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Randomized controlled trial of thermal balloon ablation versus vaginal hysterectomy for leiomyoma‐induced heavy menstrual bleeding
Author(s) -
Jain Prachi,
Rajaram Shalini,
Gupta Bindiya,
Goel Neerja,
Srivastava Himsweta
Publication year - 2016
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2016.04.020
Subject(s) - medicine , hysterectomy , endometrial ablation , leiomyoma , gynecology , randomized controlled trial , uterine leiomyoma , obstetrics , balloon , vaginal bleeding , surgery , pregnancy , biology , genetics
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.