3-Year real-world outcomes with the swedish adjustable gastric band™ in France

Obesity Surgery

Volumn 23, Issue 2, 2013, Pages 184-196

  Ribaric, G ^a   Buchwald, J N ^b   D'Orsay, G ^a   Daoud, F ^c  

^a ETHICON INC   (United States)

^b Division of Scientific Writing   (United States)

^c Data Management and Biometrics   (France)

Author keywords

BAROS; EQ 5D; Laparoscopic adjustable gastric banding; National outcomes; Obesity; QALY; Quality of life; SAGB; Swedish adjustable gastric band

Indexed keywords

ADULT; ARTHROPATHY; ARTICLE; BAROS ANALYSIS AND REPORTING OUTCOME SYSTEM; BODY MASS; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COHORT ANALYSIS; COMORBIDITY; DEVICE REMOVAL; DIABETES MELLITUS; DISEASE DURATION; DYSLIPIDEMIA; ESOPHAGUS DILATATION; FAMILY HISTORY; FEMALE; FOLLOW UP; FRANCE; GASTRIC BAND; GASTRIC BANDING; GASTROESOPHAGEAL REFLUX; HUMAN; HYPERTENSION; INTENTION TO TREAT ANALYSIS; LAPAROSCOPIC SURGERY; LAPAROTOMY; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; SLEEP DISORDERED BREATHING; SURGICAL EQUIPMENT; SURVIVAL RATE; VISUAL ANALOG SCALE; WEIGHT REDUCTION;

ADULT; BODY MASS INDEX; COMORBIDITY; DEVICE REMOVAL; FEMALE; FOLLOW-UP STUDIES; FRANCE; GASTROPLASTY; HUMANS; LAPAROSCOPY; MALE; OBESITY, MORBID; PROSPECTIVE STUDIES; QUALITY OF LIFE; TIME FACTORS; TREATMENT OUTCOME; WEIGHT LOSS;

EID: 84878867815     PISSN: 09608923     EISSN: 17080428     Source Type: Journal    
DOI: 10.1007/s11695-012-0765-2     Document Type: Article

References (80)

1. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2008. Obes Surg. 2009;19:1605-11.
2. Basdevant A, Paita M, Rodde-Dunet M-H, et al. A nationwide survey on bariatric surgery: two years prospective follow-up. Obes Surg. 2007;17:39-44.
3. Avis de la CEPP du 1er septembre 2004 modifié le 20 octobre 2004 SAGB (anneau gastrique ajustable suédois), implant annulaire ajustable pour gastroplastie. Modèles 2100-X et 2200-X. http://www.santedev.org/ biblio/pdf2/has/cepp/2004/10/20/pp020367.pdf. Accessed: March 12, 2012
4. Avis de la CEPP 8 mars 2006 SAGB (anneau gastrique ajustable suédois) Quick-Close fourni avec le site VELOCITY et son applicateur, implant annulaire ajustable pour gastroplastie. Modèle BD2XV.
5. Association Française d'Etudes et de Recherches sur l'Obésité, Association de Langue Française pour l'Etude du Diabète et des Maladies Métaboliques, Société de Nutrition et de Diététique de Langue Française. Recommandations pour le diagnostic, la prévention et le traitement des obésités en France. Cah Nutr Diet. 1998;33:10-42.
6. Haute Autorité de Santé: Obésité: prise en charge chirurgicale chez l'adulte. Recommandations de bonnes pratiques professionnelles. January 2009. http://www.has-sante.fr/portail/jcms/c-765529/ obesite-prise-en-charge-chirurgicale-chez-l-adulte. Accessed: March 12, 2012
7. Prospective National Cohort Study on Swedish Adjustable Gastric Band (SAGB) for Gastroplasty (Étude de Cohorte Nationale Prospective de l'Implant Annulaire Ajustable Pour Gastroplastie SAGB). PROTOCOL N: 05-FR-004 1.0. Protocol available at: clinicaltrials.gov: http://clinicaltrials.gov/ct2/ show/NCT01183975?term=ethicon+endo-surgery&rank=15
8. Clinical investigation of medical devices for human subjects - part 1: general requirements. International Standard Ref. ISO 14155-1:2003(E).
9. Clinical investigation of medical devices for human subjects - part 1: clinical investigation plans. International Standard Ref. ISO 14155-2:2003(E). First edition May 15, 2003.
10. World Medical Association. 7 Declaration of Helsinki: ethical principles for medical research involving human subjects, 22 October 2008. www.wma.net/en/30publications/10policies/b3/index.html.
11. NIH. Gastrointestinal surgery for severe obesity. NIH Consensus Statement 1991; Mar 25-27;9(1):1-20.
12. Fried M, Hainer V, Basdevant A, et al. Inter-disciplinary European guidelines on surgery of severe obesity. Int J Obes (Lond). 2007;31(4):569-77.
13. WHO: Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. WHO Technical Report Series 854. Geneva: World Health Organization, 1995.
14. Lorentz FH. Ein neuer Konstitionsinde. Klin Wochenschr. 1929;8:348-51.
15. Lorentz FH. Ein neuer Konstitionsinde der Frau. Klin Wochenschr. 1929;16:734-6.
16. Miller MA. A calculated method for the determination of ideal body weight. Nutr Support Serv. 1985;5(3):31-3.
17. Deitel M, Greenstein RJ. Recommendations for reporting weight loss. Obes Surg. 2003;13(2):159-60.
18. Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg. 1998;9:947-54.
19. Nini E, Slim K, Scesa JL, et al. Evaluation de la chirurgie coelioscopique de l'obésité par le score BAROS. Ann Chir. 2002;127(2):107-14.
20. Ackroyd R, Mouiel J, Chevallier JM, et al. Cost-effectiveness and budget impact of obesity surgery in patients with type 2 diabetes in 3 European countries. Obes Surg. 2006;16:1488-503.
21. EuroQoL Group. EuroQoL: a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199-208.
22. Dolan P, Gudex C, Kind P, et al. A social tariff for EuroQoL: results from a UK general population survey, in York Centre for Health Economics Discussion Paper. University of York: York, UK; 1990.
23. Kind P, Dolan P, Gudex C, et al. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ. 1998;316:736-41.
24. Dixon S, Farina C, McEwan P, et al. Evaluation of the association between health-related utility and obesity in hospital treated subjects. Value Health. 2004;7:331.
25. Brazier J, Roberts J, Tsuchiya A, et al. A comparison of the EQ-5D and SF-6D across seven patient groups. Health Econ. 2004;13:873-4.
26. Di Lorenzo N, Furbetta F, Favretti F, et al. Laparoscopic gastric banding via pars flaccida versus perigastric positioning: technique, complications, and results in 2,549 patients. Surg Endosc. 2010;24:1519-23.
27. Nguyen NT, Slone JA, Nguyen XM, et al. A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life, and costs. Ann Surg. 2009;250(4):631-41.
28. Himpens J, Cadière GB, Bazi M, et al. Long-term outcomes of laparoscopic adjustable gastric banding. Arch Surg. 2011;146(7):802-7.
29. Buchwald H, Estok R, Fahrbach K, et al. Trends in mortality in bariatric surgery: a systematic review and meta-analysis. Surgery. 2007;142(4):621-32. discussion 632-5.
30. Champault A, Duwat O, Polliand C, et al. Quality of life after laparoscopic gastric banding: prospective study (152 cases) with a follow-up of 2 years. Surg Laparosc Endosc Percutan Tech. 2006;16(3):131-6.
31. Sach TH. The relationship between BMI and HR-QoL: comparing the EQ-5D, EuroQol VAS and SF-6D. Int J Obes. 2007;31:189-96.
32. National Library of Medicine. Electronic PubMed database search for adjustable gastric banding. http://www.ncbi.nlm.nih.gov/pubmed?term= adjustable%20gastric%20banding. Accessed: March 20, 2012.
33. Apovian CM, Cummings S, Anderson W, et al. Best practice updates for multidisciplinary care in weight loss surgery. Obesity (Silver Spring). 2009;17(5):871-9. Epub 2009 Feb 19.
34. American Society for Metabolic and Bariatric Surgery (ASMBS). http://asmbs.org/2012/03/unified-national-accreditation-program-for-bariatric- surgery-centers-announced-by-american-college-of-surgeons-and-american-society- for-metabolic-and-bariatric-surgery/. Accessed: March 20, 2012
35. American College of Surgeons National Surgical Quality Improvement Program (NSQIP). http://site.acsnsqip.org/about/business-case/. Accessed: March 15, 2012
36. Surgical Review Corporation (SRC). http://www.surgicalreview.org/coe- programs/bariatric/. Accessed: March 15, 2012
37. Rubin M, Spivak H. Prospective study of 250 patients undergoing laparoscopic gastric banding using the two-step technique: a technique to prevent postoperative slippage. Surg Endosc. 2003;17(6):857-60.
38. Naef M, Naef U, Mouton WG, et al. Outcome and complications after laparoscopic Swedish adjustable gastric banding: 5-year results of a prospective clinical trial. Obes Surg. 2007;17(2):195-201.
39. Steffen R, Biertho L, Ricklin T, et al. Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg. 2003;13(3):404-11.
40. 2). Surg Endosc. 2003;17(10):1541-5.
41. Fox SR, Fox KM, Srikanth MS, et al. The Lap-Band system in a North American population. Obes Surg. 2003;13(2):275-80.
42. Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg. 2005;201(4):529-35.
43. Jan JC, Hong D, Pereira N, et al. Laparoscopic adjustable gastric banding versus laparoscopic gastric bypass for morbid obesity: a single-institution comparison study of early results. J Gastrointest Surg. 2005;9(1):30-41.
44. Buchwald H, Estok R, Fahrbach K, et al. Trends in mortality in bariatric surgery: a systematic review and meta-analysis. Surgery. 2007;142(4):621-32. discussion 632-635.
45. Garb J, Welch G, Zagarins S, et al. Bariatric surgery for the treatment of morbid obesity: a meta-analysis of weight loss outcomes for laparoscopic adjustable gastric banding and laparoscopic gastric bypass. Obes Surg. 2009;19(10):1447-55.
46. Nguyen NT, Hohmann S, Slone J, et al. Improved bariatric surgery outcomes for Medicare beneficiaries after implementation of the medicare national coverage determination. Arch Surg. 2010;145(1):72-8.
47. Sánchez-Santos R, Masdevall C, Baltasar A, et al. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg. 2009;19(9):1203-10. Epub 2009 Jul 2.
48. Sundbom M, Karlson BM. Low mortality in bariatric surgery 1995 through 2005 in Sweden, in spite of a shift to more complex procedures. Obes Surg. 2009;19(12):1697-701.
49. Schilling PL, Davis MM, Albanese CT, et al. National trends in adolescent bariatric surgical procedures and implications for surgical centers of excellence. J Am Coll Surg. 2008;206(1):1-12. Epub 2007 Oct 18.
50. Morino M, Toppino M, Forestieri P, et al. Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry. Ann Surg. 2007;246(6):1002-7. discussion 1007-9.
51. Ricciardi R, Town RJ, Kellogg TA, et al. Outcomes after open versus laparoscopic gastric bypass. Surg Laparosc Endosc Percutan Tech. 2006;16(5):317-20.
52. Davis MM, Slish K, Chao C, et al. National trends in bariatric surgery, 1996-2002. Arch Surg. 2006;141(1):71-4. discussion 75.
53. Carbonelli AM, Lincourt AE, Matthews BD, et al. National study of the effect of patient and hospital characteristics on bariatric surgery outcomes. Am Surg. 2005;71(4):308-14.
54. Nguyen NT, Root J, Zainabadi K, et al. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg. 2005;140(12):1198-202. discussion 1203.
55. Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005;294(15):1909-17.
56. Trus TL, Pope GD, Finlayson SR. National trends in utilization and outcomes of bariatric surgery. Surg Endosc. 2005;19(5):616-20. Epub 2005 Mar 11.
57. Poulose BK, Holzman MD, Zhu Y, et al. National variations in morbid obesity and bariatric surgery use. J Am Coll Surg. 2005;201(1):77-84.
58. Angrisani L, Di Lorenzo N, Favretti F, et al. The Italian Group for LAP-BAND: predictive value of initial body mass index for weight loss after 5 years of follow-up. Surg Endosc. 2004;18(10):1524-7. Epub 2004 Aug 26.
59. Belle SH, Berk PD, Courcoulas AP, et al. Longitudinal Assessment of Bariatric Surgery Consortium Writing Group. Safety and efficacy of bariatric surgery: longitudinal assessment of bariatric surgery. Surg Obes Relat Dis. 2007;3(2):116-26.
60. 2) patients? A NSQIP data analysis. Surg Obes Relat Dis. 2011;7(4):452-8.
61. Demaria EJ, Winegar DA, Pate VW, et al. Early postoperative outcomes of metabolic surgery to treat diabetes from sites participating in the ASMBS bariatric surgery center of excellence program as reported in the Bariatric Outcomes Longitudinal Database. Ann Surg. 2010;252(3):559-66. discussion 566-7.
62. World Health Organization: WHO Global Infobase: country collected data, 2010. Accessible at: https://apps.who.int/infobase/comparestart.aspx.
63. Burns EM, Naseem H, Bottle A, et al. Introduction of laparoscopic bariatric surgery in England: observational population cohort study. BMJ. 2010;341:c4296.
64. Harbottle L. Audit of nutritional and dietary outcomes of bariatric surgery patients. Obes Rev. 2011;12(3):198-204.
65. Schauer DP, Arterburn DE, Livingston EH, et al. Decision modeling to estimate the impact of gastric bypass surgery on life expectancy for the treatment of morbid obesity. Arch Surg. 2010;145(1):57-62.
66. Martin M, Beekley A, Kjorstad R, et al. Socioeconomic disparities in eligibility and access to bariatric surgery: a national population-based analysis. Surg Obes Relat Dis. 2010;6(1):8-15. Epub 2009 Jul 17.
67. Stroh C, Birk D, Flade-Kuthe R, et al. A nationwide survey on bariatric surgery in Germany - results 2005-2007. Obes Surg. 2009;19(1):105-12. Epub 2008 Oct 22.
68. Santos LM, de Oliveira IV, Peters LR, et al. Trends in morbid obesity and in bariatric surgeries covered by the Brazilian Public Health System. Obes Surg. 2010;20(7):943-8. Epub 2008 Jun 7.
69. Christou NV, Efthimiou E. Bariatric surgery waiting times in Canada. Can J Surg. 2009;52(3):229-34.
70. Dallal RM, Datta T, Braitman LE. Medicare and Medicaid status predicts prolonged length of stay after bariatric surgery. Surg Obes Relat Dis. 2007;3(6):592-6. Epub 2007 Oct 23.
71. Chevallier J-M, Paita M, Rodde-Dunet M-H. Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. Ann Surg. 2007;246(6):1034-9.
72. Tsai WS, Inge TH, Burd RS. Bariatric surgery in adolescents: recent national trends in use and in-hospital outcome. Arch Pediatr Adolesc Med. 2007;161(3):217-21.
73. Santry HP, Chin MH, Cagney KA, et al. The use of multidisciplinary teams to evaluate bariatric surgery patients: results from a national survey in the USA. Obes Surg. 2006;16(1):59-66.
74. Sjostrom L, Lindroos A-K, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. NEJM. 2004;351(26):2683-93.
75. Phillips E, Ponce J, Cunneen SA. Safety and effectiveness of REALIZE adjustable gastric band: 3-year prospective study in the United States. Surg Obes Rel Dis. 2009;5:588-97.
76. Gouillat C, Denis A, Badol-Van Straaten P, et al. Prospective, multicenter, 3-year trial of laparoscopic adjustable gastric banding with the MIDBAND™. Obes Surg. 2012;22(4):572-81.
77. Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery. 2004;135:326-51.
78. Tice JA, Karliner L, Walsh J, et al. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med. 2008;121:885-93.
79. O'Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16:1032-40.
80. Cunneen SA, Phillips E, Fielding G, et al. Studies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis. Surg Obes Relat Dis. 2008;4(2):174-85. Epub 2008 Feb 1. Review.