PDF(Pubmed)
Abstract：
During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an \'anastomosis\', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients.
To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery.
The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023.
We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients.
We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes.
Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.
To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery.
The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023.
We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients.
We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes.
Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.
摘要：
背景：在血管介入治疗期间，连接动脉的连接，静脉,或合成移植物，被称为“吻合”，可能是必要的。血管吻合可以从由吻合产生的针孔中出血。各种手术选择可用于实现止血，或者止血，包括将密封剂直接应用到出血的血管或组织上。当常规干预无效时，密封剂设计用于血管手术中作为辅助手段，并由外科医生直接应用于密封出血吻合。尽管有几种不同类型的密封剂，这些止血辅助药物在血管外科患者中的临床疗效尚不明确.
目的：评估封闭剂作为血管手术患者吻合口止血的辅助手段的益处和危害。
方法：Cochrane血管信息专家对以下数据库进行了系统搜索：通过Cochrane研究注册的Cochrane血管专业注册；Cochrane对照试验中央注册（CENTRAL）；通过Ovid的MEDLINE；通过Ovid的Embase；通过EBSCO的NAHL。我们还搜索了ClinicalTrials.gov和WHO国际临床试验注册平台进行临床试验。还检索了纳入试验的参考文献列表和相关综述。最近的搜索日期是2023年3月6日。
方法：我们纳入了随机对照试验，将纤维蛋白或合成密封剂的使用与替代干预措施（例如手动压缩，抗凝逆转），以在血管外科手术中实现吻合口部位止血。我们包括在血管手术期间进行吻合的参与者。我们排除了非血管手术患者。
方法：我们使用了标准的Cochrane方法。我们的主要结果是止血时间，止血干预失败，术中失血。我们的次要结果是手术时间，出血并发症死亡长达30天，术后出血长达30天，计划外返回手术室进行出血并发症管理长达30天，生活质量,和不良事件。我们使用等级来评估每个结果的证据的确定性。
结果：我们发现了24项随机对照试验，共包括2376名符合纳入标准的参与者。所有试验都将密封剂的使用与标准护理对照进行了比较，包括氧化纤维素,明胶海绵,和手动压缩。所有试验都存在性能偏差的高风险，检测偏差，和其他偏见的来源。我们降低了偏见风险的证据确定性，不一致,不精确和可能的出版偏见。结合止血时间的数据表明，与对照组相比，密封剂的使用可能会减少平均止血时间（平均差异（MD）-230.09秒，95%置信区间(CI)-329.24至-130.94；P<0.00001；7项研究，498名参与者；低确定性证据)。结合止血干预失败的数据表明，与对照组相比，使用密封剂可以降低失败率。但证据非常不确定（风险比（RR）0.46，95％CI0.35至0.61；P<0.00001；17项研究，2120名参与者；非常低的确定性证据)。我们没有发现密封剂组和对照组在术中失血方面的任何明显差异（MD-32.69mL，95%CI-96.21至30.83；P=0.31；3项研究，266名参与者；低确定性证据)；手术时间(MD-18.72分钟，95%CI-40.18至2.73；P=0.09；4项研究，436名参与者；低确定性证据）；术后出血（RR0.78，95％CI0.59至1.04；P=0.09；9项研究，1216名参与者；低确定性证据)，或计划外返回手术室(RR0.27，95%CI0.04至1.69；P=0.16；8项研究，721名参与者；低确定性证据)。没有研究报告出血死亡或生活质量结果。
结论：基于对2376名参与者的24项试验的荟萃分析，我们的审查表明，在血管手术患者中使用密封剂实现吻合口止血可能导致止血时间减少，并可能降低止血干预失败的发生率，虽然证据很不确定,与标准对照相比。我们的分析显示术中失血量可能没有差异，操作时间,术后出血长达30天，和计划外返回手术室出血并发症长达30天。无法分析死亡和生活质量。限制包括所有研究中的偏倚风险。我们的审查表明，使用密封剂可以减少止血所需的时间和止血失败率。然而,在纳入的研究中发现了显著的偏倚风险，和未来的试验需要提供无偏见的数据,并解决其他考虑因素,如成本效益和使用密封剂的不良事件.
目的：评估封闭剂作为血管手术患者吻合口止血的辅助手段的益处和危害。
方法：Cochrane血管信息专家对以下数据库进行了系统搜索：通过Cochrane研究注册的Cochrane血管专业注册；Cochrane对照试验中央注册（CENTRAL）；通过Ovid的MEDLINE；通过Ovid的Embase；通过EBSCO的NAHL。我们还搜索了ClinicalTrials.gov和WHO国际临床试验注册平台进行临床试验。还检索了纳入试验的参考文献列表和相关综述。最近的搜索日期是2023年3月6日。
方法：我们纳入了随机对照试验，将纤维蛋白或合成密封剂的使用与替代干预措施（例如手动压缩，抗凝逆转），以在血管外科手术中实现吻合口部位止血。我们包括在血管手术期间进行吻合的参与者。我们排除了非血管手术患者。
方法：我们使用了标准的Cochrane方法。我们的主要结果是止血时间，止血干预失败，术中失血。我们的次要结果是手术时间，出血并发症死亡长达30天，术后出血长达30天，计划外返回手术室进行出血并发症管理长达30天，生活质量,和不良事件。我们使用等级来评估每个结果的证据的确定性。
结果：我们发现了24项随机对照试验，共包括2376名符合纳入标准的参与者。所有试验都将密封剂的使用与标准护理对照进行了比较，包括氧化纤维素,明胶海绵,和手动压缩。所有试验都存在性能偏差的高风险，检测偏差，和其他偏见的来源。我们降低了偏见风险的证据确定性，不一致,不精确和可能的出版偏见。结合止血时间的数据表明，与对照组相比，密封剂的使用可能会减少平均止血时间（平均差异（MD）-230.09秒，95%置信区间(CI)-329.24至-130.94；P<0.00001；7项研究，498名参与者；低确定性证据)。结合止血干预失败的数据表明，与对照组相比，使用密封剂可以降低失败率。但证据非常不确定（风险比（RR）0.46，95％CI0.35至0.61；P<0.00001；17项研究，2120名参与者；非常低的确定性证据)。我们没有发现密封剂组和对照组在术中失血方面的任何明显差异（MD-32.69mL，95%CI-96.21至30.83；P=0.31；3项研究，266名参与者；低确定性证据)；手术时间(MD-18.72分钟，95%CI-40.18至2.73；P=0.09；4项研究，436名参与者；低确定性证据）；术后出血（RR0.78，95％CI0.59至1.04；P=0.09；9项研究，1216名参与者；低确定性证据)，或计划外返回手术室(RR0.27，95%CI0.04至1.69；P=0.16；8项研究，721名参与者；低确定性证据)。没有研究报告出血死亡或生活质量结果。
结论：基于对2376名参与者的24项试验的荟萃分析，我们的审查表明，在血管手术患者中使用密封剂实现吻合口止血可能导致止血时间减少，并可能降低止血干预失败的发生率，虽然证据很不确定,与标准对照相比。我们的分析显示术中失血量可能没有差异，操作时间,术后出血长达30天，和计划外返回手术室出血并发症长达30天。无法分析死亡和生活质量。限制包括所有研究中的偏倚风险。我们的审查表明，使用密封剂可以减少止血所需的时间和止血失败率。然而,在纳入的研究中发现了显著的偏倚风险，和未来的试验需要提供无偏见的数据,并解决其他考虑因素,如成本效益和使用密封剂的不良事件.
