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

Mark Levie, Scott G. Chudnoff

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalFertility and Sterility
DOIs
StateAccepted/In press - 1800

Fingerprint

Physicians
Equipment and Supplies
Community Hospital
Parity
Ambulatory Surgical Procedures
Teaching
Body Mass Index
Cohort Studies
Catheters
History
Outcome Assessment (Health Care)
Prospective Studies

Keywords

  • Essure
  • experience
  • Hysteroscopy
  • sterilization

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

@article{5bfc05cb6bee4e2fa02075b69775cb9a,
title = "A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial",
abstract = "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.",
keywords = "Essure, experience, Hysteroscopy, sterilization",
author = "Mark Levie and Chudnoff, {Scott G.}",
year = "1800",
doi = "10.1016/j.fertnstert.2011.06.047",
language = "English (US)",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",

}

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

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

ER -