Advertisement

LABS Project

  • Anita P. Courcoulas
  • Bruce M. Wolfe
Chapter

Abstract

In response to the growing rate of severe obesity and its consequences, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded the development of the Longitudinal Assessment of Bariatric Surgery (LABS) consortium to address some of the many questions related to the safety and efficacy of bariatric surgery. Comprised of six clinical centers and one data coordinating center with a governing body, or Steering Committee, LABS is a multicenter, observational cohort study with strategically designed protocols for data collection and maintenance. Three phases of the LABS study (LABS-1, LABS-2, and LABS-3) assess the short- and longer-term risks and benefits of bariatric surgery and its associated outcomes and also examine several underlying mechanisms of effect in more detail. LABS-1 findings have described the short-term safety of bariatric surgery: 0.3 % mortality rate and 4.3 % risk of adverse composite outcome for primary bariatric surgical procedures. These results, along with the longer-term outcomes of LABS-2, addressing many of the outcome domains, will be published over the next several years and will contribute knowledge to the field to inform and hopefully benefit both patients and providers.

Keywords

Obstructive Sleep Apnea Bariatric Surgery Gastric Bypass Laparoscopic Adjustable Gastric Banding Bariatric Procedure 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This chapter is based upon information originally provided in the published results of the LABS consortium study: Belle (2005) [13], Belle et al. (2007) [12], Belle et al. (2008) [40], Flum et al. (2009) [44], Smith et al. (2010) [45], Inabnet et al. (2010) [48], Smith et al. (2011) [49], Gosman et al. (2010) [55], King et al. (2008) [62], King et al. (2012) [67], King et al. (2012) [68], Kleiner (2009) [64], Belle et al. (2013) [50], Mackey et al. (2012) [51], Khan et al. (2013) [54], and Gourash et al. (2013) [69].

References

  1. 1.
    Wadden TA, Sternberg JA, Letizia KA, Stunkard AJ, Foster GD. Treatment of obesity by very low calorie diet, behavior therapy, and their combination: a five-year perspective. Int J Obes. 1989;13:39–46.PubMedGoogle Scholar
  2. 2.
    Dansinger ML, Gleason J, Griffith J, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone Diets for weight loss and heart disease risk reduction. JAMA. 2005;293:43–53.PubMedCrossRefGoogle Scholar
  3. 3.
    Yanovski SZ, Yanovski JA. Obesity. N Engl J Med. 2002;346:591–602.PubMedCrossRefGoogle Scholar
  4. 4.
    Safer DJ. Diet, behavior modification, and exercise: a review of obesity treatments from a long-term perspective. South Med J. 1991;84:1470–4.PubMedCrossRefGoogle Scholar
  5. 5.
    Pories WJ, Flickinger E, Meelheim D, Van Rij AM, Thomas FT. The effectiveness of gastric bypass over gastric partition in morbid obesity: consequence of distal gastric and duodenal exclusion. Ann Surg. 1982;196:389–99.PubMedCrossRefPubMedCentralGoogle Scholar
  6. 6.
    Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724–37.PubMedCrossRefGoogle Scholar
  7. 7.
    Carlsson LM, Peltonen M, Ahlin S, Anveden Å, Bouchard C, Carlsson B, et al. Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. N Engl J Med. 2012;367(8):695–704.PubMedCrossRefGoogle Scholar
  8. 8.
    Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, et al. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012;308(11):1122–31.PubMedCrossRefPubMedCentralGoogle Scholar
  9. 9.
    Encinosa WE, Bernard DM, Steiner CA, Chen CC. Use and costs of bariatric surgery and prescription weight-loss medications. Health Aff (Millwood). 2005;24(4):1039–46.CrossRefGoogle Scholar
  10. 10.
    National Institutes of Health Consensus Development Panel. National Institutes of Health Consensus Development Conference Statement: gastrointestinal surgery for severe obesity. Am J Clin Nutr. 1992;55:615S–19S.Google Scholar
  11. 11.
    NIDDK Working Group on Bariatric Surgery. Executive summary. Bethesda, NIDDK. 2002. Available from: http://www.niddk.nih.gov/fund/crfo/Bariatric-Surgery-final.pdf. Accessed 25 Jul 2012.
  12. 12.
    Belle SH, Berk PD, Courcoulas AP, Flum DR, Miles CW, Mitchell JE, Longitudinal Assessment of Bariatric Surgery Consortium Writing Group, et al. Safety and efficacy of bariatric surgery: Longitudinal Assessment of Bariatric Surgery. Surg Obes Relat Dis. 2007;3(2):116–26.PubMedCrossRefPubMedCentralGoogle Scholar
  13. 13.
    Belle SH. The NIDDK Bariatric Surgery clinical Research Consortium (LABS). Surg Obes Relat Dis. 2005;1:145–7.PubMedCrossRefGoogle Scholar
  14. 14.
    Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale: Lawrence Earlbaum Associates; 1988.Google Scholar
  15. 15.
    Brolin RE, LaMarca LB, Kenler HA, Cody RP. Malabsorptive gastric bypass in patients with superobesity. J Gastrointest Surg. 2002;6:195–205.PubMedCrossRefGoogle Scholar
  16. 16.
    Choban PS, Flancbaum L. The effect of Roux limb lengths on outcome after Roux-en-Y gastric bypass: a prospective, randomized clinical trial. Obes Surg. 2002;12:540–5.PubMedCrossRefGoogle Scholar
  17. 17.
    Orchard TJ, Temprosa M, Goldberg R, Haffner S, Ratner R, Marcovina S, Diabetes Prevention Program Research Group, et al. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program Randomized trial. Ann Intern Med. 2005;142:611–9.PubMedCrossRefPubMedCentralGoogle Scholar
  18. 18.
    Sjöström CD, Lissner L, Wedel H, Sjöström L. Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS intervention study. Obes Res. 1999;7:477–84.PubMedCrossRefGoogle Scholar
  19. 19.
    Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999;131:485–91.PubMedCrossRefGoogle Scholar
  20. 20.
    Blumenthal JA, Sherwood A, Gullette EC. Exercise and weight loss reduce blood pressure in men and women with mild hypertension: effects on cardiovascular, metabolic, and hemodynamic functioning. Arch Intern Med. 2000;160:1947–58.PubMedCrossRefGoogle Scholar
  21. 21.
    Wiggins KJ, Johnson DW. The influence of obesity on the development and survival outcomes of chronic kidney disease. Adv Chronic Kidney Dis. 2005;12:49–55.PubMedCrossRefGoogle Scholar
  22. 22.
    Coresh J, Astor B, Sarnak MJ. Evidence for increased cardiovascular disease risk in patients with chronic kidney disease. Curr Opin Nephrol Hypertens. 2004;13:73–81.PubMedCrossRefGoogle Scholar
  23. 23.
    Khurana RN, Baudendistel TE, Morgan EF, Rabkin RA, Elkin RB, Aalami OO. Postoperative rhabdomyolysis following laparoscopic gastric bypass in the morbidly obese. Arch Surg. 2004;139:73–6.PubMedCrossRefGoogle Scholar
  24. 24.
    Haynes P, Liangpunsakul S, Chalasani N. Nonalcoholic fatty liver disease in individuals with severe obesity. Clin Liver Dis. 2004;8:535–47.PubMedCrossRefGoogle Scholar
  25. 25.
    Abrams GA, Kunde SS, Lazenby AJ, Clements RH. Portal fibrosis and hepatic steatosis in morbidly obese subjects: a spectrum of nonalcoholic fatty liver disease. Hepatology. 2004;40:475–83.PubMedCrossRefGoogle Scholar
  26. 26.
    Burke A, Lucey MR. Non-alcoholic fatty liver disease, non-alcoholic steatohepatitis and orthotopic liver transplantation. Am J Transplant. 2004;4:686–93.PubMedCrossRefGoogle Scholar
  27. 27.
    Herpetz S, Kielmann R, Wolf AM, Hebebrand J, Senf W. Do psychosocial variables predict weight loss or mental health after obesity surgery? A systematic review. Obes Res. 2004;12:1554–69.CrossRefGoogle Scholar
  28. 28.
    Hsu LK, Betancourt S, Sullivan SP. Eating disturbances before and after vertical banded gastroplasty: a pilot study. Int J Eat Disord. 1996;19:23–34.PubMedCrossRefGoogle Scholar
  29. 29.
    Hsu LK, Benotti PN, Dwyer J, Roberts SB, Saltzman E, Shikora S, et al. Nonsurgical factors that influence the outcome of bariatric surgery: a review. Psychosom Med. 1998;60:338–46.PubMedCrossRefGoogle Scholar
  30. 30.
    Alvarado R, Alami RS, Hsu G, Safadi BY, Sanchez BR, Morton JM, et al. The impact of preoperative weight loss in patients undergoing laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2005;15:1282–9.PubMedCrossRefGoogle Scholar
  31. 31.
    Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561–71.PubMedCrossRefGoogle Scholar
  32. 32.
    Norman RJ, Noakes M, Wu R, Davies MJ, Moran L, Wang JX. Improving reproductive performance in overweight/obese women with effective weight management. Hum Reprod Update. 2004;10:267–80.PubMedCrossRefGoogle Scholar
  33. 33.
    Kapoor DS, Davila GW, Rosenthal RJ, Ghoniem GM. Pelvic floor dysfunction in morbidly obese women: pilot study. Obes Res. 2004;12:1104–7.PubMedCrossRefGoogle Scholar
  34. 34.
    Alvarez-Leite JI. Nutrient deficiencies secondary to bariatric surgery. Curr Opin Clin Nutr Metab Care. 2004;7:569–75.PubMedCrossRefGoogle Scholar
  35. 35.
    Faintuch J, Matsuda M, Cruz ME, Silva MM, Teivelis MP, Garrido Jr AB, et al. Severe protein-calorie malnutrition after bariatric procedures. Obes Surg. 2004;14:175–81.PubMedCrossRefGoogle Scholar
  36. 36.
    Hertz RP, Unger AN, McDonald M, Lustik MB, Biddulph-Krentar J. The impact of obesity of work limitations and cardiovascular risk factors in the U.S. workforce. J Occup Environ Med. 2004;46:1196–203.PubMedGoogle Scholar
  37. 37.
    Bungum T, Satterwhite M, Jackson AW, Morrow Jr JR. The relationship of body mass index, medical costs, and job absenteeism. Am J Health Behav. 2003;27:456–62.PubMedCrossRefGoogle Scholar
  38. 38.
    Pronk NP, Martinson B, Kessler RC, Beck AL, Simon GE, Wang P. The association between work performance and physical activity, cardiorespiratory fitness, and obesity. J Occup Environ Med. 2004;46:19–25.PubMedCrossRefGoogle Scholar
  39. 39.
    Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353–65.PubMedCrossRefGoogle Scholar
  40. 40.
    LABS Writing Group for the LABS Consortium, Belle SH, Chapman W, Courcoulas AP, Flum DR, Gagner M, Inabnet WB, et al. Relationship of body mass index with demographic and clinical characteristics in the Longitudinal Assessment of Bariatric Surgery (LABS). Surg Obes Relat Dis. 2008;4(4):474–80.PubMedCrossRefPubMedCentralGoogle Scholar
  41. 41.
    Ballantyne GH, Svahn J, Capella JF, Capella JF, Schmidt HJ, Wasielewski A, et al. Predictors of prolonged hospital stay following open and laparoscopic gastric bypass for morbid obesity: body mass index, length of surgery, sleep apnea, asthma, and the metabolic syndrome. Obes Surg. 2004;14:1042–50.PubMedCrossRefGoogle Scholar
  42. 42.
    Flancbaum L, Belsley S. Factors affecting morbidity and mortality of Roux-en-Y gastric bypass for clinically severe obesity: an analysis of 1,000 consecutive open cases by a single surgeon. J Gastrointest Surg. 2007;11:500–7.PubMedCrossRefPubMedCentralGoogle Scholar
  43. 43.
    Livingston EH, Arterburn D, Schifftner TL, Hunderson WG, DePalma RF. National Surgical Quality Improvement Program analysis of bariatric operations:modifiable risk factors contribute to bariatric surgical adverse outcomes. J Am Coll Surg. 2006;203:625–33.PubMedCrossRefGoogle Scholar
  44. 44.
    Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445–54.PubMedCrossRefGoogle Scholar
  45. 45.
    Smith MD, Patterson E, Wahed AS, Belle SH, Bessler M, Courcoulas AP, et al. Relationship between surgeon volume and adverse outcomes after RYGB in longitudinal assessment of bariatric surgery (LABS) study. Surg Obes Relat Dis. 2010;6:118–25.PubMedCrossRefPubMedCentralGoogle Scholar
  46. 46.
    Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship of surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery. 2003;134:613–21; discussion 621–3.PubMedCrossRefGoogle Scholar
  47. 47.
    Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg. 2004;240:586–93; discussion 593–4.PubMedPubMedCentralGoogle Scholar
  48. 48.
    Inabnet 3rd WB, Belle SH, Bessler M, Courcoulas A, Dellinger P, Garcia L, et al. Comparison of 30-day outcomes after non-LapBand primary and revisional bariatric surgical procedures from the Longitudinal Assessment of Bariatric Surgery study. Surg Obes Relat Dis. 2010;6(1):22–30.PubMedCrossRefPubMedCentralGoogle Scholar
  49. 49.
    Smith MD, Patterson E, Wahed AS, Belle SH, Berk PD, Courcoulas AP, et al. Thirty-day mortality after bariatric surgery: independently adjudicated causes of death in the Longitudinal Assessment of Bariatric Surgery. Obes Surg. 2011;21:1687–92.PubMedCrossRefPubMedCentralGoogle Scholar
  50. 50.
    Belle S, Berk PD, Chapman WH, Christian NJ, Courcoulas AP, Dakin GF, LABS Consortium, et al. Baseline characteristics of participants in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2). Surg Obes Relat Dis. 2013;9:926–35 [Presented at: ASMBS Annual Meeting, P-136; 2012 June 17; San Diego, CA].PubMedCrossRefGoogle Scholar
  51. 51.
    Mackey RH, Belle SH, Courcoulas AP, Dakin GF, Deveney CW, Flum DR, Longitudinal Assessment of Bariatric Surgery Consortium Writing Group, et al. Distribution of 10-year and lifetime predicted risk for cardiovascular disease prior to surgery in the Longitudinal Assessment of Bariatric Surgery-2 Study. Am J Cardiol. 2012;110(8):1130–7.PubMedCrossRefPubMedCentralGoogle Scholar
  52. 52.
    Sharkey KM, Machan JT, Tosi C, Roye GD, Harrington D, Millman RP. Predicting obstructive sleep apnea among women candidates for bariatric surgery. J Womens Health (Larchmt). 2010;19(10):1833–41.CrossRefGoogle Scholar
  53. 53.
    Valencia-Flores M, Orea A, Castaño VA, Resendiz M, Rosales M, Rebollar V, et al. Prevalence of sleep apnea and electrocardiographic disturbances in morbidly obese patients. Obes Res. 2000;8(3):262–9.PubMedCrossRefGoogle Scholar
  54. 54.
    Khan A, King WC, Patterson EJ, Laut J, Raum W, Courcoulas AP, et al. Assessment of obstructive sleep apnea in adults undergoing bariatric surgery in Longitudinal Assessment of Bariatric Surgery-2 Study. J Clin Sleep Med. 2013;9(1):21–9.PubMedPubMedCentralGoogle Scholar
  55. 55.
    Gosman GG, King WC, Schrope B, Steffen KJ, Strain GW, Courcoulas AP, et al. Reproductive health of women electing bariatric surgery. Fertil Steril. 2010;94:1426–31.PubMedCrossRefPubMedCentralGoogle Scholar
  56. 56.
    Yildiz BO, Knochenhauer ES, Azziz R. Impact of obesity on the risk for polycystic ovary syndrome. J Clin Endocrinol Metab. 2008;93(1):162–8.PubMedCrossRefPubMedCentralGoogle Scholar
  57. 57.
    Alvarez-Blasco F, Botella-Carretero JI, San Millan JL, Escobar-Morreale HF. Prevalence and characteristics of the polycystic ovary syndrome in overweight and obese women. Arch Intern Med. 2006;166(19):2081–6.PubMedCrossRefGoogle Scholar
  58. 58.
    Zinaman MJ, Clegg ED, Brown CC, O’Connor J, Selevan SG. Estimates of human fertility and pregnancy loss. Fertil Steril. 1996;65(3):503–9.PubMedGoogle Scholar
  59. 59.
    CDC/NCHS. National Health and Nutrition Examination Survey Questionnaire 2005–2006. http://www.cdc.gov/nchs/nhanes/nhanes2005-2006/quex05_06.htm. Accessed 23 May 2013.
  60. 60.
    Evers JL. Female subfertility. Lancet. 2002;360(9327):151–9.PubMedCrossRefGoogle Scholar
  61. 61.
    MacDorman MF, Munson ML, Kirmeyer S. Fetal and perinatal mortality, United States, 2004. Natl Vital Stat Rep. 2007;56(3):1–19.PubMedGoogle Scholar
  62. 62.
    King WC, Belle SH, Eid GM, Dakin GF, Inabnet WB, Mitchell JE, Longitudinal Assessment of Bariatric Surgery Study, et al. Physical activity levels of patients undergoing bariatric surgery in the Longitudinal Assessment of Bariatric Surgery Study. Surg Obes Relat Dis. 2008;4:721–8.PubMedCrossRefPubMedCentralGoogle Scholar
  63. 63.
    Diab DL, Yerian L, Schauer P, Kashyap SR, Lopez R, Hazen SL, et al. Cytokeratin 18 fragment levels as noninvasive biomarker for nonalcoholic steatohepatitis in bariatric surgery patients. Clin Gastroenterol Hepatol. 2008;6(11):1249–54.PubMedCrossRefPubMedCentralGoogle Scholar
  64. 64.
    Kleiner D, Berk PD, Hsu JY, Belle S, Courcoulas AP, Pomp A, et al. Spectrum of non-alcoholic fatty liver disease (NAFLD) in bariatric surgery patients with normal alanine aminotransferase (ALT). AASLD Annual Meeting, November 2009. Hepatology. 2009 (in Press).Google Scholar
  65. 65.
    Jacobi D, Ciangura C, Couet C, Oppert JM. Physical activity and weight loss following bariatric surgery. Obes Rev. 2010;12:366–77.CrossRefGoogle Scholar
  66. 66.
    Livhits M, Mercado DC, Yermilov I, Parikh JA, Dutson E, Mehran A, et al. Exercise following bariatric surgery: systematic review. Obes Surg. 2010;20:657–65.PubMedCrossRefPubMedCentralGoogle Scholar
  67. 67.
    King WC, Hsu JY, Belle SH, Courcoulas AP, Eid GM, Flum DR, et al. Pre- to postoperative changes in physical activity: report from the Longitudinal Assessment of Bariatric Surgery-2. Surg Obes Relat Dis. 2012;8(5):522–32.PubMedCrossRefPubMedCentralGoogle Scholar
  68. 68.
    King WC, Chen J, Mitchell JE, Kalarchian MA, Steffen KJ, Engel SG, et al. Prevalence of alcohol use disorders before and after bariatric surgery. JAMA. 2012;18:1–10.Google Scholar
  69. 69.
    Gourash WF, Ebel F, Lancaster K, Adenigi A, Iacono LK, Eagleton JK, LABS Consortium Retention Writing Group, et al. Longitudinal Assessment of Bariatric Surgery (LABS): retention strategy and results at 24 months. Surg Obes Relat Dis. 2013;9(4):514–9. [Presented at: ASMBS Annual Meeting, Presentation IH-106; 2012 June 17; San Diego, CA.]. http://www.sciencedirect.com/science/article/pii/S1550728913000932. Uncorrected proof available March 15, 2013.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  1. 1.Department of Minimally Invasive Bariatric and General SurgeryUniversity of Pittsburgh Medical CenterPittsburghUSA
  2. 2.Bariatric Surgery DepartmentOregon Health and Science UniversityPortlandUSA

Personalised recommendations