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High revision rates after laparoscopic vertical banded gastroplasty
Surgery for Obesity and Related Diseases 5 (2009) 94 –98
Original article
High revision rates after laparoscopic vertical banded gastroplasty Richard Marsk, M.D.*, Eduard Jonas, M.D., Ph.D., Helena Gartzios, Dag Stockeld, M.D., Ph.D., Lars Granström, M.D., Jacob Freedman, M.D., Ph.D. Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden
Abstract
Background: To evaluate, in a surgical department at a university hospital in Stockholm, Sweden, the long-term results after laparoscopic vertical banded gastroplasty (VBG), with special emphasis on revisional surgery. Few studies are available with long-term results after laparoscopic VBG. Some short-term studies have shown results similar to gastric banding. Methods: All consecutive patients who underwent attempted laparoscopic VBG between 1995 and 2005 were followed up regarding weight loss and the need for revisional surgery. Follow-up was from the date of surgery to the end of the observational period (December 2006). Results: In 486 patients, laparoscopic VBG was attempted. Of the 486 cases, 64 were converted to open surgery. Conversions were common in the first patients, with a conversion rate of 4% during the last 100 patients. The mean body mass index at surgery was 42.4 kg/m2. The median follow-up was 3 years (range 0 –11). All patients lost weight. A total of 104 patients (21%) required revisional surgery 114 times during the follow-up period, with food intolerance/vomiting and insufficient weight loss the most common reasons. Of the 104 patients, 31 underwent repeat VBG, of whom 10 needed a secondary revisional procedure, and 49 required conversion to gastric bypass, of whom none have required additional revisional surgery. Conclusion: Laparoscopic VBG is associated with high revisional rates. In the case of failed VBG, repeat VBG seems to be a poor option and conversion to gastric bypass yields better results. We have abandoned VBG as a surgical option in the treatment of obesity. (Surg Obes Relat Dis 2009; 5:94 –98.) © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Morbid obesity; Bariatric surgery; Vertical banded gastroplasty; Revisional surgery; Complications
The antiobesity procedures used today include purely restrictive (vertical banded gastroplasty [VBG] and gastric banding [GB]), mixed restrictive and malabsorptive (gastric bypass [GBP]), and malabsorptive (biliopancreatic diversion with duodenal switch [BPD]). All those procedures can be performed with a laparoscopic approach [1–3]. During the past 2 decades, a clear shift has occurred from restrictive procedures to mixed and purely malabsorptive procedures. In the United States, 67% of all antiobesity procedures were restrictive in 1987–1989, with VBG the predominant procedure. In contrast, in 2002–2004, 6% of the procedures were restrictive [4]. During that period, GBPs have shown a dramatic increase, from 30% to 60%. Worldwide, it has *Reprint requests: Richard Marsk, M.D., Department of Surgery, Danderyd Hospital, Stockholm SE-182 88 Sweden. E-mail: [email protected]
been estimated that 65% of the antiobesity cases performed were GBP, followed by GB and VBG at 24% and 5%, respectively [5]. In Sweden, ⬍5% of procedures were restrictive in 2005 [6]. Restrictive procedures are generally considered safe, quick, and easy to learn. VBG was introduced by Mason [7] in 1982 and has, since the middle of the 1990s, also been performed laparoscopically [1]. Previous studies regarding mid- and long-term follow-up after open VBG have shown a tendency for weight gain over time and also high rates of revisional surgery, mostly because of staple line disruption and pouch enlargement [8 –10]. Few studies have been done of laparoscopic VBG with a follow-up of ⬎2 years [11,12]. The aim of the present study was to evaluate the results of 486 consecutive patients who had undergone attempted laparoscopic VBG, with a special focus on the need for, and outcome of, revisional surgery.
1550-7289/09/$ – see front matter © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2008.05.011
R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98
95
Methods
Postoperative follow-up
Between January 1995 and December 2005, laparoscopic VBG was attempted as the primary operation for the treatment of massive obesity in 486 consecutive patients. An age of 18 – 60 years and a body mass index (BMI) ⬎35 kg/m2 was required for patients to be accepted as candidates for surgery. Gastric bypass was introduced at our institution in 2001. Since the introduction of GBP, patients with a BMI ⬎45 kg/m2 have been recommended GBP. Patients who were considered sweet eaters or patients with gastroesophageal reflux were also recommended GBP.
Patients were allowed liquids ad libitum on the day of surgery after returning to the ward. Daily thromboembolic prophylaxis of 500 mL Dextran 70 (Macrodex, Medisan, Uppsala, Sweden), starting the day of surgery until discharge was used between 1995 and 2002. This was then changed to 500 mL of Dextran during surgery and then 5000 IE of sodium dalteparin (Fragmin, anti-Xa; Pharmacia, Täby, Sweden) on the following day and every day until 10 days postoperatively (self-administered). Early mobilization was encouraged, and the patients were discharged when able to drink ⱖ1000 mL of liquids. The patients were restricted to a liquid diet for 2 months, followed by a gradual return to solid meals. The routines for follow-up changed during the study period, but most patients were followed up at 2, 6, and 12–24 months after surgery. Thereafter, patients were seen in the clinic every 2 years or when problems occurred. Supplements with vitamins and iron were prescribed routinely to all patients for the first postoperative year. Thereafter, all patients were given multivitamin supplementation and other vitamins and minerals were supplemented according to the blood biochemistry results.
Surgical techniques A modification of the Mason VBG for open surgery [7], adapted from that presented by Lonroth et al. [1] was used. In brief, five 10-mm ports were placed in the upper abdomen, and a self-retaining retractor was used to elevate the left lobe of the liver. The peritoneal fold at the angle of His was incised, and an opening to the retrogastric space was created at the angle of His by blunt dissection from the lesser omentum. A second opening through the lesser omentum was made along the lesser curvature 4 –5 cm distal to the gastroesophageal junction by blunt dissection. The upper midline port was changed to a 33-mm port (LKT33, Ethicon Endosurgery, Cincinnati, OH), and a circular stapler (ECS25, Ethicon Endosurgery, Cincinnati, OH) was introduced and fired with a 32F nasogastric catheter placed in the stomach along the lesser curvature to guide the positioning of the stapler. A linear stapler (60mm, 4-row, ETC 460, Ethicon Endosurgery) was used in the first 82 patients, a 60-mm, 6-row, Multifire Endogia 60 (U.S. Surgical, Norwalk, CN) with the knife removed for the next 236 patients, and a 45-mm, 6-row, ETC45 Endoscopic Linear Cutter (Ethicon Endosurgery, Cincinnati, OH) for the remaining 168 patients. The linear stapler, with a divided staple line, was introduced in parallel to the 32F catheter through the circular hole to the angle of His. The outlet was reinforced with a stretched polytetrafluoroethylene band (Gore-Tex, W.H. Gore & Associates, Flagstaff, AZ) that was sutured with 3 nonresorbable sutures, with the 32F catheter in place to calibrate the stoma. The band circumference was not measured in the first 87 patients, instead touch was used to calibrate the band (as had previously been done for open VBG). Because dissatisfactory weight loss was seen, the technique was modified such that a circumference of 5 cm was marked on the band before deployment. The patients whose procedures were converted to open surgery underwent surgery with a previously described modification of the Mason VBG using the TA90, 4-row stapler (US Surgical) for the vertical staple line and a silicone band to reinforce the outlet [13].
Statistical analysis The weight data are presented as the mean ⫾ standard deviation. The group data are presented as the median and range. Individual data are presented as the true value, with the percentage in parentheses. The t test was used for between-group comparisons. Loss to follow-up was defined as when the patient did not return to the clinic for a period ⬎24 months. Results The patient characteristics are presented in Table 1. The median follow-up was 36 months (range 0 –132). Sixty-six patients (13.6%) were lost to follow-up. Their weight data are included up to their last clinical visit. For patients from whom the band was removed or who underwent conversion to GBP, the data are included up to the last clinical visit before the revisional surgery. A total of 64 patients (13%) Table 1 Basic patient data Patients (n) Gender (n) Male Female Age (y) Mean Range Preoperative BMI (kg/m2) Lost to follow-up (n) BMI ⫽ body mass index.
486 78 408 40.7 18–67 42.4 ⫾ 5.6 66
96
R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98 Table 3 Reason for revisional surgery and type of procedure (n ⫽ 104) Reason
Vomiting/food intolerance Staple line rupture Insufficient weight loss Band penetration Large opening Unknown Total
Procedure (n)
Total (n)
Repeat VBG
GBP
Band removal
7 17 0 1 6 0 31
15 2 20 7 2 3 49
24 0 0 0 0 0 24
46 19 20 8 8 3 104
VBG ⫽ vertical banded gastroplasty; GBP ⫽ gastric bypass. Fig. 1. Weight change over time (mean ⫾ standard deviation) and evaluated patients at each interval.
required conversion to open surgery. The main reason for conversion was poor access owing to a large left lobe of the liver. The conversion rates decreased over time from 23% in the first 100 cases to 4% in the last 100 cases. The operative time decreased throughout the study period, with a median operating time in the first 100 patients of 120 minutes compared with 78 minutes in the last 100 patients. Weight All patients lost weight. A 5-cm circumference band did not result in improved weight loss when analyzed at 1, 3, 5, and 7 years postoperatively. The weight loss over time for the whole group is presented in Fig. 1. The data are presented as intention to treat and thus included patients who underwent conversion to open surgery. Early complications (0 –30 d) Early complications are presented in Table 2. The most common early complications were wound infections and pneumonia. One patient underwent repeat surgery after 7 days because of bowel obstruction, with perforation of the cecum and died early in the postoperative period of a myocardial infarction. Three patients developed pulmonary emTable 2 Early complications ⬍30 days Complication
n (%)
Pulmonary embolism Atrial fibrillation Leakage Bleeding Ileus Wound infection Pneumonia Urinary tract infection Fever of unknown origin Urine retention
3 (.6) 1 (.2) 5 (1.0) 6 (1.2) 1 (.2) 16 (3.3) 13 (2.7) 2 (.4) 4 (.8) 3 (.6)
bolism, 2 of whom died. All cases of pulmonary embolism were seen in patients who had undergone conversion to open surgery. With the change in thromboembolic prophylaxis from Dextran 70 to sodium dalteparin for 10 days postoperatively, no additional cases of pulmonary embolism have occurred. The total 30-day mortality rate was .6%. Four patients (.8%) had leakage requiring operative intervention. Three patients (.6%) had postoperative bleeding requiring surgery. Late complications (⬎30 d) A total of 119 patients had late complications requiring surgical procedures. Of these 119 patients, 15 underwent surgery for incisional hernia 17 times (1 patient 3 times). VBG-related complications and revisional procedures are listed in Table 3. A total of 104 patients (21.4%) underwent surgery 114 times. No difference was seen in the revisional rates between the cases completed laparoscopically and the converted cases. The median time to revisional surgery was 38 months (range 1–106). A total of 49 patients underwent conversion to GBP, 24 patients had their band removed, and 31 patients underwent repeat VBG. Of the 31 patients who underwent repeat VBG, 10 (32.3%) required additional surgery. Of these 10 patients, 3 had their band removed because of vomiting and 7 underwent conversion GBP, 5 because of insufficient weight loss, 1 because of band penetration, and 1 because of vomiting. Of the 49 patients who underwent conversion GBP, 4 underwent open surgery because the primary VBG had been performed as open surgery. Seven cases began laparoscopically but were converted because of adhesions. Postoperatively, 6 patients had leakage, of whom 3 were treated endoscopically with fibrin glue and 3 underwent reoperation with drainage. Of the latter 3, 2 reoperations were done laparoscopically and 1 as open surgery. The total 30-day mortality rate was 0%. During the follow-up period, 8 patients (16.3%) underwent surgery for internal hernias after a median interval of 14 months (range 4 – 60). The preoperative weight in the group that underwent conversion
R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98
to GBP was 35.9 ⫾ 7.2 kg/m2. After 1 and 2 years, their weight was 28.6 ⫾ 5.8 kg/m2 and 29.5 ⫾ 6.3 kg/m2, respectively. All cases of staple line insufficiency were seen in patients who had not had their staple line divided. Of the 19 patients who underwent repeat surgery because of staple line insufficiency, 17 underwent repeat VBG with a new divided staple line. Of those 17 patients, 5 (29.4%) required additional intervention. Of these 5 patients, 3 underwent conversion to GBP because of insufficient weight loss and 2 had their band removed because of food intolerance. Discussion The preoperative BMI was 42.4 ⫾ 5.6 kg/m2. This is lower than that seen in almost any American series of bariatric patients and was most likely because the Swedish obese population tends to be less obese than those seen in the United States and because we had a BMI cutoff of ⱖ35 kg/m2 for surgery. All patients lost weight during the first year after laparoscopic VBG; however, thereafter, a trend toward weight regain was noted. The reason for the slow increase in weight over time is not clear but might have resulted from changes in patients’ eating patterns with more liquid high-calorie foods and/or a distension of the pouch with time [14 –16]. We have no data available regarding the patients’ eating habits and failure rates. All patients who had their band removed or underwent conversion GBP were excluded from the study, possibly leaving only the “successful” cases at long-term follow-up and thereby boosting the long-term results regarding weight loss. The weight loss seen in this series of patients is similar to what we have previously reported for open VBG [13] and is in accordance with other published reports with similar follow-up periods [11,12]. The pouch size and diameter of the outlet of the pouch have been found to influence weight loss after VBG [7,17]. In the present series, no improvement in outcome was seen after changing to a band with a 5-cm circumference. However, we do not know the actual band circumference in the first 87 patients. Conversion to open surgery was done in 13% of the cases. The conversion rate was greater than that reported in other studies [12,18]. One possible reason for this is that the present study included all patients, beginning with the first laparoscopic VBG case at our institution. Most of the conversions occurred in the initial 100 cases, suggesting a learning curve, such as is seen for all laparoscopic procedures. Previous studies with long-term follow-up after open VBG have shown a high frequency of repeat interventions [8 –10], with a range of 25–56%. Those series had a follow-up period of 5–12 years, with the reintervention rate increasing with longer follow-up. In the present series, 104 patients (21.4%) required revisional surgery. The median follow-up in our series was 3 years, and it is likely that the
97
revision rates will continue to increase with longer followup. Staple line insufficiency was seen in 19 patients, and only in patients who did not have their staple line divided, underlining the importance of a divided staple line. The exact mechanism behind staple line insufficiency is not clear, but patient overeating in the immediate postoperative period has been suggested as 1 reason [19]. Our patients were only allowed a liquid diet during the first 2 months in an effort to minimize the risk of staple line disruption. Gastroscopy was not routinely performed in the postoperative period; thus, the incidence of staple line insufficiency was most likely underestimated. In a previous study of open VBG, staple line insufficiency was common but did not correlate with weight gain [20]. In addition to staple line insufficiency, a large group of patients will require revisional surgery because of pouch enlargement, insufficient weight loss, or intolerance to food/vomiting after VBG. Conversion to GBP, in the case of failed VBG, seems to offer better results, at least in the short term. In the repeat VBG group of 31 patients, 10 (32.3%) required additional surgery—7 later underwent conversion to GBP and 3 had their band removed. This is in accordance with the strategy as proposed by van Gemert et al. [10] who recommended GBP in the case of failed VBG. The complication rates after revisional surgery to GBP were high. In this series, conversion from laparoscopic to open surgery occurred in 15.6% of patients, and anastomotic leakage was seen in 12.2%. The high rate of anastomotic leakage caused us switch to larger size clips when creating the gastrojejunostomy. It seems to have lowered the rate of anastomotic leakage in primary, as well as revisional, GBP. These high complication rates are similar to those of other reports of revision series [21] and much greater than the anastomotic leak rates seen after primary GBP (1–2%) [22]. Weight loss after conversion has appeared to be good, at least in the short term. Since the introduction of gastric banding in the 1990s, VBG has fallen out of favor. Of all antiobesity procedures, gastric banding accounts for 24.4% and VBG for only 5.4% [5]. Comparative studies between these 2 restrictive procedures are few and have had somewhat conflicting results regarding both weight loss and postoperative morbidity [9,23,24]. To our knowledge, only 1 study has compared laparoscopic VBG and GB. Morino et al. [23] randomized 100 patients to either laparoscopic GB or VBG and found better weight loss and fewer complications in the laparoscopic VBG group with a follow-up of 3 years. Evidence of the long-term outcomes after GB is still limited; however, in a study by Balsiger et al. [25], patients who had undergone GB were followed up for 7 years. In that series, the cumulative reoperation rate was 32%. This might indicate that the revision rates are in the same range after GB and VBG. This contrasts to the very favorable results after GB reported from Australia [26], suggesting that how patients are followed up might be of importance for the results of restrictive surgery.
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R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98
A proposed benefit for restrictive surgery is its safety. That must, however, be viewed in the light of the need for revisional surgery. According to our data, ⱖ1 of 5 patients who have undergone VBG will need revisional surgery in the future. The best option at reoperation seems to be conversion to GBP. One also should consider the increased morbidity seen with revisional surgery [27]. Recent studies have shown laparoscopic VBG to be inferior to GBP both regarding weight loss and the need for revisional surgery [28,29]. Conclusion In our experience, restrictive surgery in the form of VBG provides poor results with high rates of revisional surgery. Should the need for revisional surgery occur, repeat VBG seems to be a poor option, and it would be better to convert the VBG to GBP. We have abandoned VBG as a surgical treatment of obesity at our institution. Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article. References [1] Lonroth H, Dalenback J, Haglind E, et al. Vertical banded gastroplasty by laparoscopic technique in the treatment of morbid obesity. Surg Laparosc Endosc 1996;6:102–7. [2] Lonroth H, Dalenback J, Haglind E, Lundell L. Laparoscopic gastric bypass: another option in bariatric surgery. Surg Endosc 1996;10: 636 – 8. [3] Morino M, Toppino M, Garrone C, Morino F. Laparoscopic adjustable silicone gastric banding for the treatment of morbid obesity. Br J Surg 1994;81:1169 –70. [4] Samuel I, Mason EE, Renquist KE, Huang YH, Zimmerman MB, Jamal M. Bariatric surgery trends: an 18-year report from the International Bariatric Surgery Registry. Am J Surg 2006;192:657– 62. [5] Buchwald H, Williams SE. Bariatric surgery worldwide 2003. Obes Surg 2004;14:1157– 64. [6] Marsk R, Freedman J, Tynelius P, Rasmussen F, Näslund E. Antiobesity surgery in Sweden 1980 –2005: a population based study with special focus on mortality. Ann Surg. In press. [7] Mason EE. Vertical banded gastroplasty for obesity. Arch Surg 1982; 117:701– 6. [8] Baltasar A, Bou R, Arlandis F, et al. Vertical banded gastroplasty at more than 5 years. Obes Surg 1998;8:29 –34. [9] Miller K, Pump A, Hell E. Vertical banded gastroplasty versus adjustable gastric banding: prospective long-term follow-up study. Surg Obes Relat Dis 2006;2:570 –2. [10] van Gemert WG, van Wersch MM, Greve JW, Soeters PB. Revisional surgery after failed vertical banded gastroplasty: restoration of vertical banded gastroplasty or conversion to gastric bypass. Obes Surg 1998;8:21– 8.
[11] Olbers T, Lonroth H, Dalenback J, Haglind E, Lundell L. Laparoscopic vertical banded gastroplasty—an effective long-term therapy for morbidly obese patients? Obes Surg 2001;11:726 –30. [12] Wang W, Yu PJ, Lee YC, Wei PL, Lee WJ. Laparoscopic vertical banded gastroplasty: 5-year results. Obes Surg 2005;15:1299 –303. [13] Naslund E, Backman L, Granstrom L, Stockeld D. Seven year results of vertical banded gastroplasty for morbid obesity. Eur J Surg 1997; 163:281– 6. [14] Brolin RL, Robertson LB, Kenler HA, Cody RP. Weight loss and dietary intake after vertical banded gastroplasty and Roux-en-Y gastric bypass. Ann Surg 1994;220:782–90. [15] Lindroos AK, Lissner L, Sjostrom L. Weight change in relation to intake of sugar and sweet foods before and after weight reducing gastric surgery. Int J Obes Relat Metab Disord 1996;20:634 – 43. [16] Olbers T, Bjorkman S, Lindroos A, et al. Body composition, dietary intake, and energy expenditure after laparoscopic Roux-en-Y gastric bypass and laparoscopic vertical banded gastroplasty: a randomized clinical trial. Ann Surg 2006;244:715–22. [17] Mason EE, Doherty C, Cullen JJ, Scott D, Rodriguez EM, Maher JW. Vertical gastroplasty: evolution of vertical banded gastroplasty. World J Surg 1998;22:919 –24. [18] Nocca D, Aggarwal R, Blanc P, et al. Laparoscopic vertical banded gastroplasty: a multicenter prospective study of 200 procedures. Surg Endosc 2007;21:870 – 4. [19] Brolin RE. Healing of the stapled stomach in bariatric operations. Surgery 1993;113:484 –90. [20] Svenheden KE, Akesson LA, Holmdahl C, Naslund I. Staple disruption in vertical banded gastroplasty. Obes Surg 1997;7:136 – 41. [21] Van Dessel E, Hubens G, Ruppert M, Balliu L, Weyler J, Vaneerdeweg W. Roux-en-Y gastric bypass as a re-do procedure for failed restrictive gastric surgery. Surg Endosc 2008;22:1014 – 8. [22] Nguyen NT, Silver M, Robinson M, et al. Result of a national audit of bariatric surgery performed at academic centers: a 2004 University Health System Consortium Benchmarking Project. Arch Surg 2006; 141:445–50. [23] Morino M, Toppino M, Bonnet G, del Genio G. Laparoscopic adjustable silicone gastric banding versus vertical banded gastroplasty in morbidly obese patients: a prospective randomized controlled clinical trial. Ann Surg 2003;238:835– 41; discussion 841, 832. [24] van Dielen FM, Soeters PB, de Brauw LM, Greve JW. Laparoscopic adjustable gastric banding versus open vertical banded gastroplasty: a prospective randomized trial. Obes Surg 2005;15:1292– 8. [25] Balsiger BM, Ernst D, Giachino D, Bachmann R, Glaettli A. Prospective evaluation and 7-year follow-up of Swedish adjustable gastric banding in adults with extreme obesity. J Gastrointest Surg 2007;11:1470 –7. [26] O’Brien PE, Dixon JB, Brown W, et al. The laparoscopic adjustable gastric band (Lap-Band): a prospective study of medium-term effects on weight, health and quality of life. Obes Surg 2002;12:652– 60. [27] Schouten R, van Dielen FM, van Gemert WG, Greve JW. Conversion of vertical banded gastroplasty to Roux-en-Y gastric bypass results in restoration of the positive effect on weight loss and co-morbidities: evaluation of 101 patients. Obes Surg 2007;17:622–30. [28] Lee WJ, Huang MT, Yu PJ, Wang W, Chen TC. Laparoscopic vertical banded gastroplasty and laparoscopic gastric bypass: a comparison. Obes Surg 2004;14:626 –34. [29] Olbers T, Fagevik-Olsen M, Maleckas A, Lonroth H. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity. Br J Surg 2005;92: 557– 62.
Original article
High revision rates after laparoscopic vertical banded gastroplasty Richard Marsk, M.D.*, Eduard Jonas, M.D., Ph.D., Helena Gartzios, Dag Stockeld, M.D., Ph.D., Lars Granström, M.D., Jacob Freedman, M.D., Ph.D. Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden
Abstract
Background: To evaluate, in a surgical department at a university hospital in Stockholm, Sweden, the long-term results after laparoscopic vertical banded gastroplasty (VBG), with special emphasis on revisional surgery. Few studies are available with long-term results after laparoscopic VBG. Some short-term studies have shown results similar to gastric banding. Methods: All consecutive patients who underwent attempted laparoscopic VBG between 1995 and 2005 were followed up regarding weight loss and the need for revisional surgery. Follow-up was from the date of surgery to the end of the observational period (December 2006). Results: In 486 patients, laparoscopic VBG was attempted. Of the 486 cases, 64 were converted to open surgery. Conversions were common in the first patients, with a conversion rate of 4% during the last 100 patients. The mean body mass index at surgery was 42.4 kg/m2. The median follow-up was 3 years (range 0 –11). All patients lost weight. A total of 104 patients (21%) required revisional surgery 114 times during the follow-up period, with food intolerance/vomiting and insufficient weight loss the most common reasons. Of the 104 patients, 31 underwent repeat VBG, of whom 10 needed a secondary revisional procedure, and 49 required conversion to gastric bypass, of whom none have required additional revisional surgery. Conclusion: Laparoscopic VBG is associated with high revisional rates. In the case of failed VBG, repeat VBG seems to be a poor option and conversion to gastric bypass yields better results. We have abandoned VBG as a surgical option in the treatment of obesity. (Surg Obes Relat Dis 2009; 5:94 –98.) © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Morbid obesity; Bariatric surgery; Vertical banded gastroplasty; Revisional surgery; Complications
The antiobesity procedures used today include purely restrictive (vertical banded gastroplasty [VBG] and gastric banding [GB]), mixed restrictive and malabsorptive (gastric bypass [GBP]), and malabsorptive (biliopancreatic diversion with duodenal switch [BPD]). All those procedures can be performed with a laparoscopic approach [1–3]. During the past 2 decades, a clear shift has occurred from restrictive procedures to mixed and purely malabsorptive procedures. In the United States, 67% of all antiobesity procedures were restrictive in 1987–1989, with VBG the predominant procedure. In contrast, in 2002–2004, 6% of the procedures were restrictive [4]. During that period, GBPs have shown a dramatic increase, from 30% to 60%. Worldwide, it has *Reprint requests: Richard Marsk, M.D., Department of Surgery, Danderyd Hospital, Stockholm SE-182 88 Sweden. E-mail: [email protected]
been estimated that 65% of the antiobesity cases performed were GBP, followed by GB and VBG at 24% and 5%, respectively [5]. In Sweden, ⬍5% of procedures were restrictive in 2005 [6]. Restrictive procedures are generally considered safe, quick, and easy to learn. VBG was introduced by Mason [7] in 1982 and has, since the middle of the 1990s, also been performed laparoscopically [1]. Previous studies regarding mid- and long-term follow-up after open VBG have shown a tendency for weight gain over time and also high rates of revisional surgery, mostly because of staple line disruption and pouch enlargement [8 –10]. Few studies have been done of laparoscopic VBG with a follow-up of ⬎2 years [11,12]. The aim of the present study was to evaluate the results of 486 consecutive patients who had undergone attempted laparoscopic VBG, with a special focus on the need for, and outcome of, revisional surgery.
1550-7289/09/$ – see front matter © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2008.05.011
R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98
95
Methods
Postoperative follow-up
Between January 1995 and December 2005, laparoscopic VBG was attempted as the primary operation for the treatment of massive obesity in 486 consecutive patients. An age of 18 – 60 years and a body mass index (BMI) ⬎35 kg/m2 was required for patients to be accepted as candidates for surgery. Gastric bypass was introduced at our institution in 2001. Since the introduction of GBP, patients with a BMI ⬎45 kg/m2 have been recommended GBP. Patients who were considered sweet eaters or patients with gastroesophageal reflux were also recommended GBP.
Patients were allowed liquids ad libitum on the day of surgery after returning to the ward. Daily thromboembolic prophylaxis of 500 mL Dextran 70 (Macrodex, Medisan, Uppsala, Sweden), starting the day of surgery until discharge was used between 1995 and 2002. This was then changed to 500 mL of Dextran during surgery and then 5000 IE of sodium dalteparin (Fragmin, anti-Xa; Pharmacia, Täby, Sweden) on the following day and every day until 10 days postoperatively (self-administered). Early mobilization was encouraged, and the patients were discharged when able to drink ⱖ1000 mL of liquids. The patients were restricted to a liquid diet for 2 months, followed by a gradual return to solid meals. The routines for follow-up changed during the study period, but most patients were followed up at 2, 6, and 12–24 months after surgery. Thereafter, patients were seen in the clinic every 2 years or when problems occurred. Supplements with vitamins and iron were prescribed routinely to all patients for the first postoperative year. Thereafter, all patients were given multivitamin supplementation and other vitamins and minerals were supplemented according to the blood biochemistry results.
Surgical techniques A modification of the Mason VBG for open surgery [7], adapted from that presented by Lonroth et al. [1] was used. In brief, five 10-mm ports were placed in the upper abdomen, and a self-retaining retractor was used to elevate the left lobe of the liver. The peritoneal fold at the angle of His was incised, and an opening to the retrogastric space was created at the angle of His by blunt dissection from the lesser omentum. A second opening through the lesser omentum was made along the lesser curvature 4 –5 cm distal to the gastroesophageal junction by blunt dissection. The upper midline port was changed to a 33-mm port (LKT33, Ethicon Endosurgery, Cincinnati, OH), and a circular stapler (ECS25, Ethicon Endosurgery, Cincinnati, OH) was introduced and fired with a 32F nasogastric catheter placed in the stomach along the lesser curvature to guide the positioning of the stapler. A linear stapler (60mm, 4-row, ETC 460, Ethicon Endosurgery) was used in the first 82 patients, a 60-mm, 6-row, Multifire Endogia 60 (U.S. Surgical, Norwalk, CN) with the knife removed for the next 236 patients, and a 45-mm, 6-row, ETC45 Endoscopic Linear Cutter (Ethicon Endosurgery, Cincinnati, OH) for the remaining 168 patients. The linear stapler, with a divided staple line, was introduced in parallel to the 32F catheter through the circular hole to the angle of His. The outlet was reinforced with a stretched polytetrafluoroethylene band (Gore-Tex, W.H. Gore & Associates, Flagstaff, AZ) that was sutured with 3 nonresorbable sutures, with the 32F catheter in place to calibrate the stoma. The band circumference was not measured in the first 87 patients, instead touch was used to calibrate the band (as had previously been done for open VBG). Because dissatisfactory weight loss was seen, the technique was modified such that a circumference of 5 cm was marked on the band before deployment. The patients whose procedures were converted to open surgery underwent surgery with a previously described modification of the Mason VBG using the TA90, 4-row stapler (US Surgical) for the vertical staple line and a silicone band to reinforce the outlet [13].
Statistical analysis The weight data are presented as the mean ⫾ standard deviation. The group data are presented as the median and range. Individual data are presented as the true value, with the percentage in parentheses. The t test was used for between-group comparisons. Loss to follow-up was defined as when the patient did not return to the clinic for a period ⬎24 months. Results The patient characteristics are presented in Table 1. The median follow-up was 36 months (range 0 –132). Sixty-six patients (13.6%) were lost to follow-up. Their weight data are included up to their last clinical visit. For patients from whom the band was removed or who underwent conversion to GBP, the data are included up to the last clinical visit before the revisional surgery. A total of 64 patients (13%) Table 1 Basic patient data Patients (n) Gender (n) Male Female Age (y) Mean Range Preoperative BMI (kg/m2) Lost to follow-up (n) BMI ⫽ body mass index.
486 78 408 40.7 18–67 42.4 ⫾ 5.6 66
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R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98 Table 3 Reason for revisional surgery and type of procedure (n ⫽ 104) Reason
Vomiting/food intolerance Staple line rupture Insufficient weight loss Band penetration Large opening Unknown Total
Procedure (n)
Total (n)
Repeat VBG
GBP
Band removal
7 17 0 1 6 0 31
15 2 20 7 2 3 49
24 0 0 0 0 0 24
46 19 20 8 8 3 104
VBG ⫽ vertical banded gastroplasty; GBP ⫽ gastric bypass. Fig. 1. Weight change over time (mean ⫾ standard deviation) and evaluated patients at each interval.
required conversion to open surgery. The main reason for conversion was poor access owing to a large left lobe of the liver. The conversion rates decreased over time from 23% in the first 100 cases to 4% in the last 100 cases. The operative time decreased throughout the study period, with a median operating time in the first 100 patients of 120 minutes compared with 78 minutes in the last 100 patients. Weight All patients lost weight. A 5-cm circumference band did not result in improved weight loss when analyzed at 1, 3, 5, and 7 years postoperatively. The weight loss over time for the whole group is presented in Fig. 1. The data are presented as intention to treat and thus included patients who underwent conversion to open surgery. Early complications (0 –30 d) Early complications are presented in Table 2. The most common early complications were wound infections and pneumonia. One patient underwent repeat surgery after 7 days because of bowel obstruction, with perforation of the cecum and died early in the postoperative period of a myocardial infarction. Three patients developed pulmonary emTable 2 Early complications ⬍30 days Complication
n (%)
Pulmonary embolism Atrial fibrillation Leakage Bleeding Ileus Wound infection Pneumonia Urinary tract infection Fever of unknown origin Urine retention
3 (.6) 1 (.2) 5 (1.0) 6 (1.2) 1 (.2) 16 (3.3) 13 (2.7) 2 (.4) 4 (.8) 3 (.6)
bolism, 2 of whom died. All cases of pulmonary embolism were seen in patients who had undergone conversion to open surgery. With the change in thromboembolic prophylaxis from Dextran 70 to sodium dalteparin for 10 days postoperatively, no additional cases of pulmonary embolism have occurred. The total 30-day mortality rate was .6%. Four patients (.8%) had leakage requiring operative intervention. Three patients (.6%) had postoperative bleeding requiring surgery. Late complications (⬎30 d) A total of 119 patients had late complications requiring surgical procedures. Of these 119 patients, 15 underwent surgery for incisional hernia 17 times (1 patient 3 times). VBG-related complications and revisional procedures are listed in Table 3. A total of 104 patients (21.4%) underwent surgery 114 times. No difference was seen in the revisional rates between the cases completed laparoscopically and the converted cases. The median time to revisional surgery was 38 months (range 1–106). A total of 49 patients underwent conversion to GBP, 24 patients had their band removed, and 31 patients underwent repeat VBG. Of the 31 patients who underwent repeat VBG, 10 (32.3%) required additional surgery. Of these 10 patients, 3 had their band removed because of vomiting and 7 underwent conversion GBP, 5 because of insufficient weight loss, 1 because of band penetration, and 1 because of vomiting. Of the 49 patients who underwent conversion GBP, 4 underwent open surgery because the primary VBG had been performed as open surgery. Seven cases began laparoscopically but were converted because of adhesions. Postoperatively, 6 patients had leakage, of whom 3 were treated endoscopically with fibrin glue and 3 underwent reoperation with drainage. Of the latter 3, 2 reoperations were done laparoscopically and 1 as open surgery. The total 30-day mortality rate was 0%. During the follow-up period, 8 patients (16.3%) underwent surgery for internal hernias after a median interval of 14 months (range 4 – 60). The preoperative weight in the group that underwent conversion
R. Marsk et al. / Surgery for Obesity and Related Diseases 5 (2009) 94 –98
to GBP was 35.9 ⫾ 7.2 kg/m2. After 1 and 2 years, their weight was 28.6 ⫾ 5.8 kg/m2 and 29.5 ⫾ 6.3 kg/m2, respectively. All cases of staple line insufficiency were seen in patients who had not had their staple line divided. Of the 19 patients who underwent repeat surgery because of staple line insufficiency, 17 underwent repeat VBG with a new divided staple line. Of those 17 patients, 5 (29.4%) required additional intervention. Of these 5 patients, 3 underwent conversion to GBP because of insufficient weight loss and 2 had their band removed because of food intolerance. Discussion The preoperative BMI was 42.4 ⫾ 5.6 kg/m2. This is lower than that seen in almost any American series of bariatric patients and was most likely because the Swedish obese population tends to be less obese than those seen in the United States and because we had a BMI cutoff of ⱖ35 kg/m2 for surgery. All patients lost weight during the first year after laparoscopic VBG; however, thereafter, a trend toward weight regain was noted. The reason for the slow increase in weight over time is not clear but might have resulted from changes in patients’ eating patterns with more liquid high-calorie foods and/or a distension of the pouch with time [14 –16]. We have no data available regarding the patients’ eating habits and failure rates. All patients who had their band removed or underwent conversion GBP were excluded from the study, possibly leaving only the “successful” cases at long-term follow-up and thereby boosting the long-term results regarding weight loss. The weight loss seen in this series of patients is similar to what we have previously reported for open VBG [13] and is in accordance with other published reports with similar follow-up periods [11,12]. The pouch size and diameter of the outlet of the pouch have been found to influence weight loss after VBG [7,17]. In the present series, no improvement in outcome was seen after changing to a band with a 5-cm circumference. However, we do not know the actual band circumference in the first 87 patients. Conversion to open surgery was done in 13% of the cases. The conversion rate was greater than that reported in other studies [12,18]. One possible reason for this is that the present study included all patients, beginning with the first laparoscopic VBG case at our institution. Most of the conversions occurred in the initial 100 cases, suggesting a learning curve, such as is seen for all laparoscopic procedures. Previous studies with long-term follow-up after open VBG have shown a high frequency of repeat interventions [8 –10], with a range of 25–56%. Those series had a follow-up period of 5–12 years, with the reintervention rate increasing with longer follow-up. In the present series, 104 patients (21.4%) required revisional surgery. The median follow-up in our series was 3 years, and it is likely that the
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revision rates will continue to increase with longer followup. Staple line insufficiency was seen in 19 patients, and only in patients who did not have their staple line divided, underlining the importance of a divided staple line. The exact mechanism behind staple line insufficiency is not clear, but patient overeating in the immediate postoperative period has been suggested as 1 reason [19]. Our patients were only allowed a liquid diet during the first 2 months in an effort to minimize the risk of staple line disruption. Gastroscopy was not routinely performed in the postoperative period; thus, the incidence of staple line insufficiency was most likely underestimated. In a previous study of open VBG, staple line insufficiency was common but did not correlate with weight gain [20]. In addition to staple line insufficiency, a large group of patients will require revisional surgery because of pouch enlargement, insufficient weight loss, or intolerance to food/vomiting after VBG. Conversion to GBP, in the case of failed VBG, seems to offer better results, at least in the short term. In the repeat VBG group of 31 patients, 10 (32.3%) required additional surgery—7 later underwent conversion to GBP and 3 had their band removed. This is in accordance with the strategy as proposed by van Gemert et al. [10] who recommended GBP in the case of failed VBG. The complication rates after revisional surgery to GBP were high. In this series, conversion from laparoscopic to open surgery occurred in 15.6% of patients, and anastomotic leakage was seen in 12.2%. The high rate of anastomotic leakage caused us switch to larger size clips when creating the gastrojejunostomy. It seems to have lowered the rate of anastomotic leakage in primary, as well as revisional, GBP. These high complication rates are similar to those of other reports of revision series [21] and much greater than the anastomotic leak rates seen after primary GBP (1–2%) [22]. Weight loss after conversion has appeared to be good, at least in the short term. Since the introduction of gastric banding in the 1990s, VBG has fallen out of favor. Of all antiobesity procedures, gastric banding accounts for 24.4% and VBG for only 5.4% [5]. Comparative studies between these 2 restrictive procedures are few and have had somewhat conflicting results regarding both weight loss and postoperative morbidity [9,23,24]. To our knowledge, only 1 study has compared laparoscopic VBG and GB. Morino et al. [23] randomized 100 patients to either laparoscopic GB or VBG and found better weight loss and fewer complications in the laparoscopic VBG group with a follow-up of 3 years. Evidence of the long-term outcomes after GB is still limited; however, in a study by Balsiger et al. [25], patients who had undergone GB were followed up for 7 years. In that series, the cumulative reoperation rate was 32%. This might indicate that the revision rates are in the same range after GB and VBG. This contrasts to the very favorable results after GB reported from Australia [26], suggesting that how patients are followed up might be of importance for the results of restrictive surgery.
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A proposed benefit for restrictive surgery is its safety. That must, however, be viewed in the light of the need for revisional surgery. According to our data, ⱖ1 of 5 patients who have undergone VBG will need revisional surgery in the future. The best option at reoperation seems to be conversion to GBP. One also should consider the increased morbidity seen with revisional surgery [27]. Recent studies have shown laparoscopic VBG to be inferior to GBP both regarding weight loss and the need for revisional surgery [28,29]. Conclusion In our experience, restrictive surgery in the form of VBG provides poor results with high rates of revisional surgery. Should the need for revisional surgery occur, repeat VBG seems to be a poor option, and it would be better to convert the VBG to GBP. We have abandoned VBG as a surgical treatment of obesity at our institution. Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article. References [1] Lonroth H, Dalenback J, Haglind E, et al. Vertical banded gastroplasty by laparoscopic technique in the treatment of morbid obesity. Surg Laparosc Endosc 1996;6:102–7. [2] Lonroth H, Dalenback J, Haglind E, Lundell L. Laparoscopic gastric bypass: another option in bariatric surgery. Surg Endosc 1996;10: 636 – 8. [3] Morino M, Toppino M, Garrone C, Morino F. Laparoscopic adjustable silicone gastric banding for the treatment of morbid obesity. Br J Surg 1994;81:1169 –70. [4] Samuel I, Mason EE, Renquist KE, Huang YH, Zimmerman MB, Jamal M. Bariatric surgery trends: an 18-year report from the International Bariatric Surgery Registry. Am J Surg 2006;192:657– 62. [5] Buchwald H, Williams SE. Bariatric surgery worldwide 2003. Obes Surg 2004;14:1157– 64. [6] Marsk R, Freedman J, Tynelius P, Rasmussen F, Näslund E. Antiobesity surgery in Sweden 1980 –2005: a population based study with special focus on mortality. Ann Surg. In press. [7] Mason EE. Vertical banded gastroplasty for obesity. Arch Surg 1982; 117:701– 6. [8] Baltasar A, Bou R, Arlandis F, et al. Vertical banded gastroplasty at more than 5 years. Obes Surg 1998;8:29 –34. [9] Miller K, Pump A, Hell E. Vertical banded gastroplasty versus adjustable gastric banding: prospective long-term follow-up study. Surg Obes Relat Dis 2006;2:570 –2. [10] van Gemert WG, van Wersch MM, Greve JW, Soeters PB. Revisional surgery after failed vertical banded gastroplasty: restoration of vertical banded gastroplasty or conversion to gastric bypass. Obes Surg 1998;8:21– 8.
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