Vinsamlegast notið þetta auðkenni þegar þið vitnið til verksins eða tengið í það: http://hdl.handle.net/1946/24634
Introduction: In April and again in November, 2014, the U.S. Food and Drug Administration issued a safety recommendation warning against the use of power morcellators in women with uterine fibroids due to concerns of spreading occult malignant tissue in the peritoneal cavity during morcellation.
Methods: This study is a retrospective review of all patient charts who underwent a hysterectomy for benign indications at Brigham and Women’s Hospital in Boston MA, USA from 2013-2015. Patients were identified from hospital coding records and clinical data extracted from electronic medical records. The rates of abdominal, vaginal, laparoscopic and robotic-assisted laparoscopic hysterectomy, as well as the rates of post-operative complications, 60-day readmissions, reoperations and length of stay, were compared over the study period. Postoperative complications were classified using the Clavien-Dindo complication rating. Analysis was performed using multivariable linear, multinomial and logistic regression. Regression models were adjusted for potential confounders.
Results: From 2013 to 2015, 1530 patients underwent benign hysterectomies. There was a slight but non-statistically significant change in the mode of hysterectomy over time. Comparing 2013 to 2015, abdominal hysterectomy increased by 4.4% (12.9% vs. 17.3%), vaginal hysterectomy increased by 1.2% (17.9% vs. 19.1%), laparoscopic hysterectomy decreased by 6.2% (66.1% vs. 59.9%), and there was little change in the frequency of robotic-assisted laparoscopic hysterectomy. From 2013 to 2015 there was a significant decrease in supracervical hysterectomy, by 16.2%. Both 2014 and 2015, when compared to 2013, showed significantly shorter operating room (OR) times and shorter length of stay but an increase in estimated blood loss (47 vs. 56 mL, p=0.05). Additionally, the cases in 2014 were associated with fewer post-operative complications compared with 2013 but there was no significant difference between the year of surgery and incidence of intraoperative complications, readmission or reoperation.
Conclusion: We did not observe a significant shift in the mode of hysterectomy or perioperative outcomes at our institution following the FDA’s 2014 safety recommendations regarding morcellation, although the rate of supracervical hysterectomy did decrease markedly. With changing practice patterns and vigilance surrounding power morcellation, gynecologic surgeons may still offer patients minimally invasive procedures with all of the accompanying advantages.
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