Medwrite Portfolio_20 Surgery Sample Articles

OBES SURG (2013) 23:1915–1921 1917Statistical Analysis and length of hospital stay. Mean operating time was 165 min, mean blood loss was 75 cm3, and mean hospital length of stayStatistical analyses were performed using the SPSS® was 5.6 days.software package (version 20, IBM SPSS, Chicago, IL,USA). Quantitative demographic variables were reported as Weight Lossmean, standard deviation (SD), and range. Qualitative vari-ables (demographic and outcome variables/complications) At 3- and 6-month follow-up, both groups had lost significantwere reported as number and percentage. Between-group weight relative to baseline. At 3 months, BMI in Group A hadcomparisons along quantitative measures were carried out decreased by 5.9±10.3 kg/m2 (95 % CI, 3.9, 7.9), from 43.2±using the independent samples t test. Fisher's exact test was 8.1 to 37.3±12.8 (p <0.001); Group B BMI decreased 7.3±used to assess relationships between qualitative variables. 2.3 (6.6, 8.0), from 42.5±6.1 to 35.2±5.4 (p <0.001). AtContinuous outcome variables were reported as mean, SD, 6 months, Group A BMI decreased 10.8±5.3 (9.6, 11.9), fromand 95 % confidence interval (95 % CI). Measures of weight 43.4±8.7 to 32.7±7.3 (p <0.001); Group B BMI decreasedchange from baseline at 3 and 6 months were analyzed using 11.3±3.2 (9.9, 2.7), from 42.8±5.9 to 31.5±4.7 (p <0.001).the paired-samples t test. Alpha was set at p <0.05; allstatistical tests were two-tailed. Mortality, Complications, and Leak RateResults No mortality occurred. As shown in Table 2, 15 (9.4 %) patients in Group A experienced complications vs fivePatient Characteristics, Operative Time, and Hospital Stay (6.0 %) patients in Group B (NS, p =0.46). Eight (5.0 %) of the 160 patients in Group A and one (1.2%) of the 84 patientsAs shown in Table 1, generally, baseline patient characteristics in Group B developed fistula (NS, p =0.17), interpreted as awere not significantly different with the exception of Group A manifestation of acute staple-line failure. All fistulae occurredreporting more hypertension and Group B reporting a greater in the GEJ close to the angle of His; as all fistulae werenumber of other comorbidities. For Group A, the mean age proximal, we added buttressing material to the last two Endowas 35.2 years, and 33.8 years for Group B. Mean BMI was GIA firings. In addition, in Group A, one (0.6 %) patient42.5 kg/m2 for Group A and 42.0 kg/m2 for Group B. The two experienced severe bleeding, and numerous others developedgroups did not differ with respect to operative characteristics minor bleeding from their staple lines. Without exception, BPS-reinforced staple lines had essentially no visible bleed-Table 1 Preoperative patient characteristics ing; however, no significant difference in mean blood loss between groups was observed (NS, p =0.39). Finally, fourVariable Group A Group B (BPS) p value (2.5 %) Group A patients and one (1.2 %) Group B patient required reoperation (NS, p =0.66). (oversewing) Table 3 shows characteristics of the patients who devel- n =160 n =84 oped fistulae. Data on fistulae were analyzed according to patient risk factors, time of occurrence after surgery, Mean±SD (range) manifesting signs and symptoms, location, and medical and surgical management. Both BMI and history of previousAge (years) 35.2±10.5 33.8±10.3 NS (p =0.29)a surgery appeared to correlate with fistula development: MostBMI (kg/m2) NS (p =0.59)a fistulae occurred in patients with a BMI>40 (6/9; 67.0 %), and (18.0–68.0) (15.0–64.0) five of the nine (56.0 %) patients with this complication had NS (p =0.30)b undergone previous abdominal surgery. 42.5 ± 7.5 42.0 ± 5.8 NS (p =0.36)b The nine fistulae developed between 2 and 4 weeks after (27.0–76.0) (30.0–58.0) p <0.05b surgery. Eight of nine patients (89.0 %) with fistula had fever NS (p =0.09)b and tachycardia as the first manifesting signs. Left shoulder N (%) NS (p =0.50)b pain was reported by six of nine patients (67.0 %) with fistula. p <0.001b An external drainage was the only presenting symptom in aFemales 117 (73.1) 56 (66.7) 48-year-old female patient; this patient had a BMI of 57 and a history of laparoscopic cholecystectomy and abdominoplasty.Prior surgery 37 (23.1) 24 (28.6) Laboratory studies showed an increased white blood cell count and increased CRP in all patients with fistula.Comorbidities Patients with a suspected postoperative leak underwent a barium swallow test to confirm leak/fistula. In most cases,Hypertension 50 (31.2) 16 (19.0)T2DM 45 (28.1) 15 (17.9)Respiratory 65 (40.6) 38 (45.2) 36 (42.9)disorderOther comorbidities 22 (13.8)BPS bovine pericardial strips, SD standard deviation, NS nonsignificant,BMI body mass index, T2DM type 2 diabetes mellitusa Independent samples t testb Fisher's exact test

1918 OBES SURG (2013) 23:1915–1921Table 2 Comparison of postoperative complications which can impede healing. Gastric-wall heat ischemia, due to heat generated by the cautery used during dissection of theComplication Group A Group B p valuea greater curvature, also may play a role in leaks subsequent to (oversewing) (BPS) LSG. The LSG procedure produces high intragastric pressure, n =160 n =84 which can lengthen the amount of time needed for a leak to close [41]. Innate characteristics of the stomach also play aFood intolerance, n (%) 1 (0.6) 0 (0.0) – role in post-LSG leaks. Although the blood supply to theHemorrhage, n (%) 1 (0.6) 0 (0.0) – stomach is robust, the gastroesophageal junction tends to beStenosis, n (%) 1 (0.6) 1 (1.2) – an area of decreased vascularity and, thus, is more prone toAbscess, n (%) 4 (2.5) 2 (2.4) – leaks. In addition, the stomach is typically thinner at the angleSplenic infarction, n (%) 0 (0.0) 1 (1.2) – of His, and some authors suggest that the large staple heightFistula, n (%) 8 (5.0) 1 (1.2) NS (p =0.17) used by many surgeons may not adequately seal this area [22].Total 15 (9.4) 5 (6.0) NS (p =0.46) Leak after LSG usually appears distal to the gastroesoph-BPS bovine pericardial strips ageal junction, with an incidence between 0 % and 5.7 % [6, 9,a Fischer's exact test 23–30]. Leaks in this area may be related to high intraluminal pressure caused by the vertical tubulization of the stomacha double-contrast abdominal computed tomography scan [41]. This pressure is amplified by the low compliance of thewith intravenous and water-soluble oral contrast was also sleeve, which is ten times less than the compliance of theperformed. complete stomach or the resected fundus [42]. These findings, in addition to our own Group A results, influenced our choiceDiscussion to buttress the last two stapler firings at that region in Group B.Complications of LSG Although there was no significant difference in operative blood loss between the current study groups, staple linesBleeding and staple-line leak, although rare, are the most without BPS often required electrocautery to stanch minorcommon complications of LSG [6, 9, 23–30]. Bleeding usu- bleeding, which was not necessary for any buttressed stapleally occurs along the staple line, or the greater omentum, once lines. Bleeding in the non-BPS group was usually venousfreed from the greater curvature of the stomach [20]. ooze but occasionally involved small pumping arterioles. Management of this slight bleeding probably had a marginal Numerous factors have been implicated in the development effect on case time, but it disrupted operative momentum.of staple-line leaks. Most leaks are due to local factors at thestaple line, such as inadequate blood supply and oxygenation, The surgical team readily gained proficiency in the tech- nique of BPS reinforcement (i.e., loading BPS onto stapler cartridges). In some instances, the stapler was found to jamTable 3 Patients with acute staple-line leak (fistula)Age Sex BMI Prior surgery Time of occurrence Symptoms Initial treatment Secondary Final treatment Total (if needed) treatment(years) (kg/m2) after surgery treatment duration (weeks)Group A (oversewing) Hiatal hernia 2 PT+LSP ATB+TPN+D Endoprosthesis Total gastrectomy 8 months 45 Ma 41 None 2 PT+LSP ATB+TPN+D Fibrin glue coil 21 Ma N/A None 2 PT+LSP ATB+TPN None None 8 months 26 F 40.1 Cholecystectomy + 3 External D ATB+TPN Endoclip+FJ 48 F 57 None 3 weeks abdominoplasty 3 49 F 44 Endometriosis 2 RNY 6 months 33 F 32 Gastric banding 2 22 Ma 76.2 Umbilical hernia 4 PT + LSP ATB + TPN + D RNY None 6 months 37 F NA None PT + LSP ATB + TPN 2 monthsGroup B (BPS) 4 PT ATB + TPN + D Surgical D None 8 months 52 F 43 None PT ATB + TPN + D 6 months Endoprosthesis coil RNY Coil FJ PT+LSP ATB+TPN RNY None 1 monthM male, F female, BMI body mass index, PT pyrexia and tachycardia, LSP left shoulder pain, TPN total parenteral nutrition, ATB antibiotic, Ddrainage, RNY Roux-en-Y gastric bypass, FJ feeding jejunostomy, N/A not available, BPS bovine pericardial stripsa Referred case

OBES SURG (2013) 23:1915–1921 1919secondary to excessive thickness of the stomach wall, or a The 2011 Third International Summit publication on sleevemechanical problem with the stapler itself. Nevertheless, no gastrectomy summarized questionnaire responses from 88meaningful increase in operating time was attributable to BPS experienced LSG surgeons who had performed 19,605 LSGsbuttressing. with a 1.3 % proximal leak rate. Of these practitioners, 57.0 % reinforced the staple line with buttress material and 43.0 % Specific patient risk factors may increase susceptibility to reinforced it with oversewing [52]. As summarized in a 2012staple-line leaks. Of the nine patients who developed fistulae publication of the International Sleeve Gastrectomy Expertin our study, most had a BMI>40 and had undergone an Panel (a group of expert surgeons overlapping those in theearlier abdominal surgery. In our experience, increased BMI Third International Summit report), LSG evidence fromand a history of previous abdominal procedure are potential >12,799 procedures incurring a 1.06 % leak rate led torisk factors for leak occurrence after LSG. 100.0 % consensus that staple-line reinforcement (kind unspecified) reduces staple-line bleeding, with consensus thatStaple-Line Buttressing both oversewing and buttressing reinforcement are acceptable choices [53]. Despite the low rate of leak in these expertMechanical staplers are a mainstay of laparoscopic gastroin- hands, leak was deemed a highly problematic LSG issue, withtestinal surgery, and in particular, bariatric surgery. Staple-line neither oversewing nor buttressing yet advocated as the pre-failure, although uncommon, can result in significant morbid- ferred reinforcement methodology.ity and mortality. At our institution, before we began thepractice of buttressing, we used suturing to improve the dura- Use of BPS for gastric staple lines is an attractive concept.bility of staple lines. Although staple-line buttressing is used The moderate cost per application must be considered; BPSin many bariatric operations, the practice has been explored (PSD) sleeves cost approximately $135.00 per application,with variable clinical efficacy and no conclusive data in LSG and four to seven applications may be necessary to divide[30–35, 37, 38]. the stomach. In our hands, only two BPS applications were required in the last two stapler firings, adding to the cost The procedure involves preloading buttressing material effectiveness of the procedure and lending support to theonto the stapler gun so that it becomes incorporated into the high-pressure theory at the angle of His. Application of BPSstaple line with firing. The ideal buttress material should be requires some training and experience. Increased care is nec-flexible and thin in order to be easily cut by the stapler's blade essary to choose the correct cartridge size to fit the tissueand should also enhance the strength of the staple line. thickness; if the staple height is too small to accommodateButtressing distributes the compressive force of the staples, the tissue and the BPS, or if BPS is improperly loaded, theresulting in decreased bleeding and risk of leak. In animal stapler may misfire. Also, if the BPS become wet from bloodstudies, the practice is known to increase burst pressure and or fluid, they may float off the staple cartridge. In rare in-decrease hemorrhage [43, 44], and it has proved beneficial in stances, the stapler jammed secondary to excessive thicknessother types of operations performed in humans [45–50]. of the stomach wall or a mechanical problem with the stapler itself, a problem not seen in staple lines that were sutured and Treated BPS are a buttressing material that adds thickness not buttressed.and, potentially, strength to the staple line. The treated strips ofpericardium are manufactured to fit the stapler device and are Overall, our institution observed that the advantages of“stapled” onto the tissue when the device is fired. The strips BPS buttressing far outweighed the disadvantages. Whileadd approximately 1 mm of thickness to the staple line, BPS cost is not negligible, it is a very minor considerationmaking it tighter and theoretically stronger. Two dehydrated relative to the human and financial cost of staple-line failure.BPS are secured on each side of a foam spacer by a plastic Death may result if leak is not identified and treated rapidly;mounting unit. BPS (PSD) hydrogel creates a temporary bond complications associated with staple-line failure can necessi-between the strips and the forks of the stapler, promoting tate the expenditure of hundreds of thousands of dollars. Ourrehydration of the strips. surgical team found that BPS buttressing (1) was easy to use; (2) resulted in staple lines with no visible bleeding that were There is evidence that suggests the benefits of BPS as a often completely dry; (3) created excellent, sturdy handles thatbuttressing material. Animal research has shown that staple afforded greater and safer retraction than native gastric tissue;lines incorporated with BPS (PSD product) have higher burst and (4) added only a few minutes to procedure length.pressures than those without it [51]. In humans, BPS (PSD)has been successfully used to reinforce staple lines in pulmo- Limitationsnary resections [45–47]; in that setting, the strips significantlyreduced the incidence and duration of postoperative air leaks. There are two important limitations of this study. First, thisThe initial experience with BPS (PSD) buttressing of gastric was not a randomized, prospective trial but rather a compar-staple lines in laparoscopic gastric bypass showed a trend ison of two sequential operative techniques. The 160 patientstoward decreased occurrence of hemorrhage and, possibly,of leaks as well [33].

1920 OBES SURG (2013) 23:1915–1921whose staple lines were oversewn represented the earlier part 7. Moon Han S, Kim WW, Oh JH. Results of laparoscopic sleeveof the authors' experience with LSG, and therefore, the results gastrectomy (LSG) at 1 year in morbidly obese Korean patients.may have been influenced by the significant learning curve of Obes Surg. 2005;15(10):1469–75.this procedure. Second, the relatively small sample size limit-ed the power of the study. 8. Hamoui N, Anthone GJ, Kaufman HS, et al. Sleeve gastrectomy in the high-risk patient. Obes Surg. 2006;16(11):1445–9.Conclusions 9. Armstrong J, O'Malley SP. Outcomes of sleeve gastrectomy forIncreasingly, primary health-care providers refer obese morbid obesity: a safe and effective procedure? Int J Surg.patients for bariatric surgery; the total number of bariatric 2010;8(1):69–71.procedures is rising. Any technique that reduces the staple-line failure rate will improve patient quality of life and reduce 10. Baltasar A, Serra C, Pérez N, et al. Laparoscopic sleeve gastrectomy:health-care costs. In our study, both groups were comparable a multi-purpose bariatric operation. Obes Surg. 2005;15:1124.in terms of baseline characteristics and early weight-loss out-comes. Also, although the difference in complication rates 11. Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbidbetween LSG procedures with oversewing and those with obesity in 216 patients: report of two-year results. Surg Endosc.BPS was not statistically significant, the positive results with 2007;21(10):1810–6.regard to leak rate experienced by the BPS group may repre-sent a clinically significant effect. Eight to nine percent of 12. Himpens J, Dapri G, Cadière GB. A prospective randomizedfistula observed in the current study occurred in patients that study between laparoscopic gastric banding and laparoscopicdid not receive BPS. Further study employing greater statisti- isolated sleeve gastrectomy: results after 1 and 3 years. Obescal power is required to quantify and confirm benefits of BPS Surg. 2006;16(11):1450–6.buttressing. 13. Silecchia G, Boru C, Pecchia A, et al. Effectiveness of laparoscopicAcknowledgments We thank Shelley Minden and J. N. Buchwald, sleeve gastrectomy (first stage of biliopancreatic diversion with duo-Division of Scientific Writing, Medwrite Medical Communications, denal switch) on co-morbidities in super-obese high-risk patients.LLC, Maiden Rock, WI, USA, for substantive manuscript revision and Obes Surg. 2006;16(9):1138–44.editorial review, and T. W. McGlennon, Director, Statistical Analysis andQuality of Life Assessment, McGlennon MotiMetrics (M3), Maiden 14. Roa PE, Kaidar-Person O, Pinto D, et al. Laparoscopic sleeve gas-Rock, WI, USA, for performing the statistical analysis. trectomy as treatment for morbid obesity: technique and short-term outcome. Obes Surg. 2006;16(10):1323–6.Disclosure Development of the manuscript (not the performance of thestudy) was financially supported by Synovis Life Technologies/Baxter 15. Braghetto I, Korn O, Valladares H, et al. Laparoscopic sleeve gas-International, Inc., St. Paul, MN, USA. trectomy: surgical technique, indications and clinical results. Obes Surg. 2007;17:1442.References 16. Givon-Madhala O, Spector R, Wasserberg N, et al. Technical aspects 1. Regan JP, Inabnet WB, Gagner M, et al. Early experience with two- of laparoscopic sleeve gastrectomy in 25 morbidly obese patients. stage laparoscopic Roux-en-Y gastric bypass as an alternative in the Obes Surg. 2007;17(6):722–7. super-super obese patient. Obes Surg. 2003;13(6):861–4. 17. Gagner M, Deitel M, Kalberer TL, et al. The Second International 2. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gas- Consensus Summit for Sleeve Gastrectomy, March 19–21, 2009. trectomy as an initial weight-loss procedure for high-risk patients Surg Obes Relat Dis. 2009;5(4):476–85. with morbid obesity. Surg Endosc. 2006;20(6):859–63. 18. Karamanakos SN, Vagenas K, Kalfarentzos F, et al. Weight loss, 3. Chazelet C, Verhaeghe P, Perterli R, et al. [Longitudinal sleeve appetite suppression, and changes in fasting and postprandial ghrelin gastrectomy as a stand-alone bariatric procedure: results of a multi- and peptide-YY levels after Roux-en-Y gastric bypass and sleeve center retrospective study]. J Chir (Paris). 2009;146(4):368–72. gastrectomy: a prospective, double blind study. Ann Surg. 2008; 247(3):401–7. 4. Sammour T, Hill AG, Singh P, et al. Laparoscopic sleeve gastrectomy as a single-stage bariatric procedure. Obes Surg. 2010;20(3):271–5. 19. Langer FB, Reza Hoda MA, Bohdjalian A, et al. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 5. Tucker ON, Szomstein S, Rosenthal RJ. Indications for sleeve gas- 2005;15(7):1024–9. trectomy as a primary procedure for weight loss in the morbidly obese. J Gastrointest Surg. 2008;12(4):662–7. 20. Trelles N, Gagner M. Sleeve gastrectomy. Oper Tech Gen Surg. 2007;9:123–31. 6. Fuks D, Verhaeghe P, Brehant O, et al. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. 21. Jones SB, Jones DB. Obesity surgery: patient safety and best prac- Surgery. 2009;145(1):106–13. tices. Woodbury: Cine-Med Inc.; 2008. 22. Baker RS, Foote J, Kemmeter P, et al. The science of stapling and leaks. Obes Surg. 2004;14(10):1290–8. 23. Lalor PF, Tucker ON, Szomstein S, et al. Complications after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2008;4(1): 33–8. 24. Frezza EE, Reddy S, Gee LL, et al. Complications after sleeve gastrectomy for morbid obesity. Obes Surg. 2009;19(6):684–7. 25. Lee CW, Kelly JJ, Wassef WY. Complications of bariatric surgery. Curr Opin Gastroenterol. 2007;23(6):636–43. 26. Arias E, Martínez PR, Ka Ming Li V, et al. Mid-term follow-up after sleeve gastrectomy as a final approach for morbid obesity. Obes Surg. 2009;19(5):544–8. 27. Burgos AM, Braghetto I, Csendes A, et al. Gastric leak after laparoscopic-sleeve gastrectomy for obesity. Obes Surg. 2009;19(12): 1672–7. 28. Weiner RA, Weiner S, Pomhoff I, et al. Laparoscopic sleeve gastrectomy—influence of sleeve size and resected gastric volume. Obes Surg. 2007;17(10):1297–305. 29. Kasalicky M, Michalsky D, Housova J, et al. Laparoscopic sleeve gastrectomy without an over-sewing of the staple line. Obes Surg. 2008;18:1257–62.

OBES SURG (2013) 23:1915–1921 192130. Felberbauer FX, Langer F, Shakeri-Manesch S, et al. Laparoscopic 41. Yehoshua RT, Eidelman LA, Stein M, et al. Laparoscopic sleeve sleeve gastrectomy as an isolated bariatric procedure: intermediate- gastrectomy—volume and pressure assessment. Obes Surg. 2008; term results from a large series in three Austrian centers. Obes Surg. 18(9):1083–8. 2008;18(7):814–8. 42. Chen B, Kiriakopoulos A, Tsakayannis D, et al. Reinforcement does31. Nguyen NT, Longoria M, Chalifoux S, et al. Bioabsorbable staple not necessarily reduce the rate of staple line leaks after sleeve line reinforcement for laparoscopic gastrointestinal surgery. Surg gastrectomy.A review of the literature and clinical experiences. Obes Technol Int. 2005;14:107–11. Surg. 2009;19(2):166–72.32. Consten EC, Gagner M, Pomp A, et al. Decreased bleeding after 43. Arnold W, Shikora SA. A comparison of burst pressure between laparoscopic sleeve gastrectomy with or without duodenal switch for buttressed versus non-buttressed staple-lines in an animal model. morbid obesity using a stapled buttressed absorbable polymer mem- Obes Surg. 2005;15(2):164–71. brane. Obes Surg. 2004;14(10):1360–6. 44. Downey DM, Harre JG, Dolan JP. Increased burst pressure in gas-33. Angrisani L, Lorenzo M, Borrelli V, et al. The use of bovine pericar- trointestinal staple-line using reinforcement with a bioprosthetic ma- dial strips on linear stapler to reduce extraluminal bleeding during terial. Obes Surg. 2005;15(10):1379–83. laparoscopic gastric bypass: prospective randomized clinical trial. Obes Surg. 2004;14(9):1198–202. 45. Miller JI, Landreneau RJ, Wright CE, et al. A comparative study of buttressed versus non-buttressed staple line in pulmonary resections.34. Shikora SA, Kim JJ, Tarnoff ME. Reinforcing gastric staple lines Ann Thorac Surg. 2001;71(1):319–22. with bovine pericardial strips may decrease the likelihood of gastric leak after laparoscopic Roux-en-Y gastric bypass. Obes Surg. 46. Venuta F, Rendina EA, De Giacomo T, et al. Technique to reduce air 2003;13(1):37–44. leaks after pulmonary lobectomy. Eur J Cardiothorac Surg. 1998; 13(4):361–4.35. Miller KA, Pump A. Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial. 47. Hazelrigg SR, Boley TM, Naunheim K, et al. Effect of bovine Surg Obes Relat Dis. 2007;3(4):417–21. pericardial strips on air leak after stapled pulmonary resection. Ann Thorac Surg. 1997;63(6):1573–5.36. Shikora SA. The use of staple-line reinforcement during laparoscopic gastric bypass. Obes Surg. 2004;14(10):1313– 48. Saito Y, Omiya H, Shomura Y, et al. A new bioabsorbable sleeve for 20. Review. staple-line reinforcement: report of a clinical experience. Surg Today. 2002;32(4):297–9.37. Shikora SA, Kim JJ, Tarnoff ME. Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple 49. Marien BJ, Raffetto JD, Seidman CS, et al. Bovine pericardium vs lines during laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dacron for patch angioplasty after carotid endarterectomy. Arch Dis. 2008;4(6):729–34. Surg. 2002;137(7):785–8.38. Daskalakis M, Berdan Y, Theodoridou S, et al. Impact of surgeon 50. Franklin Jr ME, Ramila GP, Treviño JM, et al. The use of experience and buttress material on postoperative complications bioabsorbable staple line reinforcement for circular stapler (BSG after laparoscopic sleeve gastrectomy. Surg Endosc. 2011;25(1): “SeamGuard”) in colorectal surgery: initial experience. Surg 88–97. Laparosc Endosc Percutan Tech. 2006;16(6):411–5.39. Fried M, Hainer V, Basdevant A, et al. Inter-disciplinary Euro- 51. Pinheiro JS, Correa JL, Cohen RV, et al. Staple line reinforcement pean guidelines on surgery of severe obesity. Int J Obes. 2007;31: with new biomaterial increased burst strength pressure: an animal 569–77. study. Surg Obes Relat Dis. 2006;2(3):397–9.40. National Institute of Health, National Heart, Lung and Blood 52. Deitel M, Gagner M, Erickson AL, et al. Third International Summit: Institute (NHLBA) in cooperation with The National Institute of current status of sleeve gastrectomy. Surg Obes Relat Dis. 2011; Diabetes and Digestive and Kidney Diseases (NIDDKD). 7(6):749–59. doi:10.1016/j.soard.2011.07.017. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the evidence report. Bethesda, 53. Rosenthal RJ. International Sleeve Gastrectomy Expert Panel, et al. MD: NIH; 1998. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012;8(1):8–19.

Surgery for Obesity and Related Diseases 4 (2008) S31–S38Efficacy of a low-pressure laparoscopic adjustable gastric band formorbid obesity: patients at long term in a multidisciplinary center Jim Toouli, M.B. B.S., Ph.D.*, Lilian Kow, M.B. B.S., Ph.D., Jane Collins, B.Nur., Ann Schloithe, B.Sc., Chris Oppermann, B.Sc. Adelaide Bariatric Center and Flinders University, Adelaide, South Australia, AustraliaAbstract Background: Obesity is an increasingly common condition with serious associated morbidity andKeywords: decreased life expectancy. Laparoscopic adjustable gastric banding (LAGB) has demonstrated its safety and efficacy as a surgical therapy for morbid obesity over the short term. The current study sought to determine the long-term safety and efficacy of a low-pressure LAGB. Methods: Between August 1996 and July 2007, 1,000 consecutive patients underwent LAGB implantation with the Swedish Adjustable Gastric Band (SAGB). This series was retrospectively reviewed with regard to weight loss and morbidity. Patients served as their own controls. Results: Preoperatively, there were 808 women (81.0%) and 192 men (19.0%) with a mean age of 46 Ϯ 11 years (range 13– 81 yrs) and mean body mass index (BMI) of 42.0 Ϯ 7.0 kg/m2 (range 27– 82 kg/m2). At 1-, 3-, 6-, and 8-year follow-up, mean percent excess weight loss was 41% (n ϭ 600), 56% (n ϭ 367), 51% (n ϭ 114), and 52% (n ϭ 43), respectively. At the same time points, BMI decreased, from 42.0 to 31.0, 32.5, and 30.5 kg/m2, respectively. Complications occurred in 197 patients. There were 2 operative complications (i.e., stomach perforation and vascular injury) and 25 conversions (2.4%) to open surgery. Major and minor wound infection in the perioperative period occurred in 47 (4.7%) and 43 (4.3%) patients, respectively. There was 1 death from a myocardial infarct 1 week after surgery. Long term, there were 30 (3.0%) band slippages, 31 (3.1%) erosions, 67 (6.7%) port problems, and 12 (1.2%) incisional hernias. Conclusion: LAGB with the SAGB is effective in achieving a mean sustainable weight loss of Ͼ50% at 8 years after surgery, with an acceptably low morbidity. (Surg Obes Relat Dis 2008;4: S31–S38.) © 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved. Morbid obesity; Laparoscopic adjustable gastric banding; Bariatric surgery; Weight loss; Comorbidity; National Health and Medical Research Council; NHMRCIntroduction great number of morbid conditions, as well as premature death [8], substantially reduced quality of life (QoL) [9], Obesity has become an increasingly prevalent global and increased demand for health care services [10].epidemic [1]. Regarded as a disease in its own right, obesity(body mass index [BMI] Ն30 kg/m2 [2]) is also a risk factor About 20% of Australian adults (approximately 2.6 mil-for numerous comorbidities, many of them life threatening lion) are obese, and the incidence of obesity in Australia has[3]. The cause of obesity is complex and multifactorial [4], doubled since 1980 [8]. Alarmingly, obesity often starts inand includes behavioral [5], genetic [6], and environmental childhood; 7% of Australian teenagers are obese [11]. Al-factors [7]. Morbid obesity (BMI Ն40 kg/m2, or Ն35 kg/m2 though many diets and medical therapies are available,with comorbidities [2]), in particular, is associated with a bariatric surgery is the only intervention that has been proven effective in achieving and maintaining weight loss in *Reprint requests: Jim Toouli, M.B. B.S., Ph.D., Adelaide Bariatric obese individuals [12]. The American GastroenterologicalCenter and Flinders University, Adelaide, South Australia, Australia. Association (AGA) statement on obesity treatment con- cluded that surgery is the most effective approach for E-mail: jim.toouli@flinders.edu.au1550-7289/08/$ – see front matter © 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved.doi:10.1016/j.soard.2008.04.005

S32 J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38achieving long-term weight loss [13]. It is not surprising information booklet describing the operation, dietary re-that surgical treatment of morbid obesity is one of the most quirements, follow-up protocol, potential complications,rapidly growing areas of surgery in Australia [14]. and the possibility of conversion to an open procedure. The risk-to-benefit ratio should be considered when as- For the management of hepatomegaly from fatty infil-sessing bariatric operations. Of the 4 current primary bari- tration, patients with BMI Ͼ50 kg/m2 were recommendedatric operations (i.e., laparoscopic adjustable gastric band- to start a supervised 6-week program of very low calorieing [LAGB], vertical banded gastroplasty, gastric bypass, diet (VLCD) using liquid protein meal-replacement shakes.biliopancreatic diversion/duodenal switch), LAGB has the Similar to the finding of others [37], we have previouslybest safety record [15]. In the 1970s and 1980s, a nonad- demonstrated a 30% decrease in liver volume following thejustable gastric band was developed for the treatment of use of 6-weeks of a VLCD preoperatively [38].obesity [16], followed by adjustable gastric bands that wereplaced by way of an open operation [17,18]; with the ad- Upper gastrointestinal (GI) endoscopy, baseline hemato-vancement of laparoscopic surgery, adjustable bands were logical and biochemical investigations, and upper abdomi-adapted for laparoscopic placement [19,20]. LAGB implan- nal ultrasound to document the presence of gallstones weretation technique has evolved, and the procedure is associ- performed for all patients before surgery. The surgical tech-ated with a very low risk of operative complications and nique, using the Swedish Adjustable Gastric Band ([SAGB]mortality [21,22]. Ethicon Endo-Surgery, Cincinnati, OH), has been described previously [39]. Patients were seen for band adjustments, as LAGB has grown in popularity, becoming the most se- needed, throughout the year, and were weighed at each visit.lected surgical therapy for morbid obesity worldwide [23]. Most adjustments were performed by direct palpation. Flu-More than 110,000 of these devices have been placed, and oroscopy was used, as needed (i.e., rarely), for difficult-to-numerous studies present their short-term efficacy [24 –28]. access ports. All patients were offered an 8-week supervisedLong-term results (Ն5 years) are starting to emerge [29 –33] gymnasium program and were encouraged to attend a pa-that demonstrate a continuation of LAGB effectiveness. The tient support group every 6 to 8 weeks.aim of this study was to review the long-term efficacy of alow-pressure LAGB in a series of morbidly obese patients Operation details were obtained from the operation re-treated at a single multidisciplinary center. We previously ports and were recorded in the database. Early postoperativereported on the first 600 patients at 5-year follow-up [34]; in complications were those that occurred within 30 days ofthe current study, we describe 1,000 patients who were the operation; long-term complications were recorded in thefollowed-up for up to 8 years. database and checked by reference to the patient’s case notes and/or by interview with the patient.Materials and methods For the purpose of this study, the database was reviewed Patients who were operated on since August 1996 were and missing data were collected by telephone contact withfollowed prospectively, and the data were recorded in a data- patients. Patients were considered to be lost to follow-up ifbase specifically developed for bariatric surgery recordkeeping they had not been reviewed in the prior 6 months or could(i.e., Lapbase 2000; Lapbase, Melbourne, Australia); all data not be contacted by telephone or mail.used for this study were drawn from this database. Efficacy of the surgery was determined by measurement of Surgery was undertaken on patients who were assessed change in BMI, absolute weight (kg), and percentage excessas suitable based on BMI, prior significant attempts to lose weight loss (%EWL) where the excess weight was calculatedweight by dietary means, and the presence of significant by using Metropolitan Height and Weight Tables [36].comorbidities. BMI criteria were those defined by the Na-tional Health and Medical Research Council (NHMRC) Statistical analysis[35]. Patients with a BMI of 30 to 35 kg/m2 were includedif the severity of their comorbidities was significant, and if Continuous data were reported as mean Ϯ standard de-the referring clinician felt that the patient was unable to viation (SD). At time points through 8 years, baseline versusachieve weight reduction by nonsurgical means. Ideal body post-SAGB %EWL and BMI group comparisons were per-weight was determined according to the Metropolitan formed using the maximum likelihood mixed-effect modelHeight and Weight tables [36]. Exclusion criteria were in- and Bonferroni pairwise comparisons. All statistical testsability to understand necessary operative and follow-up were two-sided, and P Ͻ .05 was considered statisticallyprocedures, manic disorder or schizophrenia, alcohol or significant. Data analysis was performed using SPSS ver-drug abuse, and liver cirrhosis. sion 14.0 for Windows (SPSS Inc, Chicago, IL). All patients received multidisciplinary (i.e., medical, nu- Resultstritional, psychological, and surgical) screening and educa-tion before surgery. Patients were fully informed about all Between August 1996 and July 2007, 1,000 patientsprocedures through personal interview as well as a detailed underwent LAGB. Of these 1,000 patients, 18 (1.8%) were lost to follow-up. The primary reason for not attending the

J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38 S33Table 1Preoperative demographic dataPatients (n) Age (yrs) Weight (kg) Height (cm) EW (kg) BMI (kg/m2) 119 Ϯ 23.6 (70–280) 167 Ϯ 8.7 (142–198) 58 Ϯ 20.7 (16–197) 42 Ϯ 7.0 (27–82)1,000 patients, women: 808 (81%); 46 Ϯ 11.0 (13–81) men: 192 (19%)EW ϭ excess weight.Values are presented as mean Ϯ SD (range).follow-up visits or being contactable by telephone was mov- one of the mesenteric veins from the trocar. This led to opening to another state or overseas. conversion, and control of the bleeding. The band was inserted in the usual position, and the patient made anPreoperative demographics uneventful recovery. There were 808 women (81%) and 192 men (19%), with Weight lossa mean age of 46 Ϯ 11 years (range 13– 81 yrs), and a meanheight of 167 Ϯ 8.7 cm (range 142–198 cm). Mean preop- Table 2 and Fig. 1 illustrate the %EWL over 8-yearerative weight was 119 Ϯ 23.6 kg (range 70 –280 kg), and follow-up; Fig. 2 demonstrates the change in BMI over themean BMI was 42 Ϯ 7 kg/m2 (range 27– 82 kg/m2). There same timeframe (P Ͻ .05). In the course of 8 years, there iswere 397 patients (39.7%) with a BMI Ͻ40 kg/m2, 479 statistically significant, steady, sustained mean excess(47.9%) with a BMI of 40 to 49.9 kg/m2, 107 (10.7%) with weight loss of approximately 50% (P Ͻ .001).a BMI of 50 to 59.9 kg/m2, and 17 (1.7%) with a BMI Ն60kg/m2 (Table 1). Using the Reinhold classification, originally used with gas- tric bypass as a measure of clinically meaningful weight lossOperation [40], fewer than 20% of patients consistently failed to lose Ͼ25% of their excess weight (Fig. 3), whereas Ͼ60% of The perigastric technique was used in the first 42 pa- patients lost Ͼ50% of their excess weight over the long term.tients, and the pars flaccida technique was used for bandplacement in the next 958 patients. Conversion to laparot- Weight loss subgroup analysis. The patients in the seriesomy was necessary in 25 patients, with 6 patients having were divided into groups according to preoperative BMI, asopen operations from the outset. Conversions were usually shown in Table 3. There was no significant difference inundertaken on account of adhesions from previous surgery, %EWL between the BMI groups through 8-year follow-upimpaired access due to a fatty liver, excessively fatty omen- (Fig. 4); although, at 12 months, when comparing %EWL intum, bleeding around the spleen, or inability to pass the the combined BMI groups Ն50 kg/m2 versus Ͻ40 kg/m2,band through the tunnel. There was no transfusion given to patients in the Ͻ40 kg/m2 category lost significantly moreany of the patients in the perioperative period. weight (P Ͻ .05). Beyond 12 months, there was no difference. In one patient, gastric perforation resulted from acciden- Between age subgroups, there was a significant differ-tal puncture or laceration from the initial entry trocar. Con- ence in BMI change over time through 8-year follow-upversion to open laparotomy revealed a 0.50-cm perforation (P Ͻ .05); in the early years (i.e., through year 4), theof the stomach wall, which was oversewn. The band waspositioned in the normal manner, and the patient made anuneventful recovery. A second patient sustained an injury toTable 2Distribution by %EWL over timeMonths %EWL group Ͻ25 25–49 Ն50 n% n % n%12 (n ϭ 600) 98 16.3 333 55.5 169 28.2 133 32.4 242 58.924 (n ϭ 411) 36 8.8 105 28.6 226 61.6 71 29.7 139 58.236 (n ϭ 367) 36 9.8 55 33.1 88 53.0 36 31.6 59 51.848 (n ϭ 239) 29 12.1 25 34.7 37 51.4 11 25.6 24 55.860 (n ϭ 166) 23 13.972 (n ϭ 114) 19 16.784 (n ϭ 72) 10 13.996 (n ϭ 43) 8 18.6 Fig. 1. %EWL over time.

S34 J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38 96 months 48.9 Ϯ 33.7 (13) 58.4 Ϯ 28.8 (20) Fig. 2. BMI over time. 43.0 Ϯ 25.0 (9) 51.5 (1)younger patients (i.e., aged Ͻ50 yrs) trended toward greater 52.1 Ϯ 29.3 (43)BMI loss than those in the older age group (i.e., aged Ն50yrs). As the years progressed, the trend leveled off and there 84 months 46.1 Ϯ 42.7 (23)was no difference between older and younger patients in 52.7 Ϯ 26.8 (34)BMI reduction (Table 4, Fig. 5). Similarly, with respect to 46.7 Ϯ 22.8 (12)sex, there were no significant differences in BMI through 8 42.3 Ϯ 25.6 (3)years (Table 5, Fig. 6). 49.1 Ϯ 31.8 (72)Morbidity and mortality 72 months 43.8 Ϯ 33.9 (35) Minor or major morbidity occurred in 197 of the 1,000 54.3 Ϯ 23.7 (60)patients (20%). There was 1 death (0.1%). This patient 57.0 Ϯ 29.7 (13)underwent an uneventful laparoscopic procedure and imme- 49.0 Ϯ 23.1 (6)diate postoperative recovery and was discharged on the 51.1 Ϯ 28.0 (114)second day. However, she presented to a different hospital1 week after her surgery with chest pain and collapse. She 60 months 50.4 Ϯ 30.9 (56)had a myocardial infarct, and died soon after presentation. 55.1 Ϯ 23.5 (87)There was no abnormality in her routine preoperative elec- 46.7 Ϯ 25.4 (18)trocardiogram. Although her treating clinicians did not at- 34.2 Ϯ 10.7 (5)tribute her cardiac death to the surgery, it is recorded as such 52.0 Ϯ 26.4 (166)because her death occurred within 30 days of surgery. 48 months 54.6 Ϯ 31.2 (86) 100 Reinhold Gp 56.3 Ϯ 26.7 (120) <25% 54.7 Ϯ 22.6 (26) 41.6 Ϯ 23.6 (7) 80 25-49% 55.1 Ϯ 27.9 (239) >50% 36 months 54.8 Ϯ 24.0 (137) 60 55.1 Ϯ 23.3 (184) 40 60.6 Ϯ 19.3 (41) 47.4 Ϯ 10.4 (5) 20 55.6 Ϯ 23.1 (367) 0 24 months 55.2 Ϯ 24.2 (159) 12 18 24 36 48 60 72 84 96 53.4 Ϯ 21.0 (200) 54.9 Ϯ 21.6 (44) 600 568 411 367 239 166 114 72 43 41.3 Ϯ 15.7 (8) 54.0 Ϯ 22.3 (411) Months after operation (number of patients)Mean % EWL Table 3 12 months 43.3 Ϯ 19.6 (224) NA ϭ not applicable. %EWL by preoperative BMI category over time 40.0 Ϯ 16.4 (303) Values presented as mean Ϯ SD (number of patients). Fig. 3. %EWL according to Reinhold classification [39]. 35.2 Ϯ 15.4 (63) 29.8 Ϯ 11.4 (10) 40.5 Ϯ 17.7 (600) Preoperative BMI Mean %EWL 30.5 Ϯ 19.8 (322) category (kg/m2) 26.9 Ϯ 13.0 (389) 22.2 Ϯ 10.8 (87) 6 months 23.1 Ϯ 9.6 (13) 27.7 Ϯ 16.0 (811) Ͻ40 40–49.9 50–59.9 Ն60 All

J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38 S35 Fig. 4. %EWL according to perioperative BMI. 12 months 18 months 24 months 36 months 48 months 60 months 72 months 84 months 96 months 42 Ϯ 6 (80) 39 Ϯ 6 (9) 38 Ϯ 6 (60) 36 Ϯ 5 (48) 34 Ϯ 5 (42) 33 Ϯ 6 (39) 29 Ϯ 5 (18) 30 Ϯ 5 (15) 29 Ϯ 6 (201) 30 Ϯ 7 (4) 30 Ϯ 7 (98) 30 Ϯ NA (1) NA 41 Ϯ 7 (399) 37 Ϯ 6 (380) 36 Ϯ 6 (320) 35 Ϯ 6 (264) 34 Ϯ 6 (256) 32 Ϯ 6 (240) 32 Ϯ 5 (185) 32 Ϯ 6 (157) 32 Ϯ 7 (38) 33 Ϯ 7 (76) 33 Ϯ 8 (16) 33 Ϯ 8 (31) 34 Ϯ 7 (16)Perioperative morbidity. The most common cause of peri- 9 months 44 Ϯ 7 (192) 40 Ϯ 7 (177) 38 Ϯ 7 (148) 37 Ϯ 7 (109) 35 Ϯ 7 (92) 33 Ϯ 7 (96) 32 Ϯ 7 (64) 30 Ϯ 6 (59) 31 Ϯ 7 (201) 32 Ϯ 6 (17) 31 Ϯ 5 (98) 35 Ϯ 8 (11) 31 Ϯ 8 (3)operative morbidity was wound infection. A major wound 41 Ϯ 7 (329) 37 Ϯ 6 (311) 36 Ϯ 6 (276) 35 Ϯ 6 (226) 33 Ϯ 6 (210) 32 Ϯ 6 (193) 30 Ϯ 6 (144) 30 Ϯ 5 (136) 30 Ϯ 7 (38) 31 Ϯ 7 (69) 32 Ϯ 6 (16) 32 Ϯ 7 (29) 31 Ϯ 8 (24)infection requiring surgical intervention occurred in 47 6 months NA ϭ not applicable.(4.7%) patients. The infections occurred at the site of the Values presented as mean Ϯ SD (number of patients).injection port and were generally due to skin organisms. Table 4 3 monthsAfter failure of antibiotic treatment (the criterion for a major Mean BMI by age over timewound infection), the injection port was removed, resulting Age group Mean BMI 0 monthsin control of the infection. The band was reconnected to anew injection port approximately 6 weeks later. (years) Ͻ30 30–39 Reddening, presumed minor wound infection at the port 40–49site, occurred in 43 (4.3%) patients. After antibiotic therapy, Ն50the wounds healed without further treatment.Late morbidity. Late complications included band slippage in 30(3.0%) patients, 28 of whom were operated on using the perigas-tric dissection, and 2 who were operated on with the pars flaccidatechnique. There were band erosions in 31 (3.1%), injection portor catheter leaks in 17 (1.7%), and port tubing or access difficultyrequiring revision in 67 (6.7%) patients. There were 12 (1.2%)incisional hernias and 1 (0.1%) port-site hernia. One patient developed gastric fundus necrosis as a result ofband slippage. This 41-year-old woman had undergone LAGBusing the perigastric technique. Eighteen months after the pro-cedure, she presented with epigastric pain associated withnausea and vomiting. Barium swallow demonstrated a tightrestriction with a large proximal pouch, consistent with slip-page. There was some flow of contrast into her distal stomach.Laparotomy was performed, revealing an infarcted gastric fun-dus proximal to a slipped band. The band was removed, andpartial gastrectomy was undertaken. Pathology revealed acutehemorrhagic infarction at the fundus. Four patients (0.7%) with known gallstones prior tosurgery underwent simultaneous laparoscopic cholecystec-tomy during the gastric banding procedure. To date, 19patients (1.9%) have required cholecystectomy during theirperiod of weight loss. There was no deep venous thrombo-sis, pulmonary embolism, or clinically significant esopha-geal dilation in any of the patients.

S36 J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38 80 60 Age Group 40 < 30 30 - 39 40 - 49 > 50 Mean BMI 20 Table 5 Mean BMI by sex over time 0 Sex Mean BMI 0 3 6 9 12 18 24 36 48 60 72 84 96 0 months 3 months 6 months 9 months 12 months 18 months 24 months 36 months 48 months 60 months 72 months 84 months 96 months Time after operation (months) Female 42 Ϯ 7 (808) 38 Ϯ 6 (764) 36 Ϯ 6 (654) 35 Ϯ 6 (524) 34 Ϯ 6 (486) 32 Ϯ 6 (87) 31 Ϯ 6 (334) 30 Ϯ 6 (300) 30 Ϯ 7 (201) 32 Ϯ 7 (142) 32 Ϯ 7 (98) 33 Ϯ 7 (65) 33 Ϯ 7 (40) Male 43 Ϯ 7 (192) 38 Ϯ 6 (183) 37 Ϯ 7 (150) 36 Ϯ 6 (123) 35 Ϯ 6 (114) 33 Ϯ 5 (87) 33 Ϯ 5 (77) 32 Ϯ 6 (67) 33 Ϯ 7 (38) 34 Ϯ 7 (24) 33 Ϯ 8 (16) 33 Ϯ 9 (7) 28 Ϯ 6 (3) Fig. 5. BMI according to age. NA ϭ not applicable.Discussion Values presented as mean Ϯ SD (number of patients). Long-term (Ն8 years) weight loss occurs in morbidlyobese patients after insertion of the SAGB. In excess of 60%of the patients available at each time point through 8 yearshad a sustainable weight loss of greater than 50% of theirexcess weight. Fewer than 20% of the patients available ateach time point were assessed as having failed to achieveless than 25% excess weight loss. These results are similarto those of other series using LAGB [41,42] and corroboratethe prior finding that the effectiveness of the LAGB oper-ation is sustained in the long term. Weight loss with the SAGB in the first year is not as rapid orextensive as that observed after operations such as gastric bypass,where around 70% of excess weight is lost [43]. However, withthe passage of time, at approximately 3 years from the operation,the weight loss from gastric bypass and the SAGB have beenshown to be similar [44]. Hence, in terms of weight-loss efficacyover a prolonged period, there may be little difference betweenSAGB versus gastric bypass treatment. The previously demonstrated relative safety of bariatricsurgery using LAGB is corroborated by the results of thisseries; 80% of the patients were free of any complications,and only 20% experienced one or more complication, mostof which were either minor or readily correctable. In theinitial 42 patients, band slippage was a major complication,affecting 67% of these patients. Once the operative tech-nique was changed from perigastric to pars flaccida bandplacement, this complication became uncommon. Erosion of the band into the stomach is a significant com-plication, affecting 3.1% of the patients. This is not surprisinggiven the nature of a procedure that places foreign materialaround the upper part of the stomach. Erosion has been treatedby removal of the band via an endoscopic per oral approach.Removal of the band via this technique subsequently permitseither reinsertion of an adjustable gastric band or performanceof another bariatric procedure. The cause of band erosion isunknown. It is thought that excessive fluid in the band mayproduce ischemia of the underlying stomach and, thus, permit

J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38 S37 Fig. 6. %EWL according to sex. compared to older men. In our series, patients were re- viewed regularly, and their weight-control program waserosion [45], a theoretical justification for a low-pressure band. supervised by a multidisciplinary team that included a nu-Alternatively, erosion may start as an ulcer of the mucosa, tritionist and exercise therapist. These additional interven-which erodes toward the band. In one series, it was suggested tions may negate differences as a result of age and sex.that erosion may be associated with infection of the port, theconnecting tubing, or the band itself [46]. Initial BMI also has been used to select patients for the different procedures. In this series, there was no difference Reservoir port-site infection was the most common op- demonstrated in efficacy in patients dependent on theirerative complication (4.7%). Control of the infection oc- initial BMI. In patients with a BMI Ն60 kg/m2, the rate ofcurred only after removal of the injection port. In these weight loss is less, and these patients may need to haveinstances, the port was re-sited approximately 3 to 6 months alternative or supplementary treatment. Because the numberafter removal, once the infection had resolved. Reinfection of patients with a BMI Ն60 kg/m2 in this group is small,of the injection port was rare. conclusions should not be drawn. One patient died within 30 days of laparoscopic insertion of Changes in the comorbidities of morbid obesity have notthe device. Death was unrelated to any operative complication been evaluated for this series of patients. In addition, a QoLand was thought to be due to a myocardial infarct. Periopera- assessment was not performed. A number of other seriestive mortality associated with the insertion of an adjustable have demonstrated the impact of weight reduction on thegastric band is low, and significantly lower than that reported comorbidities of diabetes [52], hypertension [53], sleep ap-for other bariatric operations [47,48]. This result makes this nea [54], and the metabolic syndrome [55]. Furthermore,operation attractive to patients, even though the initial weight studies reporting %EWL outcomes similar to those of thereduction may not be as rapid as that experienced after more current study generally report that there are patients whoinvasive procedures, such as gastric bypass. experience QoL akin to that of the normal population [56]. It has been conjectured that the more gradual weight loss This series of patients undergoing bariatric surgery usingassociated with LAGB may be protective with respect to the SAGB illustrates the effectiveness and relative safety ofpostoperative gallstone formation. The prevalence of gall- the approach when combined with a multidisciplinary pro-stone formation in our series is no different from that of the gram that ensures long-term follow-up and support.general population. In patients having gastric bypass, symp-tomatic gallstones were reported in up to 14% of patients Disclosures[49]. In the current series, only 1.9% of patients developedgallstones. We have previously shown that the rate of The authors are consultants for Ethicon Endo-Surgery; theirweight reduction affects gallbladder motility, and a weight- expenses for the symposium and an honorarium were paid byreduction rate of Ͼ1 kg per week is associated with reduced Ethicon Endo-Surgery, Inc., the manufacturer of the Realize Bandgallbladder emptying [49]. Hence, the difference in the (also known as the Swedish Adjustable Gastric Band).prevalence of gallstones may be explained by the relativedifference in the rate of weight loss between patients un- Referencesdergoing gastric bypass and SAGB. [1] Deitel M. Overweight and obesity worldwide now estimated to in- Patient age, sex, and initial BMI have been used to select volve 1.7 billion people. Obes Surg 2003;13:329 –30.patients for different bariatric procedures [50]. In this series,sex had no significant effect on long-term efficacy for [2] Clinical Guidelines on the Identification, Evaluation, and Treatmentweight loss. This result is similar to that shown in other of Overweight and Obesity in Adults; The Evidence Report. Be-studies, although a recent European study [51] showed that thesda, Md; NIH Publication: National Institute of Health, Nationalthe procedure was more effective in younger women when Heart, Lung and Blood Institute (NHLBA) in cooperation with The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD). September 1998. [3] North American Association for the Study of Obesity (NAASO) and the National Heart, Lung, and Blood Institute (NHLBI). The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Bethesda, Md; NIH Publication Number 00 – 4084. 2000. [4] Hacker DC, Deitel M. The etiology of obesity. Obes Surg 1991;1:21. [5] Goodrick GK, Foreyt JP. Why treatments for obesity don’t last. JAMA 1991;91:1243–7. [6] Bouchard C, Perusse L. Current status of the human obesity gene map. Obes Res 1996;4:81. [7] Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environ- ment: where do we go from here? Science 2003;299:853–5. [8] Australian Institute of Health and Welfare. Australia’s Health 2004. Canberra: AIHW, 2004 (AIHW Cat. No. AUS– 44).

S38 J. Toouli et al. / Surgery for Obesity and Related Diseases 4 (2008) S31–S38 [9] van Gemert WG, Adang EMM, Greve JWM, Soeters PB. Quality of [34] Anwar M, Collins J, Kow L, Toouli J. Long term efficacy of a low life assessment of morbidly obese patients: effect of weight-reducing pressure adjustable gastric band in the treatment of morbid obesity. surgery. Am J Clin Nutr 1998;67:197–201. Ann Surg 2008 (in press).[10] Christou NV, Sampalis JS, Liberman M, et al. Surgery decreases [35] National Health and Medical Research Council (NHMRC). National long-term mortality, morbidity, and health care use in morbidly obese clinical guidelines for weight control and obesity management in patients. Ann Surg 2004;240:416 –23. adults. September 2002.[11] Booth ML, Wake M, Armstrong T, et al. The epidemiology of [36] 1983 Metropolitan Height and Weight Tables. Metropolitan Life overweight and obesity among Australian children and adolescents, Foundation Statistical Bulletin 1983;64:2–9. 1995–1997. ANZ J Public Health 2001;25:162–9. [37] Fris RJ. Preoperative low energy diet diminishes liver size. Obes Surg[12] Buchwald H, Williams SE. Bariatric surgery worldwide 2003. Obes 2004;14:1165–70. Surg 2004;14:1157– 64. [38] Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH,[13] American Gastrointestinal Association. Medical statement on obesity. Toouli J. Change in liver size and fat content after treatment with Gastroenterology 2002;123:879 – 81. Optifast very low calorie diet. Obes Surg 2006;16:697–701.[14] O’Brien PE, Dixon JB, Brown W. Obesity is a surgical disease: overview [39] Greenslade J, Kow L, Toouli J. Surgical management of obesity using of obesity and bariatric surgery. ANZ J Surg 2004;74:200 – 4. a soft adjustable gastric band. ANZ J Surg 2004;74:195–9.[15] Schauer P, Ikramuddin S. Laparoscopic surgery for morbid obesity. [40] Reinhold RB. Critical analysis of long-term weight loss following Surg Clin North Am 2001;81:1145–79. gastric bypass. Surg Gynecol Obstet 1982;155:385–94.[16] Kuzmak LI. Silicone gastric banding: a simple and effective operation [41] Fielding GA, Ren CJ. Laparoscopic adjustable gastric band. Surg Clin for morbid obesity. Contemp Surg 1986;28:13– 8. N Am 2005;85:129 – 40.[17] Hallberg D, Forsell P. Ballongband vid behandling av massiv over- [42] Chapman B, Foster B, Kiroff G, et al. Laparoscopic adjustable gastric vikt. Svensk Kirurgi 1985;43:106. banding in the treatment of obesity: a systematic literature review. Surgery 2004;135:326 –51.[18] Kuzmak LI. Silicone gastric banding: a simple and effective operation for morbid obesity. Contemp Surg 1986;28:13– 8. [43] Sugerman HJ, Kellum JM, Engle KM, et al. Gastric bypass for treating severe obesity. Am J Clin Nutr 1992;55(Suppl 2):560 – 6S.[19] Belachew M, Legrand MJ, Defechereux TH, et al. Laparoscopic adjustable silicone gastric banding in the treatment of morbid obesity: [44] O’Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of a preliminary report. Surg Endosc 1994;8:1354 – 6. medium-term weight loss after bariatric operations. Obes Surg 2006; 16:1032– 4.[20] Catona A, La Manna L, Forsell P. The Swedish Adjustable Gastric Band: laparoscopic technique and preliminary results. Obes Surg [45] Abu-Abeid S, Carmon E, Keidar A. Port complications following 2000;10:15–21. laparoscopic adjustable gastric banding for morbid obesity. Obes Surg 2005;15:361–5.[21] Parikh MS, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Objec- tive comparison of complications resulting from laparoscopic bariat- [46] Weiss H, Nehoda H, Labeck B, et al. Injection port complications ric procedures. J Am Coll Surg 2006;202:252– 61. after gastric banding: incidence, management and prevention. Obes Surg 2003;10:259 – 62.[22] O’Brien PE, Dixon JB. Lap-Band: outcomes and results. J Laparoen- doscopic Adv Surg Tech A 2003;13:265–70. [47] Angrisani L, Furbetta F, Doldi SB, et al. LAGB: the Italian experience with 1863 patients operated in 6 years. Surg Endosc 2003;17:409 –12.[23] Ren CJ, Cabrera I, Rajaram K, Fielding GA. Factors influencing patient choice for bariatric operation. Obes Surg 2005;15:202– 6. [48] Podnos YD, Jimenez JC, Wilson SE, et al. Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg[24] Karlsson J, Sjöström L, Sullivan M. Swedish obese subjects (SOS): 2003;138:957– 61. an intervention study of obesity: two-year follow-up of health-related quality of life (HRQL) and eating behavior after gastric surgery for [49] Al-Jiffry B, Toouli J, Saccone G. GTP endothelin-1 is a potent severe obesity. Int J Obes Relat Metab Disord 1998;22:113–26. stimulator of human gallbladder contraction. J Gastroentrol Hepatol 2000;15(Suppl):S32– 4.[25] Wright TA, Kow L, Wilson, Toouli J. Early results of laparoscopic Swedish Adjustable Gastric Band for morbid obesity. Br J Surg [50] Polliand C, Rizk N, Barrat C, et al. Are there predictive items of 2000;87:362–73. successful surgery in morbid obesity treated by adjustable gastric banding: a prospective study. Ann Chir 2005;130:318 –22.[26] Collet D, Rault A, Sa Cunha A, Larroude D, Masson B. Laparoscopic adjustable gastric banding results after 2 years with two different [51] Jan J, Hong D, Pereira N, et al. Laparoscopic adjustable gastric bands. Obes Surg 2005;15:853–7. banding versus laparoscopic gastric bypass for morbid obesity: a single-institution comparison study of early results. J Gastroint Surg[27] Watkins BM, Montgomery KF, Ahroni JH. Laparoscopic adjustable 2005;9:30 – 41. gastric banding: early experience in 400 consecutive patients in the USA. Obes Surg 2005;15:82–7. [52] Ponce J, Haynes B, Paynter S, et al. Effect of Lap-Band-induced weight loss on type 2 diabetes mellitus and hypertension. Obes Surg[28] Zinzindohoue F, Chevallier JM, Douard R, et al. Laparoscopic gastric 2004;14:1335– 42. banding: a minimally invasive surgical treatment for morbid obesity: prospective study of 500 consecutive patients. Ann Surg 2003;237:1–9. [53] Spivak H, Hewitt MF, Onn A, et al. Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic[29] Steffen R, Biertho L, Ricklin T, Piec G, Horber FF. Laparoscopic adjustable gastric banding procedure. Am J Surg 2005;189:27–32. Swedish Adjustable Gastric banding: a five-year prospective study. Obes Surg 2003;13:404 –11. [54] Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch Intern Med[30] Vertruyen M. Experience with Lap-band System up to 7 years. Obes 2001;161:102– 6. Surg 2002;12:569 –72. [55] Matter SG, Velcu LM, Rabinovitz M, et al. Surgically-induced[31] Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic ad- weight loss significantly improves nonalcoholic fatty liver disease justable gastric banding for morbid obesity. Obes Surg 2002;12:564 – 8. and the metabolic syndrome. Ann Surg 2005;2:610 –7.[32] Martikainen T, Pirinen E, Alhava E, et al. Long-term results, late [56] Dixon JB, Dixon ME, O’Brien PE. Quality of life after Lap-Band complications and quality of life in a series of adjustable bands. Obes placement: influence of time, weight loss, and comorbidities. Obes Surg 2004;14:648 –54. Res 2001;9:713–21.[33] Weiner R, Blanco-Engert R, Weiner S, et al. Outcome after laparo- scopic adjustable gastric banding– 8 years experience. Obes Surg 2003;13:427–34.