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The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase
- 作者:Chris A Rogers (1)
Richard Welbourn (2) James Byrne (3) Jenny L Donovan (4) Barnaby C Reeves (1) Sarah Wordsworth (5) Robert Andrews (2) Janice L Thompson (6) Paul Roderick (7) David Mahon (2) Hamish Noble (2) Jamie Kelly (3) Graziella Mazza (1) Katie Pike (1) Sangeetha Paramasivan (4) Natalie Blencowe (4) Mary Perkins (8) Tanya Porter (9) Jane M Blazeby (4)
- 关键词:Complex obesity ; Gastric band ; Gastric bypass ; Integrated qualitative research
- 刊名:Trials
- 出版年:2014
- 出版时间:December 2014
- 年:2014
- 卷:15
- 期:1
- 全文大小:425 KB
- 参考文献:1. / The health survey for England - 2010 trend tables London: Health and Social Care Information Centre; 2011.
2. Public Health England Obesity Knowledge and Intelligence team 2013. Available from: [class="a-plus-plus">http://www.noo.org.uk/NOO_about_obesity/morbid_obesity/ukprev] 3. WHO: class="a-plus-plus">Obesity and overweight (WHO fact sheet number 311). 2013. Available from: [centre/factsheets/fs311/en/" class="a-plus-plus">http://www.who.int/mediacentre/factsheets/fs311/en/] 4. O’Brien PE, Dixon JB, Brown W, Schachter LM, Chapman L, Burn AJ, / et al.: class="a-plus-plus">The laparoscopic adjustable gastric band (Lap-Band): a prospective study of medium-term effects on weight, health and quality of life. / Obes Surg 2002,class="a-plus-plus">12(5):652-60. Epub 2002/11/27 class="external" href="http://dx.doi.org/10.1381/096089202321019639" target="_blank" title="It opens in new window">CrossRef 5. Clegg AJ, Colquitt J, Sidhu MK, Royle P, Loveman E, Walker A: class="a-plus-plus">The clinical effectiveness and cost-effectiveness of surgery for people with morbid obesity: a systematic review and economic evaluation. / Health Technol Assess 2002,class="a-plus-plus">6(12):1-53. Epub 2002/08/28 6. Collaboration PS, Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, / et al.: class="a-plus-plus">Body-mass index and cause-specific mortality in 900,000 adults: collaborative analyses of 57 prospective studies. / Lancet 2009,class="a-plus-plus">373(9669):1083-096. Epub 2009/03/21 class="external" href="http://dx.doi.org/10.1016/S0140-6736(09)60318-4" target="_blank" title="It opens in new window">CrossRef 7. Law C, Power C, Graham H, Merrick D: class="a-plus-plus">Obesity and health inequalities. / Obes Rev 2007,class="a-plus-plus">8(Suppl 1):19-2. Epub 2007/02/24 8. Allender S, Rayner M: class="a-plus-plus">The burden of overweight and obesity-related ill health in the UK. / Obes Rev 2007,class="a-plus-plus">8(5):467-73. Epub 2007/08/25 class="external" href="http://dx.doi.org/10.1111/j.1467-789X.2007.00394.x" target="_blank" title="It opens in new window">CrossRef 9. Puhl RM, Moss-Racusin CA, Schwartz MB, Brownell KD: class="a-plus-plus">Weight stigmatization and bias reduction: perspectives of overweight and obese adults. / Health Educ Res 2008,class="a-plus-plus">23(2):347-58. Epub 2007/09/22 class="external" href="http://dx.doi.org/10.1093/her/cym052" target="_blank" title="It opens in new window">CrossRef 10. Throsby K: class="a-plus-plus">‘How could you let yourself get like that?-Stories of the origins of obesity in accounts of weight loss surgery. / Soc Sci Med 2007,class="a-plus-plus">65(8):1561-571. Epub 2007/07/27 class="external" href="http://dx.doi.org/10.1016/j.socscimed.2007.06.005" target="_blank" title="It opens in new window">CrossRef 11. Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, / et al.: class="a-plus-plus">The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. / Health Technol Assess 2009,class="a-plus-plus">13(41):1-90. 215-57, iii-iv. Epub 2009/09/04 12. NICE: / Obesity: the Prevention, Identification, Assessment and Management of Overweight and Obesity in Adults and Children. London; 2006. Available from: [ce.org.uk/nicemedia/live/11000/30365/30365.pdf" class="a-plus-plus">http://www.nice.org.uk/nicemedia/live/11000/30365/30365.pdf] 13. Birkmeyer NJ, Dimick JB, Share D, Hawasli A, English WJ, Genaw J, / et al.: class="a-plus-plus">Hospital complication rates with bariatric surgery in Michigan. / JAMA 2010,class="a-plus-plus">304(4):435-42. Epub 2010/07/29 class="external" href="http://dx.doi.org/10.1001/jama.2010.1034" target="_blank" title="It opens in new window">CrossRef 14. Dendrite Clinical Systems Ltd: / National Bariatric Surgery Registry. 2nd report. Dendrite Clinical Systems Ltd; 2009. Available from: [com/csp/bariatric/FrontPages/nbsrfront.csp" class="a-plus-plus">http://demo.e-dendrite.com/csp/bariatric/FrontPages/nbsrfront.csp] 15. Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, / et al.: class="a-plus-plus">Perioperative safety in the longitudinal assessment of bariatric surgery. / N Engl J Med 2009,class="a-plus-plus">361(5):445-54. Epub 2009/07/31 class="external" href="http://dx.doi.org/10.1056/NEJMoa0901836" target="_blank" title="It opens in new window">CrossRef 16. Tice JA, Karliner L, Walsh J, Petersen AJ, Feldman MD: class="a-plus-plus">Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. / Am J Med 2008,class="a-plus-plus">121(10):885-93. Epub 2008/10/01 class="external" href="http://dx.doi.org/10.1016/j.amjmed.2008.05.036" target="_blank" title="It opens in new window">CrossRef 17. Puzziferri N, Nakonezny PA, Livingston EH, Carmody TJ, Provost DA, Rush AJ: class="a-plus-plus">Variations of weight loss following gastric bypass and gastric band. / Ann Surg 2008,class="a-plus-plus">248(2):233-42. Epub 2008/07/25 class="external" href="http://dx.doi.org/10.1097/SLA.0b013e3181820cbc" target="_blank" title="It opens in new window">CrossRef 18. class="a-plus-plus">Surgeon specific outcome reports for bariatric surgery 2013. Available from: [com" class="a-plus-plus">http://nbsr.e-dendrite.com] 19. Buchwald H, Oien DM: class="a-plus-plus">Metabolic/bariatric surgery worldwide 2011. / Obes Surg 2013,class="a-plus-plus">23(4):427-36. Epub 2013/01/23 class="external" href="http://dx.doi.org/10.1007/s11695-012-0864-0" target="_blank" title="It opens in new window">CrossRef 20. Angrisani L, Lorenzo M, Borrelli V: class="a-plus-plus">Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: five-year results of a prospective randomized trial. / Surg Obes Relat Dis 2007,class="a-plus-plus">3(2):127-32. discussion 32-. Epub 2007/03/03 class="external" href="http://dx.doi.org/10.1016/j.soard.2006.12.005" target="_blank" title="It opens in new window">CrossRef 21. Angrisani L, Cutolo PP, Formisano G, Nosso G, Vitolo G: class="a-plus-plus">Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: ten-year results of a prospective, randomized trial. / Surg Obes Relat Dis 2013,class="a-plus-plus">9(3):405-13. Epub 2013/03/05 class="external" href="http://dx.doi.org/10.1016/j.soard.2012.11.011" target="_blank" title="It opens in new window">CrossRef 22. Nguyen NT, Slone JA, Nguyen XM, Hartman JS, Hoyt DB: class="a-plus-plus">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,class="a-plus-plus">250(4):631-41. Epub 2009/09/05 23. The EuroQol Group: class="a-plus-plus">EuroQol - a new facility for the measurement of health-related quality of life. / Health Policy 1990,class="a-plus-plus">16(3):199-08. Epub 1990/11/05 class="external" href="http://dx.doi.org/10.1016/0168-8510(90)90421-9" target="_blank" title="It opens in new window">CrossRef 24. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, / et al.: class="a-plus-plus">Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. / BMJ 2002,class="a-plus-plus">325(7367):766-70. Epub 2002/10/05 class="external" href="http://dx.doi.org/10.1136/bmj.325.7367.766" target="_blank" title="It opens in new window">CrossRef 25. Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, / et al.: class="a-plus-plus">Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. / J Clin Epidemiol 2009,class="a-plus-plus">62(1):29-6. Epub 2008/07/16 class="external" href="http://dx.doi.org/10.1016/j.jclinepi.2008.02.010" target="_blank" title="It opens in new window">CrossRef 26. Donovan JL, Parmasivan S, de Salis I, Torrien M: class="a-plus-plus">Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled class="a-plus-plus">trials class="a-plus-plus">. / Trials 2014,class="a-plus-plus">15(1):5. class="external" href="http://dx.doi.org/10.1186/1745-6215-15-5" target="_blank" title="It opens in new window">CrossRef 27. Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, McMahon MM, / et al.: class="a-plus-plus">Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient-2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. / Endocr Pract 2013,class="a-plus-plus">19(2):337-72. Epub 2013/03/27 class="external" href="http://dx.doi.org/10.4158/EP12437.GL" target="_blank" title="It opens in new window">CrossRef 28. Sjostrom L: class="a-plus-plus">Review of the key results from the Swedish obese subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. / J Intern Med 2013,class="a-plus-plus">273(3):219-34. class="external" href="http://dx.doi.org/10.1111/joim.12012" target="_blank" title="It opens in new window">CrossRef 29. Crosby RD, Kolotkin RL, Williams GR: class="a-plus-plus">An integrated method to determine meaningful changes in health-related quality of life. / J Clin Epidemiol 2004,class="a-plus-plus">57(11):1153-160. Epub 2004/11/30 class="external" href="http://dx.doi.org/10.1016/j.jclinepi.2004.04.004" target="_blank" title="It opens in new window">CrossRef 30. Kolotkin RL, Crosby RD: class="a-plus-plus">Psychometric evaluation of the impact of weight on quality of life-lite questionnaire (IWQOL-lite) in a community sample. / Qual Life Res 2002,class="a-plus-plus">11(2):157-71. Epub 2002/05/23 class="external" href="http://dx.doi.org/10.1023/A:1015081805439" target="_blank" title="It opens in new window">CrossRef 31. Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, / et al.: class="a-plus-plus">Gastrointestinal quality of life index: development, validation and application of a new instrument. / Br J Surg 1995,class="a-plus-plus">82(2):216-22. Epub 1995/02/01 class="external" href="http://dx.doi.org/10.1002/bjs.1800820229" target="_blank" title="It opens in new window">CrossRef 32. Zigmond AS, Snaith RP: class="a-plus-plus">The hospital anxiety and depression scale. / Acta Psychiatr Scand 1983,class="a-plus-plus">67(6):361-70. Epub 1983/06/01 class="external" href="http://dx.doi.org/10.1111/j.1600-0447.1983.tb09716.x" target="_blank" title="It opens in new window">CrossRef 33. Chung F, Elsaid H: class="a-plus-plus">Screening for obstructive sleep apnea before surgery: why is it important? / Curr Opin Anaesthesiol 2009,class="a-plus-plus">22(3):405-11. Epub 2009/05/05 class="external" href="http://dx.doi.org/10.1097/ACO.0b013e32832a96e2" target="_blank" title="It opens in new window">CrossRef 34. Parkes J, Roderick P, Harris S, Day C, Mutimer D, Collier J, / et al.: class="a-plus-plus">Enhanced liver fibrosis test can predict clinical outcomes in patients with chronic liver disease. / Gut 2010,class="a-plus-plus">59(9):1245-251. Epub 2010/08/03 class="external" href="http://dx.doi.org/10.1136/gut.2009.203166" target="_blank" title="It opens in new window">CrossRef 35. Buse JB, Caprio S, Cefalu WT, Ceriello A, Del Prato S, Inzucchi SE, / et al.: class="a-plus-plus">How do we define cure of diabetes? / Diabetes Care 2009,class="a-plus-plus">32(11):2133-135. Epub 2009/10/31 class="external" href="http://dx.doi.org/10.2337/dc09-9036" target="_blank" title="It opens in new window">CrossRef 36. / Excellence NIfHaC. Available from: [ce.org.uk" class="a-plus-plus">http://www.nice.org.uk] 37. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB: class="a-plus-plus">Recommendations of the panel on cost-effectiveness in health and medicine. / JAMA 1996,class="a-plus-plus">276(15):1253-258. Epub 1996/10/16 class="external" href="http://dx.doi.org/10.1001/jama.1996.03540150055031" target="_blank" title="It opens in new window">CrossRef 38. Kind P, Dolan P, Gudex C, Williams A: class="a-plus-plus">Variations in population health status: results from a United Kingdom national questionnaire survey. / BMJ 1998,class="a-plus-plus">316(7133):736-41. Epub 1998/04/08 class="external" href="http://dx.doi.org/10.1136/bmj.316.7133.736" target="_blank" title="It opens in new window">CrossRef 39. Brolin RE: class="a-plus-plus">Bariatric surgery and long-term control of morbid obesity. / JAMA 2002,class="a-plus-plus">288(22):2793-796. Epub 2002/12/11 class="external" href="http://dx.doi.org/10.1001/jama.288.22.2793" target="_blank" title="It opens in new window">CrossRef 40. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, / et al.: class="a-plus-plus">No surgical innovation without evaluation: the IDEAL recommendations. / Lancet 2009,class="a-plus-plus">374(9695):1105-112. Epub 2009/09/29 class="external" href="http://dx.doi.org/10.1016/S0140-6736(09)61116-8" target="_blank" title="It opens in new window">CrossRef 41. Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L: class="a-plus-plus">OMERACT: an international initiative to improve outcome measurement in rheumatology. / Trials 2007, class="a-plus-plus">8:38. Epub 2007/11/28 class="external" href="http://dx.doi.org/10.1186/1745-6215-8-38" target="_blank" title="It opens in new window">CrossRef 42. / COMET Initiative. Available from: [comet-initiative.org/" class="a-plus-plus">http://www.comet-initiative.org/] 43. / MRC ConDuCT Hub. Available from: [c.uk/social-community-medicine/centres/conduct/" class="a-plus-plus">http://www.bris.ac.uk/social-community-medicine/centres/conduct/] 44. Donovan J, Hamdy F, Neal D, Peters T, Oliver S, Brindle L, / et al.: class="a-plus-plus">Prostate testing for cancer and treatment (ProtecT) feasibility study. / Health Technol Assess 2003,class="a-plus-plus">7(14):1-8. Epub 2003/04/24 45. Higgins JPT, Altman DG: class="a-plus-plus">Assessing risk of bias in included studies. In / Cochrane Handbook for Systematic Reviews of Interventions. Edited by: Higgins JPT, Green S. Chichester (UK): John Wiley & Sons; 2008:187-41. class="external" href="http://dx.doi.org/10.1002/9780470712184.ch8" target="_blank" title="It opens in new window">CrossRef
- 作者单位:Chris A Rogers (1)
Richard Welbourn (2) James Byrne (3) Jenny L Donovan (4) Barnaby C Reeves (1) Sarah Wordsworth (5) Robert Andrews (2) Janice L Thompson (6) Paul Roderick (7) David Mahon (2) Hamish Noble (2) Jamie Kelly (3) Graziella Mazza (1) Katie Pike (1) Sangeetha Paramasivan (4) Natalie Blencowe (4) Mary Perkins (8) Tanya Porter (9) Jane M Blazeby (4)
1. Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK 2. Taunton and Somerset NHS Trust, Taunton, UK 3. Southampton University Hospitals NHS Trust, Southampton, UK 4. School of Social and Community Medicine, University of Bristol, Bristol, UK 5. Economics, Health Economic Research Centre, University of Oxford, Oxford, UK 6. School of Sport and Exercise Sciences, University of Birmingham, Birmingham, UK 7. Faculty of Medicine, University of Southampton, Southampton, UK 8. University Hospitals Bristol NHS Trust, Bristol, UK 9. The Bariatric Group, Nuffield Health Taunton Hospital, Taunton, UK
- ISSN:1745-6215
文摘
Background The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment. Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed. Design This open parallel-group randomised controlled trial will compare the effectiveness, cost-effectiveness and acceptability of gastric band (Band) versus gastric bypass (Bypass) in adults with severe and complex obesity. It has an internal pilot phase (in two centres) with integrated qualitative research to establish effective and optimal methods for recruitment. Adults with a body mass index (BMI) of 40?kg/m2 or more, or a BMI of 35?kg/m2 or more and other co-morbidities will be recruited. At the end of the internal pilot the study will expand into more centres if the pre-set progression criteria of numbers and rates of eligible patients screened and randomised are met and if the expected rates of retention and adherence to treatment allocation are achieved. The trial will test the joint hypotheses that Bypass is non-inferior to Band with respect to more than 50% excess weight loss and that Bypass is superior to Band with respect to health related quality of life (HRQOL, EQ-5D) at three years. Secondary outcomes include other weight loss measures, waist circumference and remission/resolution of co-morbidities; generic and symptom-specific HRQOL; nutritional blood test results; resource use; eating behaviours and adverse events. A core outcome set for reporting the results of obesity surgery will be developed and a systematic review of the evidence for sleeve gastrectomy undertaken to inform the main study design. Discussion By-Band is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity. The design will enable and empower surgeons to learn to recruit and participate in a randomised study. Early evidence shows that timely recruitment is possible. Trial registration Current Controlled Trials ISRCTN00786323.
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