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CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting.
Fertility and Sterility 2004 July
OBJECTIVE: To evaluate the results of hysteroscopic placement of an intratubal device for permanent birth control in 85 women in an outpatient setting.
DESIGN: Prospective, observational study.
SETTING: Private university hospital.
PATIENT(S): Eighty-five premenopausal women who asked for tubal sterilization by hysteroscopy between July 2002 and July 2003.
INTERVENTION(S): Hysteroscopic placement of titanium-dacron intratubal devices in an outpatient setting.
MAIN OUTCOME MEASURE(S): Procedure feasibility without anesthesia, success rate of device implantation, patient satisfaction, and confirmation of correct placement.
RESULT(S): Successful placement was achieved in 81 patients (95%). Mean time elapsed between the start of hysteroscopy, placement of devices, and removal of optics was 9 minutes (range, 1-35 minutes). No intraoperative or postoperative complications were detected. Of 81 patients, 75 (93%) had abdominal x-ray performed at the third month; bilateral correct placement was confirmed in all of them.
CONCLUSION(S): Essure is a safe, effective, and minimally aggressive procedure with satisfactory patient acceptance that does not require anesthesia or hospitalization. It seems to be a good alternative to laparoscopic tubal sterilization.
DESIGN: Prospective, observational study.
SETTING: Private university hospital.
PATIENT(S): Eighty-five premenopausal women who asked for tubal sterilization by hysteroscopy between July 2002 and July 2003.
INTERVENTION(S): Hysteroscopic placement of titanium-dacron intratubal devices in an outpatient setting.
MAIN OUTCOME MEASURE(S): Procedure feasibility without anesthesia, success rate of device implantation, patient satisfaction, and confirmation of correct placement.
RESULT(S): Successful placement was achieved in 81 patients (95%). Mean time elapsed between the start of hysteroscopy, placement of devices, and removal of optics was 9 minutes (range, 1-35 minutes). No intraoperative or postoperative complications were detected. Of 81 patients, 75 (93%) had abdominal x-ray performed at the third month; bilateral correct placement was confirmed in all of them.
CONCLUSION(S): Essure is a safe, effective, and minimally aggressive procedure with satisfactory patient acceptance that does not require anesthesia or hospitalization. It seems to be a good alternative to laparoscopic tubal sterilization.
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