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腹腔镜手术与开腹手术治疗早期子宫内膜癌的手术安全性比较:一项随机对照试验的结果。

Improved surgical safety after laparoscopic compared to open surgery for apparent early stage endometrial cancer: results from a randomised controlled trial.

机构信息

University of Queensland School of Medicine, QLD, Australia.

出版信息

Eur J Cancer. 2012 May;48(8):1147-53. doi: 10.1016/j.ejca.2012.02.055.

DOI:10.1016/j.ejca.2012.02.055
PMID:22548907
Abstract

AIM

To compare Total Laparoscopic Hysterectomy (TLH) and Total Abdominal Hysterectomy (TAH) with regard to surgical safety.

METHODS

Between October 2005 and June 2010, 760 patients with apparent early stage endometrial cancer were enroled in a multicentre, randomised clinical trial (LACE) comparing outcomes following TLH or TAH. The main study end points for this analysis were surgical adverse events (AE), hospital length of stay, conversion from laparoscopy to laparotomy, including 753 patients who completed at least 6 weeks of follow-up. Postoperative AEs were graded according to Common Toxicity Criteria (V3), and those immediately life-threatening, requiring inpatient hospitalisation or prolonged hospitalisation, or resulting in persistent or significant disability/incapacity were regarded as serious AEs.

RESULTS

The incidence of intra-operative AEs was comparable in either group. The incidence of post-operative AE CTC grade 3+ (18.6% in TAH, 12.9% in TLH, p 0.03) and serious AE (14.3% in TAH, 8.2% in TLH, p 0.007) was significantly higher in the TAH group compared to the TLH group. Mean operating time was 132 and 107 min, and median length of hospital stay was 2 and 5 days in the TLH and TAH group, respectively (p<0.0001). The decline of haemoglobin from baseline to day 1 postoperatively was 2g/L less in the TLH group (p 0.006).

CONCLUSIONS

Compared to TAH, TLH is associated with a significantly decreased risk of major surgical AEs. A laparoscopic surgical approach to early stage endometrial cancer is safe.

摘要

目的

比较全腹腔镜子宫切除术(TLH)和全腹部子宫切除术(TAH)的手术安全性。

方法

2005 年 10 月至 2010 年 6 月,760 例早期子宫内膜癌患者参加了一项多中心随机临床试验(LACE),比较 TLH 和 TAH 术后的结果。本分析的主要研究终点为手术不良事件(AE)、住院时间、腹腔镜转为剖腹手术,包括至少完成 6 周随访的 753 例患者。术后 AE 根据常见毒性标准(V3)分级,危及生命、需要住院治疗或延长住院时间、导致持续或显著残疾/丧失能力的 AE 为严重 AE。

结果

两组术中 AE 的发生率相当。TAH 组术后 AE CTC 分级 3+(18.6%)和严重 AE(14.3%)的发生率明显高于 TLH 组(12.9%和 8.2%,p<0.03 和 p<0.007)。TLH 组和 TAH 组的平均手术时间分别为 132 分钟和 107 分钟,中位住院时间分别为 2 天和 5 天(p<0.0001)。TLH 组术后第 1 天血红蛋白从基线下降 2g/L(p<0.006)。

结论

与 TAH 相比,TLH 与重大手术 AE 的风险显著降低相关。腹腔镜手术治疗早期子宫内膜癌是安全的。

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