title: 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.
abstract: 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 laparoscopy-assisted vaginal hysterectomy, and to evaluate the efficacy of laparoscopic uterine artery ligation which can treat symptomatic uterine fibroids with the preservation of uterus.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN76790866.
authors.affiliation: Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, 110-744, Republic of Korea. bboddi0311@yahoo.co.kr
authors.forename: Hee Seung
authors.initials: HS
authors.lastname: Kim
authors.forename: Jae Weon
authors.initials: JW
authors.lastname: Kim
authors.forename: Mi-Kyung
authors.initials: MK
authors.lastname: Kim
authors.forename: Hyun Hoon
authors.initials: HH
authors.lastname: Chung
authors.forename: Taek Sang
authors.initials: TS
authors.lastname: Lee
authors.forename: Yong-Tark
authors.initials: YT
authors.lastname: Jeon
authors.forename: Yong Beom
authors.initials: YB
authors.lastname: Kim
authors.forename: Hye Won
authors.initials: HW
authors.lastname: Jeon
authors.forename: Young Ho
authors.initials: YH
authors.lastname: Yun
authors.forename: Noh Hyun
authors.initials: NH
authors.lastname: Park
authors.forename: Yong Sang
authors.initials: YS
authors.lastname: Song
authors.forename: Soon-Beom
authors.initials: SB
authors.lastname: Kang
mesh_terms: D000328:Adult; D001158:Arteries / Q000601:surgery; D005260:Female; D006801:Humans; D007045:Hysterectomy, Vaginal / Q000009:adverse effects / Q000379:methods*; D007723:Korea; D010535:Laparoscopy / Q000009:adverse effects; D007889:Leiomyoma / Q000098:blood supply / Q000601:surgery*; D008026:Ligation; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000097:blood / Q000601:surgery*; D014599:Uterus / Q000098:blood supply*; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000379:methods*