Accepted Manuscript Is Laparoscopic Sleeve Gastrectomy a Lower Risk Bariatric Procedure Compared to Laparoscopic Roux-en-Y Gastric Bypass? A Meta-analysis Jonathan D. Zellmer, MD Michelle A. Mathiason, MS Kara J. Kallies, MS Shanu N. Kothari, MD, FACS PII:

S0002-9610(14)00420-6

DOI:

10.1016/j.amjsurg.2014.08.002

Reference:

AJS 11256

To appear in:

The American Journal of Surgery

Received Date: 26 March 2014 Revised Date:

5 June 2014

Accepted Date: 11 August 2014

Please cite this article as: Zellmer JD, Mathiason MA, Kallies KJ, Kothari SN, Is Laparoscopic Sleeve Gastrectomy a Lower Risk Bariatric Procedure Compared to Laparoscopic Roux-en-Y Gastric Bypass? A Meta-analysis, The American Journal of Surgery (2014), doi: 10.1016/j.amjsurg.2014.08.002. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Is Laparoscopic Sleeve Gastrectomy a Lower Risk Bariatric Procedure Compared to Laparoscopic Roux-en-Y Gastric Bypass?

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A Meta-analysis

Jonathan D. Zellmer MD1; Michelle A. Mathiason, MS2; Kara J. Kallies, MS2; Shanu N.

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Kothari, MD, FACS3

General Surgery Residency, Department of Medical Education and 2Department of Medical

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Research, Gundersen Medical Foundation; 3Department of General and Vascular Surgery, Gundersen Health System La Crosse, WI

Shanu N. Kothari, MD, FACS

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Correspondence to:

Department of General & Vascular Surgery

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Gundersen Health System 1900 South Avenue, C05-001

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La Crosse, Wisconsin 54601 Telephone: (608) 775-5187 FAX: (608) 775-4460

Email: [email protected] There are no conflicts of interest to disclose. Running head: Complications after gastric bypass versus sleeve gastrectomy

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Abstract

Background: Laparoscopic Roux-en-Y gastric bypass (LRYGB) is the current “gold standard”

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bariatric procedure in the US. Laparoscopic sleeve gastrectomy (LSG) has recently become a commonly performed procedure for many reasons, including patients’ perception that LSG has less complexity and invasiveness, and lower risk. Our objective was to review the literature and

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compare the leak rates, morbidity, and mortality for LRYGB versus LSG.

Methods: Publications from 2002-2012 with n ≥25 and postoperative leak rate reported were

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included. Statistical analysis included χ2 according to patient number.

Results: Twenty-eight (10,906 patients) LRYGB and 33 (4,816 patients) LSG articles were evaluated. Leak rates after LRYGB versus LSG were 1.9% (n=206) versus 2.3% (n=110), respectively (P=0.077). Mortality rates were 0.4% (27/7117) for LRYGB and 0.2% (7/3594) for

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LSG (P=0.110). Timing from surgery to leak ranged from 1-12 days for LRYGB versus 1-35 days for LSG.

Conclusion: Leak and mortality rates after LRYGB and LSG were comparable. The appropriate

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procedure should be tailored based on patient factors, comorbidities, patient and surgeon comfort

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level, surgeon experience, and institutional outcomes.

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Summary

Laparoscopic Roux-en-Y gastric bypass (LRYGB) is the current “gold standard” bariatric

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procedure in the US. Laparoscopic sleeve gastrectomy (LSG) has recently become a commonly performed procedure for many reasons; including patients’ perception that LSG has less

complexity and invasiveness, and lower risk. A meta-analysis was completed to compare the

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leak rates, as well as morbidity and mortality for LRYGB versus LSG. Twenty-eight (10,906 patients) LRYGB and 33 (4,816 patients) LSG articles were evaluated, with comparable leak and

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mortality rates. The appropriate bariatric procedure should be tailored based on patient factors,

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comorbidities, patient and surgeon comfort level, surgeon experience, and institutional outcomes.

Key words: bariatric surgery; laparoscopic sleeve gastrectomy; Roux-en-Y gastric bypass;

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bleeding; anastomotic leak; postoperative complications; weight loss; outcomes

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Introduction

Current data is now showing that more than one third of the population in the United

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States is obese, with over half the population being considered overweight. This trend has

continued to rise; currently, 17% (12.5 million) of children and adolescents (2 – 19 years old) are considered obese. In 2008, an estimated 147 billion was spent on obesity-related medical costs.1

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Despite the significant resources spent on obesity and its associated medical conditions, the epidemic continues. In 1991, the National Institute of Health (NIH) Consensus Conference

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Statement stated that “Only surgery has proven effective over the long-term for most patients with clinically severe obesity”.2 Several medical associations have echoed this sentiment (American Medical Association, American Academy of Family Physicians, The National Institute of Diabetes and Digestive and Kidney Diseases). Multiple reports have now shown

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significant improvements in obesity-related co-morbidities after bariatric surgery.3 With this continued epidemic and no other intervention proven as effective, bariatric surgery has become one of the most common surgical procedures performed in the United States.3-6 Laparoscopic

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Roux-en-Y gastric bypass (LRYGB) is the “gold standard” bariatric procedure in the United States, although laparoscopic sleeve gastrectomy (LSG) has recently become a more commonly

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performed procedure for a variety of reasons, including the perceived notion among patients that LSG is associated with less complexity, lower risk, and less invasiveness. LRYGB has traditionally been thought of as both a restrictive and malabsorptive procedure although recent investigations have shown weight loss after LRYGB is related to a complex relationship between the gastrointestinal tract, brain, and specialized gastrointestinal hormones.1 LRYGB involves reconstruction of the normal intestinal anatomy. It was first

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described in 1964 by Dr. Mason, and laparoscopically in 1994 by Dr. Wittgrove, and has since become one of the most common, well-studied procedures for weight loss.7,8 LRYGB involves intestinal reconstruction and two anastomoses. This procedure can be more technically

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demanding and require more experience than other techniques. It has been repeatedly shown to result in sustained weight loss with low associated complication rates. Some advantages are that LRYGB is widely available, and data have illustrated significant improvement and resolution of

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comorbidities with sustained weight loss. Disadvantages and complications include anastomotic leaks, ulcers, stenosis, vitamin malabsorption, internal hernias, and small bowel obstructions.

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Laparoscopic sleeve gastrectomy was first performed in 1999 by Dr. Gagner as the first step in the duodenal switch procedure in the super-obese.9 In this patient population, due to the inherent complexity of the duodenal switch operation, the sleeve gastrectomy (initially a peptic ulcer procedure) was performed with plans for completion of the second stage at a later date. It

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was unexpectedly noted that these patients had excellent weight loss results without completion of the duodenal switch.10 The LSG was then utilized as a standalone procedure for weight loss. Laparoscopic sleeve gastrectomy involves a stapled gastroplasty with preservation of

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normal anatomy but permanent removal of a large portion of the stomach. It has traditionally been thought of as a purely restrictive procedure but, similar to LRYGB, has also recently been

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shown to result in a complex interplay between many gastrointestinal hormones.3 Early studies have shown promising results regarding weight loss and resolution of comorbidities but a wide range of complication rates.4-6,10,11 Advantages of LSG include that it is technically easier, without need to perform an anastomosis, results in less need for supplementation, and there is no risk of marginal ulcers or internal hernias. There are several potential complications and disadvantages associated with LSG, including leaks, fistulas, strictures, increased nausea and

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vomiting, slower progression of diet, worsening of gastroesophageal reflux, irreversibility, and relative lack of long-term data. Laparoscopic sleeve gastrectomy has become an accepted standalone procedure for

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weight loss. Each procedure has its own unique advantages and disadvantages, but LSG is rapidly gaining in popularity among surgeons and patients. The reasons for this are

multifactorial and are not entirely clear, but may include the relative ease of the procedure,

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shorter operative time, decreased popularity of gastric banding, and good outcomes regarding weight loss and comorbidity resolution. One of the reasons for the rise in LSG is the perception

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that LSG is less invasive and involves less risk of leak than LRYGB. Our objective was to review the current surgical literature over the last decade comparing the leak rates as well as

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mortality and weight loss for LRYGB and LSG.

Methods

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A MEDLINE search was performed identifying all published reports from 2000-2012. Our review was limited to the English language, human subjects and adult patients. MEDLINE

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terms utilized for the search were; “laparoscopic sleeve gastrectomy”, “gastrectomy”, “laparoscopy”, “laparosc”, “sleeve”, “gastric bypass”, “Roux-en-Y”, “anastomosis”, “anastomotic leak,” and “leak”. Publications were independently reviewed and included if they reported data for at least 25 patients and postoperative leak rates. Only the most recent publication was included from institutions with multiple publications. Variables included demographic information, length of stay (LOS), operative time, conversion to open,

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complications (specifically focusing on leak rates) and weight loss if disclosed. Statistical analysis included chi square according to patient number. A P value < 0.05 was considered

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significant.

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Results

Our initial search identified 249 articles, of which 84 passed initial screening and 61 met

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our final inclusion criteria (Figure 1). This resulted in 28 LRYGB publications and 33 LSG publications. Nearly 11,000 patients who underwent LRYGB and nearly 5,000 patients who underwent LSG were reviewed. Overall, 67% were female; with 62% female among LSG reports and 70% among LRYGB reports. The mean age was 42 years old, overall, and similar for both

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groups. Mean preoperative body mass index was 46.5 kg/m2 in the LSG group (29/33 articles reported) and 47.9 kg/m2 in the LRYGB group (24/28 articles reported). Operative characteristics were also similar between the two groups, although increased

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operative times and conversions to an open procedure were observed in the LRYGB group (Table 1). Overall, LOS was 3 days and mean operative time was 120 minutes.

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Of the articles reporting weight loss, one year excess weight loss was similar, ranging from 50 – 79% after LRYGB and 38 – 81% after LSG. Only 16 LSG articles and 5 LRYGB articles reported weight loss results. Thirty-day complication rates displayed a small but significant difference in bleeding and stenosis between the two groups. The mortality rates were not significantly different between the two groups with 0.4% and 0.2% after LRYGB and LSG respectively (Figure 2).

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A higher leak rate was noted among patients after LSG at 2.3% vs. 1.9% among patients who underwent LRYGB, though this was not found to be significant. Leak rates varied from 1 – 10% after LSG (Table 2)12-44 and from 0 – 6% after LRYGB (Table 3).45-72 Timing of clinical

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presentation of leaks ranged from 1 to 12 days for LRYGB and 1 to 35 days for LSG.

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Discussion

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Although there is widespread agreement that weight loss surgery is the only currently proven procedure for sustained weight loss and reduction of obesity-related comorbidities, there is still not one generally accepted “best” surgery. LRYGB has been the “gold standard” in the United States with several studies showing low complication rates, excellent long-term weight

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loss and resolution of obesity-related comorbidities.3,4,6 The sleeve consensus conference statement and associated data has recently shown good results regarding complication rates, short-term weight loss. and resolution of obesity-related comorbidities.73,74 With this evolving

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field, a consensus on the best bariatric procedure or general agreement on which procedure is most appropriate for specific bariatric populations has not been reached. This study is the first,

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to our knowledge, to specifically compare leak rates after LSG to those after LRYGB. The objective of this study was to compile this data and compare each procedure regarding leak rates, complications, and weight loss to improve the informed decision making process for the appropriate procedure for each individual patient. The current literature shows a wide range of leak rates for LRYGB and LSG. LRYGB has been shown to result in excess weight loss from 60 – 70% with 75% control of associated

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weight loss comorbidities. Mortality rates have been listed from 0.3 – 1.1% with leak rates between 0 – 5.6%.4,6,75,76 LSG, on the other hand, has less overall information but reported excess weight loss ranges from 33 – 90%, with mortality rates between 0 – 1.6% and proximal

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leak rates between 0 – 18% (mean 1.1 ± 2.2) in the most recent consensus statement.73 A recent review of 4888 patients who underwent LSG by Aurora and colleagues reported an average leak rate of 2.4%, with the majority at the proximal end of the staple line.11

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In the current review both operations (LRYGB, LSG) were also shown to have promising results regarding weight loss, although only a small number of articles that met inclusion criteria

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reported postoperative weight loss. Excess weight loss at one year after LSG was similar to that of LRYGB, with an upper range around 80%. With regard to surgical characteristics, it continues to hold true that operative times are longer with LRYGB as would be expected with a more complex gastrointestinal reconstruction. Complication rates, overall, were not significantly

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different, and there was even a small trend for increased leak risk with LSG. The only significant differences were noted in rates of bleeding and stenosis/stricture. The specific reasons for these differences are not well understood, and cause of mortality was not assessed in this study. The

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LSG leak rates observed ranged from 0 – 10% depending on the facility and surgeons performing the procedure compared to LRYGB as stated above from 0 – 5.6%.4,6,75 This would

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dispute a misconception that LSG is a less risky procedure. The more common proximal leaks are likely related to the long staple line and potential for partial gastric outlet obstruction (stenosis) placing significant stress to the upper edge of the staple line near the gastroesophageal junction, which has been consistently shown to be at highest risk of leak on review. Based on the current LSG data, surgeons have modified their technique, erring away from the angle of His during the final staple parting in an effort to decrease this stress.

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Based on the current review and our own institution’s experience, the choice of operation should be tailored to individual patient characteristics and institutional experience and not based solely on inherent risks (which are similar) of the operations. For example, patients with

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multiple prior lower abdominal operations or the super-obese at an institution with less

experience with LRYGB would benefit from LSG whereas a patient with significant GERD or diabetes at an institution experienced in LRYGB would more likely benefit from LRYGB.

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Further research is needed in this area. The availability of different bariatric procedures allowing surgeons to adapt to each individual patient and institutional resources may ultimately be best

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practice.

Limitations of this review and any meta-analysis include the retrospective nature with no randomization and its dependence on the publications selected and reviewed. Although we carefully reviewed each publication, these risks cannot be completely eliminated. Another

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limitation which is inherent and was considered prior to the review in the planning stages of this review was in comparing LRYGB which was initially introduced in the later 1990s with LSG as a much newer technique and the difference in surgeons experience in each group. As such,

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learning curve associated complications may have affected the LSG literature, but may have been diminished in the LRYGB literature. Including data from a time period near the inception

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of LRYGB was considered but would have led to comparing different periods in surgery. It would also not be as beneficial when using the information to make decisions in clinical practice. Finally, complication rates analysed for each procedure may have been influenced by preoperative co-morbidities present in the study populations of each report. Despite some of these limitations, to our knowledge, this is the first comprehensive review of the literature comparing LRYGB to LSG with a specific focus on leak rates. Comprehensive data collection

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and analysis through the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) may provide risk-adjusted outcomes data that surgeons can use to assist during informed consent discussions and helping prospective patients choose the

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optimal bariatric procedure.

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Conclusion

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Both LRYGB and LSG are effective surgical options for weight loss. The leak rates, mortality and weight loss for each procedure were comparable. The most appropriate weight loss procedure should be tailored based on a comprehensive multidisciplinary discussion between the patient and bariatric team based on patient factors, comorbidities, comfort level of both the

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surgeon and patient, surgeon’s experience and individual institutional results.

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References

1. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States,

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2009–2010. NCHS data brief, no 82. Hyattsville, MD: National Center for Health Statistics. 2012.

2. Gastrointestinal surgery for severe obesity: National Institutes of Health Consensus

SC

Development Conference Statement. Am J Clin Nutr. 1992;55:615S-619S.

Mol Aspects Med. 2013;34:84-94.

M AN U

3. Stefater MA, Kohli R, Inge TH. Advances in the surgical treatment of morbid obesity.

4. Dumon KR, Murayama KM. Bariatric surgery outcomes. Surg Clin North Am. 2011;91:1313-1338.

5. Al Harakeh AB. Complications of laparoscopic Roux-en-Y gastric bypass. Surg Clin

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North Am. 2011;91:1225-1237.

6. Gilbert EW, Wolfe BM. Bariatric surgery for the management of obesity: state of the field. Plast Reconstr Surg. 2012;130:948-954.

EP

7. Mason EE, Ito C. Gastric bypass in obesity. Surg Clin North Am. 1967;47:1345-1351. 8. Wittgrove AC, Clark GW, Tremblay LS. Laparoscopic gastric bypass Roux-en-Y:

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preliminary report of five cases. Obes Surg. 1994;4:353-357. 9. Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000;10:514523.

10. Brethauer SA. Sleeve gastrectomy. Surg Clin North Am. 2011;91:1265-1279.

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11. Aurora AR, Khaitan L, Saber AA. Sleeve gastrectomy and the risk of leak: a systematic analysis of 4,888 patients. Surg Endosc. 2012;26:1509-1515. 12. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial

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weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc. 2006;20:859-863.

13. Weiner RA, Weiner S, Pomhoff I, et al. Laparoscopic sleeve gastrectomy--influence of

SC

sleeve size and resected gastric volume. Obes Surg. 2007;17:1297-1305.

14. Givon-Madhala O, Spector R, Wasserberg N, et al. Technical aspects of laparoscopic

M AN U

sleeve gastrectomy in 25 morbidly obese patients. Obes Surg. 2007;17:722-727. 15. Rubin M, Yehoshua RT, Stein M, et al. Laparoscopic sleeve gastrectomy with minimal morbidity. Early results in 120 morbidly obese patients. Obes Surg. 2008;18:1567-1570. 16. Mui WL, Ng EK, Tsung BY, et al. Laparoscopic sleeve gastrectomy in ethnic obese

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Chinese. Obes Surg. 2008;18:1571-1574.

17. Kasalicky M, Michalsky D, Housova J, et al. Laparoscopic sleeve gastrectomy without an over-sewing of the staple line. Obes Surg. 2008;18:1257-1262.

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18. Felberbauer FX, Langer F, Shakeri-Manesch S, et al. Laparoscopic sleeve gastrectomy as an isolated bariatric procedure: intermediate-term results from a large series in three

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Austrian centers. Obes Surg. 2008;18:814-818. 19. Tagaya N, Kasama K, Kikkawa R, et al. Experience with laparoscopic sleeve gastrectomy for morbid versus super morbid obesity. Obes Surg. 2009;19:1371-1376. 20. Casella G, Soricelli E, Rizzello M, et al. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg. 2009;19:821-826.

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21. Goitein D, Goitein O, Feigin A, et al. Sleeve gastrectomy: radiologic patterns after surgery. Surg Endosc. 2009;23:1559-1563. 22. Arias E, Martínez PR, Ka Ming Li V, et al. Mid-term follow-up after sleeve gastrectomy

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as a final approach for morbid obesity. Obes Surg. 2009;19:544-548.

23. Frezza EE, Reddy S, Gee LL, Wachtel MS. Complications after sleeve gastrectomy for morbid obesity. Obes Surg. 2009;19:684-687.

Laparosc Endosc Percutan Tech. 2010;20:351-356.

SC

24. Lacy A, Ibarzabal A, Pando E, et al. Revisional surgery after sleeve gastrectomy. Surg

M AN U

25. Ser KH, Lee WJ, Lee YC, et al. Experience in laparoscopic sleeve gastrectomy for morbidly obese Taiwanese: staple-line reinforcement is important for preventing leakage. Surg Endosc. 2010;24:2253-2259.

26. Rice RD, Simon TE, Seery JM, et al. Laparoscopic sleeve gastrectomy: outcomes at a

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military training center. Am Surg. 2010;76:835-840.

27. Csendes A, Braghetto I, León P, Burgos AM. Management of leaks after laparoscopic sleeve gastrectomy in patients with obesity. J Gastrointest Surg. 2010;14:1343-1348.

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28. Nienhuijs SW, de Zoete JP, Berende CA, et al. Evaluation of laparoscopic sleeve gastrectomy on weight loss and co-morbidity. Int J Surg. 2010;8:302-304.

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29. Jacobs M, Bisland W, Gomez E, et al. Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. Surg Endosc. 2010;24:781-785. 30. Dapri G, Cadière GB, Himpens J. Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing three different techniques. Obes Surg. 2010;20:462-467.

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31. Sammour T, Hill AG, Singh P, et al. Laparoscopic sleeve gastrectomy as a single-stage bariatric procedure. Obes Surg. 2010;20:271-275. 32. Armstrong J, O'Malley SP. Outcomes of sleeve gastrectomy for morbid obesity: a safe

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and effective procedure? Int J Surg. 2010;8:69-71.

33. Gluck B, Movitz B, Jansma S, et al. Laparoscopic sleeve gastrectomy is a safe and

effective bariatric procedure for the lower BMI (35.0-43.0 kg/m2) population. Obes Surg.

SC

2011;21:1168-1171.

34. Alley JB, Fenton SJ, Harnisch MC, et al. Integrated bioabsorbable tissue reinforcement in

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laparoscopic sleeve gastrectomy. Obes Surg. 2011;21:1311-1315.

35. Simon TE, Scott JA, Brockmeyer JR, et al. Comparison of staple-line leakage and hemorrhage in patients undergoing laparoscopic sleeve gastrectomy with or without Seamguard. Am Surg. 2011;77:1665-1668.

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36. Gagnière J, Slim K, Launay-Savary MV, et al. Previous gastric banding increases morbidity and gastric leaks after laparoscopic sleeve gastrectomy for obesity. J Visc Surg. 2011;148:e205-e209.

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37. Stamou KM, Menenakos E, Dardamanis D, et al. Prospective comparative study of the efficacy of staple-line reinforcement in laparoscopic sleeve gastrectomy. Surg Endosc.

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2011;25:3526-3530.

38. Musella M, Milone M, Bellini M, et al. Laparoscopic sleeve gastrectomy. Do we need to oversew the staple line? Ann Ital Chir. 2011;82:273-277. 39. Angrisani L, Cutolo PP, Buchwald JN, et al. Laparoscopic reinforced sleeve gastrectomy: early results and complications. Obes Surg. 2011;21:783-793.

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ACCEPTED MANUSCRIPT

40. Albanopoulos K, Alevizos L, Linardoutsos D, et al. Routine abdominal drains after laparoscopic sleeve gastrectomy: a retrospective review of 353 patients. Obes Surg. 2011;21:687-691.

gastrectomy experience. Can J Surg. 2011;54:138-143.

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41. Behrens C, Tang BQ, Amson BJ. Early results of a Canadian laparoscopic sleeve

42. Triantafyllidis G, Lazoura O, Sioka E, et al. Anatomy and complications following

SC

laparoscopic sleeve gastrectomy: radiological evaluation and imaging pitfalls. Obes Surg. 2011;21:473-478.

M AN U

43. Bellanger DE, Greenway FL. Laparoscopic sleeve gastrectomy, 529 cases without a leak: short-term results and technical considerations. Obes Surg. 2011;21:146-150. 44. Daskalakis M, Berdan Y, Theodoridou S, et al. Impact of surgeon experience and buttress material on postoperative complications after laparoscopic sleeve gastrectomy. Surg

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Endosc. 2011;25:88-97.

45. Oliak D, Ballantyne GH, Davies RJ, et al. Short-term results of laparoscopic gastric bypass in patients with BMI > or = 60. Obes Surg. 2002;12:643-7.

EP

46. Blachar A, Federle MP, Pealer KM, et al. Gastrointestinal complications of laparoscopic Roux-en-Y gastric bypass surgery: clinical and imaging findings. Radiology.

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2002;223:625-632.

47. Champion JK, Williams MD. Prospective randomized comparison of linear staplers during laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2003;13:855-859. 48. Olbers T, Lönroth H, Fagevik-Olsén M, Lundell L. Laparoscopic gastric bypass: development of technique, respiratory function, and long-term outcome. Obes Surg. 2003;13:364-370.

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ACCEPTED MANUSCRIPT

49. Shope TR, Cooney RN, McLeod J, et al. Early results after laparoscopic gastric bypass: EEA vs GIA stapled gastrojejunal anastomosis. Obes Surg. 2003;13:355-359. 50. Kligman MD, Thomas C, Saxe J. Effect of the learning curve on the early outcomes of

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laparoscopic Roux-en-Y gastric bypass. Am Surg. 2003;69:304-309.

51. Papasavas PK, Caushaj PF, McCormick JT, et al. Laparoscopic management of

Endosc. 2003;17:610-614.

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complications following laparoscopic Roux-en-Y gastric bypass for morbid obesity. Surg

52. Suter M, Giusti V, Héraief E, et al. Laparoscopic Roux-en-Y gastric bypass: initial 2-year

M AN U

experience. Surg Endosc. 2003;17:603-609.

53. Artuso D, Wayne M, Kaul A, et al. Extremely high body mass index is not a contraindication to laparoscopic gastric bypass. Obes Surg. 2004;14:750-754. 54. Gould JC, Garren MJ, Starling JR. Lessons learned from the first 100 cases in a new

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minimally invasive bariatric surgery program. Obes Surg. 2004;14:618-625. 55. Dresel A, Kuhn JA, McCarty TM. Laparoscopic Roux-en-Y gastric bypass in morbidly obese and super morbidly obese patients. Am J Surg. 2004;187:230-232.

EP

56. Luján JA, Frutos MD, Hernández Q, et al. Experience with the circular stapler for the gastrojejunostomy in laparoscopic gastric bypass (350 cases). Obes Surg. 2005;15:1096-

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1102.

57. Lublin M, Lyass S, Lahmann B, et al. Leveling the learning curve for laparoscopic bariatric surgery. Surg Endosc. 2005;19:845-848. 58. Ballesta-López C, Poves I, Cabrera M, et al. Learning curve for laparoscopic Roux-en-Y gastric bypass with totally hand-sewn anastomosis: analysis of first 600 consecutive patients. Surg Endosc. 2005;19:519-524.

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ACCEPTED MANUSCRIPT

59. Kothari SN, Boyd WC, Larson CA, et al. Training of a minimally invasive bariatric surgeon: are laparoscopic fellowships the answer? Obes Surg. 2005;15:323-329. 60. Leifsson BG, Gislason HG. Laparoscopic Roux-en-Y gastric bypass with 2-metre long

patients. Obes Surg. 2005;15:35-42.

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biliopancreatic limb for morbid obesity: technique and experience with the first 150

61. Gonzalez R, Haines K, Gallagher SF, Murr MM. Does experience preclude leaks in

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laparoscopic gastric bypass? Surg Endosc. 2006;20:1687-1692.

62. Szomstein S, Whipple OC, Zundel N, Cal P, Rosenthal R. Laparoscopic Roux-en-Y

M AN U

gastric bypass with linear cutter technique: comparison of four-row versus six-row cartridge in creation of anastomosis. Surg Obes Relat Dis. 2006;2:431-434. 63. Suggs WJ, Kouli W, Lupovici M, et al. Complications at gastrojejunostomy after laparoscopic Roux-en-Y gastric bypass: comparison between 21- and 25-mm circular

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staplers. Surg Obes Relat Dis. 2007;3:508-514.

64. Kligman MD. Intraoperative endoscopic pneumatic testing for gastrojejunal anastomotic integrity during laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2007;21:1403-

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1405.

65. Breaux JA, Kennedy CI, Richardson WS. Advanced laparoscopic skills decrease the

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learning curve for laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2007;21:985988.

66. Lee S, Carmody B, Wolfe L, et al. Effect of location and speed of diagnosis on anastomotic leak outcomes in 3828 gastric bypass cases. J Gastrointest Surg. 2007;11:708-713.

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67. Raman R, Raman B, Raman P, et al. Abnormal findings on routine upper GI series following laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2007;17:311-316. 68. Sekhar N, Torquati A, Youssef Y, et al. A comparison of 399 open and 568 laparoscopic

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gastric bypasses performed during a 4-year period. Surg Endosc. 2007;21:665-668. 69. Madan AK, Stoecklein HH, Ternovits CA, et al. Predictive value of upper gastrointestinal studies versus clinical signs for gastrointestinal leaks after laparoscopic gastric bypass.

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Surg Endosc. 2007;21:194-196.

70. Shikora SA, Kim JJ, Tarnoff ME. Comparison of permanent and nonpermanent staple

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line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2008;4:729-734.

71. Jensen C, Tejirian T, Lewis C, et al. Postoperative CPAP and BiPAP use can be safely omitted after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2008;4:512-

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514.

72. Efthimiou E, Al-Sabah S, Sampalis JS, Christou NV. Fibrin sealant associated with increased body temperature and leukocytosis after laparoscopic gastric bypass. Surg Obes

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Relat Dis. 2010;6:46-49.

73. Gagner M, Deitel M, Erickson AL, Crosby RD. Survey on laparoscopic sleeve

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gastrectomy (LSG) at the Fourth International Consensus Summit on Sleeve Gastrectomy. Obes Surg. 2013;23:2013-2017. 74. ASMBS Clinical Issues Committee. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012;8:e21-e26. 75. Podnos YD, Jimenez JC, Wilson SE, et al. Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg. 2003;138:957-961.

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Figure Legend

Figure 1. Publication inclusion.

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EP

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Figure 2. 30-day morbidity and mortality.

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Table 1. Perioperative characteristics.

Overall

LRYGB

3.0

2.8

120.1

136.0

74 / 5703 (1.3)

62 / 4026 (1.5)

Length of stay, days Operative time, minutes

3.3

90.2

12 / 1677 (0.7)

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Conversion to open*, n (%)

LSG

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Variable

*P = 0.012 for LRYGB vs. LSG. LRYGB = laparoscopic Roux-en-Y gastric bypass; LSG =

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laparoscopic sleeve gastrectomy.

1

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Table 2. Leak and mortality rates after laparoscopic sleeve gastrectomy.

Author

Publication Year

N

Leak rate

Mortality rate

2006

126

2 (1.6)

Weiner et al13

2007

120

3 (2.5)

Givon-Madhala et al14

2007

25

0

Rubin et al15

2008

120

Mui et al16

2008

70

Kasalicky et al17

2008

Felberbauer et al18

2008

Tagaya et al19

2009

Casella et al20

2009

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Cottam et al12

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n (%) 0 0

0

0

1 (1.4)

0

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0

0

NR

126

3 (2.4)

NR

30

1 (3.3)

0

200

6 (3.0)

0

2009

55

0

0

2009

130

1 (0.8)

0

2009

53

2 (3.8)

0

2010

294

11 (3.7)

NR

2010

118

4 (3.4)

0

Rice et al26

2010

115

4 (3.5)

1 (0.9)

Csendes et al27

2010

343

16 (4.7)

0

Nienhuijs et al28

2010

74

4 (5.4)

0

Jacobs et al29

2010

247

2 (0.8)

0

Dapri et al30

2010

75

4 (5.3)

NR

Sammour et al31

2010

100

3 (3.0)

0

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61

Goitein et al21 Arias et al22

Lacy et al24

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Ser Kong-Han et al25

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Frezza et al23

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2010

185

0

0

Gluck et al33

2011

204

0

NR

Alley et al34

2011

85

0

NR

Simon et al35

2011

139

5 (3.6)

1 (0.7)

Gagniere et al36

2011

102

2 (2.0)

Stamou et al37

2011

187

6 (3.2)

Musella et al38

2011

80

3 (3.8)

Angrisani et al39

2011

121

Albanopoulos et al40

2011

Behrens et al41

2011

Triantafyllidis et al42

2011

Bellanger et al43

2011

Daskalakis et al44

2011

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NR

1 (0.5) NR

1 (0.8)

NR

353

12 (3.4)

(1)

34

1 (2.9)

0

85

3 (3.5)

0

529

0

0

230

10 (4.3)

0

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Armstrong et al32

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Table 3. Leak and mortality rates after laparoscopic Roux-en-Y gastric bypass.

Author

Publication Year

N

Leak rate

Mortality rate

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n (%) 2002

300

4 (1.3)

3 (1.0)

Blachar et al46

2002

463

16 (3.5)

0

Champion et al47

2003

100

1 (1.0)

NR

Olbers et al48

2003

150

Shope et al49

2003

61

Kligman et al50

2003

Papasavas et al51

2003

Suter et al52

2003

Artuso et al53

2004

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Oliak et al45

1 (0.7)

2 (3.3)

NR

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5 (3.3)

2 (0.8)

NR

246

4 (1.6)

3 (1.2)

107

6 (5.6)

1 (0.9)

82

1 (1.2)

1 (1.2)

2004

100

3 (3.0)

NR

2004

120

0

NR

2005

350

3 (0.9)

0

2005

100

1 (1.0)

NR

2005

600

23 (3.8)

7 (1.2)

Kothari et al59

2005

175

1 (0.6)

0

Leifsson et al60

2005

150

5 (3.3)

0

Gonzalez et al61

2006

200

9 (4.5)

NR

Szomstein et al62

2006

1240

16 (1.3)

NR

Suggs et al63

2007

438

5 (1.1)

0

Kligman et al64

2007

257

2 (0.8)

NR

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160

Gould et al54 Dresel et al55

Lublin et al57

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Ballesta-Lopez et al58

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Lujan et al56

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2007

107

0

0

Lee et al66

2007

1080

57 (5.3)

0

Raman et al67

2007

487

6 (1.2)

0

Sekhar et al68

2007

568

2

0

Madan et al69

2007

245

8 (3.3)

2 (0.8)

Shikora et al70

2008

1451

4 (0.3)

NR

Jensen et al71

2008

1095

0

0

Efthimou et al72

2010

474

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RI PT

Breaux et al65

0

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Figure 1. Publication inclusion.

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249 Abstracts identified

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84 Met initial screening criteria and the full text was reviewed

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165 Excluded after review of abstract

61 Met inclusion criteria after review of full text

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23 Excluded after review of full text

28 (10,906 patients) Reports of LRYGB met final inclusion criteria

LRYGB = laparoscopic Roux-en-Y gastric bypass; LSG = laparoscopic sleeve gastrectomy.

33 (4,816 patients) Reports of LSG met final inclusion criteria

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Figure 2. 30-day complication rates.

LRYGB

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5% LSG

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4%

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110 / 4816

0% Leak Overall N

316 / 15,722 P = 0.077

188 / 5994

74 / 3637

EP

1%

206 / 10,906

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2%

Bleed

14 / 1889

183 / 5412

56 / 1275

62 / 1794

28 / 2137

27 / 7117

5 / 795 Stomal stenosis / stricture

Re-operation

Mortality

262 / 9631

19 / 2871

211 / 7569

118 / 3069

34 / 10,711

P = 0.001

P = 0.468

P = 0.001

P = 0.184

P = 0.110

LRYGB = laparoscopic Roux-en-Y gastric bypass; LSG = laparoscopic sleeve gastrectomy; DVT = deep vein thrombosis; PE = pulmonary embolism.

7/ 3594

DVT/PE

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Patients, %

3%

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DISCUSSION

DISCUSSANT:

DR. MEGAN GILMORE (Mankato, MN):

You clearly did a

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very thorough search of the current literature on the sleeve gastrectomies and the gastric bypasses and their safety.

The

timing of this study is optimal, as we are seeing patients

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coming in not only asking questions about the efficacy but also

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the safety of the procedures that we offer to them.

My first question is about the sleeve.

At a recent meeting, an

experienced surgeon was talking about postoperative leaks after sleeve gastrectomies.

He said that when you first start doing

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sleeves, you think to yourself, “This is great, it's quick and easy, patients do well, and then you have a leak.

You get the

patient through it with great difficulty, and then you have your Then you say to yourself, well, you know, that

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second leak.

gastric bypass isn't looking so bad.”

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In your papers that you reviewed, did you see anything regarding the outcome after the leak with the sleeve versus a gastric bypass?

DR. JONATHAN ZELLMER:

Yes, when looking through the papers,

there were reports of leaks in both groups.

They discussed each

of the individual patients with a leak and the hospital course

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to follow.

The only information or data we have currently is

regarding the timing to leak, which was much wider of a range, in the sleeve gastrectomy group being up to 35 days to diagnosis In

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the leak, with gastric bypass being much less of a range.

the gastric bypass group, the leaks were usually more sudden. Patients were usually more hemodynamically unstable, that were

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delt with more often operatively and leaks healed more quickly. With the sleeve gastrectomy group, they discussed very

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complicated courses with multiple different options to deal with this complicated problem of leak and it did usually drag out longer.

Sometimes they were talking about placing stents, which

can migrate, or drains and TPN, or other nutritional

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supplements, until they can get the leak to heal.

DR. MEGAN GILMORE (Mankato, MN):

Second, as we know, the safest It has been shown to be

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of all these procedures is the band.

safer than both the gastric bypass and the sleeve.

However,

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long term, we know that the band has been fraught with complications.

My question is, should we be choosing these

procedures based on safety alone?

Do you think there's a chance

that without the long-term data that we are lacking with the sleeve, that we could find ourselves in a similar situation with the sleeve as we currently are in with the band?

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DR. JONATHAN ZELLMER:

That is a possibility.

There is more and

more data coming out regarding the sleeve gastrectomy, with the recent consensus statement and multiple articles talking about

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it, along with the bariatric NSQIP data that hopefully will be coming out down the road that will help us with this. this point, the data is very encouraging.

But at

Complication rates

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along with comorbidities and weight loss have been shown to be comparable to the gastric bypass. But that's a possibility down

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the road.

DR. DEAN MIKAMI (Columbus, OH):

I think that your conclusion is

when you do informed consent, you have to tell your patients the I

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risk factors versus a Roux-en-Y and a sleeve gastrectomy.

think the most important part of your entire presentation is about the complication of a leak after a sleeve gastrectomy.

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Leaks after Roux-en-Y gastric bypass and sleeve gastrectomy are two different animals.

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The sleeve gastrectomy leak is going to be the worst leak you ever have in your entire life to try to take care of.

At Ohio

State, that's half my practice now is taking care of leaks around our area.

They can leak for six months to five years

after surgery and continue to leak, whereas a Roux-en-Y gastric bypass usually leaks within the first month and they heal within probably a month or so.

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Is there any consideration in your practice on how you describe leaks and how the leaks are taken care of after surgery?

At our institution, in selecting patients

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DR. JONATHAN ZELLMER:

and the specific procedure, we start, like a lot of other institutions, with an informational session.

Then they meet

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with our PA, who discusses both of the procedures and the risk factors, along with each individual procedure in detail.

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they will meet with our bariatric surgeons.

Lastly

Between the

bariatric surgery team and the patient, we try to decide on the best procedure for each patient.

But it's definitely something

that we try to stress, that both procedures do have significant

different.

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potential complications and the complications are a little But we try to stress that fact to the patient.

I think it's a very timely

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DR. DMITRY OLEYNIKOV (Omaha, NE):

thing to do, to look at all these different operative outcomes

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in bariatric surgery and try to quantify these things. Unfortunately, there are two problems that you will face. is that there is publication bias. best results will be reported.

One

That is to say, only the

I guarantee you if you were able

to get your hands on the Wisconsin outcomes database and look specifically at the outcomes, those leak rates would go significantly higher, and surgeon experience will play a big

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role into the amount of leaks per procedure. difficult.

So it's a little

The best you can do is say, well, in our center,

this is what our numbers are.

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The second thing that I think is going to be foisted upon us come soon is that nobody is going to care about leak rates. What they are going to look at is total cost.

You didn't

much greater role.

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address it, and I understand why, but cost is going to play a So I think next time you're consenting your

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patients, they may be asking you, well, what's the total cost, because their insurance companies, if they are approved, are going to say, we only approve for so much money.

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things to think about.

Just two

DR. JONATHAN ZELLMER:

We did after obtaining our data attempt

to look at cost a briefly.

I didn't get a chance to put it in

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my presentation due to our limited time but at Gundersen Health System it was about a 1,000 dollar difference between the two,

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about 9,000 for sleeve, and 10,000 for gastric bypass. agree, it's tough to look at other data and know.

But I

Is laparoscopic sleeve gastrectomy a lower risk bariatric procedure compared with laparoscopic Roux-en-Y gastric bypass? A meta-analysis.

Laparoscopic Roux-en-Y gastric bypass (LRYGB) is the current "gold standard" bariatric procedure in the United States. Laparoscopic sleeve gastrectomy...
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