CCOHTA. Laparoscopic Adjustable Gastric Banding for Clinically Severe Obesity. No. 20 Apr 2003

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1 CCO No. 20 Apr 2003 PRE-ASSESSMENT Before CCO decides to undertake a health technology assessment, a pre-assessment of the literature is performed. Pre-assessments are based on a limited literature search; they are not extensive, systematic reviews of the literature. They are provided here as a quick guide to important, current assessment information on this topic. Readers are cautioned that the pre-assessments have not been externally peer reviewed. Introduction Obesity is a major health concern, particularly in North America. About 35% of Canadian men and 27% of Canadian women are obese. Obesity increases the risk of developing other health conditions such as diabetes, cardiovascular disease, arthritis, depression, sleep apnea and some types of cancer. 1,2 A 1997 study estimated that direct costs attributable to obesity in Canada totaled over $1.8 billion. 3 Diet, exercise and behavioural therapy are used for weight loss. Drug treatments may also be used if these interventions fail. Drug therapies include gastrointestinal lipase inhibitors (orlistat), serotonin norepinephrine reuptake inhibitors (sibutramine) and appetite suppressants. 1 Individuals with clinically severe (morbid) obesity are defined as a Body Mass Index (BMI) 40, or a BMI 35 with comorbid conditions and may be considered for surgical interventions. 4 According to a recent Swedish report on obesity, there are at least ten different surgical procedures used to treat morbid obesity and several variations on these procedures. 5 The surgical interventions can be divided into two types of procedures: malabsorptive (bypassing parts of the gastrointestinal tract to limit the absorption of food) and restrictive (decreasing the size of the stomach). 6 Research Questions This question is primarily concerned with the laparoscopic adjustable gastric banding device, a restrictive procedure for the treatment of morbid obesity. There are several devices used for gastric banding. The BioEnterics LAP-BAND System (INAMED Corporation) was licensed by Health Canada in 1999 and received pre-market approval from the US Food and Drug Administration in The Swedish Adjustable Gastric Banding device has been in use in Europe for many years, and has recently become available in Canada (Dave Ames, Johnson & Johnson Medical Products, Markham, ON: personal communication, 2003 Mar 17). 8 At least two other devices have been developed and used in Europe. The main questions surrounding the use of this technology are: What are the long-term outcomes associated with the laparoscopic adjustable gastric banding procedure? How does this procedure compare, in terms of safety, effectiveness and costs, to other types of bariatric surgery in the treatment of morbid obesity? How do the different devices used for laparoscopic adjustable gastric banding compare? The Canadian Coordinating Office for Health Technology Assessment (CCO)

2 CCO Assessment Process Preliminary literature searches of PubMed, The Cochrane Library (Issue 1, 2003) and the CRD databases (, DARE and NHS EED) were performed in March In addition, the web sites of health technology assessment () agencies mainly those that produce at least some of their assessments in English were scanned. Several agencies with work in on this topic were contacted for further information on their projects. The selected reports shown below are s, systematic reviews or guidelines either published since 1998 or currently in. Summary of Findings Assessments of treatments for morbid obesity have been issued by several agencies. Table 1 lists assessments which included, or focused on, laparoscopic adjustable banding for severe obesity. Table 2 lists additional assessments of other treatments for this condition, such as other surgical procedures or drug therapies. Table 1: Reports on laparoscopic adjustable gastric banding for morbid obesity Type of Reference Findings Report Chapman A, Game P, O Brien P, Maddern G, Kiroff G, Foster B, et al. Systematic review of laparoscopic adjustable gastric banding for the treatment of obesity: update & re-appraisal. 2 nd ed. Adelaide: Australian Safety and Efficacy Register of New Interventional Procedures Surgical; ASERNIP-S report no 31. This report updates an earlier (2000) systematic review. Both reports, along with a consumer summary, are available: p-s/publications_obesity.htm Obesity problems and interventions: a systematic review. Stockholm: Swedish Council on Technology Assessment in Health Care; English summary available: PUB/1240/obsesityslut.pdf. - The ASERNIP-S Review Group concluded that the evidence base was of average quality up to 4 years for laparoscopic adjustable gastric banding. Laparoscopic gastric banding is safer than vertical banded gastroplasty and Roux-en-Y gastric bypass, in terms of short-term mortality rates. Laparoscopic gastric banding is effective, at least up to 4 years, as are the comparator procedures. Up to 2 years the laparoscopic gastric band results in less weight loss than Roux-en-Y gastric bypass; from 2-4 years there is insufficient evidence to conclude that Rouxen-Y remains more effective than laparoscopic gastric banding. Long-term efficacy of laparoscopic gastric banding remains unproven and further evaluation by randomised controlled trials is recommended to define its merits relative to the comparator procedures. - The English summary does not include a detailed analysis of the laparoscopic banding procedure, but makes the following general conclusions: Of the surgical methods used in Sweden, gastric bypass has the strongest scientific documentation and the best effect on weight reduction In people with severe obesity, surgical treatment has positive, well-documented long-term effects on weight, quality of life, and morbidity from diabetes. The Canadian Coordinating Office for Health Technology Assessment (CCO)

3 CCO Guidance on the use of surgery to aid weight reduction for people with morbid obesity [Technology appraisal guidance no 46]. London: National Institute for Clinical Excellence; Available: uidance-pdf-morbid.pdf. Clegg A, Colquitt J, Sidhu MK, Royle P, Loveman E, Walker A. The clinical effectiveness and cost-effectiveness of surgery for people with morbid obesity: a systematic review and economic evaluation. Health Technol Assess 2002;6(12): Available: ullmono/mon612.pdf. Schneider WL. Laparoscopic adjustable gastric banding for clinically severe (morbid) obesity [ 7 series B]. Edmonton: Alberta Heritage Foundation for Medical Research; Available: - This guidance is based on the listed below, by Clegg et al. - Concerning gastric banding, the Guidance concluded that: Gastric banding is associated with more long-term weight loss, fewer re-operations and greater patient satisfaction than vertical banded gastroplasty, although the difference in the results is not statistically significant. It is the least invasive of the procedures, involving no permanent alteration of the anatomy. Laparoscopic surgery is as effective as open surgery, but results in fewer complications and a reduced length of hospital stay. - When compared with conventional treatment, surgery resulted in a significantly greater loss of weight (23-37 kg more weight), which was maintained at 8 years. As a consequence, there were improvements in QoL [quality of life] and comorbidities associated with the loss of weight from surgery. Comparison of the different types of surgery showed that gastric bypass appeared more beneficial, with a greater weight loss (6-14 kg more weight) and/or improvements in co-morbidities and complications than either gastroplasty or jejunoileal bypass. Assessment of open versus laparoscopic gastric bypass and adjustable silicone gastric banding showed fewer serious complications with laparoscopic placement. Laparoscopic surgery had a longer operative time compared with open surgery, but resulted in reduced blood loss, proportion of patients requiring intensive care unit stay, length of hospital stay, days to return to activities of daily living and days to return to work. - The authors caution that the costs in the report are based on several assumptions, that the evidence of clinical effectiveness varies between the different procedures, and that the costs reflect the UK setting. They concluded that The total net costs of treating morbid obesity (over 20 years) through surgical procedures varied from 9, for vertical banded gastroplasty to 10, for silicone adjustable gastric banding - Whether LAGB [laparoscopic adjustable gastric banding] will replace current standard of care (Roux-en-Y gastric bypass) or become part of mainstream treatment for morbid obesity can only be determined by well designed studies reporting greater than five year outcomes of patients who have had the procedure. The Canadian Coordinating Office for Health Technology Assessment (CCO)

4 CCO Guideline in in Systematic review in Chirurgie de l obésité morbide de l adulte. Paris: Agence Nationale d Accréditation et d Évaluation en Santé; Available: cations.nsf/npdffile/ra_assi- 57JE6F/$File/Obesite.pdf. Society of American Gastrointestinal Endoscopic Surgeons, American Society for Bariatric Surgery. SAGES guidelines for laparoscopic and conventional surgical treatment of morbid obesity. Santa Monica (CA): The Society; Publ no Available: Le traitement chirurgical de l obésité morbide. Montreal: Conseil d Évaluation des Technologies de la Santé du Québec; Rapport CÉTS 98-1 RF. Available: publications/scientifiques/aetmi s_x/1998_01_res_fr.pdf. Tratamiento quirúrgico de la obesidad mórbida. Vitoria- Gastiez: Basque Office for Health Technology Assessment / Inst. de Salud Carlos III. osteba/inv01_c.htm Laparoscopic adjustable gastric banding. Canberra: Medical Services Advisory Committee. Colquitt J, Clegg A, Sidhu M, Royle P. Surgery for morbid obesity [protocol for a Cochrane review]. Cochrane Library 2003; (Issue 1). Because of the insufficient long-term evaluation of gastroplasty rings, with regards to both their effectiveness and the attendant risks (specifically the risks concerning tolerance of the prosthetic material and of intra-gastric migration of the ring), the working group is concerned about the broad, evaluation-free distribution of this technique which is currently taking place. - Bariatric surgery currently provides the only significant, sustained weight loss. Laparoscopic techniques, based on their open counterparts, are available. When performed by appropriately trained surgeons, laparoscopic approaches appear to hasten the patient s recovery and return to normal function. Experience and training in bariatric surgery, advanced laparoscopic surgery skills, and a commitment to long-term patient management are required. - an update to this assessment is in - forthcoming Summer 2003 (will be published in Spanish, with an abstract in English and Basque.) - forthcoming - forthcoming The Canadian Coordinating Office for Health Technology Assessment (CCO)

5 CCO in in Laparoscopic adjustable gastric banding systematic review. Paris: Comité d Evaluation et de Diffusion des Innovations Technologiques. Broom J. Systematic review of the long-term outcomes of the treatments for obesity and implications for health improvement and the economic consequences for the NHS. London: National Coordinating Centre for Health Technology Assessment. Description available: sp?pjtid=1187. Laparoscopic adjustable gastric banding for morbid (clinicallysevere) obesity. Hayes, Inc. - forthcoming June forthcoming September forthcoming Table 2: Reports on other treatments for obesity Type of Reference Report Pharmacological approaches to weight loss in adults [Technology assessment report TA #71]. Bloomington (MN): Institute for Clinical Systems Improvement; Available: Patterson J. Outcomes of abdominoplasty. STEER 2003;3(2):1-9. Available: Guidance on the use of sibutramine for the treatment of obesity in adults [Technology appraisal guidance no 31]. London: National Institute for Clinical Excellence; Available: This guidance is based on the assessment: O Meara S, Riemsma R, Shirran L, Mather L, ter Riet G. The clinical effectiveness and cost-effectiveness of sibutramine in the management of obesity: a technology assessment. Health Technol Assess 2002;6(6). Available: Guidance on the use of orlistat for the treatment of obesity in adults [Technology appraisal guidance no 22]. London: National Institute for Clinical Excellence; Available: This guidance is based on the assessment: O Meara S, Riemsma R, Shirran L, Mather L, ter Riet G. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity. Health Technol Assess 2001;5(18). Available: The Canadian Coordinating Office for Health Technology Assessment (CCO)

6 CCO Guideline in Allgood P. Surgical interventions for morbid obesity. STEER 2001;1(18):1-10. Available: Appendices available: Gastric restrictive surgery for morbid obesity [Technology assessment report TA #14]. 2 nd update. Bloomington (MN): Institute for Clinical Systems Improvement; Available: Douketis JD, Feightner JW, Attia J, Feldman WF, with the Canadian Task Force on Preventive Health Care. Periodic health examination, 1999 update: 1. Detection, prevention and treatment of obesity. CMAJ 1999;160(4): Available: (An update of this guideline is in.) Gastric surgery for obesity. Glasgow: Scottish Health Purchasing Information Centre; SHPIC report Available: Treatment of obesity as an illness. Rockville (MD): Agency for Healthcare Research and Quality. Conclusion Long-term outcomes data on the effectiveness and safety of the laparoscopic adjustable gastric banding procedure is needed. The NICE guidance document recommends that hospitals wanting to offer surgery for morbid obesity maintain databases of outcomes and complications associated with the different procedures, and assessments of their impact on patient quality of life. There are a number of agencies currently assessing this technology, and several have recently published assessments on surgical interventions for morbid obesity, therefore CCO will not conduct an assessment on this topic at present. References 1. The skinny on obesity: the management of obesity in adults. Informed 2002;8(1):1,3-5. Available: (accessed 2003 Mar 10). 2. Bariatric surgery: surgery for morbid obesity. West Bloomfield (MI): YourSurgery.Com; Available: (accessed 2003 Mar 10). 3. Birmingham CL, Muller JL, Palepu A, Spinelli JJ, Anis AH. The cost of obesity in Canada. CMAJ 1999;160(4): Available: (accessed 2003 Mar 19). 4. National Heart, Lung, and Blood Institute, North American Association for the Study of Obesity. The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. Bethesda (MD): National Institutes of Health; NIH publ no Available: (accessed 2003 Mar 10). 5. Obesity - problems and interventions: a systematic review. Summary and conclusions. Stockholm: Swedish Council on Technology Assessment in Health Care; Report no 160. Available: (accessed 2003 Mar 17). The Canadian Coordinating Office for Health Technology Assessment (CCO)

7 CCO 6. Guidance on the use of surgery to aid weight reduction for people with morbid obesity [Technology appraisal guidance no 46]. London: National Institute for Clinical Excellence; Available: (accessed 2003 Mar 17). 7. P000008: LAP-BAND Adjustable Gastric Banding (LAGB ) System [approval order]. Rockville (MD): Center for Devices and Radiological Health, U.S. Food and Drug Administration; Available: (accessed 2003 Mar 10). 8. Listing of medical devices licences=déclaration d'homologation des instruments médicaux. Rev Mar 6. Ottawa: Health Canada; Available: (accessed 2003 Mar 17). 9. Schneider WL. Laparoscopic adjustable gastric banding for clinically severe (morbid) obesity [ 7 series B]. Edmonton: Alberta Heritage Foundation for Medical Research; Available: (accessed 2003 Mar 17). The Canadian Coordinating Office for Health Technology Assessment (CCO)