机对照试验(RCT)。语言或发表状态没有限制。
两位综述作者独立提取纳入试验的数据。我们通过与第三位综述作者讨论解决了任何分歧。两位综述作者使用 Cochrane 偏倚风险工具独立评估了纳入试验的偏倚风险。对于二分类结局,我们计算了比值比(OR)及其相应的 95%置信区间(CI)。对于连续性数据,我们通过计算平均差(MD)和标准偏差(SD)及其相应的 95%CI,计算了治疗效果的汇总估计值。我们使用固定效应模型汇总数据,除非我们发现存在异质性,在这种情况下,我们使用随机效应模型。我们使用 GRADE 评估证据的总体确定性。我们评估了死亡率、并发症、重症监护病房(ICU)停留时间、住院时间、失血量、主动脉阻断时间和手术时间的结局。
我们从更新的检索中没有发现新的研究。经过重新评估,我们纳入了一项先前被排除的研究。共有 5 项 RCT 纳入了 152 名参与者。由于纳入试验的方法学质量低(随机序列生成方法和分配隐藏方法不明确,结局评估者未设盲)、样本量小、事件数量少、高度异质性和纳入试验之间的不一致、没有进行功效计算和随访时间相对较短,证据的总体确定性从低到极低。腹膜后入路与经腹腔入路在死亡率方面没有差异(OR 0.32,95%CI 0.01 至 8.25;3 项研究,110 名参与者;极低确定性证据)。同样,腹膜后入路与经腹腔入路在并发症方面也没有差异,如血肿(OR 0.90,95%CI 0.13 至 6.48;2 项研究,75 名参与者;极低确定性证据)、腹壁疝(OR 10.76,95%CI 0.55 至 211.78;1 项研究,48 名参与者;极低确定性证据)或慢性伤口疼痛(OR 2.20,95%CI 0.36 至 13.34;1 项研究,48 名参与者;极低确定性证据)方面也没有差异。在择期开放 AAA 修复中,腹膜后入路可能会缩短 ICU 停留时间(MD-19.02 小时,95%CI-30.83 至-7.21;3 项研究,106 名参与者;低确定性证据)、住院时间(MD-3.30 天,95%CI-4.85 至-1.75;5 项研究,152 名参与者;低确定性证据)和失血量(MD-504.87 mL,95%CI-779.19 至-230.56;4 项研究,129 名参与者;极低确定性证据)。腹膜后入路与经腹腔入路在主动脉阻断时间(MD 0.69 分钟,95%CI-7.23 至 8.60;4 项研究,129 名参与者;极低确定性证据)或手术时间(MD-15.94 分钟,95%CI-34.76 至 2.88;4 项研究,129 名参与者;极低确定性证据)方面没有差异。
五项小型 RCT 的极低确定性证据表明,在择期开放 AAA 修复中,腹膜后入路与经腹腔入路在死亡率方面,或在血肿(极低确定性证据)、腹壁疝(极低确定性证据)或慢性伤口疼痛(极低确定性证据)等并发症发生率方面,没有明显差异。然而,与经腹腔入路相比,腹膜后入路可能会缩短 ICU 停留时间和住院时间(均为低确定性证据)。腹膜后入路后还显示失血量可能减少(极低确定性证据)。腹膜后入路与经腹腔入路在主动脉阻断时间或手术时间方面没有明显差异。需要进一步设计良好、规模较大的 RCT 来评估择期开放 AAA 修复中腹膜后入路与经腹腔入路的比较。