Department of Gynaecology, University Medical Center Groningen, University of Groningen, The Netherlands.
Eur J Cancer. 2011 Sep;47(14):2158-65. doi: 10.1016/j.ejca.2011.04.035. Epub 2011 Jun 1.
Total laparoscopic hysterectomy (TLH) is safe and cost effective in early stage endometrial cancer when compared to total abdominal hysterectomy (TAH). In non-randomised data it is often hypothesised that older and obese patients benefit most from TLH. Aim of this study is to analyse whether data support this assumption to advice patients, clinicians and policy makers.
Data of 283 patients enrolled in a randomised controlled trial comparing TAH versus TLH in early stage endometrial cancer were re-analysed. Randomisation by sequential number generation was done centrally, with stratification by trial centre. Using multivariate analysis, predictors of major complications and conversions to laparotomy were assessed. For the cost effectiveness analysis, subgroups of patients were constructed based on age and body mass index (BMI). For each subgroup, costs per major complication-free patient were estimated, using incremental cost effect ratios (extra costs per additional effect).
Older (odds ratio (OR): 1.05; 1.01-1.09) and obese (OR: 1.05; 1.01-1.10) patients had a higher risk to develop complications, for both groups. In obese (OR: 1.17; 1.09-1.25) patients and patients with a previous laparotomy (OR: 3.45; 1.19-10.04) a higher risk of conversion to laparotomy was found. For patients>70 years of age and patients with a BMI over 35 kg/m2, incremental costs per major complication-free patients were €16 and €54 for TLH compared to TAH, respectively.
In general, TLH should be recommended as the standard surgical procedure in early stage endometrial cancer, also in patients>70 years of age. In obese patients with a BMI>35 kg/m2 TLH is not cost effective because of the high conversion rate. A careful consideration of laparoscopic treatment is needed for this subgroup. Surgeon experience level may influence this choice.
与全腹部子宫切除术（TAH）相比，在早期子宫内膜癌中，全腹腔镜子宫切除术（TLH）是安全且具有成本效益的。在非随机数据中，人们常常假设年龄较大和肥胖的患者从 TLH 中获益最大。本研究旨在分析数据是否支持这一假设，以为患者、临床医生和决策者提供建议。
对 283 名入组早期子宫内膜癌随机对照试验比较 TAH 与 TLH 的患者的数据进行重新分析。通过顺序编号生成进行中央随机化，并按试验中心进行分层。使用多变量分析评估主要并发症和转为剖腹手术的预测因素。对于成本效益分析，根据年龄和体重指数（BMI）构建患者亚组。对于每个亚组，估计无主要并发症患者的每个成本，使用增量成本效果比（每增加一个效果的额外成本）。
年龄较大（比值比（OR）：1.05；1.01-1.09）和肥胖（OR：1.05；1.01-1.10）的患者发生并发症的风险更高，两组均如此。在肥胖（OR：1.17；1.09-1.25）患者和有既往剖腹手术史（OR：3.45；1.19-10.04）的患者中，转为剖腹手术的风险更高。对于>70 岁的患者和 BMI>35 kg/m2 的患者，与 TAH 相比，TLH 每例无主要并发症患者的增量成本分别为 16 欧元和 54 欧元。
一般来说，TLH 应作为早期子宫内膜癌的标准手术方法推荐，对于>70 岁的患者也是如此。对于 BMI>35 kg/m2 的肥胖患者，TLH 由于转化率较高，因此不具有成本效益。对于这个亚组，需要仔细考虑腹腔镜治疗。手术医生的经验水平可能会影响这一选择。
