Table 2.

Unadjusted Changes in Operative Approach and Morbidity Before and After the U.S. Food and Drug Administration Communication

Operative Variable	Pre-FDA (n=3,160)*	Post-FDA (n=4,378)*	P
Surgical approach
Abdominal	1,552 (49.1)	2,628 (60.0)	<.001
Laparoscopic	1,608 (50.9)	1,750 (40.0)
Burden of disease
Low	1,932 (61.1)	2,586 (59.1)	.070
High	1,228 (38.9)	1,792 (40.9)
Abdominal
Low burden	843 (54.3)	1,397 (53.2)	.468
High burden	709 (45.7)	1,231 (46.8)
Laparoscopic
Low burden	108 (67.7)	1,189 (67.9)	.892
High burden	519 (32.3)	561 (32.1)
OR time (min)	152.4±82.1	147.0±76.4	.003
Length of stay (d)	1 (0–2)	1 (0–2)	<.001
Reoperation within 30 d	23 (0.7)	37 (0.9)	.572
Readmission within 30 d	54 (1.7)	74 (1.7)	.966
Medical morbidity
DVT or PE	11 (0.4)	16 (0.4)	.901
UTI	32 (1.0)	45 (1.0)	.948
Sepsis	9 (0.3)	23 (0.5)	.113
Surgical morbidity
Blood transfusion	298 (9.4)	399 (9.1)	.640
Surgical site infections	37 (1.2)	66 (1.5)	.214
Wound dehiscence	4 (0.1)	6 (0.1)	.902
Composite morbidity†	363 (11.5)	512 (11.7)	.790

FDA, U.S. Food and Drug Administration;OR time, operative time; DVT, deep venous thrombosis;PE, pulmonary embolism; UTI, urinary tract infection.

Data are n (%), mean±standard deviation, or median (interquartile range) unless otherwise specified.

^*Pre-FDA April 2012 to December 2013; Post-FDA April 2014 to December 2015.

^†Morbidity represents a composite of blood transfusion, wound dehiscence, wound infection, UTI, sepsis or septic shock, and DVT or PE.