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

Mark D. Levie, Scott G. Chudnoff

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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. Multicenter prospective cohort study. Seventy-six sites throughout the U.S. comprising community hospitals, teaching institutions, surgery centers, and office-based practices. A total of 578 women seeking hysteroscopic sterilization. Hysteroscopic sterilization with the ESS 305 device by either experienced or novice physicians. Successful bilateral placement of the Essure 305 device. 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. The Essure procedure can be performed quickly and safely with high bilateral placement rates regardless of physician experience or patient characteristics.

Original languageEnglish (US)
JournalFertility and Sterility
Volume96
Issue number3
StatePublished - Sep 2011

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Physicians
Equipment and Supplies
Community Hospital
Parity
Ambulatory Surgical Procedures
Teaching
Body Mass Index
Cohort Studies
Catheters
History
Prospective Studies

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

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title = "A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial.",
abstract = "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. Multicenter prospective cohort study. Seventy-six sites throughout the U.S. comprising community hospitals, teaching institutions, surgery centers, and office-based practices. A total of 578 women seeking hysteroscopic sterilization. Hysteroscopic sterilization with the ESS 305 device by either experienced or novice physicians. Successful bilateral placement of the Essure 305 device. 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. The Essure procedure can be performed quickly and safely with high bilateral placement rates regardless of physician experience or patient characteristics.",
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