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Marie Plante1, Janice S Kwon1, Sarah Ferguson1
1From Centre Hospitalier Universitaire de Québec, Quebec (M.P.), the University of British Columbia, Vancouver (J.S.K., L.B.), Princess Margaret Hospital, Toronto (S.F.), Centre Hospitalier de l'Université de Montréal, Montreal (V.S.), and the Canadian Cancer Trials Group, Queen's University, Kingston, ON (D.T., L.E.S.) - all in Canada; Institut Claudius Regaud, IUCT-Oncopole, Toulouse (G.F.), and Gustave Roussy Cancer Center, Villejuif (A.M.) - both in France; Leiden University Medical Center, Leiden (C.K.), and the Netherlands Cancer Institute, Amsterdam (W.V.D.) - both in the Netherlands; Royal Hallamshire Hospital, Sheffield (J.T.), and Nottingham University Hospitals, Nottingham (K.W.) - both in the United Kingdom; LMU University Hospital, Munich (S.M.), and University of Tübingen Hospital, Tübingen (S.K.) - both in Germany; Centre Hospitalier Universitaire de Liege, Liege, Belgium (F.G.); Medical University of Graz, Graz, Austria (K.T.); Oslo University Hospital, Oslo (B.E.); Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and St. James' Hospital, Dublin (N.G.).
对于早期的宫癌,简单的子宫切除术在预防盆腔复发方面与激进的子宫切除术同样有效. 这种侵入性较小的手术也大大降低了尿失禁和尿的风险.
科学领域:
- 妇科瘤学 妇科瘤学
- 手术瘤学手术瘤学
- 临床试验 临床试验
背景情况:
- 回顾性研究表明,在早期,低风险的宫癌中,参数透率低,质疑激进子宫切除术的必要性.
- 缺乏大型随机试验,比较激进和简单子宫切除术的结果.
研究的目的:
- 在患有低风险子宫癌的患者中,比较激进子宫切除术与简单子宫切除术的疗效和安全性.
- 为了确定简单的子宫切除术是否在预防盆腔复发方面与激进的子宫切除术无差.
主要方法:
- 一个多中心的,随机的,非劣势性试验,涉及700名患有低风险子宫癌的患者 (≤2厘米的病变,有限的肌层侵袭).
- 激进子宫切除术与简单子宫切除术与淋巴结评估的比较.
- 主要结局:三年后的盆腔复发,非劣势率为4个百分点.
主要成果:
- 3年后的盆腔复发率为激进子宫切除术的2.17%,简单子宫切除术的2.52% (绝对差异:0.35个百分点).
- 简单的子宫切除术在盆腔复发方面并不低于激进的子宫切除术.
- 在手术后的简单子宫切除组中观察到尿失禁和尿的较低发病率.
结论:
- 简单的子宫切除术是针对低风险子宫癌的激进子宫切除术的可行的替代方案,提供可比的瘤结果.
- 简单的子宫切除术显示,与激进的子宫切除术相比,术后泌尿功能障碍显著减少.
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