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胃癌R2与R1切除术对比:一项前瞻性随机试验中的发病率和死亡率

R2 compared with R1 resection for gastric cancer: morbidity and mortality in a prospective, randomised trial.

作者信息

Bonenkamp J J, van de Velde C J, Sasako M, Hermans J

机构信息

Department of Surgery, University Hospital, Leiden, The Netherlands.

出版信息

Eur J Surg. 1992 Aug;158(8):413-8.

PMID:1356480
Abstract

OBJECTIVE

To compare the postoperative course of patients in the Dutch nationwide randomised trial of R1 (conventional) compared with R2 resection (including extended lymph node dissection) in the treatment of gastric cancer.

DESIGN

Prospective randomised controlled trial.

SETTING

National multicentre trial with 72 participating hospitals in The Netherlands.

SUBJECTS

192 patients who were operated on between August 1989 and May 1990.

INTERVENTIONS

96 patients were randomised for a R1, and 96 for a R2 resection.

MAIN OUTCOME MEASURES

Morbidity and mortality among 131 patients (64 R1 and 67 R2) for whom the resection was performed with curative intent.

RESULTS

The groups were comparable for age, sex, type of resection, site of tumour and depth of invasion. Complications developed in 23 R1 (36%) and in 29 R2 patients (43%). Seven patients died in the postoperative period. Median hospital stay was significantly longer after R2 (18 days, range 7-122) than after R1 resection (15 days, range 2-63) (p < 0.05). Morbidity and mortality among the patients whose R2 resection was done by the Japanese instructor (n = 34) did not differ significantly from those among patients operated on by the Dutch supervisors (n = 33), but those operated on by the Japanese instructor stayed in hospital significantly longer (20 compared with 16 days, p < 0.05).

CONCLUSIONS

If R2 resections are carried out by properly trained surgeons under supervision, they can be done safely. The reported high morbidity after R2 resection in Western countries seems to result from a lack of proper instruction and quality control.

摘要

目的

在荷兰全国性随机试验中,比较胃癌治疗中R1(传统)切除术与R2切除术(包括扩大淋巴结清扫术)患者的术后病程。

设计

前瞻性随机对照试验。

地点

荷兰72家参与医院的全国多中心试验。

研究对象

1989年8月至1990年5月间接受手术的192例患者。

干预措施

96例患者随机接受R1切除术,96例接受R2切除术。

主要观察指标

131例(64例R1和67例R2)行根治性切除术患者的发病率和死亡率。

结果

两组在年龄、性别、切除类型、肿瘤部位和浸润深度方面具有可比性。23例R1患者(36%)和29例R2患者(43%)出现并发症。7例患者在术后死亡。R2切除术后的中位住院时间(18天,范围7 - 122天)明显长于R1切除术后(15天,范围2 - 63天)(p < 0.05)。由日本指导医生进行R2切除术的患者(n = 34)的发病率和死亡率与由荷兰主管医生进行手术的患者(n = 33)相比无显著差异,但由日本指导医生进行手术的患者住院时间明显更长(分别为20天和16天,p < 0.05)。

结论

如果在监督下由经过适当培训的外科医生进行R2切除术,手术可以安全完成。西方国家报道的R2切除术后高发病率似乎是由于缺乏适当的指导和质量控制。

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