Miao Chunmu, Hu Yali, Bai Guijuan, Cheng Nansheng, Cheng Yao, Wang Weimin
Department of Hepatobiliary Surgery, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Department of Clinical Laboratory, Community Health Center of Dingshan Street Jiangjin District Chongqing City, Jiangjin, China.
Cochrane Database Syst Rev. 2025 May 16;5(5):CD010583. doi: 10.1002/14651858.CD010583.pub6.
This is the fourth update of a Cochrane review first published in 2015 and last updated in 2021. The use of surgical drains is a very common practice after pancreatic surgery. The role of prophylactic abdominal drainage to reduce postoperative complications after pancreatic surgery is controversial.
To assess the benefits and harms of routine abdominal drainage after pancreatic surgery; to compare the effects of different types of surgical drains; and to evaluate the optimal time for drain removal.
We searched CENTRAL, MEDLINE, three other databases, and five trials registers, together with reference checking and contact with study authors, to identify studies for inclusion in the review. The search dates were 20 April 2024 and 20 July 2024.
We included randomised controlled trials (RCTs) in participants undergoing pancreatic surgery comparing (1) drain use versus no drain use, (2) different types of drains, or (3) different schedules for drain removal. We excluded quasi-randomised and non-randomised studies.
Our critical outcomes were 30-day mortality, 90-day mortality, intra-abdominal infection, wound infection, and drain-related complications.
We used the Cochrane RoB 1 tool to assess the risk of bias in RCTs.
We synthesised the results for each outcome using meta-analysis with the random-effects model where possible. We used GRADE to assess the certainty of evidence for each outcome.
We included 12 RCTs with a total of 2550 participants. The studies were conducted in North America, Europe, and Asia and were published between 2001 and 2024. All studies were at overall high risk of bias.
We considered the certainty of the evidence for intra-abdominal infection for the comparison of early versus late drain removal following pancreaticoduodenectomy to be moderate, downgraded due to indirectness. We considered the certainty of the evidence for the other outcomes to be low or very low, mainly downgraded due to high risk of bias, inconsistency, indirectness, and imprecision. Drain use versus no drain use following pancreaticoduodenectomy We included two RCTs with 532 participants randomised to the drainage group (N = 270) and the no drainage group (N = 262) after pancreaticoduodenectomy. The evidence is very uncertain about the effect of drain use on 30-day mortality (risk ratio (RR) 0.49, 95% confidence interval (CI) 0.07 to 3.66; 2 studies, 532 participants), 90-day mortality (RR 0.25, 95% CI 0.06 to 1.15; 1 study, 137 participants), intra-abdominal infection rate (RR 0.85, 95% CI 0.21 to 3.51; 2 studies, 532 participants), and wound infection rate (RR 0.85, 95% CI 0.55 to 1.31; 2 studies, 532 participants) compared with no drain use. Neither study reported on drain-related complications. Drain use versus no drain use following distal pancreatectomy We included two RCTs with 626 participants randomised to the drainage group (N = 318) and the no drainage group (N = 308) after distal pancreatectomy. There were no deaths at 30 days in either group. The evidence is very uncertain about the effect of drain use on 90-day mortality (RR 0.16, 95% CI 0.02 to 1.35; 2 studies, 626 participants), intra-abdominal infection rate (RR 1.20, 95% CI 0.60 to 2.42; 1 study, 344 participants), and wound infection rate (RR 2.12, 95% CI 0.93 to 4.87; 2 studies, 626 participants) compared with no drain use. Neither study reported on drain-related complications. Active versus passive drain following pancreaticoduodenectomy We included three RCTs with 441 participants randomised to the active drain group (N = 222) and the passive drain group (N = 219) after pancreaticoduodenectomy. The evidence is very uncertain about the effect of an active drain on 30-day mortality (RR 1.24, 95% CI 0.30 to 5.07; 2 studies, 321 participants), intra-abdominal infection rate (RR 0.58, 95% CI 0.06 to 5.43; 3 studies, 441 participants), and wound infection rate (RR 0.92, 95% CI 0.44 to 1.90; 2 studies, 321 participants) compared with a passive drain. None of the studies reported on 90-day mortality. There were no drain-related complications in either group (1 study, 161 participants; very low-certainty evidence). Early versus late drain removal following pancreaticoduodenectomy We included three RCTs with 557 participants with a low risk of postoperative pancreatic fistula, randomised to the early drain removal group (N = 279) and the late drain removal group (N = 278) after pancreaticoduodenectomy. Low-certainty evidence suggests that early drain removal may result in little to no difference in 30-day mortality (RR 0.99, 95% CI 0.06 to 15.45; 3 studies, 557 participants) and wound infection rate (RR 1.07, 95% CI 0.47 to 2.46; 3 studies, 557 participants) compared with late drain removal. Moderate-certainty evidence shows that early drain removal probably results in a slight reduction in intra-abdominal infection rate compared with late drain removal (RR 0.45, 95% CI 0.26 to 0.79; 3 studies, 557 participants). Approximately 58 (34 to 102 participants) out of 1000 participants in the early removal group developed intra-abdominal infections compared with 129 out of 1000 participants in the late removal group. There were no deaths at 90 days in either study group (2 studies, 416 participants). None of the studies reported on drain-related complications.
AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effect of drain use compared with no drain use on 90-day mortality, intra-abdominal infection rate, and wound infection rate in people undergoing either pancreaticoduodenectomy or distal pancreatectomy. The evidence is also very uncertain whether an active drain is superior, equivalent, or inferior to a passive drain following pancreaticoduodenectomy. Moderate-certainty evidence suggests that early drain removal is probably superior to late drain removal in terms of intra-abdominal infection rate following pancreaticoduodenectomy for people with low risk of postoperative pancreatic fistula.
None.
Registration: not available. Protocol and previous versions available via doi.org/10.1002/14651858.CD010583, doi.org/10.1002/14651858.CD010583.pub2, doi.org/10.1002/14651858.CD010583.pub3, doi.org/10.1002/14651858.CD010583.pub4, and doi.org/10.1002/14651858.CD010583.pub5.
这是一篇Cochrane系统评价的第四次更新，该评价首次发表于2015年，上次更新于2021年。胰腺手术后使用手术引流管是一种非常常见的做法。预防性腹腔引流在降低胰腺手术后并发症方面的作用存在争议。
评估胰腺手术后常规腹腔引流的益处和危害；比较不同类型手术引流管的效果；评估拔除引流管的最佳时间。
我们检索了Cochrane系统评价资料库（CENTRAL）、医学期刊数据库（MEDLINE）、其他三个数据库以及五个试验注册库，并进行参考文献核对以及与研究作者联系，以确定纳入该评价的研究。检索日期为2024年4月20日和2024年7月20日。
我们纳入了接受胰腺手术的参与者的随机对照试验（RCT），比较（1）使用引流管与不使用引流管，（2）不同类型的引流管，或（3）不同的引流管拔除方案。我们排除了半随机和非随机研究。
我们的关键结局指标是30天死亡率、90天死亡率、腹腔内感染、伤口感染和与引流管相关的并发症。
我们使用Cochrane偏倚风险评估工具1（Cochrane RoB 1）来评估RCT中的偏倚风险。
我们尽可能使用随机效应模型的荟萃分析来综合每个结局指标的结果。我们使用GRADE来评估每个结局指标的证据确定性。
我们纳入了12项RCT，共2550名参与者。这些研究在北美、欧洲和亚洲进行，发表时间为2001年至2024年。所有研究总体偏倚风险较高。
对于胰十二指肠切除术后早期与晚期拔除引流管比较腹腔内感染的证据确定性，我们认为为中等，因间接性而降级。对于其他结局指标的证据确定性，我们认为为低或极低，主要因偏倚风险高、不一致性、间接性和不精确性而降级。
我们纳入了两项RCT，共532名参与者，在胰十二指肠切除术后随机分为引流组（N = 270）和无引流组（N = 262）。关于使用引流管对30天死亡率（风险比（RR）0.49，95%置信区间（CI）0.oo7至3.66；2项研究，53名参与者）、90天死亡率（RR 0.25，95% CI 0.06至1.15；1项研究，137名参与者）、腹腔内感染率（RR 0.85，95% CI 0.21至3.51；2项研究，532名参与者）和伤口感染率（RR 0.85，95% CI 0.55至1.31；2项研究，532名参与者）的影响，与不使用引流管相比，证据非常不确定。两项研究均未报告与引流管相关的并发症。
我们纳入了两项RCT，共626名参与者，在胰体尾切除术后随机分为引流组（N = 318）和无引流组（N = 308）。两组在30天均无死亡。关于使用引流管对90天死亡率（RR 0.16，95% CI 0.02至1.35；2项研究，626名参与者）、腹腔内感染率（RR 1.20，95% CI 0.60至2.42；1项研究，344名参与者）和伤口感染率（RR 2.12，95% CI 0.93至4.87；2项研究，626名参与者）的影响，与不使用引流管相比，证据非常不确定。两项研究均未报告与引流管相关的并发症。
我们纳入了三项RCT，共441名参与者，在胰十二指肠切除术后随机分为主动引流组（N = 222）和被动引流组（N = 219）。关于主动引流对30天死亡率（RR 1.24，95% CI 0.30至5.07；2项研究，321名参与者）、腹腔内感染率（RR 0.58，95% CI 0.06至5.43；3项研究，441名参与者）和伤口感染率（RR 0.92，95% CI 0.44至1.90；2项研究，321名参与者）的影响，与被动引流相比，证据非常不确定。没有研究报告90天死亡率。两组均无与引流管相关的并发症（1项研究，161名参与者；极低确定性证据）。
我们纳入了三项RCT，共557名术后胰瘘风险较低的参与者，在胰十二指肠切除术后随机分为早期拔除引流管组（N = 279）和晚期拔除引流管组（N = 278）。低确定性证据表明，与晚期拔除引流管相比，早期拔除引流管在30天死亡率（RR 0.99，95% CI 0.06至15.45；3项研究，557名参与者）和伤口感染率（RR 1.07，95% CI 0.47至2.46；3项研究，557名参与者）方面可能几乎没有差异。中等确定性证据表明，与晚期拔除引流管相比，早期拔除引流管可能会使腹腔内感染率略有降低（RR 0.45，95% CI 0.26至0.79；3项研究，557名参与者）。早期拔除引流管组每1000名参与者中约有58（34至102名参与者）发生腹腔内感染，而晚期拔除引流管组每1000名参与者中有129名发生腹腔内感染。两个研究组在90天均无死亡（2项研究，416名参与者）。没有研究报告与引流管相关的并发症。
对于接受胰十二指肠切除术或胰体尾切除术的患者，与不使用引流管相比，使用引流管对90天死亡率、腹腔内感染率和伤口感染率的影响，证据非常不确定。对于胰十二指肠切除术后主动引流是否优于、等同于或劣于被动引流，证据也非常不确定。中等确定性证据表明，对于术后胰瘘风险较低的患者，在胰十二指肠切除术后腹腔内感染率方面，早期拔除引流管可能优于晚期拔除引流管。
无。
未注册。方案及以前版本可通过doi.org/10.1002/14651858.CD010583、doi.org/10.1002/14651858.CD010583.pub2、doi.org/10.1002/14651858.CD010583.pub3、doi.org/10.1002/14651858.CD010583.pub4和doi.org/10.1002/14651858.CD010583.pub5获取。
