摘要
Objectives - Hysteroscopic flexible micro- insert (Essure- R is an ambulatory improvement of fallopian tube sterilization, which is a deliberated suppression of fertility. The aim of this study was an evaluation of feasibility (learning curve) and the first year outcome of this method. Patients and methods. - This prospective study, carried out between February 2002 and March 2003, included patients who were matching with manufacturer recommendations. One surgeon only realized all the device placements. Results. - Fifty patients were included (one year follow- up). Mean age was 41 (± 3.3), mean parity was 2.7 (± 0.8). Mean time needed for device placement was 26 minutes (± 6.5) and was reduced with increased experience. Six failures of placement (12% ) were related, because of submucus leiomyomas, proximal tubal stenotic disease or too retroverted uterus. Only 5 patients (11.4% ) described intensive pelvic pain during the placement. The only case of device expulsion benefited from a successful second placement. The one- year follow- up showed no significant difference of body weight increasing, duration or quantity of menstruation, neither significant pelvic pain nor vaginal bleeding. Tolerance was rated at least at “ somewhat satisfied". There have been no pregnancies reported in 670 woman- months of effectiveness. Discussion and conclusion. - Our results agree in any point with those of larger studies. We think that hysteroscopy micro- insert placement is not only reserved to specialized centers but also to any gynecologist who is used to performing hysteroscopy because of its feasibility.
Objectives - Hysteroscopic flexible micro - insert (Essure (R) - is an ambulatory improvement of fallopian tube sterilization, which is a deliberated suppression of fertility. The aim of this study was an evaluation of feasibility (learning curve) and the first year outcome of this method. Patients and methods. - This prospective study, carried out between February 2002 and March 2003, included patients who were matching with manufacturer recommendations. One surgeon only realized all the device placements. Resuits. - Fifty patients were included (one year follow - up) . Mean age was 41 ( + 3.3), mean parity was 2. 7 ( ± 0. 8). Mean time needed for device placement was 26 minutes ( ±6. 5) and was reduced with increased experience. Six failures of placement (12%) were related, because of submucus leiomyomas, proximal tubal stenotic disease or too retroverted uterus. Only 5 patients ( 11.4% ) described intensive pelvic pain during the placement. The only case of device expulsion benefited from a successful second placement. The one- year follow- up showed no significant difference of body weight increasing, duration or quantity of menstruation, neither significant pelvic pain nor vaginal bleeding. Tolerance was rated at least at "somewhat satisfied". There have been no pregnancies reported in 670 woman- months of effectiveness. Discussion and conclusion. - Our results agree in any point with those of larger studies. We think that hysteroscopy micro- insert placement is not only reserved to specialized centers but also to any gynecologist who is used to performing hysteroscopy because of its feasibility.