TY - JOUR
T1 - A comparison of novice and experienced physicians performing hysteroscopic sterilization
T2 - an analysis of an FDA-mandated trial
AU - Levie, Mark
AU - Chudnoff, Scott G.
PY - 1800
Y1 - 1800
N2 - Objective: To assess the placement rates for experienced users versus newly trained physicians using the new ESS 305 delivery catheter for the Essure microinsert hysteroscopic sterilization system. Design: Multicenter prospective cohort study. Setting: Seventy-six sites throughout the U.S. comprising community hospitals, teaching institutions, surgery centers, and office-based practices. Patient(s): A total of 578 women seeking hysteroscopic sterilization. Intervention(s): Hysteroscopic sterilization with the ESS 305 device by either experienced or novice physicians. Main Outcome Measure(s): Successful bilateral placement of the Essure 305 device. Result(s): A total of 625 patients were recruited with 578 eligible cases performed by 37 newly trained and 39 experienced physicians: 562/578 (97.2%) overall had successful placement, with 98% successful placement rate versus 96.1% for experienced versus novice physicians, respectively. Mean procedural time was 9 minutes (±7 SD), with experienced physicians completing it on average quicker at 7.9 minutes (±5.8 SD) and novices completing it in 10.7 minutes (±8.3 SD). There was no significant association between successful placement with patient characteristics such as body mass index, surgical history, parity, or prior vaginal deliveries observed. Conclusion(s): The Essure procedure can be performed quickly and safely with high bilateral placement rates regardless of physician experience or patient characteristics.
AB - Objective: To assess the placement rates for experienced users versus newly trained physicians using the new ESS 305 delivery catheter for the Essure microinsert hysteroscopic sterilization system. Design: Multicenter prospective cohort study. Setting: Seventy-six sites throughout the U.S. comprising community hospitals, teaching institutions, surgery centers, and office-based practices. Patient(s): A total of 578 women seeking hysteroscopic sterilization. Intervention(s): Hysteroscopic sterilization with the ESS 305 device by either experienced or novice physicians. Main Outcome Measure(s): Successful bilateral placement of the Essure 305 device. Result(s): A total of 625 patients were recruited with 578 eligible cases performed by 37 newly trained and 39 experienced physicians: 562/578 (97.2%) overall had successful placement, with 98% successful placement rate versus 96.1% for experienced versus novice physicians, respectively. Mean procedural time was 9 minutes (±7 SD), with experienced physicians completing it on average quicker at 7.9 minutes (±5.8 SD) and novices completing it in 10.7 minutes (±8.3 SD). There was no significant association between successful placement with patient characteristics such as body mass index, surgical history, parity, or prior vaginal deliveries observed. Conclusion(s): The Essure procedure can be performed quickly and safely with high bilateral placement rates regardless of physician experience or patient characteristics.
KW - Essure
KW - experience
KW - Hysteroscopy
KW - sterilization
UR - http://www.scopus.com/inward/record.url?scp=79960445737&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79960445737&partnerID=8YFLogxK
U2 - 10.1016/j.fertnstert.2011.06.047
DO - 10.1016/j.fertnstert.2011.06.047
M3 - Article
SN - 0015-0282
JO - Fertility and Sterility
JF - Fertility and Sterility
ER -