Jesus E C, Karliczek A, Matos D, Castro A A, Atallah A N
Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD002100. doi: 10.1002/14651858.CD002100.pub2.
There is little agreement on prophylactic use of drains in anastomoses in elective colorectal surgery despite many randomized clinical trials. Results of these trials are contradictory, quality and statistical power of these individual studies have been questioned. Once anastomotic leakage has occurred it is generally agreed that drains should be used for therapeutic purposes. However, on prophylactic use no such agreement exists.
Comparison of safety and effectiveness of routine drainage and non-drainage regimes after colorectal surgery. The following hypothesis was tested: The use of prophylactic anastomotic drainage after elective colorectal surgery does not prevent development of complications.
The studies were identified from CINAHL, EMBASE, LILACS, MEDLINE, Controlled Clinical Trials Database, Trials Register of the Cochrane Colorectal Cancer Group, reference lists.
Randomized controlled trials comparing drainage with non-drainage regimes after anastomoses in elective colorectal surgery were reviewed. Outcome measures were: 1. mortality; 2. clinical anastomotic dehiscence; 3. radiological anastomotic dehiscence; 4. wound infection; 5. reoperation; 6. extra-abdominal complications.
Data were independently extracted and cross-checked by the two reviewers. The methodological quality of each trial was assessed. Details of the randomization (generation and concealment), blinding, and the number of patients lost to follow-up were recorded. The RCTs were stratified based on experimental group, according to clinical homogeneity (external validity).
Of the 1140 patients enrolled (6 RCTs), 573 were allocated for drainage and 567 for no drainage. The patients assigned to the drainage group compared with the ones assigned to non-drainage group showed: a) Mortality: 3% (18 of 573 patients) compared with 4% (25 of 567 patients); b) Clinical anastomotic dehiscence: 2% (11 of 522 patients) compared with 1% (7 of 519 patients); c) Radiological anastomotic dehiscence: 3% (16 of 522 patients) compared with 4% (19 of 519 patients); d) Wound infection: 5% (29 of 573 patients) compared with 5% (28 of 567 patients); e) Reintervention: 6% (34 of 542 patients) compared with 5% (28 of 539 patients); f) Extra abdominal complications: 7% (34 of 522 patients) compared with 6% (32 of 519 patients).
REVIEWERS' CONCLUSIONS: There is insufficient evidence showing that routine drainage after colorectal anastomoses prevents anastomotic and other complications.
尽管有许多随机临床试验,但对于择期结直肠手术吻合口预防性使用引流管的问题,目前仍未达成共识。这些试验的结果相互矛盾,且这些个体研究的质量和统计效力也受到质疑。一旦发生吻合口漏,普遍认为应使用引流管进行治疗。然而,对于预防性使用引流管,尚无此类共识。
比较结直肠手术后常规引流和不引流方案的安全性和有效性。检验了以下假设:择期结直肠手术后预防性使用吻合口引流不能预防并发症的发生。
从护理学与健康领域数据库(CINAHL)、荷兰医学文摘数据库(EMBASE)、拉丁美洲和加勒比地区卫生科学数据库(LILACS)、医学文献数据库(MEDLINE)、临床对照试验数据库、Cochrane结直肠癌组试验注册库以及参考文献列表中检索相关研究。
对择期结直肠手术吻合口后引流与不引流方案进行比较的随机对照试验进行综述。观察指标包括:1. 死亡率;2. 临床吻合口裂开;3. 影像学吻合口裂开;4. 伤口感染;5. 再次手术;6. 腹部外并发症。
由两位评价者独立提取数据并交叉核对。评估每个试验的方法学质量。记录随机化(产生和隐藏)、盲法以及失访患者数量的详细信息。根据实验组,按照临床同质性(外部有效性)对随机对照试验进行分层。
在纳入的1140例患者(6项随机对照试验)中,573例被分配至引流组,567例被分配至不引流组。与不引流组患者相比,引流组患者表现为:a)死亡率:3%(573例患者中有18例),而不引流组为4%(567例患者中有25例);b)临床吻合口裂开:2%(522例患者中有11例),而不引流组为1%(519例患者中有7例);c)影像学吻合口裂开:3%(522例患者中有16例),而不引流组为4%(519例患者中有19例);d)伤口感染:5%(573例患者中有29例),而不引流组为5%(567例患者中有28例);e)再次干预:6%(542例患者中有34例),而不引流组为5%(539例患者中有28例);f)腹部外并发症:7%(522例患者中有34例),而不引流组为6%(519例患者中有32例)。
没有足够的证据表明结直肠吻合术后常规引流可预防吻合口及其他并发症。