A randomized prospective trial of the postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy for the treatment of symptomatic uterine fibroids: clinical trial design
A randomized prospective trial of the postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy for the treatment of symptomatic uterine fibroids: clinical trial design
复制标题
DOI：
10.1186/1745-6215-10-8
复制
发表时间：
2009-01-29
期刊：
影响因子：
2.5
通讯作者：
Kang, Soon-Beom
中科院分区：
文献类型：
--
作者：
Kim, Hee Seung;Kim, Jae Weon;Kang, Soon-Beom
背景资料：腹腔镜辅助阴式子宫切除术是治疗症状性子宫肌瘤的确切方法之一，与经腹子宫切除术相比，术中出血少，住院时间短。但腹腔镜辅助阴式子宫切除术不能保留子宫，且可通过盆腔结构的改变显示术后并发症。因此，腹腔镜子宫动脉结扎术已被引入，以缓解子宫肌瘤引起的症状，而不是子宫切除术。本研究旨在比较腹腔镜子宫动脉结扎术和腹腔镜辅助阴式子宫切除术术后的生活质量，并评估腹腔镜子宫动脉结扎术的疗效，腹腔镜子宫动脉结扎术可以治疗症状性子宫肌瘤与preservationofuterus.Methods和设计：患者参加本研究随机腹腔镜子宫动脉结扎术或腹腔镜辅助阴式子宫切除术。主要结局是使用欧洲癌症研究和治疗组织癌症患者生活质量问卷3.0版比较腹腔镜子宫动脉结扎术和腹腔镜辅助阴式子宫切除术的术后生活质量。次要结局是评价2种治疗方法对子宫、子宫肌瘤和卵巢的体积缩小情况，比较腹腔镜子宫动脉结扎术和腹腔镜辅助阴式子宫切除术对主观症状（使用11分症状评分）的改善情况和术后临床结局，并研究腹腔镜子宫动脉结扎术对术后阴道出血的改善情况。讨论：在保留子宫的症状性子宫肌瘤的治疗方法中，腹腔镜子宫动脉结扎术预期具有与子宫动脉栓塞术相似的疗效，后者似乎可安全地常规使用，症状缓解。目前的研究于2008年6月招募完毕，结果将于2009年6月公布。如果腹腔镜子宫动脉结扎术和腹腔镜辅助阴式子宫切除术治疗症状性子宫肌瘤的术后生活质量没有差异，那么腹腔镜子宫动脉结扎术和子宫动脉栓塞术作为保留子宫的手术治疗，也需要比较两者的生活质量。
Background: Laparoscopy-assisted vaginal hysterectomy is one of the definite methods for the treatment of symptomatic uterine fibroids with lesser intraoperative bleeding and shorter hospitalization compared with abdominal hysterectomy. However, laparoscopy-assisted vaginal hysterectomy cannot preserve uterus and can show postoperative complications by the change of pelvic structure. Thus, laparoscopic uterine artery ligation has been introduced for relieving the symptoms caused by uterine fibroids in place of hysterectomy. The current study was designed to compare postoperative quality of life between laparoscopic uterine artery ligation and laparoscopyassisted vaginal hysterectomy, and to evaluate the efficacy of laparoscopic uterine artery ligation which can treat symptomatic uterine fibroids with the preservation of uterus.Methods and design: Patients enrolled the current study are randomized to laparoscopic uterine artery ligation or laparoscopy-assisted vaginal hysterectomy. The primary outcome is to compare postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients version 3.0. Secondary outcomes are to evaluate the volume reduction of uterus, uterine fibroids and ovaries by the 2 treatments, to compare the improvement of subjective symptoms using 11-point symptom score and postoperative clinical outcomes between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy, and to investigate the improvement of postoperative vaginal bleeding by laparoscopic uterine artery ligation.Discussion: Among treatment methods for symptomatic uterine fibroids with the preservation of uterus, laparoscopic uterine artery ligation is expected to have the efficacy like uterine artery embolization, which appeared to be safe for routine use with symptomatic relief. The current study fully recruited in June 2008 and the results will be available in June 2009. If there is no difference of postoperative QOL between laparoscopic uterine artery ligation and laparoscopy- assisted vaginal hysterectomy for the treatment of symptomatic uterine fibroids, the comparison of quality of life between laparoscopic uterine artery ligation and uterine artery embolization will be also needed as a surgical treatment for preserving uterus.Trial registration: Current Controlled Trials ISRCTN76790866