Journal of the American Association of Gynecologic Laparoscopists
Volume 10, Issue 1 , Pages 17-26, February 2003

A Randomized Study Comparing Endometrial Cryoablation and Rollerball Electroablation for Treatment of Dysfunctional Uterine Bleeding

  • Antoni J. Duleba, M.D.

      Affiliations

    • Department of Obstetrics, Yale University, School of Medicine, New Haven, Connecticut
    • Corresponding Author InformationAddress reprint requests to Antoni J. Duleba, M.D., Department of Obstetrics and Gynecology, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06520; fax 203 785 7134
  • ,
  • Martha C. Heppard, M.D.

      Affiliations

    • Department of Obstetrics, Yale University, School of Medicine, New Haven, Connecticut
  • ,
  • Richard M. Soderstrom, M.D.

      Affiliations

    • Department of Obstetrics, Yale University, School of Medicine, New Haven, Connecticut
  • ,
  • Duane E. Townsend, M.D.

      Affiliations

    • Department of Obstetrics, Yale University, School of Medicine, New Haven, Connecticut

Accepted 27 June 2002.

Abstract 

Study Objective

To determine the effectiveness of endometrial cryoablation in comparison with rollerball electroablation.

Design

Prospective, randomized study (Canadian Task Force classification I).

Setting

Ten university and private medical centers in the United States.

Patients

Two hundred seventy-nine women with menorrhagia due to benign causes.

Intervention

Endometrial ablation using a Her Option cryoablation device in 193 women and rollerball electroablation in 86.

Measurements and Main Results

Women treated by cryoablation received significantly less general anesthesia (46%) than those treated by electroablation (92%). Subjects maintained menstrual diaries for at least one cycle before and for 12 months after the procedure. Success was defined as reduction of menstrual bleeding to a score of 75 or less in the absence of retreatment. Success rates in the cryoablation and electroablation groups were 77.3% and 83.8%, respectively. Bleeding declined by 92% and 94%, respectively. Both procedures led to significant improvements in a broad range of symptoms including menses-related pain, mood, and overall improvement in quality of life.

Conclusion

Endometrial cryoablation is a safe and effective procedure in treatment of dysfunctional uterine bleeding. Its advantages include technical ease of performance, direct ultrasonographic view of depth of ablation, little anesthetic, and avoidance of potential complications related to distention media.

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 Endometrial cryoablation study group: Antoni J. Duleba, M.D., Yale University School of Medicine, New Haven, Connecticut; Charles Coddington III, M.D., Denver Health Medical Center, Denver, Colorado; Martha C. Heppard, M.D., Columbia Rose Medical Center, Denver, Colorado; Paul Indman, M.D., Los Gatos, California; Keith B. Isaacson, M.D., Massachusetts General Hospital, Boston, Massachusetts; Beverly Love, M.D., Women's Wellness Center, Montgomery, Alabama; Donna Shoupe, M.D., University of Southern California Medical Center, Los Angeles, California; Richard M. Soderstrom, M.D., Swedish Hospital, Seattle, Washington; Duane E. Townsend, M.D., LDS Hospital, Salt Lake City, Utah; Brian W. Walsh, M.D., Brigham and Women's Hospital, Boston, Massachusetts; John J. Willems, M.D., Scripps Clinic, La Jolla, California; Cheryl Shea, R.N., CryoGen, Inc., San Diego, California; and John D. Dobak, M.D., CryoGen, Inc., San Diego, California.

 Supported by Cryogen Inc., San Diego, CA. Antoni J. Duleba, Richard M. Soderstrom, and Duane E. Townsend are consultants to Cryogen Inc.

PII: S1074-3804(05)60229-0

doi:10.1016/S1074-3804(05)60229-0

Journal of the American Association of Gynecologic Laparoscopists
Volume 10, Issue 1 , Pages 17-26, February 2003