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.
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.
Kim
Hee Seung
HS
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
Kim
Jae Weon
JW
Kim
Mi-Kyung
MK
Chung
Hyun Hoon
HH
Lee
Taek Sang
TS
Jeon
Yong-Tark
YT
Kim
Yong Beom
YB
Jeon
Hye Won
HW
Yun
Young Ho
YH
Park
Noh Hyun
NH
Song
Yong Sang
YS
Kang
Soon-Beom
SB
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*