124 results on '"Shikora SA"'
Search Results
2. Nutrition and gastrointestinal complications of bariatric surgery.
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Shikora SA, Kim JJ, and Tarnoff ME
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- 2007
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3. Morbid obesity is an independent determinant of death among surgical critically ill patients.
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Nasraway SA Jr., Albert M, Donnelly AM, Ruthazer R, Shikora SA, and Saltzman E
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- 2006
4. Pregnancy after gastric bypass surgery and internal hernia formation.
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Kakarla N, Dailey C, Marino T, Shikora SA, and Chelmow D
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- 2005
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5. Incidence of arrhythmia with central venous catheter insertion and exchange
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Stuart, RK, primary, Shikora, SA, additional, Akerman, P, additional, Lowell, JA, additional, Baxter, JK, additional, Apovian, C, additional, Champagne, C, additional, Jennings, A, additional, Keane-Ellison, M, additional, and Bistrian, BR, additional
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- 1990
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6. Long-term outcomes and complications of obesity surgery: an overview.
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Furtado MM, Shikora SA, and Saltzman E
- Published
- 2004
7. Surgical treatment for extreme obesity: evolution of a rapidly growing field.
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Kim JJ, Tarnoff ME, and Shikora SA
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- 2003
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8. Techniques and procedures. Surgical treatment for severe obesity: the state-of-the-art for the new millennium.
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Shikora SA
- Published
- 2000
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9. The thermodilution technique for measuring resting energy expenditure does not agree with indirect calorimetry for the critically ill patient.
- Author
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Ogawa AM, Shikora SA, Burke LM, Heetderks-Cox JE, Bergren CT, Muskat PC, Ogawa, A M, Shikora, S A, Burke, L M, Heetderks-Cox, J E, Bergren, C T, and Muskat, P C
- Published
- 1998
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10. Multidisciplinary approach to the bariatric surgery patient.
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Saltzman E and Shikora SA
- Published
- 2004
11. Compilation of recommendations from summit on increasing physician nutrition experts.
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McClave SA, Mechanick JI, Kushner RF, DeLegge MH, Apovian CM, Brill JV, Friedman G, Heimburger DC, Jaksic T, Martindale RG, Moore FA, and Shikora SA
- Published
- 2010
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12. Surgical approaches to weight loss.
- Author
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Kim JJ, Tarnoff ME, and Shikora SA
- Published
- 2004
13. Metabolic and Bariatric Surgeon Criteria-An International Experts' Consensus.
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Kermansaravi M, Chiappetta S, Shikora SA, Musella M, Kow L, Aarts E, Abbas SI, Aly A, Aminian A, Angrisani L, Asghar ST, Bashir A, Behrens E, Billy H, Boza C, Brown WA, Caina DO, Carbajo MA, Chevallier JM, Clapp B, Cohen RV, Jazi AHD, De Luca M, Dilemans B, Fried M, Gagner M, Neto MG, Garneau PY, Gawdat K, Ghanem OM, Al Hadad M, Haddad A, ElFawal MH, Herrera MF, Higa K, Himpens J, Husain F, Kasama K, Kassir R, Khoursheed M, Khwaja H, Kristinsson JA, Kroh M, Kurian MS, Lakdawala M, LaMasters T, Lee WJ, Madhok B, Mahawar K, Mahdy T, Almomani H, Melissas J, Miller K, Neimark A, Omarov T, Palermo M, Papasavas PK, Parmar C, Pazouki A, Peterli R, Pintar T, Poggi L, Ponce J, Prasad A, Pratt JSA, Ramos AC, Rezvani M, Rheinwalt K, Ribeiro R, Ruiz-Ucar E, Sabry K, Safadi B, Shabbir A, ShahabiShahmiri S, Stenberg E, Suter M, Taha S, Taskin HE, Torres A, Verboonen S, Vilallonga R, Voon K, Wafa A, Wang C, Weiner R, Yang W, Zundel N, Prager G, and Nimeri A
- Subjects
- Humans, Surgeons standards, Surgeons education, Fellowships and Scholarships standards, Clinical Competence standards, Obesity, Morbid surgery, Female, Male, Learning Curve, Bariatric Surgery standards, Bariatric Surgery education, Consensus, Delphi Technique
- Abstract
Purpose: With the global epidemic of obesity, the importance of metabolic and bariatric surgery (MBS) is greater than ever before. Performing these surgeries requires academic training and the completion of a dedicated fellowship training program. This study aimed to develop guidelines based on expert consensus using a modified Delphi method to create the criteria for metabolic and bariatric surgeons that must be mastered before obtaining privileges to perform MBS., Methods: Eighty-nine recognized MBS surgeons from 42 countries participated in the Modified Delphi consensus to vote on 30 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus., Results: Consensus was reached on 29 out of 30 statements. Most experts agreed that before getting privileges to perform MBS, surgeons must hold a general surgery degree and complete or have completed a dedicated fellowship training program. The experts agreed that the learning curves for the various operative procedures are approximately 25-50 operations for the LSG, 50-75 for the OAGB, and 75-100 for the RYGB. 93.1% of experts agreed that MBS surgeons should diligently record patients' data in their National or Global database., Conclusion: MBS surgeons should have a degree in general surgery and have been enrolled in a dedicated fellowship training program with a structured curriculum. The learning curve of MBS procedures is procedure dependent. MBS surgeons must demonstrate proficiency in managing postoperative complications, collaborate within a multidisciplinary team, commit to a minimum 2-year patient follow-up, and actively engage in national and international MBS societies., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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14. Revision/Conversion Surgeries After One Anastomosis Gastric Bypass-An Experts' Modified Delphi Consensus.
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Kermansaravi M, Chiappetta S, Parmar C, Carbajo MA, Musella M, Chevallier JM, Ribeiro R, Ramos AC, Weiner R, Nimeri A, Aarts E, Abbas SI, Bashir A, Behrens E, Billy H, Cohen RV, Caina D, De Luca M, Dillemans B, Fobi MAL, Neto MG, Gawdat K, ElFawal MH, Kasama K, Kassir R, Khan A, Kow L, Kular KDS, Lakdawala M, Layani L, Lee WJ, Luque-de-León E, Mahawar K, Almomani H, Miller K, González JCO, Prasad A, Rheinwalt K, Rutledge R, Safadi B, Salminen P, Shabbir A, Taskin HE, Verboonen JS, Vilallonga R, Wang C, Shikora SA, and Prager G
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- Humans, Weight Loss, Female, Postoperative Complications etiology, Male, Weight Gain, Gastric Bypass adverse effects, Delphi Technique, Reoperation, Obesity, Morbid surgery, Consensus
- Abstract
Purpose: There is a lack of evidence for treatment of some conditions including complication management, suboptimal initial weight loss, recurrent weight gain, or worsening of a significant obesity complication after one anastomosis gastric bypass (OAGB). This study was designed to respond to the existing lack of agreement and to provide a valuable resource for clinicians by employing an expert-modified Delphi consensus method., Methods: Forty-eight recognized bariatric surgeons from 28 countries participated in the modified Delphi consensus to vote on 64 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus., Results: A consensus was achieved for 46 statements. For recurrent weight gain or worsening of a significant obesity complication after OAGB, more than 85% of experts reached a consensus that elongation of the biliopancreatic limb (BPL) is an acceptable option and the total bowel length measurement is mandatory during BPL elongation to preserve at least 300-400 cm of common channel limb length to avoid nutritional deficiencies. Also, more than 85% of experts reached a consensus on conversion to Roux-en-Y gastric bypass (RYGB) with or without pouch downsizing as an acceptable option for the treatment of persistent bile reflux after OAGB and recommend detecting and repairing any size of hiatal hernia during conversion to RYGB., Conclusion: While the experts reached a consensus on several aspects regarding revision/conversion surgeries after OAGB, there are still lingering areas of disagreement. This highlights the importance of conducting further studies in the future to address these unresolved issues., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2024
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15. Indications and Coverage of Metabolic and Bariatric Surgery: A Worldwide IFSO Survey Comparing Different National Guidelines.
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Pujol-Rafols J, Carmona-Maurici J, Felsenreich DM, Shikora SA, Prager G, Di Lorenzo N, De Luca M, Uyanik O, Mazzarella M, D'Arco S, Angrisani L, Pardina E, and Balibrea JM
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- Humans, Obesity surgery, Societies, Medical, Obesity, Morbid surgery, Bariatric Surgery, Metabolic Diseases surgery
- Abstract
Introduction: Knowing how metabolic and bariatric surgery (MBS) is indicated in different countries is essential information for the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO)., Aim: To analyze the indications for MBS recommended by each of the national societies that comprise the IFSO and how MBS is financed in their countries., Methods: All IFSO societies were asked to fill out a survey asking whether they have, and which are their national guidelines, and if MBS is covered by their public health service., Results: Sixty-three out of the 72 IFSO national societies answered the form (87.5%). Among them, 74.6% have some kind of guidelines regarding indications for MBS. Twenty-two percent are still based on the US National Institute of Health (NIH) 1991 recommendations, 43.5% possess guidelines midway the 1991s and ASMBS/IFSO 2022 ones, and 34% have already adopted the latest ASMBS/IFSO 2022 guidelines. MBS was financially covered in 65% of the countries., Conclusions: Most of the IFSO member societies have MBS guidelines. While more than a third of them have already shifted to the most updated ASMBS/IFSO 2022 ones, another significant number of countries are still following the NIH 1991 guidelines or even do not have any at all. Besides, there is a significant number of countries in which surgical treatment is not yet financially covered. More effort is needed to standardize indications worldwide and to influence insurers and health policymakers to increase the coverage of MBS., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2024
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16. Current recommendations for procedure selection in class I and II obesity developed by an expert modified Delphi consensus.
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Kermansaravi M, Chiappetta S, Parmar C, Shikora SA, Prager G, LaMasters T, Ponce J, Kow L, Nimeri A, Kothari SN, Aarts E, Abbas SI, Aly A, Aminian A, Bashir A, Behrens E, Billy H, Carbajo MA, Clapp B, Chevallier JM, Cohen RV, Dargent J, Dillemans B, Faria SL, Neto MG, Garneau PY, Gawdat K, Haddad A, ElFawal MH, Higa K, Himpens J, Husain F, Hutter MM, Kasama K, Kassir R, Khan A, Khoursheed M, Kroh M, Kurian MS, Lee WJ, Loi K, Mahawar K, McBride CL, Almomani H, Melissas J, Miller K, Misra M, Musella M, Northup CJ, O'Kane M, Papasavas PK, Palermo M, Peterson RM, Peterli R, Poggi L, Pratt JSA, Alqahtani A, Ramos AC, Rheinwalt K, Ribeiro R, Rogers AM, Safadi B, Salminen P, Santoro S, Sann N, Scott JD, Shabbir A, Sogg S, Stenberg E, Suter M, Torres A, Ugale S, Vilallonga R, Wang C, Weiner R, Zundel N, Angrisani L, and De Luca M
- Subjects
- Humans, Delphi Technique, Obesity surgery, Gastrectomy, Treatment Outcome, Retrospective Studies, Diabetes Mellitus, Type 2 surgery, Bariatric Surgery methods, Gastric Bypass methods, Obesity, Morbid surgery
- Abstract
Metabolic and bariatric surgery (MBS) is widely considered the most effective option for treating obesity, a chronic, relapsing, and progressive disease. Recently, the American Society of Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued new guidelines on the indications for MBS, which have superseded the previous 1991 National Institutes of Health guidelines. The aim of this study is to establish the first set of consensus guidelines for selecting procedures in Class I and II obesity, using an Expert Modified Delphi Method. In this study, 78 experienced bariatric surgeons from 32 countries participated in a two-round Modified Delphi consensus voting process. The threshold for consensus was set at an agreement or disagreement of ≥ 70.0% among the experts. The experts reached a consensus on 54 statements. The committee of experts reached a consensus that MBS is a cost-effective treatment option for Class II obesity and for patients with Class I obesity who have not achieved significant weight loss through non-surgical methods. MBS was also considered suitable for patients with Type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30 kg/m
2 or higher. The committee identified intra-gastric balloon (IGB) as a treatment option for patients with class I obesity and endoscopic sleeve gastroplasty (ESG) as an option for patients with class I and II obesity, as well as for patients with T2DM and a BMI of ≥ 30 kg/m2 . Sleeve gastrectomy (1) and Roux-en-Y gastric bypass (RYGB) were also recognized as viable treatment options for these patient groups. The committee also agreed that one anastomosis gastric bypass (OAGB) is a suitable option for patients with Class II obesity and T2DM, regardless of the presence or severity of obesity-related medical problems. The recommendations for selecting procedures in Class I and II obesity, developed through an Expert Modified Delphi Consensus, suggest that the use of standard primary bariatric endoscopic (IGB, ESG) and surgical procedures (SG, RYGB, OAGB) are acceptable in these patient groups, as consensus was reached regarding these procedures. However, randomized controlled trials are still needed in Class I and II Obesity to identify the best treatment approach for these patients in the future., (© 2024. The Author(s).)- Published
- 2024
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17. Yitka Graham: a Brief Biography.
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Mahawar K and Shikora SA
- Published
- 2024
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18. Reply to "New IFSO/ASMBS Indications for Metabolic and Bariatric Surgery? Yes, After Failure of Best Nonsurgical Therapy".
- Author
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Eisenberg D, Shikora SA, and Kothari SN
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- Humans, Obesity surgery, Obesity, Morbid surgery, Bariatric Surgery
- Published
- 2023
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19. Reconsideration of the Gastroparetic Syndrome.
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Gilbert RJ, Siamwala JH, Kumar V, Thompson CC, and Shikora SA
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- Humans, Gastrointestinal Agents therapeutic use, Abdominal Pain, Gastric Emptying physiology, Gastroparesis diagnosis, Gastroparesis etiology, Gastroparesis therapy
- Abstract
Purpose of Review: Gastroparesis is a chronic disorder characterized by a constellation of foregut symptoms, including postprandial nausea, vomiting, distension, epigastric pain, and regurgitation in the absence of gastric outlet obstruction. Despite considerable research over the past decades, there remains to be only nominal understanding of disease classification, diagnostic criteria, pathogenesis, and preferred therapy., Recent Findings: We critically reassess current approaches for disease identification and stratification, theories of causation, and treatment for gastroparesis. Gastric scintigraphy, long considered a diagnostic standard, has been re-evaluated in light of evidence showing low sensitivity, whereas newer testing modalities are incompletely validated. Present concepts of pathogenesis do not provide a unified model linking biological impairments with clinical manifestations, whereas available pharmacological and anatomical treatments lack explicit selection criteria or evidence for sustained effectiveness. We propose a disease model that embodies the re-programming of distributed neuro-immune interactions in the gastric wall by inflammatory perturbants. These interactions, combined with effects on the foregut hormonal milieu and brain-gut axis, are postulated to generate the syndromic attributes characteristically linked with gastroparesis. Research linking models of immunopathogenesis with diagnostic and therapeutic paradigms will lead to reclassifications of gastroparesis that guide future trials and technological developments., Key Points: • The term gastroparesis embodies a heterogenous array of symptoms and clinical findings based on a complex assimilation of afferent and efferent mechanisms, gastrointestinal locations, and pathologies. • There currently exists no single test or group of tests with sufficient capacity to be termed a definitional standard for gastroparesis. • Present research regarding pathogenesis suggests the importance of immune regulation of intrinsic oscillatory activity involving myenteric nerves, interstitial cells of Cajal, and smooth muscle cells. • Prokinetic pharmaceuticals remain the mainstay of management, although novel treatments are being studied that are directed to alternative muscle/nerve receptors, electromodulation of the brain-gut axis, and anatomical (endoscopic, surgical) interventions., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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20. Reply to Letter to the Editor: Beyond the BMI: a Critical Analysis of the Edmonton Obesity Staging System and the New Guidelines for Indications for Metabolic and Bariatric Surgery.
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Eisenberg D, Shikora SA, and Kothari SN
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- Humans, Body Mass Index, Obesity surgery, Obesity, Morbid surgery, Bariatric Surgery
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- 2023
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21. Thirty-One Years Maybe Desirable for Antique Cars But Not for Patient Care.
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Shikora SA and Cohen RV
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- Humans, Patient Care, Automobiles, Obesity, Morbid surgery
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- 2023
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22. The impact of procedure type on 30-day readmissions following metabolic and bariatric surgery: postoperative complications of bariatric surgery.
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Vierra BM, Edgerton CA, and Shikora SA
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- Humans, Female, Patient Readmission, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Reoperation adverse effects, Retrospective Studies, Gastrectomy adverse effects, Gastrectomy methods, Obesity, Morbid surgery, Bariatric Surgery adverse effects, Bariatric Surgery methods, Gastric Bypass methods, Laparoscopy methods
- Abstract
Background: Hospital readmission (HR) rates following metabolic/bariatric surgery (MBS) are used as a surrogate for quality outcomes and are increasingly tied to reimbursement rates. There are limited data concerning predictors of HR rates with regard to type of bariatric procedure., Methods: This study is a retrospective review of prospectively collected data from patients who underwent MBS from January 2014 to December 2019 at Brigham and Women's Hospital in Boston, Massachusetts. The causes of all HRs and reoperations within 30 days of the original discharge were analyzed. Statistical significance was determined using Chi Squared test and T test., Results: 2815 patients underwent MBS. 2373 patients (84.3%) had primary procedures, while 442 patients (15.7%) had secondary or revisional procedures. The overall 30-day readmission rate was 5.7%, with no significant difference for patients who underwent primary vs. secondary MBS. Among primary procedures, the readmission rate was higher for Roux-en-Y Gastric Bypass (RYGB) than laparoscopic sleeve gastrectomy (SG) (10.32% vs. 4.77%). Readmissions were most often due to nontechnical causes. The overall reoperation rate was 1.14% and was higher for patients undergoing secondary vs. primary procedures (2.94% vs 0.80%)., Conclusions: Readmission rate was similar to that in existing literature. Revisional/secondary surgery did not lead to increased readmissions, although was associated with a higher reoperation rate. Most HRs were due to nontechnical causes. Optimization of postoperative care, such as fluid status, may reduce the incidence of postoperative complications., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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23. Publisher Correction: 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery.
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Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, and Kothari SN
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- 2023
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24. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery.
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Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, and Kothari SN
- Subjects
- Adolescent, Child, Humans, United States epidemiology, Obesity complications, Obesity surgery, Body Mass Index, Obesity, Morbid surgery, Bariatric Surgery methods, Metabolic Diseases surgery
- Abstract
MAJOR UPDATES TO 1991 NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR BARIATRIC SURGERY: Metabolic and bariatric surgery (MBS) is recommended for individuals with a body mass index (BMI) >35 kg/m
2 , regardless of presence, absence, or severity of co-morbidities.MBS should be considered for individuals with metabolic disease and BMI of 30-34.9 kg/m2 .BMI thresholds should be adjusted in the Asian population such that a BMI >25 kg/m2 suggests clinical obesity, and individuals with BMI >27.5 kg/m2 should be offered MBS.Long-term results of MBS consistently demonstrate safety and efficacy.Appropriately selected children and adolescents should be considered for MBS.(Surg Obes Relat Dis 2022; https://doi.org/10.1016/j.soard.2022.08.013 ) © 2022 American Society for Metabolic and Bariatric Surgery. All rights reserved., (© 2022. The Author(s). Published by Elsevier Inc on behalf of American Society for Metabolic & Bariatric Surgery (ASMBS) and Springer Nature on behalf of International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO).)- Published
- 2023
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25. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery.
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Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, De Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, and Kothari SN
- Subjects
- United States, Humans, Obesity complications, Obesity surgery, Bariatric Surgery, Metabolic Diseases surgery, Obesity, Morbid complications, Obesity, Morbid surgery
- Abstract
Major updates to 1991 National Institutes of Health guidelines for bariatric surgery., (Published by Elsevier Inc.)
- Published
- 2022
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26. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial.
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Li M, Liu Y, Lee WJ, Shikora SA, Robert M, Wang W, Wong SKH, Kong Y, Tong DKH, Tan CH, Zeng N, Zhu S, Wang C, Zhang P, Gu Y, Bai R, Meng F, Mao Z, Zhao X, Wu L, Liu Y, Zhang S, Zhang P, and Zhang Z
- Subjects
- Blood Glucose, Glycated Hemoglobin, Humans, Hypoglycemic Agents therapeutic use, Multicenter Studies as Topic, Prospective Studies, Quality of Life, Randomized Controlled Trials as Topic, Diabetes Mellitus, Type 2 surgery, Gastric Bypass
- Abstract
Introduction: Previous studies have demonstrated that one anastomosis gastric bypass (OAGB) is not inferior to Roux-en-Y gastric bypass (RYGB) in treating obesity. However, high level evidence comparing the efficacy and safety of both procedures in type 2 diabetes (T2D) treatment is still lacking, which is another main aim of bariatric surgery. The presented trial has been designed to aim at investigating the superiority of OAGB over the reference procedure RYGB in treating T2D as primary endpoint. And diabetes-related microvascular and macrovascular complications, cardiovascular comorbidities, weight loss, postoperative nutritional status, quality of life and overall complications will be followed up for 5 years as secondary endpoints., Methods and Analysis: This prospective, multicentre, randomised superiority open-label trial will be conducted in patients of Asian descent. A total of 248 patients (BMI≥27.5 kg/m
2 ) who are diagnosed with T2D will be randomly assigned (1:1) to OAGB or RYGB with blocks of four. The primary endpoint is the complete diabetes remission rate defined as HbA1c≤6.0% and fasting plasma glucose≤5.6 mmol/L without any antidiabetic medications at 1 year after surgery. All secondary endpoints will be measured at different follow-up visit points, which will start at least 3 months after enrolment, with a continuous annual follow-up for five postoperative years in order to provide solid evidence on the efficacy and safety of OAGB in patients with T2D., Ethics and Dissemination: The study has been approved by the ethics committee of leading centre (Beijing Friendship Hospital, Capital Medical University, no. 2021-P2-037-03). The results generated from this work will be disseminated to academic audiences and the public via publications in international peer-reviewed journals and conferences. The data presented will be imported into a national data registry. Findings are expected to be available in 2025, which will facilitate clinical decision-making in the field., Trial Registration Number: NCT05015283., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2022
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27. In Celebration of Professor Henry Buchwald's 90 th Birthday.
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Shikora SA
- Subjects
- History, 20th Century, Humans, Obesity, Morbid surgery
- Published
- 2022
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28. The first international Delphi consensus statement on Laparoscopic Gastrointestinal surgery.
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Omar I, Miller K, Madhok B, Amr B, Singhal R, Graham Y, Pouwels S, Abu Hilal M, Aggarwal S, Ahmed I, Aminian A, Ammori BJ, Arulampalam T, Awan A, Balibrea JM, Bhangu A, Brady RR, Brown W, Chand M, Darzi A, Gill TS, Goel R, Gopinath BR, Henegouwen MVB, Himpens JM, Kerrigan DD, Luyer M, Macutkiewicz C, Mayol J, Purkayastha S, Rosenthal RJ, Shikora SA, Small PK, Smart NJ, Taylor MA, Udwadia TE, Underwood T, Viswanath YK, Welch NT, Wexner SD, Wilson MSJ, Winter DC, and Mahawar KK
- Subjects
- Consensus, Delphi Technique, Humans, Digestive System Surgical Procedures, Laparoscopy, Surgeons
- Abstract
Background: Laparoscopic surgery has almost replaced open surgery in many areas of Gastro-Intestinal (GI) surgery. There is currently no published expert consensus statement on the principles of laparoscopic GI surgery. This may have affected the training of new surgeons. This exercise aimed to achieve an expert consensus on important principles of laparoscopic GI surgery., Methods: A committee of 38 international experts in laparoscopic GI surgery proposed and voted on 149 statements in two rounds following a strict modified Delphi protocol., Results: A consensus was achieved on 133 statements after two rounds of voting. All experts agreed on tailoring the first port site to the patient, whereas 84.2% advised avoiding the umbilical area for pneumoperitoneum in patients who had a prior midline laparotomy. Moreover, 86.8% agreed on closing all 15 mm ports irrespective of the patient's body mass index. There was a 100% consensus on using cartridges of appropriate height for stapling, checking the doughnuts after using circular staplers, and keeping the vibrating blade of the ultrasonic energy device in view and away from vascular structures. An 84.2% advised avoiding drain insertion through a ≥10 mm port site as it increases the risk of port-site hernia. There was 94.7% consensus on adding laparoscopic retrieval bags to the operating count and ensuring any surgical specimen left inside for later removal is added to the operating count., Conclusion: Thirty-eight experts achieved a consensus on 133 statements concerning various aspects of laparoscopic GI Surgery. Increased awareness of these could facilitate training and improve patient outcomes., (Crown Copyright © 2022. Published by Elsevier Ltd. All rights reserved.)
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- 2022
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29. Metabolic surgery.
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Shikora SA, Edgerton C, Harris D, and Buchwald H
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- Humans, Bariatric Surgery, Diabetes Mellitus, Type 2 surgery, Obesity, Morbid surgery
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- 2022
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30. Concomitant Cholecystectomy for Asymptomatic Gallstones in Bariatric Surgery-Safety Profile and Feasibility in a Large Tertiary Referral Bariatric Center.
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Allatif REA, Mannaerts GHH, Al Afari HST, Hammo AN, Al Blooshi MS, Bekdache OA, Alawadhi O, Isied SH, Hamid S, and Shikora SA
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- Cholecystectomy adverse effects, Feasibility Studies, Gastrectomy methods, Humans, Postoperative Complications etiology, Prospective Studies, Referral and Consultation, Retrospective Studies, Bariatric Surgery adverse effects, Bariatric Surgery methods, Gallstones epidemiology, Gallstones etiology, Gallstones surgery, Gastric Bypass adverse effects, Gastric Bypass methods, Laparoscopy methods, Obesity, Morbid surgery
- Abstract
Background: Obesity is a risk factor for gallstone formation, which can be exacerbated by bariatric surgery-induced rapid weight loss. Current guidelines do not recommend concomitant cholecystectomy (CC) for asymptomatic gallstones during the bariatric surgery procedure. However, long-term follow-up studies have shown that the incidence of post-bariatric surgery symptomatic gallstones necessitating therapeutic cholecystectomy increases to 40%. Therefore, some surgeons advocate simultaneous cholecystectomy during the bariatric surgery for asymptomatic individuals. This study aims to evaluate the safety of performing cholecystectomy for asymptomatic gallstones during the bariatric procedure., Methods: Data from a consecutive series of patients that underwent primary laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB) or conversion of LSG to a LRYGB with or without concomitant cholecystectomy for asymptomatic gallstones between Jan 2010 and Dec 2017 were retrieved from the database. The primary endpoint was the complication rate. Secondary endpoints were the surgical operating room time (ORT) and the length of hospital stay (LOS)., Results: Out of the 2828 patients who were included, 120 patients underwent a concomitant cholecystectomy during their bariatric procedure (LSG or LRYGB) for asymptomatic gallbladder stones and were compared to the 2708 remaining patients who only had bariatric surgery. None of the concomitant cholecystectomy patients developed a gallbladder-related complication. There was no significant increase in the rate of minor or major complications between the CC groups and the non-CC groups (LSG: 6.7% vs. 3.2%, p=0.132; LRYGB: 0% vs. 2.3%, p =0.55; and conversion of LSG to LRYGB: 20% vs. 7.1%, p = 0.125, respectively). In addition, there was no significant increase in the length of hospital stay (1.85 ±4.19 days vs. 2.24 ±1.82, p=0.404) for LSG group and (1.75 ±2.0 vs. 2.3 ±2.1, p=0.179) for LRYGB group. Adding the cholecystectomy to the bariatric procedure only added an average of 23 min (min) (27 min when added to LSG and 18 min when added to LRYGB)., Conclusion: As one of the largest series reviewing concomitant cholecystectomy in bariatric surgery, this study showed that in skilled laparoscopic bariatric surgical hands, concomitant cholecystectomy during bariatric surgery is safe and prevents potential future gallstone-related complications. Long-term large prospective randomized trials are needed to further clarify the recommendation of prophylactic concomitant cholecystectomy during bariatric surgery., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2022
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31. The first modified Delphi consensus statement on sleeve gastrectomy.
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Mahawar KK, Omar I, Singhal R, Aggarwal S, Allouch MI, Alsabah SK, Angrisani L, Badiuddin FM, Balibrea JM, Bashir A, Behrens E, Bhatia K, Biertho L, Biter LU, Dargent J, De Luca M, DeMaria E, Elfawal MH, Fried M, Gawdat KA, Graham Y, Herrera MF, Himpens JM, Hussain FA, Kasama K, Kerrigan D, Kow L, Kristinsson J, Kurian M, Liem R, Lutfi RE, Menon V, Miller K, Noel P, Ospanov O, Ozmen MM, Peterli R, Ponce J, Prager G, Prasad A, Raj PP, Rodriguez NR, Rosenthal R, Sakran N, Santos JN, Shabbir A, Shikora SA, Small PK, Taylor CJ, Wang C, Weiner RA, Wylezol M, Yang W, and Aminian A
- Subjects
- Consensus, Delphi Technique, Gastrectomy, Humans, Retrospective Studies, Treatment Outcome, Weight Loss, Gastric Bypass, Obesity, Morbid surgery
- Abstract
Introduction: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG., Methods: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus., Results: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE., Conclusion: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic., (© 2021. Crown.)
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- 2021
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32. The First Modified Delphi Consensus Statement for Resuming Bariatric and Metabolic Surgery in the COVID-19 Times.
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Pouwels S, Omar I, Aggarwal S, Aminian A, Angrisani L, Balibrea JM, Bhandari M, Biter LU, Blackstone RP, Carbajo MA, Copaescu CA, Dargent J, Elfawal MH, Fobi MA, Greve JW, Hazebroek EJ, Herrera MF, Himpens JM, Hussain FA, Kassir R, Kerrigan D, Khaitan M, Kow L, Kristinsson J, Kurian M, Lutfi RE, Moore RL, Noel P, Ozmen MM, Ponce J, Prager G, Purkayastha S, Rafols JP, Ramos AC, Ribeiro RJS, Sakran N, Salminen P, Shabbir A, Shikora SA, Singhal R, Small PK, Taylor CJ, Torres AJ, Vaz C, Yashkov Y, and Mahawar K
- Subjects
- Consensus, Delphi Technique, Humans, Obesity, Morbid surgery, Pandemics, SARS-CoV-2, Bariatric Surgery, COVID-19
- Abstract
The purpose of this study was to achieve consensus amongst a global panel of expert bariatric surgeons on various aspects of resuming Bariatric and Metabolic Surgery (BMS) during the Coronavirus Disease-2019 (COVID-19) pandemic. A modified Delphi consensus-building protocol was used to build consensus amongst 44 globally recognised bariatric surgeons. The experts were asked to either agree or disagree with 111 statements they collectively proposed over two separate rounds. An agreement amongst ≥ 70.0% of experts was construed as consensus as per the predetermined methodology. We present here 38 of our key recommendations. This first global consensus statement on the resumption of BMS can provide a framework for multidisciplinary BMS teams planning to resume local services as well as guide future research in this area.
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- 2021
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33. Another Consequence of Obesity: Chronic Traumatic Encephalopathy.
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Shikora SA
- Published
- 2020
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34. The first consensus statement on revisional bariatric surgery using a modified Delphi approach.
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Mahawar KK, Himpens JM, Shikora SA, Ramos AC, Torres A, Somers S, Dillemans B, Angrisani L, Greve JWM, Chevallier JM, Chowbey P, De Luca M, Weiner R, Prager G, Vilallonga R, Adamo M, Sakran N, Kow L, Lakdawala M, Dargent J, Nimeri A, and Small PK
- Subjects
- Adult, Biliopancreatic Diversion methods, Duodenum surgery, Female, Gastrectomy methods, Gastric Bypass methods, Humans, Middle Aged, Obesity, Morbid surgery, Preoperative Care, Reoperation, Bariatric Surgery methods, Consensus, Delphi Technique
- Abstract
Background: Revisional bariatric surgery (RBS) constitutes a possible solution for patients who experience an inadequate response following bariatric surgery or significant weight regain following an initial satisfactory response. This paper reports results from the first modified Delphi consensus-building exercise on RBS., Methods: We created a committee of 22 recognised opinion-makers with a special interest in RBS. The committee invited 70 RBS experts from 27 countries to vote on 39 statements concerning RBS. An agreement amongst ≥ 70.0% experts was regarded as a consensus., Results: Seventy experts from twenty-seven countries took part. There was a consensus that the decision for RBS should be individualised (100.0%) and multi-disciplinary (92.8%). Experts recommended a preoperative nutritional (95.7%) and psychological evaluation (85.7%), endoscopy (97.1%), and a contrast series (94.3%). Experts agreed that Roux-Y gastric bypass (RYGB) (94.3%), One anastomosis gastric bypass (OAGB) (82.8%), and single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) (71.4%) were acceptable RBS options after gastric banding (84.3%). OAGB (84.3%), bilio-pancreatic diversion/duodenal switch (BPD/DS) (81.4%), and SADI-S (88.5%) were agreed as consensus RBS options after sleeve gastrectomy. lengthening of bilio-pancreatic limb was the only consensus RBS option after RYGB (94.3%) and OAGB (72.8%)., Conclusion: Experts achieved consensus on a number of aspects of RBS. Though expert opinion can only be regarded as low-quality evidence, the findings of this exercise should help improve the outcomes of RBS while we develop robust evidence to inform future practice.
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- 2020
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35. Low Incidence of Postoperative Leaks When Using Small-Diameter Calibrated Bougies During Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study.
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Sakran N, Raziel A, Gralnek IM, Perry Z, Mahawar KK, Shikora SA, and Goitein D
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- Adolescent, Adult, Aged, Anastomotic Leak epidemiology, Female, Gastrectomy adverse effects, Humans, Incidence, Laparoscopy adverse effects, Male, Middle Aged, Postoperative Complications epidemiology, Retrospective Studies, Weight Loss, Young Adult, Anastomotic Leak prevention & control, Gastrectomy methods, Laparoscopy methods, Obesity, Morbid surgery, Postoperative Complications prevention & control
- Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) is a well-established bariatric procedure. A staple line leak is a recognized complication of LSG. Bougie size has been suggested to impact leak rates. In this study, we evaluate the impact of using 32-34F bougie sizes with LSG on early postoperative outcomes including staple line leaks within our practice., Methods: This is a retrospective cohort analysis of a prospectively maintained database of all LSG procedures performed between January 2012 and December 2018 at a single medical center. Data collected and analyzed included bougie size, postoperative leak rate, need for re-operation, 12-month excess weight loss, and 30-day morbidity and mortality., Results: During the study period, 3153 patients underwent LSG, of whom 1977 (62.7%) were female. Mean age and body mass index (BMI) were 42.9 ± 12.2 years (range 15-76 years) and 42.4 ± 5.2 kg/m
2 (range 27-73), respectively. No intraoperative complications or mortality occurred. There was one case of perioperative mortality due to bleeding (0.03%). Early postoperative adverse events occurred in 131 patients (4.1%): 17 leaks (0.5%), 75 bleeds (2.4%), and 39 (1.2%) other., Conclusion: The use of smaller-sized (32-34F) bougies had no impact on staple line leaks in the hands of experienced bariatric surgeons at a high-volume center.- Published
- 2020
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36. Revision of Roux-en-Y Gastric Bypass with Limb Distalization for Inadequate Weight Loss or Weight Regain.
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Shin RD, Goldberg MB, Shafran AS, Shikora SA, Majumdar MC, and Shikora SA
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- Humans, Postoperative Complications epidemiology, Retrospective Studies, Weight Gain, Weight Loss, Gastric Bypass adverse effects, Gastric Bypass methods, Gastric Bypass statistics & numerical data, Obesity, Morbid surgery, Reoperation adverse effects, Reoperation methods, Reoperation statistics & numerical data
- Abstract
Background: Of patients undergoing Roux-en-Y gastric bypass (RYGB), 15-35% of patients fail to achieve "adequate" weight loss or regain significant weight. Multiple solutions have been proposed, but not well studied. We report our experience with limb distalization with lengthening the biliopancreatic (BP) limb and shortening the common channel (CC)., Methods: We retrospectively reviewed data from patients undergoing laparoscopic limb distalization for excess weight loss (EWL) <50% or BMI >35 kg/m
2 after RYGB from 2012 to 2017. The BP limb was lengthened and CC was shortened to 100-200 cm. Perioperative outcomes such as morbidity, weight loss, nutritional deficiencies, comorbidity remission, and operative details were analyzed., Results: Twenty-two patients were included. The mean BMI prior to RYGB was 54.1 ± 8.5 kg/m2 and 43.0 ± 5.5 kg/m2 prior to limb distalization. The mean follow-up was 18.3 ± 12.9 months with a mean BMI change, %EWL, and %TWL (total weight loss) of 11.8 ± 7.4 kg/m2 , 62.3 ± 32.4%, and 25.4 ± 14.4%, respectively. The total mean BMI change, %EWL, and %TWL from RYGB was 22.2 ± 9.9 kg/m2 , 77.8 ± 23.6%, and 40.2 ± 13.3%, respectively. Of patients with persistent comorbidities, remission rates of diabetes, hypertension, and gastroesophageal reflux disease were 100%, 17%, and 38%, respectively. The mean operative time was 132.6 ± 54.4 min and mean hospital stay was 2.2 ± 1.3 days. Overall morbidity was 27.3%. Three patients (13.6%) developed nutritional deficiencies requiring reversal surgery., Conclusion: In patients with inadequate weight loss or weight regain after RYGB, limb distalization with lengthening of the BP limb is an effective procedure for additional weight loss and further improvement of comorbidities. Nutritional complications are a risk, but can be minimized with close follow-up and patient compliance.- Published
- 2019
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37. From the Editor's Desk.
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Shikora SA
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- 2018
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38. Extensive Thrombus and Brain Microabscesses After Sleeve Gastrectomy.
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Chao GF, Hirji S, and Shikora SA
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- Anti-Bacterial Agents therapeutic use, Anticoagulants therapeutic use, Biomarkers analysis, Brain Abscess drug therapy, Contrast Media, Drug Therapy, Combination, Female, Humans, Iohexol, Organometallic Compounds, Tomography, X-Ray Computed, Ultrasonography, Doppler, Color, Venous Thrombosis drug therapy, Young Adult, Brain Abscess diagnostic imaging, Gastrectomy methods, Portal Vein diagnostic imaging, Postoperative Complications diagnostic imaging, Venous Thrombosis diagnostic imaging
- Abstract
Sleeve gastrectomy is a relatively newer bariatric surgical procedure and has become the most common of all bariatric surgeries performed. Complication rates reported with sleeve gastrectomies are relatively low and are generally due to staple line leaks, hemorrhage, or sleeve stricture. Portal vein thrombosis is an uncommon but potentially dangerous complication. We present a case of a 21-year-old woman who developed thrombosis of the portal, splenic, and right common iliac veins that then resulted in multifocal brain abscesses from presumed Fusobacterium septic emboli following an uncomplicated laparoscopic sleeve gastrectomy.
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- 2018
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39. The history of metabolic and bariatric surgery: Development of standards for patient safety and efficacy.
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Phillips BT and Shikora SA
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- Animals, Bariatric Medicine history, Bariatric Surgery history, History, 20th Century, History, 21st Century, Humans, Bariatric Medicine standards, Bariatric Surgery standards, Patient Safety standards, Treatment Outcome
- Abstract
Weight loss surgery, also referred to as bariatric surgery, has been in existence since the 1950's. Over the decades, it has been demonstrated to successfully achieve meaningful and sustainable weight loss in a large number of patients who undergo these procedures. Additionally, the benefits observed across a number of metabolic disorders such as type 2 diabetes mellitus and hyperlipidemia, are often to a degree, independent of the weight loss, thus the term "metabolic bariatric surgery (MBS)" has become a better descriptor. Throughout its long history, MBS has evolved from an era of high morbidity and mortality to one of laudable safety despite the high-risk nature of the patients undergoing these major gastrointestinal procedures. This article will describe the historic evolution of MBS and concentrate on those events that were instrumental in reducing the morbidity of these operations., (Copyright © 2018. Published by Elsevier Inc.)
- Published
- 2018
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40. The First Consensus Statement on One Anastomosis/Mini Gastric Bypass (OAGB/MGB) Using a Modified Delphi Approach.
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Mahawar KK, Himpens J, Shikora SA, Chevallier JM, Lakdawala M, De Luca M, Weiner R, Khammas A, Kular KS, Musella M, Prager G, Mirza MK, Carbajo M, Kow L, Lee WJ, and Small PK
- Subjects
- Bariatric Surgery methods, Bariatric Surgery standards, Consensus, Delphi Technique, Geography, Humans, Internationality, Stomach surgery, Gastric Bypass methods, Gastric Bypass standards, Obesity, Morbid surgery
- Abstract
Background: An increasing number of surgeons worldwide are now performing one anastomosis/mini gastric bypass (OAGB/MGB). Lack of a published consensus amongst experts may be hindering progress and affecting outcomes. This paper reports results from the first modified Delphi consensus building exercise on this procedure., Methods: A committee of 16 recognised opinion-makers in bariatric surgery with special interest in OAGB/MGB was constituted. The committee invited 101 OAGB/MGB experts from 39 countries to vote on 55 statements in areas of controversy or variation associated with this procedure. An agreement amongst ≥ 70.0% of the experts was considered to indicate a consensus., Results: A consensus was achieved for 48 of the 55 proposed statements after two rounds of voting. There was no consensus for seven statements. Remarkably, 100.0% of the experts felt that OAGB/MGB was an "acceptable mainstream surgical option" and 96.0% felt that it could no longer be regarded as a new or experimental procedure. Approximately 96.0 and 91.0% of the experts felt that OAGB/MGB did not increase the risk of gastric and oesophageal cancers, respectively. Approximately 94.0% of the experts felt that the construction of the gastric pouch should start in the horizontal portion of the lesser curvature. There was a consensus of 82, 84, and 85% for routinely supplementing iron, vitamin B
12 , and vitamin D, respectively., Conclusion: OAGB/MGB experts achieved consensus on a number of aspects concerning this procedure but several areas of disagreements persist emphasising the need for more studies in the future.- Published
- 2018
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41. Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.
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Apovian CM, Shah SN, Wolfe BM, Ikramuddin S, Miller CJ, Tweden KS, Billington CJ, and Shikora SA
- Subjects
- Adult, Autonomic Nerve Block adverse effects, Cross-Over Studies, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Obesity, Morbid metabolism, Quality of Life, Risk Factors, Treatment Outcome, Vagus Nerve pathology, Vagus Nerve Stimulation adverse effects, Vagus Nerve Stimulation instrumentation, Weight Loss physiology, Autonomic Nerve Block instrumentation, Electric Stimulation Therapy adverse effects, Electric Stimulation Therapy instrumentation, Electric Stimulation Therapy methods, Electrodes, Implanted, Obesity, Morbid therapy, Vagus Nerve surgery, Vagus Nerve Stimulation methods
- Abstract
Background: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes., Methods: Participants with body mass index (BMI) 40 to 45 kg/m
2 , or 35 to 40 kg/m2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years., Results: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3 %), and systolic (-11 mmHg) and diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %., Conclusions: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years., Trial Registration: https://clinicaltrials.gov/ct2/show/NCT01327976., Competing Interests: The role of the Funder/Sponsor EnteroMedics Inc. was involved in the design and conduct of the study, site selection, and database management. The sponsor provided funding to the clinical sites for patient enrollment, core laboratory analyses, clinical events adjudications, and database entry. Author 1: sponsor provided fees for assistance in preparing and presenting these data to an independent FDA advisory committee. Author 2: sponsor provided fees for surgeon training outside of the study conduct. Author 3 and 4: sponsor provided fees for assistance in preparing and presenting these data to an independent FDA advisory committee. Author 5: sponsor provided fees for data analysis and critical revision of manuscript. Author 6 and 8: sponsor representatives allowed to review and participate in critical revision of manuscript. Author 7: sponsor provided consulting fees for oversight of the trial (National PI). Ethics Statements All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.- Published
- 2017
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42. Safety and efficacy of single-stage conversion of failed adjustable gastric band to laparoscopic Roux-en-Y gastric bypass: a case-control study.
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Samakar K, McKenzie TJ, Kaberna J, Tavakkoli A, Vernon AH, Madenci AL, Shikora SA, and Robinson MK
- Subjects
- Adult, Case-Control Studies, Databases, Factual, Female, Follow-Up Studies, Gastroplasty instrumentation, Humans, Male, Middle Aged, Patient Safety, Retrospective Studies, Treatment Outcome, Gastric Bypass methods, Gastroplasty methods, Laparoscopy methods, Obesity, Morbid surgery
- Abstract
Background: We conducted the following study to evaluate the safety and efficacy of single-stage conversion of failed laparoscopic adjustable gastric band (LAGB) to laparoscopic Roux-en-Y gastric bypass (LRYGB) as compared to a cohort of primary LRYGB patients., Methods: A single-institution, prospectively maintained bariatric database was used to retrospectively identify consecutive patients who underwent single-stage removal of LAGB with concomitant conversion to LRYGB between the years of 2007 and 2013. The study cohort was matched 1:1 for age, gender, body mass index (BMI), and approximate date of operation to patients who underwent primary LRYGB. Primary endpoints were operative time, complication rate, length of hospital stay (LOS), and percent excess BMI lost (%EBMIL) at 24-month follow-up., Results: Ninety-four conversion patients met inclusion criteria. There were no statistically significant differences in the mean LOS (3.1 vs. 3.0 days, p = 0.97) or the major complication rate (3.2 vs. 1.1 %, p = 0.62) at 30 days postoperatively. Likewise, 30-day minor complication rates, including readmission, were similar between groups (7.5 vs. 6.4 %, p = 0.77). The average operative time was significantly longer for conversion compared to primary LRYGB (193.5 vs. 132 min; p < 0.01). At most recent follow-up after conversion or primary LRYGB, median %EBMIL was 61.3 and 77.3 % (p < 0.01), percent total weight loss was 23.6 and 30.5 % (p < 0.01), and percent change in BMI was 23.4 and 30.5 % (p < 0.01), respectively. Median follow-up time was 17 and 18.6 months after conversion and primary LRYGB, respectively., Conclusion: Single-stage conversion of LAGB to LRYGB is safe with an acceptable complication rate and similar LOS compared to primary LRYGB.
- Published
- 2016
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43. An Effort to Develop an Algorithm to Target Abdominal CT Scans for Patients After Gastric Bypass.
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Pernar LI, Lockridge R, McCormack C, Chen J, Shikora SA, Spector D, Tavakkoli A, Vernon AH, and Robinson MK
- Subjects
- Algorithms, Female, Humans, Male, Retrospective Studies, Abdominal Pain etiology, Gastric Bypass adverse effects, Obesity surgery, Tomography, X-Ray Computed
- Abstract
Abdominal CT (abdCT) scans are frequently ordered for Roux-en-Y gastric bypass (RYGB) patients presenting to the emergency department (ED) with abdominal pain, but often do not reveal intra-abdominal pathology. We aimed to develop an algorithm for rational ordering of abdCTs. We retrospectively reviewed our institution's RYGB patients presenting acutely with abdominal pain, documenting clinical and laboratory data, and scan results. Associations of clinical parameters to abdCT results were examined for outcome predictors. Of 1643 RYGB patients who had surgery between 2005 and 2015, 355 underwent 387 abdCT scans. Based on abdCT, 48 (12 %) patients required surgery and 86 (22 %) another intervention. No clinical or laboratory parameter predicted imaging results. Imaging decisions for RYGB patients do not appear to be amenable to a simple algorithm, and patient work-up should be based on astute clinical judgment.
- Published
- 2016
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44. Gastric bypass reversal: a 7-year experience.
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Pernar LI, Kim JJ, and Shikora SA
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- Abdominal Pain etiology, Adult, Female, Gastroscopy methods, Humans, Incisional Hernia etiology, Male, Malnutrition etiology, Malnutrition surgery, Malnutrition therapy, Middle Aged, Obesity, Morbid surgery, Parenteral Nutrition methods, Postoperative Complications etiology, Postoperative Nausea and Vomiting etiology, Prospective Studies, Reoperation, Retrospective Studies, Treatment Outcome, Weight Loss physiology, Gastric Bypass adverse effects, Laparoscopy adverse effects
- Abstract
Background: After gastric bypass, some patients develop conditions that ultimately require reversal of the bypass. There are currently few publications on the topic to guide clinicians., Objectives: To describe the indications, techniques, and outcomes for gastric bypass reversal., Setting: Two academic medical centers., Methods: We conducted a retrospective chart review of all patients who underwent gastric bypass reversal at our institutions between 2008 and 2015. Information regarding the original operation, the indications for reversal, procedures performed, and the postoperative outcomes were collected and analyzed., Results: Nineteen patients underwent gastric bypass reversal. All but 4 reversal operations were performed laparoscopically. The indications for reversal were malnutrition or excessive weight loss (6 patients); chronic nausea, vomiting, and abdominal pain (5); neuroglycopenia (4); massive small bowel loss due to internal hernia (3); and need for surveillance gastric endoscopy (1). In the perioperative period, 4 patients had a complication that required intervention. Five patients required additional delayed procedures. One patient was lost to follow-up. The remaining patients' mean follow-up was 22±18 months. Symptoms that prompted reversal of the gastric bypass resolved in the majority of patients. However, 1 patient's hypoglycemia did not resolve and 2 continued to have diarrhea. Six patients were weaned off of total parenteral nutrition., Conclusions: Laparoscopic gastric bypass reversal is feasible and well tolerated. The procedure can be employed to treat a variety of conditions that may occur after gastric bypass and the majority of patients benefit, with resolution of symptoms. In a carefully selected patient population, gastric bypass reversal should be considered if conservative approaches to adverse conditions fail., (Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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45. Rafael Álvarez Cordero, MD.
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Shikora SA
- Published
- 2016
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46. Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study.
- Author
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Shikora SA, Toouli J, Herrera MF, Kulseng B, Brancatisano R, Kow L, Pantoja JP, Johnsen G, Brancatisano A, Tweden KS, Knudson MB, and Billington CJ
- Subjects
- Adult, Cardiovascular Diseases blood, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 complications, Female, Follow-Up Studies, Glycated Hemoglobin metabolism, Humans, Male, Middle Aged, Obesity blood, Risk Factors, Weight Loss physiology, Autonomic Nerve Block methods, Blood Glucose metabolism, Cardiovascular Diseases etiology, Diabetes Mellitus, Type 2 surgery, Obesity complications, Obesity surgery, Vagus Nerve surgery
- Abstract
Background: One-year results of the VBLOC DM2 study found that intermittent vagal blocking (VBLOC therapy) was safe among subjects with obesity and type 2 diabetes mellitus (T2DM) and led to significant weight loss and improvements in glycemic parameters and cardiovascular risk factors. Longer-term data are needed to determine whether the results are sustained., Methods: VBLOC DM2 is a prospective, observational study of 28 subjects with T2DM and body mass index (BMI) between 30 and 40 kg/m(2) to assess mid-term safety and weight loss and improvements in glycemic parameters, and other cardiovascular risk factors with VBLOC therapy. Continuous outcome variables are reported using mixed models., Results: At 24 months, the mean percentage of excess weight loss was 22% (95% CI, 15 to 28, p < 0.0001) or 7.0% total body weight loss (95% CI, 5.0 to 9.0, p < 0.0001). Hemoglobin A1c decreased by 0.6 percentage points (95% CI, 0.2 to 1.0, p = 0.0026) on average from 7.8% at baseline. Fasting plasma glucose declined by 15 mg/dL (95% CI, 0 to 29, p = 0.0564) on average from 151 mg/dL at baseline. Among subjects who were hypertensive at baseline, systolic blood pressure declined 10 mmHg (95% CI, 2 to 19, p = 0.02), diastolic blood pressure declined by 6 mmHg (95% CI, 0 to 12, p = 0.0423), and mean arterial pressure declined 7 mmHg (95% CI, 2 to 13, p = 0.014). Waist circumference was significantly reduced by 7 cm (95% CI, 4 to 10, p < 0.0001) from a baseline of 120 cm. The most common adverse events were mild or moderate heartburn, implant site pain, and constipation., Conclusions: Improvements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with a well-tolerated risk profile.
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- 2016
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47. Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.
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Morton JM, Shah SN, Wolfe BM, Apovian CM, Miller CJ, Tweden KS, Billington CJ, and Shikora SA
- Subjects
- Adult, Body Mass Index, Diabetes Mellitus, Type 2 complications, Double-Blind Method, Dyslipidemias complications, Female, Humans, Hypertension complications, Male, Middle Aged, Obesity complications, Treatment Outcome, Nerve Block methods, Obesity therapy, Vagus Nerve, Weight Loss physiology
- Abstract
Background: Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity., Methods: The ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40-45 or 35-40 kg/m(2) with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35-40 kg/m(2)) at randomization., Results: Fifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73%), hypertension (58%), sleep apnea (33%), and type 2 diabetes (8%). The vBloc group achieved a percentage excess weight loss (%EWL) of 33% (11% total weight loss (%TWL)) compared to 19% EWL (6% TWL) with sham at 12 months (treatment difference 14 percentage points, 95% CI, 7-22; p < 0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate., Conclusions: vBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.
- Published
- 2016
- Full Text
- View/download PDF
48. Erratum to: Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study.
- Author
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Shikora SA, Toouli J, Herrera MF, Kulseng B, Brancatisano R, Kow L, Pantoja JP, Johnsen G, Brancatisano A, Tweden KS, Knudson MB, and Billington CJ
- Published
- 2016
- Full Text
- View/download PDF
49. Dr. Pradeep Chowbey, MS, MNAMS, FRCS (Lond), FIMSA, FAIS, FICS, FACS, FALS, FIAGES.
- Author
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Chowbey P and Shikora SA
- Published
- 2016
- Full Text
- View/download PDF
50. Mathias A. L. (MAL) Fobi, M. D. F.A.C.S., F.I.C.S., F.A.C.N.
- Author
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Wiener R and Shikora SA
- Published
- 2016
- Full Text
- View/download PDF
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