Table 3.

Complications at 3 Years.^*

Complication	Medical Therapy (N = 43)	Gastric Bypass (N = 50) number of patients (percent)	Sleeve Gastrectomy (N = 49)
Gastrointestinal
Bowel obstruction	1 (2)	1 (2)	1 (2)
Stricture	0	1 (2)	1 (2)
Ulcer	1 (2)	4 (8)	0
Leak	0	0	1 (2)
Intraabdominal bleeding	0	2 (4)	0
Dumping syndrome	0	4 (8)	1 (2)
Gallstone diseases	0	1 (2)	1 (2)
Microvascular or macrovascular
Stroke	0	0	1 (2)
Retinopathy	0	1 (2)	2 (4)
Nephropathy†	4 (9)	7 (14)	5 (10)
Foot ulcer	0	2 (4)	1 (2)
Nutritional and metabolic
Anemia	6 (14)	8 (16)	15 (31)
Intravenous treatment for dehydration	3 (7)	7 (14)	4 (8)
Hypoglycemic episode	39 (91)	32 (64)	40 (82)
Severe hypoglycemia requiring intervention	0	1 (2)	0
Excessive weight gain‡	7 (16)	0	0
Other
Wound infection	0	1 (2)	0
Hernia	1 (2)	3 (6)	1 (2)
Pneumonia	0	2 (4)	1 (2)
Renal calculus	6 (14)	5 (10)	4 (8)
Cancer	2 (5)	2 (4)	2 (4)

^*Not included in the safety analysis were seven patients in the medical-therapy group who withdrew immediately after randomization and one patient in the sleeve-gastrectomy group who had anemia before withdrawing from the study before surgery. Five patients who started the study but later withdrew or were lost to follow-up are included in this analysis until their discontinuation.

^†Nephropathy was defined as any one of the following criteria: doubling of the serum creatinine level or a decrease in the glomerular filtration rate of more than 20%; development of macroalbuminuria (urine albumin-to-creatinine ratio, >300 [as measured in milligrams of albumin to grams of creatinine]); or renal transplantation, initiation of dialysis, or an increase in the serum creatinine level of more than 3.3 mg per deciliter (290 µmol per liter) in the absence of an acute reversible cause.

^‡Excessive weight gain was defined as a 5% increase in body weight over baseline. P<0.05 for the comparison between the medical-therapy group and each of the surgical groups.