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CLINICAL TRIAL, PHASE IV
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
A comparative study of hysteroscopic sterilization performed in-office versus a hospital operating room.
Journal of Minimally Invasive Gynecology 2006 September
STUDY OBJECTIVE: To compare hysteroscopic female sterilization procedures performed in-office versus a hospital operating room (OR) among newly trained physicians.
DESIGN: Multisite hospital operating rooms and physician offices.
PATIENTS: Women desiring permanent hysteroscopic sterilization.
INTERVENTION: Hysteroscopic female sterilization with the Essure system.
MEASUREMENTS AND MAIN RESULTS: Procedure time (scope in/scope out time), device placement rates, and incidence of complications and adverse events were compared. There was no significant difference in scope time between the 2 settings. There was no significant difference in placement rates, although the placement rate was somewhat higher in-office (91% vs 88%). There were no complications among any of the procedures, and the incidence of minor adverse events was extremely low in both settings (OR=2%, in-office=1%).
CONCLUSION: There is no clear advantage to performing hysteroscopic sterilization in a hospital OR. Hysteroscopic sterilization can be performed safely and efficiently in an office setting.
DESIGN: Multisite hospital operating rooms and physician offices.
PATIENTS: Women desiring permanent hysteroscopic sterilization.
INTERVENTION: Hysteroscopic female sterilization with the Essure system.
MEASUREMENTS AND MAIN RESULTS: Procedure time (scope in/scope out time), device placement rates, and incidence of complications and adverse events were compared. There was no significant difference in scope time between the 2 settings. There was no significant difference in placement rates, although the placement rate was somewhat higher in-office (91% vs 88%). There were no complications among any of the procedures, and the incidence of minor adverse events was extremely low in both settings (OR=2%, in-office=1%).
CONCLUSION: There is no clear advantage to performing hysteroscopic sterilization in a hospital OR. Hysteroscopic sterilization can be performed safely and efficiently in an office setting.
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