腹部大手术中中线切口与横切口的比较：一项随机、双盲等效性试验（POVATI：ISRCTN60734227）

Midline versus transverse incision in major abdominal surgery: a randomized, double-blind equivalence trial (POVATI: ISRCTN60734227).

作者信息

Seiler Christoph M, Deckert Andreas, Diener Markus K, Knaebel Hanns-Peter, Weigand Markus A, Victor Norbert, Büchler Markus W

机构信息

Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.

出版信息

Ann Surg. 2009 Jun;249(6):913-20. doi: 10.1097/SLA.0b013e3181a77c92.

DOI:10.1097/SLA.0b013e3181a77c92

PMID:19474689

Abstract

OBJECTIVE

There are 2 main types of access for patients requiring major open, elective abdominal surgery: the midline or the transverse approach. The aim of this study is to compare both approaches by focusing on postoperative pain, complications, and frequency of incisional hernias.

SUMMARY BACKGROUND DATA

A recent Cochrane review suggested that transverse incisions may be less painful but incisional hernia rates do not differ.

METHODS

Randomized, patient- and observer-blinded, monocentric, equivalence clinical trial. Patients were scheduled for elective primary abdominal incisions. Composite primary end point measured 48 hours after surgery was the total amount of analgesics (piritramide) required in the last 24 hours and pain (Visual Analogue Scale). Secondary end points were early-onset and late complications. This study is registered in the ISRCTN registry and has the ID number ISRCTN60734227.

RESULTS

Two hundred patients (101 midline and 99 transverse) were randomized. Both incision types resulted in similar amounts of required analgesics (95% confidence interval [-0.38; -0.33] was included in the equivalence level). For the Visual Analogue Scale, both the 95% and 90% CI (0-10) were neither within the equivalence levels nor were their differences significant at the 5% level. No relevant differences between midline and transverse incisions were observed for 30-day mortality (2 vs. 2, P = 0.99), mortality after one year (15 vs. 23, P = 0.15), pulmonary complications (13 vs. 17, P = 0.43), median length of hospital stay (11 vs. 12 days, P = 0.08), median time to tolerance of solid food (12 vs. 14 days, P = 0.30), and incisional hernias after one year (13 vs. 8, P = 0.48). More wound infections occurred in the transverse group (15 vs. 5, P = 0.02).

CONCLUSION

The decision about the incision should be driven by surgeon preference with respect to the patient's disease and anatomy.

摘要

目的

对于需要进行大型开放性择期腹部手术的患者，主要有两种手术入路方式：中线入路或横向入路。本研究的目的是通过关注术后疼痛、并发症和切口疝的发生率来比较这两种入路方式。

总结背景数据

最近一项Cochrane综述表明，横向切口可能疼痛较轻，但切口疝发生率并无差异。

方法

随机、患者和观察者双盲、单中心、等效性临床试验。患者计划进行择期原发性腹部切口手术。术后48小时测量的复合主要终点是过去24小时所需镇痛药（匹利卡明）的总量和疼痛程度（视觉模拟评分法）。次要终点是早期和晚期并发症。本研究已在ISRCTN注册中心注册，注册号为ISRCTN60734227。

结果

200例患者（101例中线入路和99例横向入路）被随机分组。两种切口类型所需的镇痛药用量相似（95%置信区间[-0.38；-0.33]包含在等效范围内）。对于视觉模拟评分法，95%和90%置信区间（0-10）既不在等效范围内，其差异在5%水平也无统计学意义。在30天死亡率（2例对2例，P = 0.99）、一年后死亡率（15例对23例，P = 0.15）、肺部并发症（13例对17例，P = 0.43）、中位住院时间（11天对12天，P = 0.08）、固体食物耐受中位时间（12天对14天）和一年后切口疝发生率（13例对8例，P = 0.48）方面，中线和横向切口之间未观察到相关差异。横向组发生的伤口感染更多（15例对5例，P = 0.02）。