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Thermal balloon ablation in myoma-induced menorrhagia under local anesthesia
August 2003, Vol. 10, No. 3 Supplement TheJournal of the American Association of Gynecologic Laparoscopists
for women with menorrhagia and submucous myomas up to 4 cm. in diameter.
96. Preliminary Clinical Results with the Use of the NovaSure System in Patients with Submucous Fibroids R Sabbah. Sacred Heart Hospital, University of Montreal, Montreal, Canada. Objective. To evaluate the performance of the NovaSure device in patients with submucous fibroids. Design and Methods. Prospective analysis of 125 patients treated with the NovaSure System. Patients selected for analysis (n=24) were those with intra-uterine pathology diagnosed during hysteroscopy. Data were collected on the type and size of pathology, complications, and patient satisfaction. Change in menstrual pattern at the longest followup interval. Patients. Twenty-four patients with confirmed intra-uterine pathology. Size of the fibroids varied from 1-to-3 cm. Results. Twenty-four of 125 (19%) patients had a documented benign uterine pathology. The procedure was performed in all patients with no complications. Patient satisfaction was 96%. The follow-up (1-18 months) was available for 18/24 (75%) of patients. Remaining patients are scheduled for follow-up visits. Successful control of bleeding was observed in 16 patients (89%) with 12 (67%) patients reporting anlenorrhea. 4 patients (22%) reported spotting. Two patients reported a slight improvement and although satisfied are reported as failures. Conclusion. Preliminary results indicate that patients with submucous fibroids can be successfully treated using the NovaSure System. The use of the NovaSure System for endometrial ablation is a less aggressive approach compared to hysterectomy and will reduce morbidity rate and convalescence time.
97. Thermal Balloon Ablation in Myoma-lnduced Menorrhagia under Local Anesthesia SK Soysal, ME Soysal. Pamukkale University Denizli, Denizli, Turkey. Objective. To compare thermal balloon ablation and rollerball ablation in myoma-induced menorrhagia on two levels of endpoints. Primary endpoints, measured at 12 months, were 1) menstrual blood flow reduction, and 2) increase in hemoglobin values. Secondary endpoints were 3) operating time; 4) complication rates; 5) post-operative pain scores at 12 hours; and 6) an~enorrhea rates at 12 months. Design. Randomized, prospective study of 96 patients to thermal balloon ablation under local anesthesia and rollerball ablation under general anesthesia. Setting. A university medical center in Turkey. Patients. Ninety-six women aged 40+ with a mobile myomatous uterus smaller than 12-week pregnancy. Interventions. Thermal balloon ablation and rollerball ablation after pharmacological endometrial thinning.
Measurements and Main Results. At 12 months, mean PBAC scores fell 89.7% in the rollerball group and 89.3% in the thermal balloon ablation group. Hemoglobin levels rose from baseline levels of 10 Hb g/dl to 12.8 for thermal ablation and 12.9 for rollerball ablation. Those who underwent endometrial roller ball ablation had significantly more intraoperative complications. Conclusion. Thermal balloon ablation under local anesthesia for myoma-induced menorrhagia provided both significant and statistically similar reductions in menstrual blood flow and increases in hemoglobin values with no intraoperative complications compared to roller ball endometrial ablation.
Plenary 12--Miscellaneous II 98. The Incidence of Endometrial Carcinoma Following Endometrial Ablation in a Low Risk Population 1RS Neuwirth, 2B Levin, 3FD Loffer, 4T Trenheile. 1St. Luke's Roosevelt Hospital Centre; 2Columbia University School of Public Health, New York, New York; 3OB Gyn Associates, Phoenix, Arizona; 4OB Gyn Associates, Rockford, Illinois This study is a preliminary evaluation of the long term risk of endometrial cancer in low risk patients undergoing endometrial ablation between 1978 and 1995. Two of the authors performed 509 hysteroscopic endometrial ablations in the study period on patients who had benign preoperative endometrium. Thirty patients were omitted due to missing charts or pertinent identification information leaving 478 patients. A total of 244 patients were contacted directly revealing one case of early endometrial cancer. Two hundred thirty-four patients were submitted to the National Death Index. Eight were confirmed dead but none from endometrial cancer. Eleven were omitted from the NDI review due to insufficient information. To determine the status of the remaining patients believed to be alive searches were done of the of the Cancer Registries of the states and District of Columbia. One additional case was identified in New Jersey. Age adjusted rates for endometrial cancer are being calculated for the study group and being compared to the age adjusted rates in the general population in order to determine the relative risk. Although the data is at best a rough approximation of the actual incidence of endometrial cancer in low risk women undergoing endometrial ablation it is helpful data. As more women are undergoing endometrial ablation with global ablation techniques this question is becoming more important. The current study, although flawed in many respects, should serve as a benchmark for future work and a prospective investigation.
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for women with menorrhagia and submucous myomas up to 4 cm. in diameter.
96. Preliminary Clinical Results with the Use of the NovaSure System in Patients with Submucous Fibroids R Sabbah. Sacred Heart Hospital, University of Montreal, Montreal, Canada. Objective. To evaluate the performance of the NovaSure device in patients with submucous fibroids. Design and Methods. Prospective analysis of 125 patients treated with the NovaSure System. Patients selected for analysis (n=24) were those with intra-uterine pathology diagnosed during hysteroscopy. Data were collected on the type and size of pathology, complications, and patient satisfaction. Change in menstrual pattern at the longest followup interval. Patients. Twenty-four patients with confirmed intra-uterine pathology. Size of the fibroids varied from 1-to-3 cm. Results. Twenty-four of 125 (19%) patients had a documented benign uterine pathology. The procedure was performed in all patients with no complications. Patient satisfaction was 96%. The follow-up (1-18 months) was available for 18/24 (75%) of patients. Remaining patients are scheduled for follow-up visits. Successful control of bleeding was observed in 16 patients (89%) with 12 (67%) patients reporting anlenorrhea. 4 patients (22%) reported spotting. Two patients reported a slight improvement and although satisfied are reported as failures. Conclusion. Preliminary results indicate that patients with submucous fibroids can be successfully treated using the NovaSure System. The use of the NovaSure System for endometrial ablation is a less aggressive approach compared to hysterectomy and will reduce morbidity rate and convalescence time.
97. Thermal Balloon Ablation in Myoma-lnduced Menorrhagia under Local Anesthesia SK Soysal, ME Soysal. Pamukkale University Denizli, Denizli, Turkey. Objective. To compare thermal balloon ablation and rollerball ablation in myoma-induced menorrhagia on two levels of endpoints. Primary endpoints, measured at 12 months, were 1) menstrual blood flow reduction, and 2) increase in hemoglobin values. Secondary endpoints were 3) operating time; 4) complication rates; 5) post-operative pain scores at 12 hours; and 6) an~enorrhea rates at 12 months. Design. Randomized, prospective study of 96 patients to thermal balloon ablation under local anesthesia and rollerball ablation under general anesthesia. Setting. A university medical center in Turkey. Patients. Ninety-six women aged 40+ with a mobile myomatous uterus smaller than 12-week pregnancy. Interventions. Thermal balloon ablation and rollerball ablation after pharmacological endometrial thinning.
Measurements and Main Results. At 12 months, mean PBAC scores fell 89.7% in the rollerball group and 89.3% in the thermal balloon ablation group. Hemoglobin levels rose from baseline levels of 10 Hb g/dl to 12.8 for thermal ablation and 12.9 for rollerball ablation. Those who underwent endometrial roller ball ablation had significantly more intraoperative complications. Conclusion. Thermal balloon ablation under local anesthesia for myoma-induced menorrhagia provided both significant and statistically similar reductions in menstrual blood flow and increases in hemoglobin values with no intraoperative complications compared to roller ball endometrial ablation.
Plenary 12--Miscellaneous II 98. The Incidence of Endometrial Carcinoma Following Endometrial Ablation in a Low Risk Population 1RS Neuwirth, 2B Levin, 3FD Loffer, 4T Trenheile. 1St. Luke's Roosevelt Hospital Centre; 2Columbia University School of Public Health, New York, New York; 3OB Gyn Associates, Phoenix, Arizona; 4OB Gyn Associates, Rockford, Illinois This study is a preliminary evaluation of the long term risk of endometrial cancer in low risk patients undergoing endometrial ablation between 1978 and 1995. Two of the authors performed 509 hysteroscopic endometrial ablations in the study period on patients who had benign preoperative endometrium. Thirty patients were omitted due to missing charts or pertinent identification information leaving 478 patients. A total of 244 patients were contacted directly revealing one case of early endometrial cancer. Two hundred thirty-four patients were submitted to the National Death Index. Eight were confirmed dead but none from endometrial cancer. Eleven were omitted from the NDI review due to insufficient information. To determine the status of the remaining patients believed to be alive searches were done of the of the Cancer Registries of the states and District of Columbia. One additional case was identified in New Jersey. Age adjusted rates for endometrial cancer are being calculated for the study group and being compared to the age adjusted rates in the general population in order to determine the relative risk. Although the data is at best a rough approximation of the actual incidence of endometrial cancer in low risk women undergoing endometrial ablation it is helpful data. As more women are undergoing endometrial ablation with global ablation techniques this question is becoming more important. The current study, although flawed in many respects, should serve as a benchmark for future work and a prospective investigation.
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