TY - JOUR
T1 - Immediate versus delayed treatment of perimenopausal bleeding due to benign causes by balloon thermal ablation
AU - Lissak, Arie
AU - Fruchter, Oren
AU - Mashiach, Shlomo
AU - Brandes-Klein, Orly
AU - Sharon, Avi
AU - Kogan, Olga
AU - Abramovici, Haim
PY - 1999/5
Y1 - 1999/5
N2 - Study Objective. To compare the effectiveness and safety of thermal balloon ablation without pretreatment with endometrium-thinning agents compared with delayed ablation with pretreatment for women with perimenopausal menorrhagia. Design. Prospective, randomized, controlled trial (Canadian Task Force classification I). Setting. Hospital-based ambulatory medical center. Patients. Thirty women age 46 to 51 years with severe enough perimenopausal menorrhagia to make them candidates for either hysterectomy or endometrial ablation. Two patients with submucosal myomas and six who had undergone cesarean section were included. Interventions. Thirteen patients were randomly assigned to be treated within 30 days and received a single intramuscular administration of gonadotropin releasing hormone (GnRH) analog; 17 women were allocated to be treated within 3 days of enrollment without uterine preparation. A thermal balloon was inserted transcervically under general anesthesia, and after inflation in the endometrial cavity with 5% dextrose in water, was heated to 87°C for 8 minutes. Measurements and Main Results. Immediate and long-term major and minor complications and success rates were analyzed. Bleeding patterns and mean duration of menstrual flow were compared between groups at 6-month follow-up. No major intraoperative or postoperative complications occurred in either group, including the women who had recently undergone hysteroscopic myomectomy or had a history of cesarean section. Minor side effects were similar in both groups, and did not exceed 5%. Overall, at 6-month follow-up, 7 women were amenorrheic 20 hypomenorrheic and 3 eumenorrheic. No significant differences were noted between women treated with immediate or delayed ablation in either the distribution of bleeding patterns or days of flow per cycle (mean ± SEAl 1.8 ± 0.42 vs 2.1 ± 0.75 days, respectively). Conclusion. This pilot study suggests that prompt treatment of perimenopausal menorrhagia with thermal balloon endometrial ablation is as effective and safe as deferred therapy combined with GnRH analog as an endometrium-thinning agent. In light of our results, the theory that previous cesarean section and presence of small submucosal myomas constitute relative contraindications for the procedure merits further consideration.
AB - Study Objective. To compare the effectiveness and safety of thermal balloon ablation without pretreatment with endometrium-thinning agents compared with delayed ablation with pretreatment for women with perimenopausal menorrhagia. Design. Prospective, randomized, controlled trial (Canadian Task Force classification I). Setting. Hospital-based ambulatory medical center. Patients. Thirty women age 46 to 51 years with severe enough perimenopausal menorrhagia to make them candidates for either hysterectomy or endometrial ablation. Two patients with submucosal myomas and six who had undergone cesarean section were included. Interventions. Thirteen patients were randomly assigned to be treated within 30 days and received a single intramuscular administration of gonadotropin releasing hormone (GnRH) analog; 17 women were allocated to be treated within 3 days of enrollment without uterine preparation. A thermal balloon was inserted transcervically under general anesthesia, and after inflation in the endometrial cavity with 5% dextrose in water, was heated to 87°C for 8 minutes. Measurements and Main Results. Immediate and long-term major and minor complications and success rates were analyzed. Bleeding patterns and mean duration of menstrual flow were compared between groups at 6-month follow-up. No major intraoperative or postoperative complications occurred in either group, including the women who had recently undergone hysteroscopic myomectomy or had a history of cesarean section. Minor side effects were similar in both groups, and did not exceed 5%. Overall, at 6-month follow-up, 7 women were amenorrheic 20 hypomenorrheic and 3 eumenorrheic. No significant differences were noted between women treated with immediate or delayed ablation in either the distribution of bleeding patterns or days of flow per cycle (mean ± SEAl 1.8 ± 0.42 vs 2.1 ± 0.75 days, respectively). Conclusion. This pilot study suggests that prompt treatment of perimenopausal menorrhagia with thermal balloon endometrial ablation is as effective and safe as deferred therapy combined with GnRH analog as an endometrium-thinning agent. In light of our results, the theory that previous cesarean section and presence of small submucosal myomas constitute relative contraindications for the procedure merits further consideration.
UR - http://www.scopus.com/inward/record.url?scp=0033031428&partnerID=8YFLogxK
U2 - 10.1016/S1074-3804(99)80092-9
DO - 10.1016/S1074-3804(99)80092-9
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AN - SCOPUS:0033031428
SN - 1074-3804
VL - 6
SP - 145
EP - 150
JO - Journal of the American Association of Gynecologic Laparoscopists
JF - Journal of the American Association of Gynecologic Laparoscopists
IS - 2
ER -