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Clinical Trial
. 2001 Feb;8(1):48-54.
doi: 10.1016/s1074-3804(05)60548-8.

Three-year comparison of thermal balloon and rollerball ablation in treatment of menorrhagia

Affiliations
Clinical Trial

Three-year comparison of thermal balloon and rollerball ablation in treatment of menorrhagia

F D Loffer. J Am Assoc Gynecol Laparosc. 2001 Feb.

Erratum in

  • J Am Assoc Gynecol Laparosc 2001 May;8(2):330

Abstract

Study objective: To compare uterine balloon therapy and hysteroscopic rollerball endometrial ablation with respect to efficacy and safety in treatment of menorrhagia.

Design: Multicenter, prospective, randomized study (Canadian Task Force classification I).

Setting: Fourteen North American university and private practice sites.

Patients: Women undergoing endometrial ablation for menorrhagia.

Intervention: Rollerball endometrial ablation or uterine balloon therapy.

Measurements and main results: Of 275 women randomized to one of these procedures, 255 were treated under the protocol and 214 were followed for 3 years. Results of uterine balloon therapy and rollerball endometrial ablation remained similar, with little difference at 3 years compared with results at 1 year. We noted a suggestion of an increase in hysterectomies in the rollerball group (14) compared with the uterine balloon therapy group (8) at 3 years.

Conclusion: Endometrial ablation with the ThermaChoice uterine balloon or rollerball continues at 3 years to be a successful method for treating menorrhagia, avoiding hysterectomy, decreasing dysmenorrhea and premenstrual symptoms, and improving quality of life. (J Am Assoc Gynecol Laparosc 8(1):48-54, 2001)

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