A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial

• Published in: Fertility and sterility Vol. 96; no. 3; pp. 643 - 648.e1
• Main Authors: Levie, Mark, M.D, Chudnoff, Scott G., M.D., M.S
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.2011; Elsevier
• Subjects: Adult; Biological and medical sciences; body mass index; Clinical Competence - standards; cohort studies; Device Approval; Essure; experience; Female; Gynecology. Andrology. Obstetrics; hospitals; Humans; Hysteroscopy; Hysteroscopy - standards; Internal Medicine; Medical sciences; Obstetrics and Gynecology; Outcome Assessment (Health Care); patients; physicians; Physicians - standards; Physicians' Offices - statistics & numerical data; Prospective Studies; sterilization; Sterilization, Reproductive - standards; surgery; United States; United States Food and Drug Administration; women; United States; Hysteroscopy; Essure; experience; sterilization; Gynecology; Sterilization; Physician; Clinical trial; Obstetrics; Comparative study
• ISSN: 0015-0282; 1556-5653
• DOI: 10.1016/j.fertnstert.2011.06.047

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.