Table 5.
Operative Variable | Pre-FDA* | Post-FDA* | P |
---|---|---|---|
Abdominal approach† | 1.0 (referent) | 1.5 (1.3–1.6) | <.001 |
All OR time (min)‡ | 125.2 (110.1–140.2) | 116.5 (97.6–135.4) | <.001 |
Abdominal OR time‡ | 85.8 (68.3–103.4) | 80.3 (58.1–102.4) | .017 |
Laparoscopic OR time‡ | 157.0 (133.4–180.5) | 153.2 (123.5–182.9) | .230 |
Length of stay§ | 1.0 (referent) | 1.0 (1.0–1.1) | .143 |
Readmission† | 1.0 (referent) | 1.0 (0.7–1.5) | .897 |
Transfusion† | 1.0 (referent) | 1.0 (0.8–1.1) | .628 |
Composite morbidit†‖ | 1.0 (referent) | 1.0 (0.9–1.2) | .809 |
FDA, U.S. Food and Drug Administration; OR time, operative time.
All analyses adjusted for age, race, ethnicity, body mass index, and myoma burden. Given the limited number of events, adjusted analysis was unable to be completed for reoperation, deep vein thrombosis or pulmonary embolism, urinary tract infection, sepsis, surgical site infections, and wound dehiscence.
Pre-FDA, April 2012 to December 2013; post-FDA, April 2014 to December 2015.
Results from logistic regression models, expressed as adjusted means with 95% confidence intervals (CIs).
Results from linear regression models, expressed as adjusted odds ratios with 95% CIs.
Results from an overdispersed Poisson regression model, expressed as adjusted incidence rate ratios with 95% CIs.
Morbidity represents a composite of blood transfusion, wound dehiscence, wound infection, urinary tract infection, sepsis or septic shock, and deep vein thrombosis or pulmonary embolism.