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Comment on: Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial
M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32 [37] Watkins B, Ahroni J, Michaelson R, et al. Laparoscopic adjustable gastric banding in an ambulatory surgery center. Surg Obes Relat Dis 2008;4:S56 – 62. [38] Mittermair RP, Obermüller S, Perathoner A, et al. Results and complications after Swedish adjustable gastric banding—10 years’ experience. Obes Surg 2009;19:1636 – 41. [39] Weiner RA. Gastric banding: surgical and technical aspects. Chirurg 2005;76:678 – 88. [40] Favretti F, Cadiere GB, Segato G, et al. Laparoscopic placement of adjustable silicone gastric banding: early experience. Obes Surg 1995;5:71–3. [41] Berrevoet F, Pattyn P, Cardon A, et al. Retrospective analysis of laparoscopic gastric banding technique: short-term and mid-term follow-up. Obes Surg 1999;9:272–5. [42] Belachew M, Legrand LM, Vincent V, et al. Laparoscopic adjustable gastric banding. World J Surg 1998;22:955– 63. [43] Cardon A, Berrevoet F, Pattyn P, Hesse U, de Hemptinne B. Alternative technique for creation of a proximal gastric pouch in laparoscopic adjustable silicone gastric banding. Obes Surg 1999;9:410 –2. [44] Mizrahi S, Avinoah E. Technical tips for laparoscopic gastric banding: 6 years’ experience in 2800 procedures by a single surgical team. Am J Surg 2007;193:160 –5. [45] Ramos A, Neto M, Galvao M, et al. Stitchless technique with Swedish adjustable gastric band. Surg Obes Relat Dis 2007;3:319. [46] Steffen R, Biertho L, Ricklin T, et al. Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg 2003;13;404–11.
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[47] Frering V, Fontaumard E. Does stitching band increase slipping? (abstract). Surg Obes Relat Dis 2008;4:289 –311. [48] National Institutes of Health, National Heart, Lung and Blood Institute (NHLBA) in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report. Bethesda: National Institutes of Health; 1998. [49] Fried M, Hainer V, Basdevant A, et al. Inter-disciplinary European guidelines on surgery of severe obesity. Int J Obes 2007;31:569 –77. [50] Toouli J, Kow L, Ramos AC, et al. International multicenter study of safety and effectiveness of Swedish adjustable gastric band in 1-, 3-, and 5-year follow-up cohorts. Surg Obes Relat Dis 2009;5:598 – 609. [51] Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001; 357:1191– 4. [52] Phillips E, Ponce J, Cunneen SA. Safety and effectiveness of REALIZE adjustable gastric band: 3-year prospective study in the United States. Surg Obes Relat Dis 2009;5:588 –97. [53] Fried M, Peskova M. Gastric banding: advantages and complications—a 5- and 10-year follow-up. Obes Surg 1995;5:372– 4. [54] Fried M, Peskova M, Kasalicky M. Bariatric surgery at the 1st Surgical Department in Prague: history and some technical aspects. Obes Surg 1996;7:22–5.
Editorial comment
Comment on: Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial Since its earliest descriptions, the procedural steps of laparoscopic adjustable gastric banding (LAGB) have undergone several modifications, each designed to further minimize the associated complications such as slippage and erosion. By avoiding perigastric dissection and instead using pars flaccida dissection with minimal posterior dissection, randomized prospective studies have shown that the incidence of band slippage (gastric prolapse) can be significantly reduced [1]. The results have since been validated in multiple large volume and meta-analysis studies [2]. An additional method thought to reduce the risk of postoperative band complications has included the use of strategically placed anterior gastrogastric imbrication sutures (ISs) [3– 6]. However, until this excellent report by Fried et al., the use of ISs as an independent variable affecting the short- and longterm outcomes has not been scientifically challenged in a prospective randomized fashion. Although once thought to be a mandatory key step in LAGB, as the authors point out, banding with and without ISs has led to conflicting published results. Therefore, a randomized prospective study was clearly indicated. The authors are to be congratulated for completing this very clearly defined randomized trial that was sufficiently powered to detect a difference between performing adjustable gastric banding with and without ISs. Their overall
band slippage rate of 2.0 –2.2% is testament to their depth of experience. Most importantly, they can conclude that, in their hands, the use of ISs does not significantly result in superior weight loss or lower complication rates. They also appropriately conclude that the use of ISs should be at the surgeon’s discretion. As with many randomized, prospective trials, before widespread acceptance of the conclusions can be adopted into practice, further validation by other multiple, large-volume, prospective studies would be helpful. Certainly, avoiding unnecessary sutures, such as ISs, in the stomach has some potential advantages. For instance, as many bariatric surgeons are aware, reoperation or revision after adjustable gastric banding has been considered a high-risk procedure, in part because the takedown of the ISs has been associated with an elevated risk of gastric injury and leak, sometimes requiring meticulous dissection, wedge resection, or oversewing [7]. Revisional surgery after laparoscopic adjustable gastric banding performed without ISs would theoretically reduce that same risk and perhaps make those procedures safer for the patient, should they be needed. In addition to the gastrogastric ISs, some surgeons performing LAGB have advocated an additional IS on the stomach, placed just 2 cm distal to the band’s location, suturing together the lesser curve to the greater curve of the
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M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32
stomach and sometimes incorporating the redundant anterior body in the same stitch. This suture thereby reduces the mobility of the proximal stomach body that would otherwise be free to prolapse through the band at a future point. The belief, although not yet validated scientifically, has been that this suture will lead to a reduction in the anterior slippage rate or would completely eliminate any anterior slippage. The present randomized study does not comment on this particular suture; however by not using this suture routinely in any of their cases, the authors’ conclusions suggest that low slippage rates can be obtained without any suturing whatsoever. However, since adding this additional suture to routine ISs and using the pars flaccida technique, our group’s slippage rate after LAGB has been ⬍2%, with 95% of the patients reporting for follow-up for 1 month to 4 years. LAGB (with ISs) continues to be a safe and reproducible bariatric surgery that can lead to modest weight loss with minimal morbidity, assuming the proper follow-up regimen has been used. If the same results can be achieved without ISs, this could indeed be beneficial to the patient. This randomized prospective trial is clear level 1 evidence that routine placement of ISs during LAGB might not be necessary and should be left to the surgeon’s discretion. Similar studies at other large-volume centers would help to validate the conclusions.
Disclosures The author has no commercial associations that might be a conflict of interest in relation to this article. Brian P. Jacob, M.D., F.A.C.S. Laparoscopic Surgical Center of New York Department of Surgery Mount Sinai Medical Center New York, New York References [1] O’Brien PE, Dixon JB, Laurie C, Anderson M. A prospective randomized trial of placement of the laparoscopic adjustable gastric band: comparison of the perigastric and pars flaccid pathways. Obes Surg 2005;15:820 – 6. [2] Singhal R, Bryant C, Kitchen M, et al. Band slippage and erosion after laparoscopic gastric banding: a meta-analysis. Surg Endosc 2010 Jul 31. [3] Allen JW, Coleman MG, Fielding GA. Lessons learned from laparoscopic gastric banding for morbid obesity. Am J Surg 2001;182:10 – 4. [4] Fielding GA, Allen JW. A step-by-step guide to placement of the LAP-BAND adjustable gastric banding system. Am J Surg 2002;184: 26s–30s. [5] Ren CJ, Fielding GA. Laparoscopic adjustable gastric banding: surgical technique. J Laparoendosc Adv Surg Tech A 2003;13: 257– 63. [6] Spikvak H, Favretti F. Avoiding postoperative complications with the LAP-BAND system. Am J Surg 2002;184:31s–7s. [7] Spivak H, Oscar RB, Slavchev P, Wilson EB. Laparoscopic revision from lap-band to gastric bypass. Surg Endosc 2007;21:1388 –92.
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[47] Frering V, Fontaumard E. Does stitching band increase slipping? (abstract). Surg Obes Relat Dis 2008;4:289 –311. [48] National Institutes of Health, National Heart, Lung and Blood Institute (NHLBA) in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report. Bethesda: National Institutes of Health; 1998. [49] Fried M, Hainer V, Basdevant A, et al. Inter-disciplinary European guidelines on surgery of severe obesity. Int J Obes 2007;31:569 –77. [50] Toouli J, Kow L, Ramos AC, et al. International multicenter study of safety and effectiveness of Swedish adjustable gastric band in 1-, 3-, and 5-year follow-up cohorts. Surg Obes Relat Dis 2009;5:598 – 609. [51] Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001; 357:1191– 4. [52] Phillips E, Ponce J, Cunneen SA. Safety and effectiveness of REALIZE adjustable gastric band: 3-year prospective study in the United States. Surg Obes Relat Dis 2009;5:588 –97. [53] Fried M, Peskova M. Gastric banding: advantages and complications—a 5- and 10-year follow-up. Obes Surg 1995;5:372– 4. [54] Fried M, Peskova M, Kasalicky M. Bariatric surgery at the 1st Surgical Department in Prague: history and some technical aspects. Obes Surg 1996;7:22–5.
Editorial comment
Comment on: Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial Since its earliest descriptions, the procedural steps of laparoscopic adjustable gastric banding (LAGB) have undergone several modifications, each designed to further minimize the associated complications such as slippage and erosion. By avoiding perigastric dissection and instead using pars flaccida dissection with minimal posterior dissection, randomized prospective studies have shown that the incidence of band slippage (gastric prolapse) can be significantly reduced [1]. The results have since been validated in multiple large volume and meta-analysis studies [2]. An additional method thought to reduce the risk of postoperative band complications has included the use of strategically placed anterior gastrogastric imbrication sutures (ISs) [3– 6]. However, until this excellent report by Fried et al., the use of ISs as an independent variable affecting the short- and longterm outcomes has not been scientifically challenged in a prospective randomized fashion. Although once thought to be a mandatory key step in LAGB, as the authors point out, banding with and without ISs has led to conflicting published results. Therefore, a randomized prospective study was clearly indicated. The authors are to be congratulated for completing this very clearly defined randomized trial that was sufficiently powered to detect a difference between performing adjustable gastric banding with and without ISs. Their overall
band slippage rate of 2.0 –2.2% is testament to their depth of experience. Most importantly, they can conclude that, in their hands, the use of ISs does not significantly result in superior weight loss or lower complication rates. They also appropriately conclude that the use of ISs should be at the surgeon’s discretion. As with many randomized, prospective trials, before widespread acceptance of the conclusions can be adopted into practice, further validation by other multiple, large-volume, prospective studies would be helpful. Certainly, avoiding unnecessary sutures, such as ISs, in the stomach has some potential advantages. For instance, as many bariatric surgeons are aware, reoperation or revision after adjustable gastric banding has been considered a high-risk procedure, in part because the takedown of the ISs has been associated with an elevated risk of gastric injury and leak, sometimes requiring meticulous dissection, wedge resection, or oversewing [7]. Revisional surgery after laparoscopic adjustable gastric banding performed without ISs would theoretically reduce that same risk and perhaps make those procedures safer for the patient, should they be needed. In addition to the gastrogastric ISs, some surgeons performing LAGB have advocated an additional IS on the stomach, placed just 2 cm distal to the band’s location, suturing together the lesser curve to the greater curve of the
32
M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32
stomach and sometimes incorporating the redundant anterior body in the same stitch. This suture thereby reduces the mobility of the proximal stomach body that would otherwise be free to prolapse through the band at a future point. The belief, although not yet validated scientifically, has been that this suture will lead to a reduction in the anterior slippage rate or would completely eliminate any anterior slippage. The present randomized study does not comment on this particular suture; however by not using this suture routinely in any of their cases, the authors’ conclusions suggest that low slippage rates can be obtained without any suturing whatsoever. However, since adding this additional suture to routine ISs and using the pars flaccida technique, our group’s slippage rate after LAGB has been ⬍2%, with 95% of the patients reporting for follow-up for 1 month to 4 years. LAGB (with ISs) continues to be a safe and reproducible bariatric surgery that can lead to modest weight loss with minimal morbidity, assuming the proper follow-up regimen has been used. If the same results can be achieved without ISs, this could indeed be beneficial to the patient. This randomized prospective trial is clear level 1 evidence that routine placement of ISs during LAGB might not be necessary and should be left to the surgeon’s discretion. Similar studies at other large-volume centers would help to validate the conclusions.
Disclosures The author has no commercial associations that might be a conflict of interest in relation to this article. Brian P. Jacob, M.D., F.A.C.S. Laparoscopic Surgical Center of New York Department of Surgery Mount Sinai Medical Center New York, New York References [1] O’Brien PE, Dixon JB, Laurie C, Anderson M. A prospective randomized trial of placement of the laparoscopic adjustable gastric band: comparison of the perigastric and pars flaccid pathways. Obes Surg 2005;15:820 – 6. [2] Singhal R, Bryant C, Kitchen M, et al. Band slippage and erosion after laparoscopic gastric banding: a meta-analysis. Surg Endosc 2010 Jul 31. [3] Allen JW, Coleman MG, Fielding GA. Lessons learned from laparoscopic gastric banding for morbid obesity. Am J Surg 2001;182:10 – 4. [4] Fielding GA, Allen JW. A step-by-step guide to placement of the LAP-BAND adjustable gastric banding system. Am J Surg 2002;184: 26s–30s. [5] Ren CJ, Fielding GA. Laparoscopic adjustable gastric banding: surgical technique. J Laparoendosc Adv Surg Tech A 2003;13: 257– 63. [6] Spikvak H, Favretti F. Avoiding postoperative complications with the LAP-BAND system. Am J Surg 2002;184:31s–7s. [7] Spivak H, Oscar RB, Slavchev P, Wilson EB. Laparoscopic revision from lap-band to gastric bypass. Surg Endosc 2007;21:1388 –92.