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Early Experience with Low-Dose Phentermine for Preoperative Bariatric Weight Loss: A Prospective Randomized Trial
2017 Quickshot Abstracts / Surgery for Obesity and Related Diseases 13 (2017) S52–S65
(BMI) and the different categories compared to LRYGB in terms of %EWL postoperatively. Results: A total of 450 patients were included in our analysis; 158 patients underwent LSG and 292 underwent LRYGB. The 4-year follow-up rates for LSG and LRYGB were 63% and 58%, respectively. Major and minor complication rates at 30 days (defined by ASMBS guidelines) for LSG and LRYGB were 0.6 and 0.6 % vs. 1.4 and 5.5 %, respectively (p 4 0.05). Overall major and minor complication rates for LSG and LRYGB were 5.7 and 0% vs. 11 and 4.1 %, respectively (p 4 0.05). Readmission and reoperation rates at 30 days for LSG and LRYGB were 0 % vs. 3.4 and 1.4 %, respectively (p 4 0.05). Median operative times were 104 and 79 minutes for LRYGB and LSG, respectively (p o 0.05). LRYGB resulted in significantly greater %EWL than LSG at 3, 6, 12, 24, 36, and 48 months (Table) . However, LSG patients with BMI o 40 achieved similar %EWL compared to LRYGB up to 24 months postoperatively. Conclusion: In our center, LSG and LRYGB shared a similar safety profile. In addition, LRYGB patients achieved significantly greater %EWL compared to LSG . However, LSG patients with BMI o 40 achieved similar weight loss compared to LRYGB patients in the first two years postoperatively.
A525
EARLY EXPERIENCE WITH LOW-DOSE PHENTERMINE FOR PREOPERATIVE BARIATRIC WEIGHT LOSS: A PROSPECTIVE RANDOMIZED TRIAL John Morton1; Habib Khoury2; Dan Azagury1; Homero Rivas3; 1 Stanford School of Medicine, Stanford CA; 2Stanford School of Medicine, San Francisco CA; 3Stanford School of Medicine, Palo Alto CA Introduction: In 2016, a low dose (8mg) phentermine weight loss drug was FDA approved. Mandated preoperative weight loss with a specific time frame remains a requirement for many bariatric surgery patients. There are limited Level 1 data for pre-operative weight loss for bariatric surgery. Here we present the first randomized trial examining the impact of adjuvant pharmaceutical therapy upon preoperative weight loss. Methods: 24 patients in one month consented to participate in the study with an enrollment goal of 70 patients. Study participants were randomized to low-dose phentermine (Lomaira®) or placebo. Treatment was designated to be completed within a 60-90 day preoperative time period. Patients and surgeons were blinded regarding treatment assignment. Demographic and clinical data were collected at the patients’ consult visit. On a weekly basis, dietary intake and physical activity were assessed with the HealthWatch 360 smartphone application and weight loss was recorded via a digital, connected scale. CT scans to assess liver
S63
volume and serological exams were scheduled at initial consult and again at preoperative visit. Mann-Whitney and Wilcoxon ttests were used to assess weight loss. Results: 14 and 10 patients were assigned to the Low-Dose Phentermine (LDP) treatment and placebo groups respectively. LDP and Placebo patients were on average 26 and 29 days respectively into their treatment. LDP patients were on average 43.42 ± 3.9 years old, and Placebo patients were on average 46.33 ± 3.5 (p¼0.5974). LDP and Placebo patients had similar BMI (50.0 ± 2.3 vs. 47.0 ± 3.0, p¼0.4259) and systolic blood pressure (136.4 ± 5.4 vs. 144.8 ± 8.8 mmHg, p¼0.4025) at the first clinic visit. There were no differences between LDP and Placebo patients in initial liver volume (2131 vs. 2273 CC, p¼0.8480) or daily caloric intake (1678 ± 215 vs. 1517 ± 224 calories, p¼0.6888). LDP patients showed significant weight loss in terms of a change in BMI within a month of treatment (-1.4, p¼0.0066), unlike Placebo patients (-0.3, p¼0.2852). Additionally, there was a significant difference between LDP and Placebo patients in percentage of excess body weight loss within one month (6.3 ± 1.5% vs. 1.4 ± 1.5%, p¼0.0465). Only one patient in the treatment group discontinued treatment, due to a feeling of noncardiac chest discomfort. Conclusions: This first randomized, double-blinded pharmaceutical pre-operative weight loss trial demonstrates in preliminary results that Low Dose Phentermine is a safe and effective in delivering significant weight loss within a month of treatment.
A526
INCIDENCE OF CHOLECYSTECTOMY FOLLOWING BARIATRIC SURGERY Maria Altieri1; Jie Yang2; Lizhou Nie2; Salvatore Docimo2; Mark Talamini2; Aurora Pryor2; 1Stony Brook University Medical Center, Rocky Point NY; 2Stony Brook Hospital, Stony Brook NY Introduction: Cholecystectomy is the most commonly performed procedure in the United States. Bariatric surgery predisposes patients to development of cholelithiasis and therefore the need of a subsequent cholecystectomy. The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. Methods: Following IRB approval, the SPARCS administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010 through the use of ICD-9 and CPT codes. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least four years (up to 2014). Patients who underwent cholecystectomy at the time of the initial procedure were excluded (n¼140 for LAGB, 1186 for RYGB, and 36 for SG). Univariate and multivariate analysis was used to identify risk factors for subsequent cholecystectomy. P-valueo0.05 was considered significant. Results: During this time period, there were 15,327 LAGB procedures, 19,674 RYGB, and 1,578 SG. There were 977 (6.4%) patients who underwent cholecystectomy following LAGB, 1903 (9.7%) patients following RYGB, and 167 (10.6%) following SG. Majority of follow-up cholecystectomies were performed at the same institutions (50.34% for LAGB, 55.61% for
(BMI) and the different categories compared to LRYGB in terms of %EWL postoperatively. Results: A total of 450 patients were included in our analysis; 158 patients underwent LSG and 292 underwent LRYGB. The 4-year follow-up rates for LSG and LRYGB were 63% and 58%, respectively. Major and minor complication rates at 30 days (defined by ASMBS guidelines) for LSG and LRYGB were 0.6 and 0.6 % vs. 1.4 and 5.5 %, respectively (p 4 0.05). Overall major and minor complication rates for LSG and LRYGB were 5.7 and 0% vs. 11 and 4.1 %, respectively (p 4 0.05). Readmission and reoperation rates at 30 days for LSG and LRYGB were 0 % vs. 3.4 and 1.4 %, respectively (p 4 0.05). Median operative times were 104 and 79 minutes for LRYGB and LSG, respectively (p o 0.05). LRYGB resulted in significantly greater %EWL than LSG at 3, 6, 12, 24, 36, and 48 months (Table) . However, LSG patients with BMI o 40 achieved similar %EWL compared to LRYGB up to 24 months postoperatively. Conclusion: In our center, LSG and LRYGB shared a similar safety profile. In addition, LRYGB patients achieved significantly greater %EWL compared to LSG . However, LSG patients with BMI o 40 achieved similar weight loss compared to LRYGB patients in the first two years postoperatively.
A525
EARLY EXPERIENCE WITH LOW-DOSE PHENTERMINE FOR PREOPERATIVE BARIATRIC WEIGHT LOSS: A PROSPECTIVE RANDOMIZED TRIAL John Morton1; Habib Khoury2; Dan Azagury1; Homero Rivas3; 1 Stanford School of Medicine, Stanford CA; 2Stanford School of Medicine, San Francisco CA; 3Stanford School of Medicine, Palo Alto CA Introduction: In 2016, a low dose (8mg) phentermine weight loss drug was FDA approved. Mandated preoperative weight loss with a specific time frame remains a requirement for many bariatric surgery patients. There are limited Level 1 data for pre-operative weight loss for bariatric surgery. Here we present the first randomized trial examining the impact of adjuvant pharmaceutical therapy upon preoperative weight loss. Methods: 24 patients in one month consented to participate in the study with an enrollment goal of 70 patients. Study participants were randomized to low-dose phentermine (Lomaira®) or placebo. Treatment was designated to be completed within a 60-90 day preoperative time period. Patients and surgeons were blinded regarding treatment assignment. Demographic and clinical data were collected at the patients’ consult visit. On a weekly basis, dietary intake and physical activity were assessed with the HealthWatch 360 smartphone application and weight loss was recorded via a digital, connected scale. CT scans to assess liver
S63
volume and serological exams were scheduled at initial consult and again at preoperative visit. Mann-Whitney and Wilcoxon ttests were used to assess weight loss. Results: 14 and 10 patients were assigned to the Low-Dose Phentermine (LDP) treatment and placebo groups respectively. LDP and Placebo patients were on average 26 and 29 days respectively into their treatment. LDP patients were on average 43.42 ± 3.9 years old, and Placebo patients were on average 46.33 ± 3.5 (p¼0.5974). LDP and Placebo patients had similar BMI (50.0 ± 2.3 vs. 47.0 ± 3.0, p¼0.4259) and systolic blood pressure (136.4 ± 5.4 vs. 144.8 ± 8.8 mmHg, p¼0.4025) at the first clinic visit. There were no differences between LDP and Placebo patients in initial liver volume (2131 vs. 2273 CC, p¼0.8480) or daily caloric intake (1678 ± 215 vs. 1517 ± 224 calories, p¼0.6888). LDP patients showed significant weight loss in terms of a change in BMI within a month of treatment (-1.4, p¼0.0066), unlike Placebo patients (-0.3, p¼0.2852). Additionally, there was a significant difference between LDP and Placebo patients in percentage of excess body weight loss within one month (6.3 ± 1.5% vs. 1.4 ± 1.5%, p¼0.0465). Only one patient in the treatment group discontinued treatment, due to a feeling of noncardiac chest discomfort. Conclusions: This first randomized, double-blinded pharmaceutical pre-operative weight loss trial demonstrates in preliminary results that Low Dose Phentermine is a safe and effective in delivering significant weight loss within a month of treatment.
A526
INCIDENCE OF CHOLECYSTECTOMY FOLLOWING BARIATRIC SURGERY Maria Altieri1; Jie Yang2; Lizhou Nie2; Salvatore Docimo2; Mark Talamini2; Aurora Pryor2; 1Stony Brook University Medical Center, Rocky Point NY; 2Stony Brook Hospital, Stony Brook NY Introduction: Cholecystectomy is the most commonly performed procedure in the United States. Bariatric surgery predisposes patients to development of cholelithiasis and therefore the need of a subsequent cholecystectomy. The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. Methods: Following IRB approval, the SPARCS administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010 through the use of ICD-9 and CPT codes. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least four years (up to 2014). Patients who underwent cholecystectomy at the time of the initial procedure were excluded (n¼140 for LAGB, 1186 for RYGB, and 36 for SG). Univariate and multivariate analysis was used to identify risk factors for subsequent cholecystectomy. P-valueo0.05 was considered significant. Results: During this time period, there were 15,327 LAGB procedures, 19,674 RYGB, and 1,578 SG. There were 977 (6.4%) patients who underwent cholecystectomy following LAGB, 1903 (9.7%) patients following RYGB, and 167 (10.6%) following SG. Majority of follow-up cholecystectomies were performed at the same institutions (50.34% for LAGB, 55.61% for