Ladefoged Martin Riis, Korang Steven Kwasi, Hildorf Simone Engmann, Oehlenschlæger Jacob, Poulsen Susanne, Fossum Magdalena, Lausten-Thomsen Ulrik
Copenhagen Trial Unit, Department 7812, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Front Pediatr. 2022 Mar 18;10:849992. doi: 10.3389/fped.2022.849992. eCollection 2022.
Esophageal atresia is corrected surgically by anastomosing and recreating esophageal continuity. To allow the removal of excess fluid and air from the anastomosis, a prophylactic and temporary intraoperative chest tube (IOCT) has traditionally been placed in this area during surgery. However, whether the potential benefits of this prophylactic IOCT overweigh the potential harms is unclear.
To assess the benefits and harms of using a prophylactic IOCT during primary surgical repair of esophageal atresia.
We conducted a systematic review with a meta-analysis. We searched Cochrane Central Register of Controlled Trials (2021, Issue 12), MEDLINE Ovid, Embase Ovid, CINAHL, and Science Citation Index Expanded and Conference Proceedings Citation Index-(Web of Science). Search was performed from inception until December 3rd, 2021.
Randomized clinical trials (RCT) assessing the effect of a prophylactic IOCT during primary surgical repair of esophageal atresia and observational studies identified during our searches for RCT.
Two independent reviewers screened studies and performed data extraction. The certainty of the evidence was assessed by GRADE and ROBINS-I.
A protocol for this review has been registered on PROSPERO (CRD42021257834).
We included three RCTs randomizing 162 neonates, all at overall "some risk of bias." The studies compared the placement of an IOCT vs. none. The meta-analysis did not identify any significant effect of profylacitic IOCT, as confidence intervals were compatible with no effect, but the analyses suggests that the placement of an IOCT might lead to an increase in all-cause mortality (RR 1.66, 95% CI 0.76-3.65; three trials), serious adverse events (RR 1.08, 95% CI 0.58-2.00; three trials), intervention-requiring pneumothorax (RR 1.65, 95% CI 0.28-9.50; two trials), and anastomosis leakage (RR 1.66, 95% CI 0.63-4.40). None of our included studies assessed esophageal stricture or pain. Certainty of evidence was very low for all outcomes.
Evidence from RCTs does not support the routine use of a prophylactic IOCT during primary surgical repair of esophageal atresia.
食管闭锁通过吻合和重建食管连续性进行手术矫正。为了从吻合口排出多余的液体和空气，传统上在手术期间会在该区域放置一根预防性临时术中胸管（IOCT）。然而，这种预防性IOCT的潜在益处是否超过潜在危害尚不清楚。
评估在食管闭锁一期手术修复中使用预防性IOCT的益处和危害。
我们进行了一项系统评价并进行荟萃分析。我们检索了Cochrane对照试验中心注册库（2021年第12期）、MEDLINE Ovid、Embase Ovid、CINAHL以及科学引文索引扩展版和会议论文引文索引（科学网）。检索从数据库创建至2021年12月3日。
评估预防性IOCT在食管闭锁一期手术修复中效果的随机临床试验（RCT）以及我们在检索RCT过程中识别出的观察性研究。
两名独立的评审员筛选研究并进行数据提取。证据的确定性通过GRADE和ROBINS - I进行评估。
PROSPERO注册：本综述的方案已在PROSPERO上注册（CRD42021257834）。
我们纳入了三项RCT，共随机分配162名新生儿，所有研究总体上都存在“一定的偏倚风险”。这些研究比较了放置IOCT与不放置IOCT的情况。荟萃分析未发现预防性IOCT有任何显著效果，因为置信区间与无效果相符，但分析表明放置IOCT可能导致全因死亡率增加（风险比1.66，95%置信区间0.76 - 3.65；三项试验）、严重不良事件增加（风险比1.08，95%置信区间0.58 - 2.00；三项试验）、需要干预的气胸增加（风险比1.65，95%置信区间0.28 - 9.50；两项试验）以及吻合口漏增加（风险比1.66，95%置信区间0.63 - 4.40）。我们纳入的研究均未评估食管狭窄或疼痛情况。所有结局的证据确定性都非常低。
随机对照试验的证据不支持在食管闭锁一期手术修复中常规使用预防性IOCT。
