TY - JOUR
T1 - Response to Letter to the Editor: "incidence of Hypoglycemia after Gastric Bypass vs Sleeve Gastrectomy: A Randomized Trial"
AU - Capristo, Esmeralda
AU - Panunzi, Simona
AU - De Gaetano, Andrea
AU - Spuntarelli, Valerio
AU - Bellantone, Rocco Domenico Alfonso
AU - Giustacchini, Piero
AU - Birkenfeld, Andreas L
AU - Amiel, Stephanie
AU - Bornstein, Stefan R
AU - Raffaelli, Marco
AU - Mingrone, Geltrude
PY - 2018
Y1 - 2018
N2 - First, we would like to clarify that the sample size of our RCT was calculated correctly, based on the relevant data available from reported studies before our RCT began. An incidence of 68% and 20% was reported for RYGB (2) and SG (3), respectively. Therefore, the absolute difference in the occurrence of hypoglycemia between the two surgical procedures was ∼50%. However, we considered a more conservative difference of 30% and calculated that, with two-tailed P < 0.05 and a test power of 0.90, 50 subjects in each group would have been sufficient to meet the criteria for superiority compared with SG treatment. Considering an attrition rate of 20%, the patients enrolled were 120 overall, with 60 in each group.
AB - First, we would like to clarify that the sample size of our RCT was calculated correctly, based on the relevant data available from reported studies before our RCT began. An incidence of 68% and 20% was reported for RYGB (2) and SG (3), respectively. Therefore, the absolute difference in the occurrence of hypoglycemia between the two surgical procedures was ∼50%. However, we considered a more conservative difference of 30% and calculated that, with two-tailed P < 0.05 and a test power of 0.90, 50 subjects in each group would have been sufficient to meet the criteria for superiority compared with SG treatment. Considering an attrition rate of 20%, the patients enrolled were 120 overall, with 60 in each group.
KW - Biochemistry
KW - Biochemistry (medical)
KW - Clinical Biochemistry
KW - Endocrinology
KW - Endocrinology, Diabetes and Metabolism
KW - Biochemistry
KW - Biochemistry (medical)
KW - Clinical Biochemistry
KW - Endocrinology
KW - Endocrinology, Diabetes and Metabolism
UR - http://hdl.handle.net/10807/131675
UR - http://jcem.endojournals.org
U2 - 10.1210/jc.2018-01813
DO - 10.1210/jc.2018-01813
M3 - Article
SN - 0021-972X
VL - 104
SP - 732
EP - 733
JO - THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
JF - THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
ER -