- Email: [email protected]
Use and Outcomes of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Gastric Bypass: Analysis of the American College of Surgeons NSQIP
Use and Outcomes of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Gastric Bypass: Analysis of the American College of Surgeons NSQIP Monica T Young,
MD,
Alana Gebhart,
BA,
Michael J Phelan,
PhD,
Ninh T Nguyen,
MD, FACS
Laparoscopic sleeve gastrectomy is gaining popularity in the United States. However, few studies have examined outcomes of sleeve gastrectomy compared with those of the “gold standard” bariatric operation: Roux-en-Y gastric bypass. STUDY DESIGN: Using the American College of Surgeons National Surgical Quality Improvement Program database, clinical data were obtained for all patients who underwent laparoscopic sleeve gastrectomy or laparoscopic gastric bypass between 2010 and 2011. Main outcomes measures were risk-adjusted 30-day serious morbidity and mortality. RESULTS: We analyzed 24,117 patients who underwent laparoscopic sleeve gastrectomy or laparoscopic gastric bypass for the treatment of morbid obesity. Gastric bypass comprised 79.5% of cases and sleeve gastrectomy comprised 20.5%; the proportion of sleeve gastrectomy cases increased from 14.6% in 2010 to 25.8% in 2011. On univariate analysis, sleeve gastrectomy had a shorter mean operative time (101 vs 133 minutes, p < 0.01), a lower rate of blood loss requiring transfusion (0.6% vs 1.5%, p < 0.01), a lower rate of deep wound infections (0.06% vs 0.20%, p ¼ 0.05), lower serious morbidity rate (3.8% vs 5.8%, p < 0.01), and 30-day reoperation rate (1.6% vs 2.5%, p < 0.01), but a higher rate of deep venous thrombosis (0.47% vs 0.21%, p < 0.01). Compared with sleeve gastrectomy, gastric bypass patients had higher risk-adjusted 30-day serious morbidity (odds ratio [OR] 1.32; 95% CI1.11 to 1.56, p < 0.01). Patients who were older, had higher BMI, smoked, or had hypertension were at significantly greater risk of serious morbidity. The 30-day mortality was similar between groups (0.10% for sleeve vs 0.15% for bypass). CONCLUSIONS: Use of laparoscopic sleeve gastrectomy is increasing on a national level. Compared with laparoscopic gastric bypass, laparoscopic sleeve gastrectomy is associated with lower 30-day riskadjusted serious morbidity and equivalent 30-day mortality. (J Am Coll Surg 2015;220: 880e885. 2015 by the American College of Surgeons)
BACKGROUND:
substantial weight loss after the initial stage, LSG developed into a stand-alone procedure. Weight loss and alteration of comorbidities after LSG appear to be related to biochemical changes from the gastric resection and/or expedited transport of stomach contents into the small bowel.3 In 2012, the American Society for Metabolic and Bariatric Surgery released a position statement recognizing LSG as an acceptable option as a primary bariatric procedure.3 This was based on randomized studies demonstrating equivalent weight loss outcomes and amelioration of comorbidities between LSG and LGB.4,5 Over the past several years LSG appears to be gaining popularity in the United States. A recent study using the University HealthSystem Consortium clinical database found that the use of LSG has increased from 0.9% in 2008 to 36.3% in 2012.6 Although the
Laparoscopic sleeve gastrectomy (LSG) first originated as part of the biliopancreatic diversion with duodenal switch operation.1 In 2003, Regan and colleagues2 described it as the first portion of a 2-stage procedure for super-super obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LGB). When patients were found to have Disclosure Information: Nothing to disclose. Presented at the American College of Surgeons 100th Annual Clinical Congress, San Francisco, CA, October 2014. Received November 30, 2014; Revised January 27, 2015; Accepted January 27, 2015. From the Departments of Surgery (Young, Gebhart, Nguyen) and Statistics (Phelan), University of California, Irvine, Irvine, CA. Correspondence address: Ninh T Nguyen, MD, FACS, Department of Surgery, University of California, Irvine Medical Center, 333 City Blvd West Suite 1600, Orange, CA 92868. email: [email protected]
ª 2015 by the American College of Surgeons Published by Elsevier Inc.
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University HealthSystem Consortium is based on data collected from academic institutions; this finding likely represents a larger national trend. There are few largescale studies examining the outcomes of LSG compared with those of LGB. Therefore, this study aimed to examine national trends and outcomes of LSG vs LGB.
METHODS Database The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database is the first national validated, outcomes-based program designed for the purpose of improving surgical quality of care. It is comprised of more than 500 hospitals, which collect and receive hospital-level data on preoperative risk factors, intraoperative variables, and 30-day morbidity and mortality after inpatient and outpatient surgical procedures. A trained surgical clinical reviewer is used at participating hospitals to standardize data capture and ensure reliability. Additional information about the ACS NSQIP sampling strategy, data abstraction, and program specifics can be found on the ACS NSQIP website.7 Approval for the use of patient level data analyzed in this study was obtained from the Institutional Review Board of the University of California Irvine Medical Center and from the ACS NSQIP. Selection and description of participants The ACS NSQIP database was retrospectively reviewed for all patients undergoing LSG or LGB for the treatment of morbid obesity between 2010 and 2011. Appropriate diagnosis and procedural codes were selected using the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnosis codes and Current Procedural Terminology (CPT) codes. The principle diagnosis codes used were obesity (278.00) and morbid obesity
Figure 1. Trends in use of laparoscopic gastric bypass and laparoscopic sleeve gastrectomy, 2010 to 2011. Gray, laparoscopic sleeve gastrectomy, black, laparoscopic gastric bypass.
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(287.01). The CPT procedural codes were 43775 for laparoscopic sleeve gastrectomy and 43644 and 43645 for laparoscopic gastric bypass. Patients who underwent emergent procedures were excluded from analysis. Demographics and outcomes variables Analyzed variables included patient demographics (age, sex, and ethnicity), body mass index (BMI), comorbid conditions (diabetes, stroke, COPD, congestive heart failure, myocardial infarction, coronary artery disease, hypertension, peripheral vascular disease, cancer, smoking, and alcohol use) and American Society of Anesthesiologists (ASA) class. The mean number of comorbidities per patient was calculated for each group. Missing descriptive patient data were excluded from analysis. Operative variables included operative time and anesthesia time. Primary outcomes measures included 30-day serious Table 1. Demographics of Patients Undergoing Laparoscopic Gastric Bypass vs Laparoscopic Sleeve Gastrectomy, 2010 to 2011
Variable
Age, y, mean (SD) Age category, % <40 y 40e60 y 61e80 y >80 y Sex, % Male Female Race, % White Asian African American Pacific Islander Unknown BMI, kg/m2, mean (SD) BMI category, % >50 kg/m2 50 kg/m2 ASA Class, % 1-No Disturb 2-Mild Disturb 3-Severe Disturb 4-Life Threat 5-Moribund
Laparoscopic Laparoscopic gastric sleeve bypass gastrectomy (n ¼ 19,172) (n ¼ 4,945) p Value
45 (12)
44 (11)*
<0.01
34.53 55.73 9.73 0.01
34.07 57.86* 8.01* 0.06
0.56 <0.01 <0.01 0.12
20.36 78.72
23.56* 75.67*
<0.01 <0.01
73.87 0.55 13.98 0.44 8.61 46 (8)
70.01* 0.75 20.04* 0.34 7.02* 46 (9)
<0.01 0.12 <0.01 0.63 <0.01 0.99
25.91 73.95
27.1 72.8
0.09 0.11
0.33 32.75 64.45 2.32 0.01
0.34 33.69 63.42 2.41 0
0.98 0.22 0.18 0.92 0.47
*p 0.05, compared with laparoscopic gastric bypass. ASA, American Society of Anesthesiologists.
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Table 2.
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Sleeve Gastrectomy vs Gastric Bypass
Comorbidities of Patients Undergoing Laparoscopic Gastric Bypass vs Laparoscopic Sleeve Gastrectomy
Variable
Diabetes Stroke COPD Congestive heart failure Myocardial infarction, last 6 mo Coronary artery disease Hypertension Peripheral vascular disease History of cancer Smoking Alcohol, > 2 drinks/d Comorbidity count per patient, mean (SD)
Laparoscopic gastric bypass, % (n ¼ 19,172)
Laparoscopic sleeve gastrectomy, % (n ¼ 4,945)
p Value
30.4 0.73 1.77 0.08 0.04 2.76 54.25 0.23 0.01 11.20 0.16 1.2 (0.4)
24.47* 0.55 1.17* 0.14 0 2.39 52.28* 0.10 0.02 10.17* 0.24 0.9 (0.4)*
<0.01 0.17 <0.01 0.36 0.38 0.16 0.01 0.10 0.58 0.03 0.31 <0.01
*p 0.05, compared with laparoscopic gastric bypass.
morbidity and mortality. Individual complications analyzed included urinary tract infection, wound infection, abscess formation, pneumonia, pulmonary embolism, deep venous thrombosis, acute renal failure, bleeding requiring transfusion, stroke, myocardial infarction, sepsis, and cardiac arrest. Secondary outcomes measures were length of hospital stay, 30-day readmission, and 30-day reoperation. Readmission data were available only for 2011 ACS NSQIP and were defined as readmission to a surgical service within 30 days of the index operation. Statistical analysis Statistical analysis was performed using SAS version 9.3 (SAS) and the R statistical environment.8 Differences in patient characteristics, complications, operative variables, hospital length of stay, 30-day readmission, morbidity, and mortality were analyzed between groups. Binary outcomes were compared using chi-square tests with Yates correction. Two-sample t-tests with unequal variance were used to compare continuous variables. Multivariate logistic regression analysis was performed for 30-day morbidity between patients undergoing LGB and LSG. Independent variables used for risk adjustment included patient demographics, BMI, American Society of Anesthesiologists classification, and individual comorbid conditions. Multivariate analysis was unable to be performed for 30-day mortality due to the small number of deaths within the dataset. Comparisons were considered statistically significant if p < 0.05.
RESULTS A total of 24,117 patients who underwent LGB or LSG for the treatment of morbid obesity were sampled from the ACS NSQIP database between 2010 and 2011.
Between 2010 and 2011, the total number of LGB and LSG cases increased from 11,387 to 12,730 (Fig. 1). Laparoscopic gastric bypass comprised 79.5% and LSG comprised 20.5% of all cases included in the analysis. Comparisons of patient demographics and comorbidities between patients who underwent LGB and LSG are listed in Table 1. Mean age was higher in LGB patients compared with LSG patients (45 vs 44 years old, p < 0.01), and this group also had a higher proportion of women (78.7% vs 75.6%, p < 0.01) and Caucasians (73.9% vs 70.0%, p < 0.01), but a lower proportion of African Americans (13.9% vs 20.0%, p < 0.01). There were no significant differences in mean BMI (46 vs 46 kg/m2) or American Society of Anesthesiologists class distributions between groups (Table 1). Table 2 displays comorbidities of patients undergoing LGB vs LSG. Compared with LSG, patients undergoing LGB had significantly higher rates of diabetes (30.4% vs 24.5%, p < 0.01), COPD (1.8% vs 1.2%, p < 0.01), hypertension (54.3% vs 52.3%, p ¼ 0.01), and smoking (11.2% vs 10.2%, p ¼ 0.03). The mean number of comorbidities per patient was also higher for patients undergoing LGB compared with LSG (1.2 vs 0.9 comorbidities, p < 0.01). Intraoperative and postoperative outcomes are shown in Table 3. Compared with LSG, LGB was found to have significantly longer operative time (133 minutes vs 101 minutes, p < 0.01) and anesthesia time (187 minutes vs 147 minutes, p < 0.01). The majority of individual complication rates were similar between groups, but LGB was associated with higher rates of wound infection (0.2% vs 0.06%, p ¼ 0.05), bleeding requiring transfusion (1.5% vs 0.65%, p < 0.01), and sepsis (0.58% vs 0.34%, p ¼ 0.05). Deep venous thrombosis was the only complication found to be higher after LSG (0.21%
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Table 3. Intraoperative and Postoperative Outcomes of Patients Undergoing Laparoscopic Gastric Bypass vs Laparoscopic Sleeve Gastrectomy, 2010 to 2011
Variable
Operative time, min, mean (SD) Anesthesia time, min, mean (SD) Complications, % Urinary tract infection Wound infection Abscess Pneumonia Pulmonary embolism Deep venous thrombosis Acute renal failure Bleeding requiring transfusion Stroke/CVA Myocardial infarction Sepsis Cardiac arrest Serious morbidity, % Length of stay, d, mean (SD) 30-day readmission, %y 30-day reoperation, % 30-day mortality, %
Laparoscopic Laparoscopic gastric sleeve bypass gastrectomy (n ¼ 19,172) (n ¼ 4,945) p Value
133 (56)
101 (50)*
<0.01
187 (70)
147 (65)*
<0.01
0.91 0.2 0.63 0.5 0.21 0.21 0.11
0.71 0.06* 0.69 0.38 0.18 0.47* 0.14
0.21 0.05 0.73 0.37 0.79 <0.01 0.72
1.5 0.03 0.1 0.58 0.08 5.8
0.65* 0.02 0.06 0.34* 0.04 3.8*
<0.01 0.82 0.53 0.05 0.55 <0.01
2 (6) 6.08 2.46 0.15
2 (11) 4.05* 1.6* 0.1
0.99 <0.01 <0.01 0.58
*p 0.05, compared to laparoscopic gastric bypass. y Based on 2011 data only. CVA, cerebrovascular accident.
vs 0.47%, p < 0.01). Overall postoperative morbidity was significantly higher after LGB compared with LSG (8.76% vs 6.74%, p < 0.01), and was also associated with higher 30-day reoperation rates compared with LSG (2.46% vs 1.6%, p < 0.01). Hospital length of stay was equivalent between groups (2 days). Using the 2011 ACS NSQIP data, 30-day readmission was analyzed and was higher after LGB compared with LSG (6.08% vs 4.05%, p < 0.01). There was no significant difference found in 30-day mortality between groups (0.15% LGB vs 0.1% LSG, p ¼ 0.58). Laparoscopic Roux-en-Y gastric bypass was associated with significantly higher risk-adjusted 30-day serious morbidity compared with LSG (odds ratio [OR] 1.32; 95% CI [1.11, 1.56], p < 0.01) (Table 4). The risk-adjusted odds of mortality could not be calculated due to the low overall mortality rate (0.14%). On multivariate analysis, patients who were older, had higher BMI, smoked, or had hypertension were at significantly greater risk for serious morbidity.
Figure 2. Readmission and reoperation rates after laparoscopic gastric bypass (LGB) and laparoscopic sleeve gastrectomy (LSG) based on ACS NSQIP data from 2007 to 201021 and 2010 to 2011 (current study). *Results of ACS NSQIP data from 2007 to 2010 published by Hutter and colleagues.21
DISCUSSION Over the past decade, laparoscopic sleeve gastrectomy has emerged as a commonly used bariatric procedure.6 Laparoscopic sleeve gastrectomy has several advantages over LGB, including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of an intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation.9 Initial literature investigating LSG was restricted to small, single-center studies with limited follow-up of long-term excess body weight loss and comorbidity remission. However, increasingly, more large-scale studies have documented long-term weight loss.5,10-15 Excess body weight loss reported for LSG in several randomized controlled trials has been reported to range from 69% to 76% at 12 months5,16 and 67% to 68% at 36 months.4,11,17 Multiple studies have also reported long-term weight loss outcomes at 5 years, with percent excess body weight loss ranging from 53% to 69%.17-19 Remission rates for type 2 diabetes after LSG typically range between 60% and 80%.3,11,20 With effective weight loss and remission of comorbidities, one of the advantages cited for LSG compared with LGB is a lower risk for reoperation and serious adverse events.10 The aim of this study was to further examine trends and compare postoperative outcomes between LSG and the well-established “gold standard” LGB. Table 4. Risk-Adjusted Outcomes of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Gastric Bypass Risk-adjusted morbidity
Adjusted odds ratio (95% CI)
Laparoscopic gastric bypass vs sleeve gastrectomy (reference) 1.32 (1.11, 1.56)
Naive p value
Adjusted p value
<0.01
<0.01
On multivariate analysis, older patients, patients with higher BMI, smokers, and those on antihypertensive medicines are at higher risk for serious morbidity.
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We found that the rate of LSG use increased from 14.6% in 2010 to 24.8% in 2011, while the rate of LGB decreased from 85.4% to 74.2%. These findings are consistent with increasing trends in use of LSG as reported by data from the University HealthSystem Consortium database.6 The increasing use of LSG is likely due to an improved outcomes and safety profile compared with that of LGB.11,13,21 We found LSG had decreased rates of wound infection, bleeding, sepsis, serious morbidity, 30-day readmission, and 30-day reoperation compared with LGB. These findings are consistent with those of Carlin and colleagues,11 who performed a matched cohort study of 2,949 LSG patients and noted a 30-day postoperative complication rate of 6.3% after LSG, in between that of LGB (10%) and laparoscopic adjustable gastric banding (2.4%). Staple line leaks and bleeding after LSG have been reported to be some of the most serious postoperative complications. Several large published series have reported these 2 complications to occur in 1% to 3% of patients.22-28 These rates are similar to our findings of a 1.5% bleeding rate after LGB and 0.65% bleeding rate after LSG. Postoperative bleeding after LGB has been noted to occur intra-abdominally or intraluminally from staple lines at the gastrojejunostomy, the gastric pouch, the jejunojejunostomy, or the excluded stomach.29 The decreased rate of bleeding we found after LSG is likely due to less overall length of staple lines compared with LGB as well as the absence of 2 stapled anastomoses. Our findings are also consistent with a recent meta-analysis of 10,906 patients that showed significantly lower rates of bleeding after LGB (3.1%) vs LSG (2.0%).30 The ACS NSQIP database does not have a specific code to document anastomotic leak or staple line leaks; however, the rates of intra-abdominal abscess in this study were found to be similar between LGB and LSG (0.63% and 0.69%). Interestingly, rates of sepsis were significantly higher after LGB (0.58%) compared with LSG (0.34%, p < 0.01). This indicates that although the rate of intra-abdominal infection was similar between groups, LGB may result in a greater number of clinically significant staple line leaks. We found extremely low rates of 30-day mortality after both LGB and LSG (0.15% and 0.1%, respectively). These rates were similar to those reported by Hutter and associates,21 who found mortality rates of 0.11% for LSG, 0.05% for gastric banding, and 0.14% for LGB. In his study, a total of 33 deaths occurred within 30 days, which was too few to complete a multivariate analysis of mortality. Although risk-adjusted mortality could not be analyzed, we found significantly lower odds of risk-adjusted 30-day serious morbidity after LSG compared with LGB. This is similar to results of a recent meta-analysis by Zhang and
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coworkers,13 who reported significantly more major complications after LBG compared with LSG (odds ratio 1.98, 95% CI 1.22 to 3.22, p < 0.01). To further analyze trends in reoperation and readmission, we compared the results of our study spanning 2010 to 2011 with those of Hutter and colleagues,21 who used the same database (NSQIP) to examined 28,616 patients undergoing LSG, laparoscopic adjustable gastric banding, and LGB between 2007 and 2010. Figure 2 shows readmission and reoperation rates after LGB and LSG based on NSQIP data reported from 2007 to 2010 and 2010 to 2011. Reoperation rates after gastric bypass and sleeve gastrectomy dramatically decreased, but readmission rates continued to be elevated over time. Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery. One such project is set to start in 2015. The MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) has initiated a national collaborative to reduce 30-day readmissions by 20% and is currently enrolling centers. There are a few limitations to this study. The ACS NSQIP database is limited to 30-day postoperative morbidity and mortality; therefore, any complications or readmissions occurring after this time period are not captured. Also, quality of life and long-term outcomes such as patient satisfaction, weight loss, and comorbidity resolution were not captured or included in the study. Finally, the study population is generated by hospitals using the NSQIP program, and outcomes from this study may not be generalizable to all hospitals across the United States. Despite these limitations, this study provides a large representative sample for evaluating trends and outcomes of patients undergoing LSG and LGB.
CONCLUSIONS The use of laparoscopic sleeve gastrectomy is increasing on a national level. This is likely due to increasing evidence of effective long-term weight loss, significant remission of comorbidities, and very low rates of postoperative morbidity and mortality. In this study, we found laparoscopic sleeve gastrectomy to be associated with lower riskadjusted 30-day serious morbidity and equivalent 30-day mortality compared with laparoscopic gastric bypass. Further randomized controlled trials are needed to evaluate differences in long-term outcomes between these bariatric procedures. Author Contributions Study conception and design: Young, Gebhart, Nguyen Acquisition of data: Young, Phelan
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Analysis and interpretation of data: Young, Gebhart, Phelan, Nguyen Drafting of manuscript: Young, Phelan, Nguyen, Critical revision: Young, Gebhart, Nguyen REFERENCES 1. Hess DS, Hess DW. Biliopancreatic diversion with a duodenal switch. Obes Surg 1998;8:267282. 2. Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 2003; 13:861e864. 3. Committee ACI. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis 2012;8:e2126. 4. Kehagias I, Karamanakos SN, Argentou M, Kalfarentzos F. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the management of patients with BMI < 50 kg/m2. Obes Surg 2011;21: 1650e1656. 5. Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg 2008;247:401e407. 6. Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg 2013;216: 252e257. 7. American College of Surgeons National Surgical Quality Improvement Program. Available at: http://site.acsnsqip.org. Accessed February 24, 2015. 8. Harrell FE. Regression Modeling Strategies : with Applications to Linear Models, Logistic Regression, and Survival Analysis. New York: Springer; 2001. 9. Paluszkiewicz R, Kalinowski P, Wroblewski T, et al. Prospective randomized clinical trial of laparoscopic sleeve gastrectomy versus open Roux-en-Y gastric bypass for the management of patients with morbid obesity. Wideochir Inne Tech Malo Inwazyjne 2012;7:225e232. 10. Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev 2014;8: CD003641. 11. Carlin AM, Zeni TM, English WJ, et al. The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity. Ann Surg 2013;257:791e797. 12. Zhang C, Yuan Y, Qiu C, Zhang W. A meta-analysis of 2-year effect after surgery: laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for morbid obesity and diabetes mellitus. Obes Surg 2014;24:1528e1535. 13. Zhang Y, Ju W, Sun X, et al. Laparoscopic sleeve gastrectomy versus laparoscopic Roux-En-Y gastric bypass for morbid obesity and related comorbidities: a meta-analysis of 21 studies. Obes Surg 2015;25:19e26. 14. Zhang Y, Zhao H, Cao Z, et al. A randomized clinical trial of laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy
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for the treatment of morbid obesity in China: a 5-year outcome. Obes Surg 2014;24:1617e1624. Keidar A, Hershkop KJ, Marko L, et al. Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial. Diabetologia 2013;56: 1914e1918. Lee WJ, Chong K, Ser KH, et al. Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg 2011;146:143e148. Himpens J, Dapri G, Cadiere GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006;16:1450e1456. Bohdjalian A, Langer FB, Shakeri-Leidenmuhler S, et al. Sleeve gastrectomy as sole and definitive bariatric procedure: 5-year results for weight loss and ghrelin. Obes Surg 2010; 20:535e540. Sarela AI, Dexter SP, O’Kane M, et al. Long-term follow-up after laparoscopic sleeve gastrectomy: 8-9-year results. Surg Obes Relat Dis 2012;8:679e684. Abbatini F, Rizzello M, Casella G, et al. Long-term effects of laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding on type 2 diabetes. Surg Endosc 2010;24: 1005e1010. Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg 2011;254:410e420; discussion 420e422. Basso N, Casella G, Rizzello M, et al. Laparoscopic sleeve gastrectomy as first stage or definitive intent in 300 consecutive cases. Surg Endosc 2011;25:444e449. Bellanger DE, Greenway FL. Laparoscopic sleeve gastrectomy, 529 cases without a leak: short-term results and technical considerations. Obes Surg 2011;21:146e150. Gadiot RP, Biter LU, Zengerink HJ, et al. Laparoscopic sleeve gastrectomy with an extensive posterior mobilization: technique and preliminary results. Obes Surg 2012;22:320e329. Menenakos E, Stamou KM, Albanopoulos K, et al. Laparoscopic sleeve gastrectomy performed with intent to treat morbid obesity: a prospective single-center study of 261 patients with a median follow-up of 1 year. Obes Surg 2010; 20:276e282. Rice RD, Simon TE, Seery JM, et al. Laparoscopic sleeve gastrectomy: outcomes at a military training center. Am Surg 2010;76:835e840. Spyropoulos C, Argentou MI, Petsas T, et al. Management of gastrointestinal leaks after surgery for clinically severe obesity. Surg Obes Relat Dis 2012;8:609e615. Rosenthal RJ, Szomstein S, Kennedy CI, et al. Laparoscopic surgery for morbid obesity: 1,001 consecutive bariatric operations performed at The Bariatric Institute, Cleveland Clinic Florida. Obes Surg 2006;16:119e124. Nguyen NT, Rivers R, Wolfe BM. Early gastrointestinal hemorrhage after laparoscopic gastric bypass. Obes Surg 2003;13:62e65. Zellmer JD, Mathiason MA, Kallies KJ, Kothari SN. Is laparoscopic sleeve gastrectomy a lower risk bariatric procedure compared with laparoscopic Roux-en-Y gastric bypass? A meta-analysis. Am J Surg 2014;208:903e910.
MD,
Alana Gebhart,
BA,
Michael J Phelan,
PhD,
Ninh T Nguyen,
MD, FACS
Laparoscopic sleeve gastrectomy is gaining popularity in the United States. However, few studies have examined outcomes of sleeve gastrectomy compared with those of the “gold standard” bariatric operation: Roux-en-Y gastric bypass. STUDY DESIGN: Using the American College of Surgeons National Surgical Quality Improvement Program database, clinical data were obtained for all patients who underwent laparoscopic sleeve gastrectomy or laparoscopic gastric bypass between 2010 and 2011. Main outcomes measures were risk-adjusted 30-day serious morbidity and mortality. RESULTS: We analyzed 24,117 patients who underwent laparoscopic sleeve gastrectomy or laparoscopic gastric bypass for the treatment of morbid obesity. Gastric bypass comprised 79.5% of cases and sleeve gastrectomy comprised 20.5%; the proportion of sleeve gastrectomy cases increased from 14.6% in 2010 to 25.8% in 2011. On univariate analysis, sleeve gastrectomy had a shorter mean operative time (101 vs 133 minutes, p < 0.01), a lower rate of blood loss requiring transfusion (0.6% vs 1.5%, p < 0.01), a lower rate of deep wound infections (0.06% vs 0.20%, p ¼ 0.05), lower serious morbidity rate (3.8% vs 5.8%, p < 0.01), and 30-day reoperation rate (1.6% vs 2.5%, p < 0.01), but a higher rate of deep venous thrombosis (0.47% vs 0.21%, p < 0.01). Compared with sleeve gastrectomy, gastric bypass patients had higher risk-adjusted 30-day serious morbidity (odds ratio [OR] 1.32; 95% CI1.11 to 1.56, p < 0.01). Patients who were older, had higher BMI, smoked, or had hypertension were at significantly greater risk of serious morbidity. The 30-day mortality was similar between groups (0.10% for sleeve vs 0.15% for bypass). CONCLUSIONS: Use of laparoscopic sleeve gastrectomy is increasing on a national level. Compared with laparoscopic gastric bypass, laparoscopic sleeve gastrectomy is associated with lower 30-day riskadjusted serious morbidity and equivalent 30-day mortality. (J Am Coll Surg 2015;220: 880e885. 2015 by the American College of Surgeons)
BACKGROUND:
substantial weight loss after the initial stage, LSG developed into a stand-alone procedure. Weight loss and alteration of comorbidities after LSG appear to be related to biochemical changes from the gastric resection and/or expedited transport of stomach contents into the small bowel.3 In 2012, the American Society for Metabolic and Bariatric Surgery released a position statement recognizing LSG as an acceptable option as a primary bariatric procedure.3 This was based on randomized studies demonstrating equivalent weight loss outcomes and amelioration of comorbidities between LSG and LGB.4,5 Over the past several years LSG appears to be gaining popularity in the United States. A recent study using the University HealthSystem Consortium clinical database found that the use of LSG has increased from 0.9% in 2008 to 36.3% in 2012.6 Although the
Laparoscopic sleeve gastrectomy (LSG) first originated as part of the biliopancreatic diversion with duodenal switch operation.1 In 2003, Regan and colleagues2 described it as the first portion of a 2-stage procedure for super-super obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LGB). When patients were found to have Disclosure Information: Nothing to disclose. Presented at the American College of Surgeons 100th Annual Clinical Congress, San Francisco, CA, October 2014. Received November 30, 2014; Revised January 27, 2015; Accepted January 27, 2015. From the Departments of Surgery (Young, Gebhart, Nguyen) and Statistics (Phelan), University of California, Irvine, Irvine, CA. Correspondence address: Ninh T Nguyen, MD, FACS, Department of Surgery, University of California, Irvine Medical Center, 333 City Blvd West Suite 1600, Orange, CA 92868. email: [email protected]
ª 2015 by the American College of Surgeons Published by Elsevier Inc.
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University HealthSystem Consortium is based on data collected from academic institutions; this finding likely represents a larger national trend. There are few largescale studies examining the outcomes of LSG compared with those of LGB. Therefore, this study aimed to examine national trends and outcomes of LSG vs LGB.
METHODS Database The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database is the first national validated, outcomes-based program designed for the purpose of improving surgical quality of care. It is comprised of more than 500 hospitals, which collect and receive hospital-level data on preoperative risk factors, intraoperative variables, and 30-day morbidity and mortality after inpatient and outpatient surgical procedures. A trained surgical clinical reviewer is used at participating hospitals to standardize data capture and ensure reliability. Additional information about the ACS NSQIP sampling strategy, data abstraction, and program specifics can be found on the ACS NSQIP website.7 Approval for the use of patient level data analyzed in this study was obtained from the Institutional Review Board of the University of California Irvine Medical Center and from the ACS NSQIP. Selection and description of participants The ACS NSQIP database was retrospectively reviewed for all patients undergoing LSG or LGB for the treatment of morbid obesity between 2010 and 2011. Appropriate diagnosis and procedural codes were selected using the International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnosis codes and Current Procedural Terminology (CPT) codes. The principle diagnosis codes used were obesity (278.00) and morbid obesity
Figure 1. Trends in use of laparoscopic gastric bypass and laparoscopic sleeve gastrectomy, 2010 to 2011. Gray, laparoscopic sleeve gastrectomy, black, laparoscopic gastric bypass.
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(287.01). The CPT procedural codes were 43775 for laparoscopic sleeve gastrectomy and 43644 and 43645 for laparoscopic gastric bypass. Patients who underwent emergent procedures were excluded from analysis. Demographics and outcomes variables Analyzed variables included patient demographics (age, sex, and ethnicity), body mass index (BMI), comorbid conditions (diabetes, stroke, COPD, congestive heart failure, myocardial infarction, coronary artery disease, hypertension, peripheral vascular disease, cancer, smoking, and alcohol use) and American Society of Anesthesiologists (ASA) class. The mean number of comorbidities per patient was calculated for each group. Missing descriptive patient data were excluded from analysis. Operative variables included operative time and anesthesia time. Primary outcomes measures included 30-day serious Table 1. Demographics of Patients Undergoing Laparoscopic Gastric Bypass vs Laparoscopic Sleeve Gastrectomy, 2010 to 2011
Variable
Age, y, mean (SD) Age category, % <40 y 40e60 y 61e80 y >80 y Sex, % Male Female Race, % White Asian African American Pacific Islander Unknown BMI, kg/m2, mean (SD) BMI category, % >50 kg/m2 50 kg/m2 ASA Class, % 1-No Disturb 2-Mild Disturb 3-Severe Disturb 4-Life Threat 5-Moribund
Laparoscopic Laparoscopic gastric sleeve bypass gastrectomy (n ¼ 19,172) (n ¼ 4,945) p Value
45 (12)
44 (11)*
<0.01
34.53 55.73 9.73 0.01
34.07 57.86* 8.01* 0.06
0.56 <0.01 <0.01 0.12
20.36 78.72
23.56* 75.67*
<0.01 <0.01
73.87 0.55 13.98 0.44 8.61 46 (8)
70.01* 0.75 20.04* 0.34 7.02* 46 (9)
<0.01 0.12 <0.01 0.63 <0.01 0.99
25.91 73.95
27.1 72.8
0.09 0.11
0.33 32.75 64.45 2.32 0.01
0.34 33.69 63.42 2.41 0
0.98 0.22 0.18 0.92 0.47
*p 0.05, compared with laparoscopic gastric bypass. ASA, American Society of Anesthesiologists.
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Table 2.
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Comorbidities of Patients Undergoing Laparoscopic Gastric Bypass vs Laparoscopic Sleeve Gastrectomy
Variable
Diabetes Stroke COPD Congestive heart failure Myocardial infarction, last 6 mo Coronary artery disease Hypertension Peripheral vascular disease History of cancer Smoking Alcohol, > 2 drinks/d Comorbidity count per patient, mean (SD)
Laparoscopic gastric bypass, % (n ¼ 19,172)
Laparoscopic sleeve gastrectomy, % (n ¼ 4,945)
p Value
30.4 0.73 1.77 0.08 0.04 2.76 54.25 0.23 0.01 11.20 0.16 1.2 (0.4)
24.47* 0.55 1.17* 0.14 0 2.39 52.28* 0.10 0.02 10.17* 0.24 0.9 (0.4)*
<0.01 0.17 <0.01 0.36 0.38 0.16 0.01 0.10 0.58 0.03 0.31 <0.01
*p 0.05, compared with laparoscopic gastric bypass.
morbidity and mortality. Individual complications analyzed included urinary tract infection, wound infection, abscess formation, pneumonia, pulmonary embolism, deep venous thrombosis, acute renal failure, bleeding requiring transfusion, stroke, myocardial infarction, sepsis, and cardiac arrest. Secondary outcomes measures were length of hospital stay, 30-day readmission, and 30-day reoperation. Readmission data were available only for 2011 ACS NSQIP and were defined as readmission to a surgical service within 30 days of the index operation. Statistical analysis Statistical analysis was performed using SAS version 9.3 (SAS) and the R statistical environment.8 Differences in patient characteristics, complications, operative variables, hospital length of stay, 30-day readmission, morbidity, and mortality were analyzed between groups. Binary outcomes were compared using chi-square tests with Yates correction. Two-sample t-tests with unequal variance were used to compare continuous variables. Multivariate logistic regression analysis was performed for 30-day morbidity between patients undergoing LGB and LSG. Independent variables used for risk adjustment included patient demographics, BMI, American Society of Anesthesiologists classification, and individual comorbid conditions. Multivariate analysis was unable to be performed for 30-day mortality due to the small number of deaths within the dataset. Comparisons were considered statistically significant if p < 0.05.
RESULTS A total of 24,117 patients who underwent LGB or LSG for the treatment of morbid obesity were sampled from the ACS NSQIP database between 2010 and 2011.
Between 2010 and 2011, the total number of LGB and LSG cases increased from 11,387 to 12,730 (Fig. 1). Laparoscopic gastric bypass comprised 79.5% and LSG comprised 20.5% of all cases included in the analysis. Comparisons of patient demographics and comorbidities between patients who underwent LGB and LSG are listed in Table 1. Mean age was higher in LGB patients compared with LSG patients (45 vs 44 years old, p < 0.01), and this group also had a higher proportion of women (78.7% vs 75.6%, p < 0.01) and Caucasians (73.9% vs 70.0%, p < 0.01), but a lower proportion of African Americans (13.9% vs 20.0%, p < 0.01). There were no significant differences in mean BMI (46 vs 46 kg/m2) or American Society of Anesthesiologists class distributions between groups (Table 1). Table 2 displays comorbidities of patients undergoing LGB vs LSG. Compared with LSG, patients undergoing LGB had significantly higher rates of diabetes (30.4% vs 24.5%, p < 0.01), COPD (1.8% vs 1.2%, p < 0.01), hypertension (54.3% vs 52.3%, p ¼ 0.01), and smoking (11.2% vs 10.2%, p ¼ 0.03). The mean number of comorbidities per patient was also higher for patients undergoing LGB compared with LSG (1.2 vs 0.9 comorbidities, p < 0.01). Intraoperative and postoperative outcomes are shown in Table 3. Compared with LSG, LGB was found to have significantly longer operative time (133 minutes vs 101 minutes, p < 0.01) and anesthesia time (187 minutes vs 147 minutes, p < 0.01). The majority of individual complication rates were similar between groups, but LGB was associated with higher rates of wound infection (0.2% vs 0.06%, p ¼ 0.05), bleeding requiring transfusion (1.5% vs 0.65%, p < 0.01), and sepsis (0.58% vs 0.34%, p ¼ 0.05). Deep venous thrombosis was the only complication found to be higher after LSG (0.21%
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Table 3. Intraoperative and Postoperative Outcomes of Patients Undergoing Laparoscopic Gastric Bypass vs Laparoscopic Sleeve Gastrectomy, 2010 to 2011
Variable
Operative time, min, mean (SD) Anesthesia time, min, mean (SD) Complications, % Urinary tract infection Wound infection Abscess Pneumonia Pulmonary embolism Deep venous thrombosis Acute renal failure Bleeding requiring transfusion Stroke/CVA Myocardial infarction Sepsis Cardiac arrest Serious morbidity, % Length of stay, d, mean (SD) 30-day readmission, %y 30-day reoperation, % 30-day mortality, %
Laparoscopic Laparoscopic gastric sleeve bypass gastrectomy (n ¼ 19,172) (n ¼ 4,945) p Value
133 (56)
101 (50)*
<0.01
187 (70)
147 (65)*
<0.01
0.91 0.2 0.63 0.5 0.21 0.21 0.11
0.71 0.06* 0.69 0.38 0.18 0.47* 0.14
0.21 0.05 0.73 0.37 0.79 <0.01 0.72
1.5 0.03 0.1 0.58 0.08 5.8
0.65* 0.02 0.06 0.34* 0.04 3.8*
<0.01 0.82 0.53 0.05 0.55 <0.01
2 (6) 6.08 2.46 0.15
2 (11) 4.05* 1.6* 0.1
0.99 <0.01 <0.01 0.58
*p 0.05, compared to laparoscopic gastric bypass. y Based on 2011 data only. CVA, cerebrovascular accident.
vs 0.47%, p < 0.01). Overall postoperative morbidity was significantly higher after LGB compared with LSG (8.76% vs 6.74%, p < 0.01), and was also associated with higher 30-day reoperation rates compared with LSG (2.46% vs 1.6%, p < 0.01). Hospital length of stay was equivalent between groups (2 days). Using the 2011 ACS NSQIP data, 30-day readmission was analyzed and was higher after LGB compared with LSG (6.08% vs 4.05%, p < 0.01). There was no significant difference found in 30-day mortality between groups (0.15% LGB vs 0.1% LSG, p ¼ 0.58). Laparoscopic Roux-en-Y gastric bypass was associated with significantly higher risk-adjusted 30-day serious morbidity compared with LSG (odds ratio [OR] 1.32; 95% CI [1.11, 1.56], p < 0.01) (Table 4). The risk-adjusted odds of mortality could not be calculated due to the low overall mortality rate (0.14%). On multivariate analysis, patients who were older, had higher BMI, smoked, or had hypertension were at significantly greater risk for serious morbidity.
Figure 2. Readmission and reoperation rates after laparoscopic gastric bypass (LGB) and laparoscopic sleeve gastrectomy (LSG) based on ACS NSQIP data from 2007 to 201021 and 2010 to 2011 (current study). *Results of ACS NSQIP data from 2007 to 2010 published by Hutter and colleagues.21
DISCUSSION Over the past decade, laparoscopic sleeve gastrectomy has emerged as a commonly used bariatric procedure.6 Laparoscopic sleeve gastrectomy has several advantages over LGB, including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of an intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation.9 Initial literature investigating LSG was restricted to small, single-center studies with limited follow-up of long-term excess body weight loss and comorbidity remission. However, increasingly, more large-scale studies have documented long-term weight loss.5,10-15 Excess body weight loss reported for LSG in several randomized controlled trials has been reported to range from 69% to 76% at 12 months5,16 and 67% to 68% at 36 months.4,11,17 Multiple studies have also reported long-term weight loss outcomes at 5 years, with percent excess body weight loss ranging from 53% to 69%.17-19 Remission rates for type 2 diabetes after LSG typically range between 60% and 80%.3,11,20 With effective weight loss and remission of comorbidities, one of the advantages cited for LSG compared with LGB is a lower risk for reoperation and serious adverse events.10 The aim of this study was to further examine trends and compare postoperative outcomes between LSG and the well-established “gold standard” LGB. Table 4. Risk-Adjusted Outcomes of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Gastric Bypass Risk-adjusted morbidity
Adjusted odds ratio (95% CI)
Laparoscopic gastric bypass vs sleeve gastrectomy (reference) 1.32 (1.11, 1.56)
Naive p value
Adjusted p value
<0.01
<0.01
On multivariate analysis, older patients, patients with higher BMI, smokers, and those on antihypertensive medicines are at higher risk for serious morbidity.
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We found that the rate of LSG use increased from 14.6% in 2010 to 24.8% in 2011, while the rate of LGB decreased from 85.4% to 74.2%. These findings are consistent with increasing trends in use of LSG as reported by data from the University HealthSystem Consortium database.6 The increasing use of LSG is likely due to an improved outcomes and safety profile compared with that of LGB.11,13,21 We found LSG had decreased rates of wound infection, bleeding, sepsis, serious morbidity, 30-day readmission, and 30-day reoperation compared with LGB. These findings are consistent with those of Carlin and colleagues,11 who performed a matched cohort study of 2,949 LSG patients and noted a 30-day postoperative complication rate of 6.3% after LSG, in between that of LGB (10%) and laparoscopic adjustable gastric banding (2.4%). Staple line leaks and bleeding after LSG have been reported to be some of the most serious postoperative complications. Several large published series have reported these 2 complications to occur in 1% to 3% of patients.22-28 These rates are similar to our findings of a 1.5% bleeding rate after LGB and 0.65% bleeding rate after LSG. Postoperative bleeding after LGB has been noted to occur intra-abdominally or intraluminally from staple lines at the gastrojejunostomy, the gastric pouch, the jejunojejunostomy, or the excluded stomach.29 The decreased rate of bleeding we found after LSG is likely due to less overall length of staple lines compared with LGB as well as the absence of 2 stapled anastomoses. Our findings are also consistent with a recent meta-analysis of 10,906 patients that showed significantly lower rates of bleeding after LGB (3.1%) vs LSG (2.0%).30 The ACS NSQIP database does not have a specific code to document anastomotic leak or staple line leaks; however, the rates of intra-abdominal abscess in this study were found to be similar between LGB and LSG (0.63% and 0.69%). Interestingly, rates of sepsis were significantly higher after LGB (0.58%) compared with LSG (0.34%, p < 0.01). This indicates that although the rate of intra-abdominal infection was similar between groups, LGB may result in a greater number of clinically significant staple line leaks. We found extremely low rates of 30-day mortality after both LGB and LSG (0.15% and 0.1%, respectively). These rates were similar to those reported by Hutter and associates,21 who found mortality rates of 0.11% for LSG, 0.05% for gastric banding, and 0.14% for LGB. In his study, a total of 33 deaths occurred within 30 days, which was too few to complete a multivariate analysis of mortality. Although risk-adjusted mortality could not be analyzed, we found significantly lower odds of risk-adjusted 30-day serious morbidity after LSG compared with LGB. This is similar to results of a recent meta-analysis by Zhang and
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coworkers,13 who reported significantly more major complications after LBG compared with LSG (odds ratio 1.98, 95% CI 1.22 to 3.22, p < 0.01). To further analyze trends in reoperation and readmission, we compared the results of our study spanning 2010 to 2011 with those of Hutter and colleagues,21 who used the same database (NSQIP) to examined 28,616 patients undergoing LSG, laparoscopic adjustable gastric banding, and LGB between 2007 and 2010. Figure 2 shows readmission and reoperation rates after LGB and LSG based on NSQIP data reported from 2007 to 2010 and 2010 to 2011. Reoperation rates after gastric bypass and sleeve gastrectomy dramatically decreased, but readmission rates continued to be elevated over time. Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery. One such project is set to start in 2015. The MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) has initiated a national collaborative to reduce 30-day readmissions by 20% and is currently enrolling centers. There are a few limitations to this study. The ACS NSQIP database is limited to 30-day postoperative morbidity and mortality; therefore, any complications or readmissions occurring after this time period are not captured. Also, quality of life and long-term outcomes such as patient satisfaction, weight loss, and comorbidity resolution were not captured or included in the study. Finally, the study population is generated by hospitals using the NSQIP program, and outcomes from this study may not be generalizable to all hospitals across the United States. Despite these limitations, this study provides a large representative sample for evaluating trends and outcomes of patients undergoing LSG and LGB.
CONCLUSIONS The use of laparoscopic sleeve gastrectomy is increasing on a national level. This is likely due to increasing evidence of effective long-term weight loss, significant remission of comorbidities, and very low rates of postoperative morbidity and mortality. In this study, we found laparoscopic sleeve gastrectomy to be associated with lower riskadjusted 30-day serious morbidity and equivalent 30-day mortality compared with laparoscopic gastric bypass. Further randomized controlled trials are needed to evaluate differences in long-term outcomes between these bariatric procedures. Author Contributions Study conception and design: Young, Gebhart, Nguyen Acquisition of data: Young, Phelan
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Analysis and interpretation of data: Young, Gebhart, Phelan, Nguyen Drafting of manuscript: Young, Phelan, Nguyen, Critical revision: Young, Gebhart, Nguyen REFERENCES 1. Hess DS, Hess DW. Biliopancreatic diversion with a duodenal switch. Obes Surg 1998;8:267282. 2. Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 2003; 13:861e864. 3. Committee ACI. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis 2012;8:e2126. 4. Kehagias I, Karamanakos SN, Argentou M, Kalfarentzos F. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the management of patients with BMI < 50 kg/m2. Obes Surg 2011;21: 1650e1656. 5. Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg 2008;247:401e407. 6. Nguyen NT, Nguyen B, Gebhart A, Hohmann S. Changes in the makeup of bariatric surgery: a national increase in use of laparoscopic sleeve gastrectomy. J Am Coll Surg 2013;216: 252e257. 7. American College of Surgeons National Surgical Quality Improvement Program. Available at: http://site.acsnsqip.org. Accessed February 24, 2015. 8. Harrell FE. Regression Modeling Strategies : with Applications to Linear Models, Logistic Regression, and Survival Analysis. New York: Springer; 2001. 9. Paluszkiewicz R, Kalinowski P, Wroblewski T, et al. Prospective randomized clinical trial of laparoscopic sleeve gastrectomy versus open Roux-en-Y gastric bypass for the management of patients with morbid obesity. Wideochir Inne Tech Malo Inwazyjne 2012;7:225e232. 10. Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev 2014;8: CD003641. 11. Carlin AM, Zeni TM, English WJ, et al. The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity. Ann Surg 2013;257:791e797. 12. Zhang C, Yuan Y, Qiu C, Zhang W. A meta-analysis of 2-year effect after surgery: laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for morbid obesity and diabetes mellitus. Obes Surg 2014;24:1528e1535. 13. Zhang Y, Ju W, Sun X, et al. Laparoscopic sleeve gastrectomy versus laparoscopic Roux-En-Y gastric bypass for morbid obesity and related comorbidities: a meta-analysis of 21 studies. Obes Surg 2015;25:19e26. 14. Zhang Y, Zhao H, Cao Z, et al. A randomized clinical trial of laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy
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