Containment Bag Use Among Women Who Undergo Hysterectomy With Laparoscopic Power Morcellation.
Journal
Obstetrics and gynecology
ISSN: 1873-233X
Titre abrégé: Obstet Gynecol
Pays: United States
ID NLM: 0401101
Informations de publication
Date de publication:
01 09 2022
01 09 2022
Historique:
received:
31
01
2022
accepted:
19
05
2022
pubmed:
5
8
2022
medline:
15
11
2022
entrez:
4
8
2022
Statut:
ppublish
Résumé
To estimate trends in use of laparoscopic power morcellators in women undergoing minimally invasive hysterectomy and to examine use of containment systems in these patients in relation to safety guidance from the U.S. Food and Drug Administration (FDA). We examined data that were recorded in the Premier Healthcare Database from patients who underwent laparoscopic supracervical hysterectomy from 2010 to 2018. Patients were stratified based on use of laparoscopic power morcellators. The cohort was further stratified as either pre-FDA guidance (2010 quarter 1-2014 quarter 1) or post-FDA guidance (2014 quarter 2-2018 quarter 2). Interrupted time series analyses were performed to determine the effect of FDA guidance on the use of laparoscopic power morcellators and containment bags. Among 67,115 patients, laparoscopic power morcellator use decreased from 66.7% in 2013 quarter 4 to 13.3% by 2018 quarter 2. The likelihood of laparoscopic power morcellator use decreased by 9.5% for each quarter elapsed in the post-FDA warning period (risk ratio [RR] 0.91, 95% CI 0.90-0.91). Containment bag use rose from 5.2% in 2013 quarter 4 to 15.2% by 2018 quarter 2. The likelihood of containment bag use increased by 3% for each quarter elapsed in the post-FDA warning period (RR 1.03, 95% CI 1.02-1.05). Among women who had laparoscopic power morcellator use, uterine cancers or sarcomas were identified in 54 (0.17%) before the FDA guidance compared with seven (0.12%) after the guidance ( P =.45). Containment bags were used in 11.1% of women with uterine cancers or sarcomas before the FDA guidance compared with 14.3% after the guidance ( P =.12). The perioperative complication rate was 3.3% among women who had laparoscopic power morcellator use without a containment bag compared with 4.5% ( P =.001) in those with a containment bag (aRR 1.35, 95% CI 1.12-1.64). Use of laparoscopic power morcellators has decreased over time. Containment bag use increased after the FDA's 2014 guidance; however, most procedures employing laparoscopic power morcellators are still performed without a containment bag.
Identifiants
pubmed: 35926199
doi: 10.1097/AOG.0000000000004886
pii: 00006250-990000000-00536
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
371-380Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Financial Disclosure Dr. Wright has received royalties from UpToDate and received research support from Merck. Dr. Hou has served as a consultant for Foundation Medicine and Natera. The other authors did not report any potential conflicts of interest.
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