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Journal of Minimally Invasive Gynecology, Vol 12, No 5, September/October Supplement 2005
went an operative office hysteroscopic procedure to treat single or multiple benign intrauterine pathologies (cervical and endometrial polyps, synechiae, septae and submucous myomas). Intervention: Office hysteroscopy was performed using the vaginoscopic approach (no speculum or tenaculum), without analgesia/anesthesia in an office setting. All the procedures were performed in the early proliferative phase or, for endocavitary pathologies ⬎ 1 cm, after a treatment with 3 months of GnRH analogue. 5F mechanical instruments were used (4,863 patients), as well as the 5F Versapoint bipolar electrode (1,360 patients). All patients underwent hysteroscopic follow-up within 3 months from the surgical procedure, to verify the completeness of the treatment. Measurements and Main Results: Persistence of the pathology, shown by visualization of the stalk of the polyps or of the polyp itself, was observed in 64 (7.98%) cases of endometrial polyps ⬎ 1 cm treated by the mechanical procedure and in 37 (11.28%) cervical polyps. No recurrence of the pathology was observed in those patients treated with the Versapoint bipolar electrode. Patient satisfaction was acceptable in all cases (from 71.9 % to 93.5 % of the patients underwent the procedure without discomfort), for all the pathologies treated. Conclusion: Simple mechanical instruments enable us to perform many operative procedures in an office setting, with excellent patient satisfaction. Unfortunately, due to the structure of the polyps (particularly of the cervix), these instruments cannot guarantee complete removal of the polyp stalk. The use of the bipolar Versapoint system has improved the treatment of those pathologies, allowing the surgeon to coagulate/vaporize the stalk. SATURDAY, NOVEMBER 12, 2005 (12:48 PM–12:54 PM) Open Communications 9 —Hysteroscopy 184 Use of the Novasure System in Patients with Submucous Fibroids Sabbah R, Desaulniers G. Montreal, Canada Study Objective: To evaluate the performance of the NovaSure device in patients with submucous fibroids. Design: Prospective analysis of 68 patients with intra-uterine pathology treated with NovaSure system. Data were collected on the type and size of pathology, complications, bleeding status and patient satisfaction. GnRH agonists weren’t used for the purpose of endometrial pre-treatment and/or shrinkage of the fibroids. Setting: Sacred Heart Hospital, University of Montreal, Canada. Patients: Sixty-eight patients with confirmed Type I & II fibroids. Size of the fibroids varied from 1 to 3 cm. Follow-up at the time of abstract submission is 27 months. Intervention: None. Measurements and Main Results: NovaSure ablation was
performed in all patients with no complications. Patient satisfaction was 91%. Successful control of bleeding was observed in 98.6% of patients with 71% reporting amenorrhea. Reduction in dysmenorrhea was reported by 63% of patients. Two patients underwent hysterectomy due to confirmed adenomyosis. Conclusion: Preliminary results indicate that patients with Type I & II fibroids can be successfully treated using the NovaSure system, yielding durable clinical outcomes. Use of NovaSure ablation as a less aggressive approach compared to hysterectomy and will reduce morbidity rate and convalescence time. SATURDAY, NOVEMBER 12, 2005 (12:54 PM–1:00 PM) Open Communications 9 —Hysteroscopy 185 Novasure Impedance Controlled Endometrial Ablation System. Long-Term Follow-Up Results in 107 Patients Gallinat A. Center Gynecological Endoscopy, Hamburg, Germany Study Objective: Assess the efficacy and safety of the NovaSure system in women with severe menorrhagia secondary to DUB. Design: A prospective, single-arm, controlled, study of 107 women undergoing endometrial ablation using the NovaSure system. Setting: Specialized freestanding center for gynecological endoscopy. Patients: One hundred seven pre-menopausal women with menorrhagia secondary to DUB. Intervention: Endometrial ablation using the NovaSure Impedance Controlled Endometrial Ablation System. Measurements and Main Results: The NovaSure System was used to treat 107 patients with menorrhagia secondary to DUB. PBAC diary sampling was used to qualify the patients for the study, as well as to conduct the post-treatment evaluation of menstrual blood loss and bleeding pattern. No drug or mechanical endometrial pre-treatment was used in this group of patients. Position of the uterus was not a factor in patient selection. All patients received the treatment under intravenous sedation. Results: No intra-operative or post-operative complications were observed. Treatment time averaged 94 seconds. Of 107 patients, 69 reached 5-year follow-up, of which 74% reported amenorrhea, with 96% of patients reporting reduction in bleeding to normal levels or less. Three patients (3/107) underwent hysterectomy and one patient (1/107) had a repeat ablation during five years of follow-up representing a 96.3% avoidance of any surgical intervention five years post-NovaSure ablation. Conclusion: 1. Endometrial pretreatment is not required when using the NovaSure system. 2. Active bleeding during the time of the operative visit is not a limiting factor when NovaSure system is used. 3. Long-term follow-up results