- Email: [email protected]
Long-term outcomes of laparoscopic sleeve gastrectomy as a primary bariatric procedure
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Surgery for Obesity and Related Diseases ] (2014) 00–00
Original article
Long-term outcomes of laparoscopic sleeve gastrectomy as a primary bariatric procedure Camilo Boza, M.D.*, David Daroch, M.D., Diego Barros, M.D., Felipe León, M.D., Ricardo Funke, M.D., Fernando Crovari, M.D. Department of Digestive Surgery, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile Received December 5, 2013; accepted March 26, 2014
Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) has been established as a reliable bariatric procedure, but questions have emerged regarding its long-term results. Our aim is to report the longterm outcomes of LSG as a primary bariatric procedure. Methods: Retrospective analysis of patients submitted to LSG between 2005 and 2007 in our institution. Long-term outcomes at 5 years were analyzed in terms of body mass index (BMI), excess weight loss (EWL) and co-morbidities resolution. Surgical success was defined as % EWL 4 50%. Also, we compared long-term results according to preoperative BMI, using MannWhitney test. Results: A total of 161 LSG were analyzed, and 114 patients (70.8%) were women. The median age was 36 years old (range 16–65), median preoperative BMI was 34.9 kg/m2 (interquartile range [IQR], 33.3–37.5). A total of 112 patients (70%) completed 5 years of follow-up. At the fifth year, median BMI and %EWL was 28.5 kg/m2 (IQR: 25.8–31.9) and 62.9% (IQR: 45.3–89.6), respectively, with a surgical success of 73.2% of followed patients. According to preoperative BMI, surgical success was achieved in 80% of patients with BMI o 35 kg/m2, 75% of BMI 35–40 kg/m2, and 52.6% of BMI 4 40 kg/m2, with significant lower %EWL in patients with BMI 4 40 kg/m2 (P ¼ .001 and .004). Dyslipidemia and insulin resistance resolution was 80.7% and 84.7%, respectively. A total of 26.7% of patients reported new-onset gastroesophageal reflux symptoms at 5 years. Conclusion: LSG as a primary procedure is a reliable surgery. We observed positive long-term outcomes of %EWL and co-morbidities resolution. In our series, best results are seen in patients with preoperative BMI o 40 kg/m2. (Surg Obes Relat Dis 2014;]:00–00.) r 2014 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
Keywords:
Laparoscopic sleeve gastrectomy; Bariatric surgery; Long-term results
Bariatric surgery has proven to be an effective treatment for obesity and the only intervention with stable long-term outcomes. Over the last years, laparoscopic sleeve gastrectomy (LSG) has been established as a reliable bariatric procedure with general acceptance among surgeons due to favorable * Correspondence: Camilo Boza, M.D., Department of Digestive Surgery, School of Medicine. Pontificia Universidad Católica de Chile. Marcoleta 350. Santiago, Chile. E-mail: [email protected]
outcomes reported regarding weight loss, resolution of comorbidities and postoperative complications [1]. Different publications reporting short- and mid-term outcomes have shown the effectiveness of LSG as a primary bariatric procedure [2,3], but questions have emerged regarding its long-term results [4,5]. Because it is a relative novel bariatric procedure, there still are a limited number of long-term studies and follow-up reported vary considerably. The aim of this study is to report the long-term outcomes of patients who underwent a LSG as a primary bariatric
http://dx.doi.org/10.1016/j.soard.2014.03.024 1550-7289/r 2014 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
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procedure in our institution and have completed at least 5 years of follow-up. Methods Retrospective analysis of the electronic database of the Bariatric Surgery Program at the Clinical Hospital of the Pontificia Universidad Católica de Chile, between December 2005 and June 2007. We included all patients that were submitted to a LSG as a primary bariatric procedure during this period. The database was complemented by electronic medical records, laboratory-tests results, and a standardized telephonic survey during follow-up. Patients with Revisional surgery and pregnancy during the follow-up period were excluded from the analysis. Written informed consent was obtained from all patients. Data analyzed included patient’s demographic, co-morbidities, prior surgeries, preoperative and postoperative body mass index (BMI), excess weight loss (EWL), perioperative results, complications, and long-term outcomes. Diagnosis of prior co-morbidities was according to specific criteria: arterial hypertension was defined by World Health Organization criteria. Dyslipidemia was defined according ATP III criteria. Hypothyroidism and insulin resistance was defined according to the American Association of Clinical Endocrinologists. Diagnosis of type 2 diabetes mellitus (T2DM) was performed according to the criteria established by the American Diabetes Association. The diagnosis of gastroesophageal reflux disease (GERD) during follow-up was made clinically with a GERD symptoms questionnaire and by endoscopy in selected patients in whom esophagitis or other complications were suspected. Surgical success was defined as a percentage excess weight loss (%EWL) 4 50% and co-morbidities resolution was defined as absence of medication due to adequate medical control at 5 years. Also, we compared the long-term results of %EWL according to preoperative BMI between 3 groups of patients: BMI o 35 kg/m2, BMI: 35–40 kg/m2, and BMI 4 40 kg/m2.
was reinforced with a running absorbable suture. The resected stomach was removed in a plastic bag through the left flank trocar. Statistical analysis SPSS version 21.0 (Chicago, IL, USA) was used to statistical analysis. The results are reported as median with their range or interquartiles ranges (IQR). Comparison of %EWL according to preoperative BMI was performed with U-Mann-Whitney test. Confidence intervals were established for an alpha value of 95%. Results Between December 2005 and June 2007, 161 patients were submitted to a LSG as a primary bariatric procedure in our institution. One hundred and fourteen patients (70.8%) were women. Median age was 36 years old (range, 16–65) and median preoperative BMI was 34.9 kg/m2 (IQR 33.3–37,5). Preoperative co-morbidities of the series were insulin resistance: 87 patients (54%), dyslipidemia: 87 patients (54%), arterial hypertension: 38 patients (23.6%), hypothyroidism: 22 patients (13.6%), and T2DM: 8 patients (4.9%). In regard to surgical data, median operative time was 82.5 minutes (range, 45–360), with no conversions to open surgery. Simultaneous cholecystectomy was performed in 10 patients (6.2%) due to cholelitiasis. Median in-hospital stay was 3 days (range, 2–16). Six patients (3.7%) developed postoperative complications; 2 patients (1.2%) had surgical wound infection, 1 patient (0.6%) developed a portomesenteric thrombosis requiring anticoagulation, and 1 patient (0.6%) presented a mild hemoperitoneum managed without surgery. Two patients required a reoperation, 1 due to staple-line leak requiring a laparoscopic drainage on postoperative day 2 and the other due to antral stenosis, who was converted to laparoscopic Roux-en-Y gastric bypass (LRYGB) 1 month after surgery. No other reoperations and no mortality were reported in our series. Long-term outcomes
Surgical technique In our center, LSG is performed with a 5-trocar technique that has been previously reported [6]. In this series, gastric greater curvature was dissected 6 cm proximal to the pylorus, preserving the antrum. Short gastric vessels were sectioned using the harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH, USA) up to the gastroesophageal junction. A 60-Fr bougie was inserted transorally and then 4 to 5 60-mm laparoscopic staplers were fired adjacent to bougie to transect the stomach (Echelon Endopath stapler, Ethicon Endosurgery, Cincinnati, OH, USA). Green, gold, and blue cartridges were used depending on the thickness of the stomach. The staple line
Four patients (2.5%) required revisional surgery after the LSG. As was mentioned before, 1 patient was converted to LRYGB due to antral stenosis and the remaining 3 patients underwent a second bariatric procedure due to weight regain: 2 patients were submitted to a LRYGB at 3 and 5 years after LSG, respectively, and 1 patient underwent a duodenaljejunal bypass liner implantation 3 years after LSG. The percentage of follow-up was 88% (141 patients) at 1 year, 78% (126 patients) at 3 years, 70% (112 patients) at 5 years, and 37% (59 patients) at 6 years. Median and mean follow-up were 60 (range, 6–72) months and 54 ⫾ 19 months, respectively. The lowest overall median BMI was 26.4 kg/m2 and it was achieved at a median of 12 months
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Fig. 1. Excess weight loss progression at long-term follow-up in patients submitted to a laparoscopic sleeve gastrectomy as a primary bariatric procedure. % EWL¼ excess weight loss percentage; LSG ¼ laparoscopic sleeve gastrectomy
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after surgery. At 5 years follow-up, median BMI and % EWL was 28.5 kg/m2 (IQR: 25.9–31.2) and 62.9% (IQR: 45.3–89.6), respectively. %EWL progression during followup is shown in Fig. 1. At 5 years follow-up, surgical success (%EWL 4 50%) was achieved in 82 of the followed patients (73.2%). According to preoperative BMI, surgical success was achieved in 80% of patients with BMI o 35 kg/m2, 75% with BMI 35–40 kg/m2, and 52.6% with BMI 4 40 kg/m2, with significant differences in %EWL in groups with BMI o 40 kg/m2 (BMI o 35 kg/m2 and BMI 35–40 kg/ m2) compared to BMI 4 40 kg/m2 (P ¼ .001 and P ¼ .004, respectively). No significant differences were observed between groups with BMI o 40 kg/m2, P ¼ .436. The %EWL and percentage of surgical success achieved at 5 years follow-up according to preoperative BMI are shown in Table 1. Co-morbidities that had higher resolution rates at 5 years were dyslipidemia and insulin resistance with 80.7% and 84.7% of patients without requiring medication, respectively. Arterial hypertension had resolution in 57.6% of cases and in 40% of patients with T2DM. Finally, 7 patients (4.3%) had the diagnosis of GERD before surgery. No patients reported symptoms resolution after LSG and at 5 years follow-up 30 patients (26.7% of followed patients) reported GERD symptoms that were not present before surgery. Of note, no patients had to be reoperated due to GERD symptoms. Discussion LSG is rapidly gaining popularity among surgeons because its apparent technical simplicity and promising results despite a relative lack of long-term outcomes reported. In recent years, it has become a reliable and frequently performed primary procedure with good food tolerance and satisfaction among patients [7]. Numerous publications support LSG as a definitive operation, with
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good short- and mid-term outcomes reported that have placed it among other traditional procedures. In the case of long-term results, most published series show satisfactory weight loss outcomes. Weiner et al. [8] achieved 40% EWL at 5 years in a small series. Kehagias et al. [9] reported 57.6% EWL and 66.7% EWL 4 50%; and Zachariah et al. [10] recently published the experience at an Asian center achieving 63.7% EWL at 5 years. The 62.9% EWL observed in our series at 5 years is consistent with most publications as well as the 73.2% success of surgery achieved. In our series, %EWL and BMI progression showed some weight regain after the second year, similar to other reports [11–13]. We believe that these results are promising especially considering the less restrictive technical aspects used as a gastric dissection 6 cm from the pylorus and the use of a 60 F calibration bougie, which could have otherwise determined even better results. Rawlins et al. [12] achieved 86 %EWL at 5 year follow-up with a close transection from the pylorus (3 cm), a narrow calibrated sleeve (26.4 F), and a structured dietary and exercise program. There is limited information published on weight loss progression after 5 years. D’Hondt et al. [7] studied 83 patients up to 6 years after LSG, they observed that between the 4th and 6th years, the %EWL dropped from 72.3% to 55.9%, demonstrating some weight regain after the 5th year. They also reported a %EWL 4 50% in 54.5% of the patients at 6 years, similar to others studies [13]. Sarela et al. [11] reported the longest follow-up to date of LSG with a small series of patients studied at 9th year, with a % EWL of 69% and %EWL 4 50% of 55%. In our series, 59 patients have documented 6 years follow-up. Despite being a small number of cases, the %EWL showed no significant changes between the fifth and sixth year, reflecting that EWL can be sustained after fifth year. These findings require further study and longer follow-up to see if these results will be prolonged over time.
Table 1 Excess weight loss and surgical success at 5 years follow-up according to preoperative body mass index. Preoperative n ¼ 112* %EWL (IQR) BMI (median) (%) o35 kg/m2 35–40 kg/m2 440 kg/m2
%EWL P value 4 50% (%)
50 (45%) 72.7% (50.1–100.7) 80% 43 (38%) 69.2% (52.2–90.1) 75% 19 (17%) 50.2% (39.3–60.2) 52.6%
.436† .001‡ .004§
BMI ¼ body mass index; %EWL ¼ percentage of excess weight loss; IQR ¼ interquartile range. * According to 70% follow-up at 5 years. † P values obtained when comparing % EWL of BMI o 35 kg/m2 to BMI 35–40 kg/m2 with Mann-Whitney test. ‡ P values obtained when comparing % EWL of BMI o 35 kg/m2 to BMI 4 40 kg/m2 with Mann-Whitney test. § P values obtained when comparing % EWL of BMI 35–40 kg/m2 to BMI 4 40 kg/m2 with Mann-Whitney test.
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Preoperative BMI seems to be an important factor predicting long-term outcomes after LSG. Eid et al. [14] reported results in patients with mean preoperative BMI of 66 kg/m2. They observed 48% EWL at 8 years of followup, results worse than others series with lower preoperative BMI. Bohdjalian et al. [15] studied 26 patients after LSG with mean BMI of 48.2 kg/m2, reporting 55% EWL at 5 years and 15% of them went to RYGB due to weight regain. We observed similar results in our patients, because the group of patients with preoperative BMI 4 40 kg/m2 achieved significant lower %EWL (50.2%) at 5 years in opposition to groups with BMI o 40 kg/m2 (72.7% in BMI o 35 kg/m2 and 69.2% in BMI 35–40 kg/m2). Co-morbidities resolution after LSG varies between different series, reaching even 100% of resolution in most diseases [9,12]. Consistent with a previous publication [7], dyslipidemia and insulin resistance are the co-morbidities that show the greatest long-term resolution in this study, reaching 81% and 85%, respectively. On the other hand, dissimilar to previous reports, arterial hypertension showed a moderate response to surgery in our series, with 57% of patients free of medication at 5 years. In the case of T2DM, previous publications with mid-term follow-up showed a T2DM remission in 69.6 to 80.9% of the patients [16–19]. In our series, only 40% of patients achieved resolution at 5 years, less than reported by other authors [10,12,19], but it is difficult to draw conclusions from these results given our limited number of patients with T2DM. Regarding GERD, many authors have established a relationship with LSG, but current data is not convincing and contradictory results have been reported [20,21]. Rawlin et al. [12] reported 53% of resolution and 16% new onset of GERD symptoms after LSG. Kehagias et al. [9] reported GERD symptoms in 7.4% of patients. Bohdjalian et al. [15] reported that 33% of patients were taking chronic acid suppression medication for GERD symptoms at 5 years follow-up. Himpens et al [13] reported GERD symptoms in 23% of patients at long-term follow-up. They state, based on their previous report [22], that GERD presents a biphasic pattern after LSG. The first peak develops during the first postoperative year and disappears before the third postoperative year, most likely thanks to increased gastric compliance and improved gastric emptying. A second peak of GERD shows up at long-term, secondary to the development of a neofundus [13]. Regarding bougie size, Abd Ellatif et al. [23] compared incidence of GERD according to bougie size in 1400 patients. They compared bougie r36Fr versus Z44Fr, with GERD symptoms at 1 year of 11.7% versus 12.1%, respectively. At 4 years, 2% of patients had GERD symptoms, with no report of differences between groups. Of note, 1.3% had to be converted to RYGB due to severe GERD symptoms. Spivak et al. [24] reported a comparison between bougie 42Fr versus 32Fr at 1-year follow-up. They reported GERD in 42% versus 19%, respectively. We think
that bigger size of bougie is probably associated with GERD, so probably 60Fr bougie used in our study can explain our high rate of GERD symptoms at long term. Actually, now we are using 34Fr bougie in our institution. Compared to other bariatric procedures, some authors [21,22,26] have found that rates of resolution of GERD symptoms were not significantly different for LSG versus laparoscopic gastric banding. On the other hand, recent studies [22,27] have reported reduction of GERD symptoms after RYGB compared to gastric banding or LSG at 6 months. In our series, no patient had GERD symptoms resolution after LSG and 26.7% had new symptoms onset. These results allow us to presume that LSG can increase GERD symptoms. Therefore, in our institution LSG is usually avoided when previous history of GERD is present and other bariatric procedure as LRYGB is offered to our patients instead. There are several limitations in our study. First, to establish adequately the long-term effect of LSG in terms of %EWL-BMI progression and co-morbidities resolution, a comparison between LSG and other treatments has to be performed, as an optimal medical therapy or other bariatric procedures as LRYGB. However, this was not performed due to our limited number of patients. Second, to analyze % EWL achieved according to preoperative BMI, a multivariate analysis is necessary to include all of the variables involved in weight progression and eliminate confounding factors, especially all of the postoperative factors affecting weight progression (i.e., dietary habits and exercise) that were not included in our study. Also, our low number of patients (19) with BMI 4 40 kg/m2 followed at 5 years limit our results. Third, definitions of co-morbidities resolution used were nonstandardized and no metabolic goal of remission was incorporated as suggested by medical guidelines. We have to include standardized definitions in the future to compare studies adequately and therefore establish the real role of bariatric surgery in co-morbidities resolution and improvement. Finally, it is well known that this kind of study has a follow-up bias and independently of our acceptable long-term follow-up achieved, perhaps patients with poor outcomes were lost to follow-up. Conclusion In our series, LSG as a primary bariatric procedure is a reliable operation with a low complication rate. Despite presenting some amount of weight regain, it shows positive outcomes in terms of %EWL and co-morbidities resolution at 5 years follow-up. In our series, best results are seen in patients with preoperative BMI o 40 kg/m2. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article.
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Uncited references [25] References [1] Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009;5:469–75. [2] Sammour T, Hill AG, Singh P, Ranasinghe A, Babor R, Rahman H. Laparoscopic sleeve gastrectomy as a single-stage bariatric procedure. Obes Surg 2010;20:271–5. [3] Srinivasa S, Hill LS, Sammour T, Hill AG, Babor R, Rahman H. Early and mid-term outcomes of single-stage laparoscopic sleeve gastrectomy. Obes Surg 2010;20:1484–90. [4] Prasad P, Tantia O, Patle N, Khanna S, Sen B. An analysis of 1-3year follow-up results of laparoscopic sleeve gastrectomy: an Indian perspective. Obes Surg 2012;22:507–14. [5] Armstrong J, O’Malley SP. Outcomes of sleeve gastrectomy for morbid obesity: a safe and effective procedure? Int J Surg 2010;8:69–71 [6] Boza C, Salinas J, Salgado N, et al. Laparoscopic sleeve gastrectomy as a stand-alone procedure for morbid obesity: report of 1,000 cases and 3-year follow-up. Obes Surg 2012;22:866–71. [7] D’Hondt M, Vanneste S, Pottel H, Devriendt D, Van Rooy F, Vansteenkiste F. Laparoscopic sleeve gastrectomy as a single-stage procedure for the treatment of morbid obesity and the resulting quality of life, resolution of comorbidities, food tolerance, and 6-year weight loss. Surg Endosc 2011;25:2498–504. [8] Weiner RA, Weiner S, Pomhoff I, Jacobi C, Makarewicz W, Weigand G. Laparoscopic sleeve gastrectomy–influence of sleeve size and resected gastric volume. Obes Surg 2007;17:1297–305. [9] Kehagias I, Spyropoulos C, Karamanakos S, Kalfarentzos F. Efficacy of sleeve gastrectomy as sole procedure in patients with clinically severe obesity (BMI o / ¼ 50 kg/m(2)). Surg Obes Relat Dis 2013;9: 363–9. [10] Zachariah SK, Chang PC, Ooi AS, Hsin MC, Kin Wat JY, Huang CK. Laparoscopic sleeve gastrectomy for morbid obesity: 5 years experience from an Asian center of excellence. Obes Surg 2013;23: 939–46. [11] Sarela AI, Dexter SP, O’Kane M, Menon A, McMahon MJ. Longterm follow-up after laparoscopic sleeve gastrectomy: 8-9-year results. Surg Obes Relat Dis 2012;8:679–84. [12] Rawlins L, Rawlins MP, Brown CC, Schumacher DL. Sleeve gastrectomy: 5-year outcomes of a single institution. Surg Obes Relat Dis 2013;9:21–5. [13] Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg 2010;252:319–24.
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[14] Eid GM, Brethauer S, Mattar SG, Titchner RL, Gourash W, Schauer PR. Laparoscopic sleeve gastrectomy for super obese patients: fortyeight percent excess weight loss after 6 to 8 years with 93% followup. Ann Surg 2012;256:262–5. [15] Bohdjalian A, Langer FB, Shakeri-Leidenmuhler S, et al. Sleeve gastrectomy as sole and definitive bariatric procedure: 5-year results for weight loss and ghrelin. Obes Surg 2010;20:535–40. [16] Abbatini F, Rizzello M, Casella G, et al. Long-term effects of laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding on type 2 diabetes. Surg Endosc 2010;24:1005–10. [17] Jimenez A, Casamitjana R, Flores L, et al. Long-term effects of sleeve gastrectomy and Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus in morbidly obese subjects. Ann Surg 2012;256:1023–9. [18] Todkar JS, Shah SS, Shah PS, Gangwani J. Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus. Surg Obes Relat Dis 2010;6:142–5. [19] Abbatini F, Capoccia D, Casella G, Soricelli E, Leonetti F, Basso N. Long-term remission of type 2 diabetes in morbidly obese patients after sleeve gastrectomy. Surg Obes Relat Dis 2013;9:498–502. [20] Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg 2013;23:987–91. [21] Chiu S, Birch DW, Shi X, Sharma AM, Karmali S. Effect of sleeve gastrectomy on gastroesophageal reflux disease: a systematic review. Surg Obes Relat Dis 2011;7:510–5. [22] Himpens J, Dapri G, Cadiere GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006;16:1450–6. [23] Abd Ellatif ME, Abdallah E, Askar W, et al. Long term predictors of success after laparoscopic sleeve gastrectomy. Int J Surg 2014. (In press). [24] Spivak H, Rubin M, Sadot E, Pollak E, Feygin A, Goitein D. Laparoscopic sleeve gastrectomy using 42-french versus 32-french bougie: the first-year outcome. Obes Surg. Epub 2014 Mar:1. [25] Omana JJ, Nguyen SQ, Herron D, Kini S. Comparison of comorbidity resolution and improvement between laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding. Surg Endosc 2010;24: 2513–7. [26] Dupree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease: a national analysis. JAMA Surg 2014. (In press). [27] Pallati PK, Shaligram A, Shostrom VK, Oleynikov D, McBride CL, Goede MR. Improvement in gastroesophageal reflux disease symptoms after various bariatric procedures: review of the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis. Epub 2013 Aug 29.
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Original article
Long-term outcomes of laparoscopic sleeve gastrectomy as a primary bariatric procedure Camilo Boza, M.D.*, David Daroch, M.D., Diego Barros, M.D., Felipe León, M.D., Ricardo Funke, M.D., Fernando Crovari, M.D. Department of Digestive Surgery, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile Received December 5, 2013; accepted March 26, 2014
Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) has been established as a reliable bariatric procedure, but questions have emerged regarding its long-term results. Our aim is to report the longterm outcomes of LSG as a primary bariatric procedure. Methods: Retrospective analysis of patients submitted to LSG between 2005 and 2007 in our institution. Long-term outcomes at 5 years were analyzed in terms of body mass index (BMI), excess weight loss (EWL) and co-morbidities resolution. Surgical success was defined as % EWL 4 50%. Also, we compared long-term results according to preoperative BMI, using MannWhitney test. Results: A total of 161 LSG were analyzed, and 114 patients (70.8%) were women. The median age was 36 years old (range 16–65), median preoperative BMI was 34.9 kg/m2 (interquartile range [IQR], 33.3–37.5). A total of 112 patients (70%) completed 5 years of follow-up. At the fifth year, median BMI and %EWL was 28.5 kg/m2 (IQR: 25.8–31.9) and 62.9% (IQR: 45.3–89.6), respectively, with a surgical success of 73.2% of followed patients. According to preoperative BMI, surgical success was achieved in 80% of patients with BMI o 35 kg/m2, 75% of BMI 35–40 kg/m2, and 52.6% of BMI 4 40 kg/m2, with significant lower %EWL in patients with BMI 4 40 kg/m2 (P ¼ .001 and .004). Dyslipidemia and insulin resistance resolution was 80.7% and 84.7%, respectively. A total of 26.7% of patients reported new-onset gastroesophageal reflux symptoms at 5 years. Conclusion: LSG as a primary procedure is a reliable surgery. We observed positive long-term outcomes of %EWL and co-morbidities resolution. In our series, best results are seen in patients with preoperative BMI o 40 kg/m2. (Surg Obes Relat Dis 2014;]:00–00.) r 2014 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
Keywords:
Laparoscopic sleeve gastrectomy; Bariatric surgery; Long-term results
Bariatric surgery has proven to be an effective treatment for obesity and the only intervention with stable long-term outcomes. Over the last years, laparoscopic sleeve gastrectomy (LSG) has been established as a reliable bariatric procedure with general acceptance among surgeons due to favorable * Correspondence: Camilo Boza, M.D., Department of Digestive Surgery, School of Medicine. Pontificia Universidad Católica de Chile. Marcoleta 350. Santiago, Chile. E-mail: [email protected]
outcomes reported regarding weight loss, resolution of comorbidities and postoperative complications [1]. Different publications reporting short- and mid-term outcomes have shown the effectiveness of LSG as a primary bariatric procedure [2,3], but questions have emerged regarding its long-term results [4,5]. Because it is a relative novel bariatric procedure, there still are a limited number of long-term studies and follow-up reported vary considerably. The aim of this study is to report the long-term outcomes of patients who underwent a LSG as a primary bariatric
http://dx.doi.org/10.1016/j.soard.2014.03.024 1550-7289/r 2014 Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
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procedure in our institution and have completed at least 5 years of follow-up. Methods Retrospective analysis of the electronic database of the Bariatric Surgery Program at the Clinical Hospital of the Pontificia Universidad Católica de Chile, between December 2005 and June 2007. We included all patients that were submitted to a LSG as a primary bariatric procedure during this period. The database was complemented by electronic medical records, laboratory-tests results, and a standardized telephonic survey during follow-up. Patients with Revisional surgery and pregnancy during the follow-up period were excluded from the analysis. Written informed consent was obtained from all patients. Data analyzed included patient’s demographic, co-morbidities, prior surgeries, preoperative and postoperative body mass index (BMI), excess weight loss (EWL), perioperative results, complications, and long-term outcomes. Diagnosis of prior co-morbidities was according to specific criteria: arterial hypertension was defined by World Health Organization criteria. Dyslipidemia was defined according ATP III criteria. Hypothyroidism and insulin resistance was defined according to the American Association of Clinical Endocrinologists. Diagnosis of type 2 diabetes mellitus (T2DM) was performed according to the criteria established by the American Diabetes Association. The diagnosis of gastroesophageal reflux disease (GERD) during follow-up was made clinically with a GERD symptoms questionnaire and by endoscopy in selected patients in whom esophagitis or other complications were suspected. Surgical success was defined as a percentage excess weight loss (%EWL) 4 50% and co-morbidities resolution was defined as absence of medication due to adequate medical control at 5 years. Also, we compared the long-term results of %EWL according to preoperative BMI between 3 groups of patients: BMI o 35 kg/m2, BMI: 35–40 kg/m2, and BMI 4 40 kg/m2.
was reinforced with a running absorbable suture. The resected stomach was removed in a plastic bag through the left flank trocar. Statistical analysis SPSS version 21.0 (Chicago, IL, USA) was used to statistical analysis. The results are reported as median with their range or interquartiles ranges (IQR). Comparison of %EWL according to preoperative BMI was performed with U-Mann-Whitney test. Confidence intervals were established for an alpha value of 95%. Results Between December 2005 and June 2007, 161 patients were submitted to a LSG as a primary bariatric procedure in our institution. One hundred and fourteen patients (70.8%) were women. Median age was 36 years old (range, 16–65) and median preoperative BMI was 34.9 kg/m2 (IQR 33.3–37,5). Preoperative co-morbidities of the series were insulin resistance: 87 patients (54%), dyslipidemia: 87 patients (54%), arterial hypertension: 38 patients (23.6%), hypothyroidism: 22 patients (13.6%), and T2DM: 8 patients (4.9%). In regard to surgical data, median operative time was 82.5 minutes (range, 45–360), with no conversions to open surgery. Simultaneous cholecystectomy was performed in 10 patients (6.2%) due to cholelitiasis. Median in-hospital stay was 3 days (range, 2–16). Six patients (3.7%) developed postoperative complications; 2 patients (1.2%) had surgical wound infection, 1 patient (0.6%) developed a portomesenteric thrombosis requiring anticoagulation, and 1 patient (0.6%) presented a mild hemoperitoneum managed without surgery. Two patients required a reoperation, 1 due to staple-line leak requiring a laparoscopic drainage on postoperative day 2 and the other due to antral stenosis, who was converted to laparoscopic Roux-en-Y gastric bypass (LRYGB) 1 month after surgery. No other reoperations and no mortality were reported in our series. Long-term outcomes
Surgical technique In our center, LSG is performed with a 5-trocar technique that has been previously reported [6]. In this series, gastric greater curvature was dissected 6 cm proximal to the pylorus, preserving the antrum. Short gastric vessels were sectioned using the harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH, USA) up to the gastroesophageal junction. A 60-Fr bougie was inserted transorally and then 4 to 5 60-mm laparoscopic staplers were fired adjacent to bougie to transect the stomach (Echelon Endopath stapler, Ethicon Endosurgery, Cincinnati, OH, USA). Green, gold, and blue cartridges were used depending on the thickness of the stomach. The staple line
Four patients (2.5%) required revisional surgery after the LSG. As was mentioned before, 1 patient was converted to LRYGB due to antral stenosis and the remaining 3 patients underwent a second bariatric procedure due to weight regain: 2 patients were submitted to a LRYGB at 3 and 5 years after LSG, respectively, and 1 patient underwent a duodenaljejunal bypass liner implantation 3 years after LSG. The percentage of follow-up was 88% (141 patients) at 1 year, 78% (126 patients) at 3 years, 70% (112 patients) at 5 years, and 37% (59 patients) at 6 years. Median and mean follow-up were 60 (range, 6–72) months and 54 ⫾ 19 months, respectively. The lowest overall median BMI was 26.4 kg/m2 and it was achieved at a median of 12 months
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Fig. 1. Excess weight loss progression at long-term follow-up in patients submitted to a laparoscopic sleeve gastrectomy as a primary bariatric procedure. % EWL¼ excess weight loss percentage; LSG ¼ laparoscopic sleeve gastrectomy
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after surgery. At 5 years follow-up, median BMI and % EWL was 28.5 kg/m2 (IQR: 25.9–31.2) and 62.9% (IQR: 45.3–89.6), respectively. %EWL progression during followup is shown in Fig. 1. At 5 years follow-up, surgical success (%EWL 4 50%) was achieved in 82 of the followed patients (73.2%). According to preoperative BMI, surgical success was achieved in 80% of patients with BMI o 35 kg/m2, 75% with BMI 35–40 kg/m2, and 52.6% with BMI 4 40 kg/m2, with significant differences in %EWL in groups with BMI o 40 kg/m2 (BMI o 35 kg/m2 and BMI 35–40 kg/ m2) compared to BMI 4 40 kg/m2 (P ¼ .001 and P ¼ .004, respectively). No significant differences were observed between groups with BMI o 40 kg/m2, P ¼ .436. The %EWL and percentage of surgical success achieved at 5 years follow-up according to preoperative BMI are shown in Table 1. Co-morbidities that had higher resolution rates at 5 years were dyslipidemia and insulin resistance with 80.7% and 84.7% of patients without requiring medication, respectively. Arterial hypertension had resolution in 57.6% of cases and in 40% of patients with T2DM. Finally, 7 patients (4.3%) had the diagnosis of GERD before surgery. No patients reported symptoms resolution after LSG and at 5 years follow-up 30 patients (26.7% of followed patients) reported GERD symptoms that were not present before surgery. Of note, no patients had to be reoperated due to GERD symptoms. Discussion LSG is rapidly gaining popularity among surgeons because its apparent technical simplicity and promising results despite a relative lack of long-term outcomes reported. In recent years, it has become a reliable and frequently performed primary procedure with good food tolerance and satisfaction among patients [7]. Numerous publications support LSG as a definitive operation, with
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good short- and mid-term outcomes reported that have placed it among other traditional procedures. In the case of long-term results, most published series show satisfactory weight loss outcomes. Weiner et al. [8] achieved 40% EWL at 5 years in a small series. Kehagias et al. [9] reported 57.6% EWL and 66.7% EWL 4 50%; and Zachariah et al. [10] recently published the experience at an Asian center achieving 63.7% EWL at 5 years. The 62.9% EWL observed in our series at 5 years is consistent with most publications as well as the 73.2% success of surgery achieved. In our series, %EWL and BMI progression showed some weight regain after the second year, similar to other reports [11–13]. We believe that these results are promising especially considering the less restrictive technical aspects used as a gastric dissection 6 cm from the pylorus and the use of a 60 F calibration bougie, which could have otherwise determined even better results. Rawlins et al. [12] achieved 86 %EWL at 5 year follow-up with a close transection from the pylorus (3 cm), a narrow calibrated sleeve (26.4 F), and a structured dietary and exercise program. There is limited information published on weight loss progression after 5 years. D’Hondt et al. [7] studied 83 patients up to 6 years after LSG, they observed that between the 4th and 6th years, the %EWL dropped from 72.3% to 55.9%, demonstrating some weight regain after the 5th year. They also reported a %EWL 4 50% in 54.5% of the patients at 6 years, similar to others studies [13]. Sarela et al. [11] reported the longest follow-up to date of LSG with a small series of patients studied at 9th year, with a % EWL of 69% and %EWL 4 50% of 55%. In our series, 59 patients have documented 6 years follow-up. Despite being a small number of cases, the %EWL showed no significant changes between the fifth and sixth year, reflecting that EWL can be sustained after fifth year. These findings require further study and longer follow-up to see if these results will be prolonged over time.
Table 1 Excess weight loss and surgical success at 5 years follow-up according to preoperative body mass index. Preoperative n ¼ 112* %EWL (IQR) BMI (median) (%) o35 kg/m2 35–40 kg/m2 440 kg/m2
%EWL P value 4 50% (%)
50 (45%) 72.7% (50.1–100.7) 80% 43 (38%) 69.2% (52.2–90.1) 75% 19 (17%) 50.2% (39.3–60.2) 52.6%
.436† .001‡ .004§
BMI ¼ body mass index; %EWL ¼ percentage of excess weight loss; IQR ¼ interquartile range. * According to 70% follow-up at 5 years. † P values obtained when comparing % EWL of BMI o 35 kg/m2 to BMI 35–40 kg/m2 with Mann-Whitney test. ‡ P values obtained when comparing % EWL of BMI o 35 kg/m2 to BMI 4 40 kg/m2 with Mann-Whitney test. § P values obtained when comparing % EWL of BMI 35–40 kg/m2 to BMI 4 40 kg/m2 with Mann-Whitney test.
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Preoperative BMI seems to be an important factor predicting long-term outcomes after LSG. Eid et al. [14] reported results in patients with mean preoperative BMI of 66 kg/m2. They observed 48% EWL at 8 years of followup, results worse than others series with lower preoperative BMI. Bohdjalian et al. [15] studied 26 patients after LSG with mean BMI of 48.2 kg/m2, reporting 55% EWL at 5 years and 15% of them went to RYGB due to weight regain. We observed similar results in our patients, because the group of patients with preoperative BMI 4 40 kg/m2 achieved significant lower %EWL (50.2%) at 5 years in opposition to groups with BMI o 40 kg/m2 (72.7% in BMI o 35 kg/m2 and 69.2% in BMI 35–40 kg/m2). Co-morbidities resolution after LSG varies between different series, reaching even 100% of resolution in most diseases [9,12]. Consistent with a previous publication [7], dyslipidemia and insulin resistance are the co-morbidities that show the greatest long-term resolution in this study, reaching 81% and 85%, respectively. On the other hand, dissimilar to previous reports, arterial hypertension showed a moderate response to surgery in our series, with 57% of patients free of medication at 5 years. In the case of T2DM, previous publications with mid-term follow-up showed a T2DM remission in 69.6 to 80.9% of the patients [16–19]. In our series, only 40% of patients achieved resolution at 5 years, less than reported by other authors [10,12,19], but it is difficult to draw conclusions from these results given our limited number of patients with T2DM. Regarding GERD, many authors have established a relationship with LSG, but current data is not convincing and contradictory results have been reported [20,21]. Rawlin et al. [12] reported 53% of resolution and 16% new onset of GERD symptoms after LSG. Kehagias et al. [9] reported GERD symptoms in 7.4% of patients. Bohdjalian et al. [15] reported that 33% of patients were taking chronic acid suppression medication for GERD symptoms at 5 years follow-up. Himpens et al [13] reported GERD symptoms in 23% of patients at long-term follow-up. They state, based on their previous report [22], that GERD presents a biphasic pattern after LSG. The first peak develops during the first postoperative year and disappears before the third postoperative year, most likely thanks to increased gastric compliance and improved gastric emptying. A second peak of GERD shows up at long-term, secondary to the development of a neofundus [13]. Regarding bougie size, Abd Ellatif et al. [23] compared incidence of GERD according to bougie size in 1400 patients. They compared bougie r36Fr versus Z44Fr, with GERD symptoms at 1 year of 11.7% versus 12.1%, respectively. At 4 years, 2% of patients had GERD symptoms, with no report of differences between groups. Of note, 1.3% had to be converted to RYGB due to severe GERD symptoms. Spivak et al. [24] reported a comparison between bougie 42Fr versus 32Fr at 1-year follow-up. They reported GERD in 42% versus 19%, respectively. We think
that bigger size of bougie is probably associated with GERD, so probably 60Fr bougie used in our study can explain our high rate of GERD symptoms at long term. Actually, now we are using 34Fr bougie in our institution. Compared to other bariatric procedures, some authors [21,22,26] have found that rates of resolution of GERD symptoms were not significantly different for LSG versus laparoscopic gastric banding. On the other hand, recent studies [22,27] have reported reduction of GERD symptoms after RYGB compared to gastric banding or LSG at 6 months. In our series, no patient had GERD symptoms resolution after LSG and 26.7% had new symptoms onset. These results allow us to presume that LSG can increase GERD symptoms. Therefore, in our institution LSG is usually avoided when previous history of GERD is present and other bariatric procedure as LRYGB is offered to our patients instead. There are several limitations in our study. First, to establish adequately the long-term effect of LSG in terms of %EWL-BMI progression and co-morbidities resolution, a comparison between LSG and other treatments has to be performed, as an optimal medical therapy or other bariatric procedures as LRYGB. However, this was not performed due to our limited number of patients. Second, to analyze % EWL achieved according to preoperative BMI, a multivariate analysis is necessary to include all of the variables involved in weight progression and eliminate confounding factors, especially all of the postoperative factors affecting weight progression (i.e., dietary habits and exercise) that were not included in our study. Also, our low number of patients (19) with BMI 4 40 kg/m2 followed at 5 years limit our results. Third, definitions of co-morbidities resolution used were nonstandardized and no metabolic goal of remission was incorporated as suggested by medical guidelines. We have to include standardized definitions in the future to compare studies adequately and therefore establish the real role of bariatric surgery in co-morbidities resolution and improvement. Finally, it is well known that this kind of study has a follow-up bias and independently of our acceptable long-term follow-up achieved, perhaps patients with poor outcomes were lost to follow-up. Conclusion In our series, LSG as a primary bariatric procedure is a reliable operation with a low complication rate. Despite presenting some amount of weight regain, it shows positive outcomes in terms of %EWL and co-morbidities resolution at 5 years follow-up. In our series, best results are seen in patients with preoperative BMI o 40 kg/m2. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article.
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