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全腹腔镜子宫切除术与经腹全子宫切除术加双侧输卵管卵巢切除术治疗子宫内膜癌的比较:一项为期5年随访的随机对照试验

Total laparoscopic hysterectomy versus total abdominal hysterectomy with bilateral salpingo-oophorectomy for endometrial carcinoma: a randomised controlled trial with 5-year follow-up.

作者信息

Kluivers Kirsten B, Ten Cate Florien A, Bongers Marlies Y, Brölmann Hans A M, Hendriks Jan C M

出版信息

Gynecol Surg. 2011 Nov;8(4):427-434. doi: 10.1007/s10397-011-0668-6. Epub 2011 Mar 11.

Abstract

This report is on recovery and long-term outcomes in a small-scale randomised controlled trial (RCT) after total laparoscopic hysterectomy versus total abdominal hysterectomy in (potential) endometrial carcinoma patients. An RCT was performed among women with atypical endometrial hyperplasia and endometrial carcinoma scheduled for hysterectomy in a teaching hospital in The Netherlands. Women were randomised to total laparoscopic hysterectomy versus total abdominal hysterectomy both with bilateral salpingo-oophorectomy and were followed until 5 years after the intervention. Patients completed the RAND 36-Item Short Form Health Survey (RAND-36), Quality of Recovery-40 (QoR-40) and Recovery Index-10 (RI-10) until 12 weeks after surgery. Main outcome measure was quality of life and recovery in the first 12 weeks after surgery. A linear mixed model was used for statistical analysis while accounting for baseline values where applicable. Seventeen women were included, of whom 11 allocated to the laparoscopic arm and 6 to the abdominal arm. Laparoscopic hysterectomy performed better on all scales and subscales used in the study. A statistically significant treatment effect, favouring laparoscopic hysterectomy, was found in the total RAND-36 (difference between groups 142 units, 95% confidence interval 46; 236). Clinical follow-up was completed after median 60 months, but this study was too small for conclusions regarding the safety and survival. Laparoscopic hysterectomy results in better postoperative quality of life in the first 12 weeks after surgery when compared with abdominal hysterectomy.

摘要

本报告是关于在(潜在)子宫内膜癌患者中,全腹腔镜子宫切除术与经腹全子宫切除术对比的小规模随机对照试验(RCT)的恢复情况和长期预后。在荷兰一家教学医院,对计划进行子宫切除术的非典型子宫内膜增生和子宫内膜癌女性患者开展了一项随机对照试验。女性患者被随机分为全腹腔镜子宫切除术组和经腹全子宫切除术组,两组均进行双侧输卵管卵巢切除术,并随访至干预后5年。患者在术后12周内完成了兰德36项简明健康调查(RAND-36)、恢复质量-40(QoR-40)和恢复指数-10(RI-10)。主要结局指标为术后前12周的生活质量和恢复情况。在适用时,使用线性混合模型进行统计分析,并考虑基线值。纳入了17名女性,其中11名分配至腹腔镜手术组,6名分配至经腹手术组。在该研究使用的所有量表和子量表上,腹腔镜子宫切除术表现更佳。在总兰德36项量表上发现了有利于腹腔镜子宫切除术的具有统计学意义的治疗效果(组间差异为142分,95%置信区间为46;236)。中位随访60个月后完成了临床随访,但该研究规模过小,无法得出关于安全性和生存率的结论。与经腹子宫切除术相比,腹腔镜子宫切除术在术后前12周可带来更好的生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfa4/3205270/4a55c1e3a16d/10397_2011_668_Fig1_HTML.jpg

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