A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study
A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study
复制标题
DOI：
10.1007/s00192-012-1885-x
复制
发表时间：
2013-03-01
影响因子：
1.8
通讯作者：
Waterfield, M.
中科院分区：
文献类型：
--
作者：
Freeman, R. M.;Pantazis, K.;Waterfield, M.
这项前瞻性的多中心真双侧等效性试验旨在利用客观和主观结果测试开放(ASCP)和腹腔镜(LSCP)固定术的临床等效性。该研究在英国和英国的三个泌尿外科病房进行，患者群体包括有症状和麻烦的子宫切除后阴道穹隆脱垂在处女膜残端上方或之外至少1厘米的妇女。在随机选择其中一种手术方式后，分别采用腹式或腹腔镜式固定术。1年后的主要结果(POP-Q上的C点)，开腹ASCP组为-6.63 cm，LSCP组为-6.67 cm。一年后的主观结果显示，90%的ASCP组和80%的LSCP组“好得多”。与ASCP组相比，LSCP组在失血量、血红蛋白和住院时间方面都有改善。这项完全有效的随机对照试验比较了开放和腹腔镜下的固定术，显示出临床上的等效性。
This prospective multi-centre true two-sided equivalence trial was designed to test the clinical equivalence of open (ASCP) and laparoscopic (LSCP) sacrocolpopexy using objective and subjective outcomesThe study was carried out in three urogynaecology units in England, UK and the patient population consisted of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions were either abdominal or laparoscopic sacrocolpopexy following randomisation to one of the types of surgery.For the primary outcome (point C on the POP-Q) the results at 1 year were -6.63 cm for the open ASCP and -6.67 cm for the LSCP respectively. Subjective outcomes at 1 year showed that 90% of the ASCP group and 80% of the LSCP group were "much better". There were improvements with regard to blood loss, haemoglobin and shorter length of stay in the LSCP group compared with the ASCP group.This fully powered randomised controlled trial comparing open and laparoscopic sacrocolpopexy has shown clinical equivalence.