Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Jan 29:10:8.
doi: 10.1186/1745-6215-10-8.

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

Hee Seung Kim  1 , Jae Weon Kim, Mi-Kyung Kim, Hyun Hoon Chung, Taek Sang Lee, Yong-Tark Jeon, Yong Beom Kim, Hye Won Jeon, Young Ho Yun, Noh Hyun Park, Yong Sang Song, Soon-Beom Kang
Affiliations
Randomized Controlled Trial

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

Hee Seung Kim et al. Trials. .

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 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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) version 3.0. for comparing postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy.
Figure 2
Figure 2
Calculation of volumes of uterus, uterine fibroids and bilateral ovaries by use of transvaginal ultrasonography.
Figure 3
Figure 3
11-point symptoms score for evaluating of postoperative symptoms 12 months after surgery.
Figure 4
Figure 4
Bleeding chart score by a simple visual assessment technique for evaluating vaginal bleeding in patients treated with laparoscopic uterine artery ligation.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Townsend DE, Sparkes RS, Baluda MC, McClelland G. Unicellular histogenesis of uterine leiomyomas as determined by electrophoresis by glucose-6-phosphate dehydrogenase. Am J Obstet Gynecol. 1970;107:1168–1173. - PubMed
    1. Marshall LM, Spiegelman D, Barbieri RL, Goldman MB, Manson JE, Colditz GA, Willett WC, Hunter DJ. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967–973. doi: 10.1016/S0029-7844(97)00534-6. - DOI - PubMed
    1. Na WS, Kim KH, Lee BK, Rho JH, Son CU, Choung M, Yang YS, Park JS. Laparoscopic assisted vaginal hysterectomy for large uterus; the comparison of conventional LAVH with LH. J Gynecol Oncol. 2006;18:227–234.
    1. Mettler L, Ahmed-Ebbiary N, Schollmeyer T. Laparoscopic hysterectomy: challenges and limitations. Minim Invasive Ther Allied Technol. 2005;14:145–159. doi: 10.1080/13645700510034010. - DOI - PubMed
    1. Liu WM, Ng HT, Wu YC, Yen YK, Yuan CC. Laparoscopic bipolar coagulation of uterine vessels: a new method for treating symptomatic fibroids. Fertil Steril. 2001;75:417–422. doi: 10.1016/S0015-0282(00)01724-6. - DOI - PubMed

Publication types

MeSH terms

Associated data