International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2016
Randomized controlled trial of thermal balloon ablation versus vaginal hysterectomy for leiomyoma-induced heavy menstrual bleeding.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Jain Prachi, Rajaram Shalini, Gupta Bindiya, Goel Neerja, Srivastava Himsweta
Аннотация
OBJECTIVE: To compare the efficacy of thermal balloon ablation (TBA) with that of vaginal hysterectomy in the treatment of leiomyoma-induced heavy menstrual bleeding (HMB).
METHODS: An open-label randomized controlled trial was conducted between November 1, 2012, and October 31, 2014, in a tertiary care hospital in Delhi, India. Eligible women with HMB (aged ≥40 years, uterus size ≤14 weeks of pregnancy, leiomyoma ≤5 cm, uterocervical length ≤12 cm) were randomly assigned (1:1) to undergo TBA or vaginal hysterectomy using computer-generated random number tables. The primary outcome was the number of women in the TBA group with HMB 6 months after surgery. Analyses were by intention to treat.
RESULTS: Each group contained 20 women. No women in the TBA group had HMB at 6 months. Nineteen women were amenorrheic by 6 months and one was hypomenorrheic.
CONCLUSION: TBA can replace vaginal hysterectomy in some perimenopausal women with uterine leiomyomas. Clinical Trials Registry India: CTRI/2016/07/007119.
METHODS: An open-label randomized controlled trial was conducted between November 1, 2012, and October 31, 2014, in a tertiary care hospital in Delhi, India. Eligible women with HMB (aged ≥40 years, uterus size ≤14 weeks of pregnancy, leiomyoma ≤5 cm, uterocervical length ≤12 cm) were randomly assigned (1:1) to undergo TBA or vaginal hysterectomy using computer-generated random number tables. The primary outcome was the number of women in the TBA group with HMB 6 months after surgery. Analyses were by intention to treat.
RESULTS: Each group contained 20 women. No women in the TBA group had HMB at 6 months. Nineteen women were amenorrheic by 6 months and one was hypomenorrheic.
CONCLUSION: TBA can replace vaginal hysterectomy in some perimenopausal women with uterine leiomyomas. Clinical Trials Registry India: CTRI/2016/07/007119.