Randomized controlled trial of thermal balloon ablation versus vaginal hysterectomy for leiomyoma‐induced heavy menstrual bleeding. Issue 2 (November 2016)

• Record Type: Journal Article
• Authors: Jain, Prachi; Rajaram, Shalini; Gupta, Bindiya; Goel, Neerja; Srivastava, Himsweta
• Is Part Of: International journal of gynaecology and obstetrics. Volume 135:Issue 2(2016:Nov.)
• Page Start: 140
• Page End: 144
• Publication Date: 2016-11
• Subjects: Abnormal uterine bleeding -- Fibroid uterus -- Heavy menstrual bleeding -- Hysterectomy -- Thermal balloon ablation -- Uterine leiomyoma -- Vaginal hysterectomy; Gynecology -- Periodicals; Obstetrics -- Periodicals; Electronic journals; 618
• DOI: 10.1016/j.ijgo.2016.04.020
• Languages: English
• ISSNs: 0020-7292

Abstract

Abstract: 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.