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癌切除术后手工与机械食管胃吻合术:一项对照试验。法国外科研究协会

Manual versus mechanical esophagogastric anastomosis after resection for carcinoma: a controlled trial. French Associations for Surgical Research.

作者信息

Valverde A, Hay J M, Fingerhut A, Elhadad A

机构信息

Surgical Unit, Hôpital Louis Mourìer, Colombes, France.

出版信息

Surgery. 1996 Sep;120(3):476-83. doi: 10.1016/s0039-6060(96)80066-3.

Abstract

BACKGROUND

Mechanical anastomosis has been claimed to reduce the rate of leakage compared with manual anastomosis. No randomized trials have been performed to date to prove this specifically in esophagogastric anastomosis.

METHODS

One hundred fifty-four patients, 139 men and 15 women ranging in age from 36 to 83 years (mean, 50 +/- 10 years) and undergoing elective resection of esophageal or cardial carcinoma, were included in this multiinstitutional (14 centers) randomized study comparing the rate of anastomotic leakage after esophagogastric anastomosis performed manually or mechanically. Eligible for this study were patients with esophageal or cardial carcinoma located between the esophagogastric junction (included) and the upper border of the aortic arch. The choice between resection with or without thoracotomy was left to the discretion of the operating surgeon. Proximal resection of the fundus was mandatory. Intestinal tract continuity was reestablished in a one-stage procedure by an esophagogastric anastomosis without interposition of either the jejunum or the colon. The site of the anastomosis could be either intrathoracic or cervical. The principal end point was anastomotic leakage as judged by (1) egress of intestinal fluids or orally ingested methylene blue through drains, (2) sodium diatrozate swallow prescribed either routinely for all patients between postoperative days 3 and 8 or because of signs of leakage, or (3) reoperation or autopsy.

RESULTS

After two patients were withdrawn for protocol violation, 152 patients, 74 in the manual group and 78 in the mechanical group, were studied. The number of anastomotic leakages was identical in both groups (n = 12, 16% and 15%, respectively). Overall 30-day mortality was 11%. Fewer deaths occurred in the manual group (7%), which had three anastomotic leakages, than in the mechanical group (15%), which had five anastomotic leakages, and fewer repeat operations were done in the manual group (n = 9) than in the mechanical group (n = 13), but both of these differences were not statistically significant. The duration of anastomosis and of operation was similar in both groups. In the mechanical group 16 anastomoses (20%) gave rise to technical mishaps (either in the fashioning of the purse-string, dilation of the esophagus, or in stapling). Among the factors recognized as potentially preventing leakage, only testing for airtightness was significantly correlated with less postoperative leakage (p < 0.05). Eight postoperative strictures were recorded at 3 months in 62 (13%) patients in the manual group, whereas seven strictures occurred in 53 (13%) patients in the mechanical group.

CONCLUSIONS

When mechanical staples rather than manual sutures are chosen, the disadvantages (technical mishaps and higher costs) are not counterbalanced by a gain of time or a decrease in the rate or severity of anastomotic leakage.

摘要

背景

与手工吻合相比,机械吻合被认为可降低吻合口漏发生率。迄今为止,尚无随机试验专门证实这一点在食管胃吻合术中是否成立。

方法

本多中心(14个中心)随机研究纳入了154例患者,其中男性139例,女性15例,年龄36至83岁(平均50±10岁),均接受食管癌或贲门癌择期切除术,比较手工或机械进行食管胃吻合术后的吻合口漏发生率。纳入本研究的患者为食管胃交界(包括)至主动脉弓上缘之间的食管癌或贲门癌患者。是否行开胸手术由手术医生自行决定。必须进行胃底近端切除。通过食管胃吻合一期重建肠道连续性,不插入空肠或结肠。吻合部位可为胸内或颈部。主要终点为吻合口漏,判断标准为:(1)肠液或口服亚甲蓝经引流管流出;(2)术后3至8天常规为所有患者或因漏出体征进行泛影葡胺吞咽检查;(3)再次手术或尸检。

结果

2例患者因违反方案被撤出研究后,对152例患者进行了研究,其中手工组74例,机械组78例。两组吻合口漏的数量相同(分别为12例,16%和15%)。30天总死亡率为11%。手工组(7%)有3例吻合口漏,死亡人数少于机械组(15%),机械组有5例吻合口漏,且手工组再次手术的次数(n = 9)少于机械组(n = 13),但这两个差异均无统计学意义。两组吻合和手术时间相似。机械组有16例吻合(2

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