- Email: [email protected]
Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus
Surgery for Obesity and Related Diseases 6 (2010) 142–145
Original article
Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus Jayashree S. Todkar, M.S., Shashank S. Shah, M.S.*, Poonam S. Shah, M.D., Jayashri Gangwani, B.A.M.S. Laparascopic and Bariatric Surgery, Ruby Hall Clinic, Pune, Maharashtra, India Received May 21, 2009; revised June 21, 2009; accepted June 29, 2009
Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) is becoming popular as a stand-alone procedure for the treatment of morbid obesity and related diseases. This retrospective study presents the outcomes of LSG with regard to weight loss and improvement in co-morbidities and quality of life (QOL) at the end of 3 years after surgery in a tertiary care hospital in Pune, India. Methods: A total of 23 patients with type 2 diabetes mellitus (6 men and 17 women) with morbid obesity (mean body mass index 40.7 ⫾ 6.6 kg/m2) who had undergone LSG from 2004 to 2005 were selected for the present analysis. The percentage of excess weight loss and changes in co-morbidity status and QOL at the end of 3 years were calculated. The patients were simultaneously evaluated using the Bariatric Analysis and Reporting Outcome System scores. P values ⬍.05 were considered significant. Results: At 36 months after surgery, the percentage of excess weight loss was 74.58%, a significant number of patients (16 of 23, P ⬍.05) had had improvement in all co-morbidities, and 7 showed improvement in ⱖ1 co-morbidity. All patients indicated improvement in their QOL but not equally for all parameters included in the questionnaire. The Bariatric Analysis and Reporting Outcome System score was good in 4, very good in 4, and excellent in 15 of the 23 patients. Conclusion: Our data have shown that LSG is a highly effective and safe procedure for achieving weight loss, improving co-morbidities, and improving the QOL in patients with type 2 diabetes mellitus and morbid obesity during a long-term period. (Surg Obes Relat Dis 2010; 6:142–145.) © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Bariatric Analysis and Reporting Outcome System, BAROS; Percentage of excess weight loss; Quality of life; Laparoscopic sleeve gastrectomy; Long-term effects; Morbid obesity
Obesity affects 1.7 million people worldwide [1]. With improvement in the economic status of the general population, even developing countries such as India are experiencing an increased prevalence of obesity and the metabolic syndrome, in turn leading to increased morbidity and mortality from type 2 diabetes mellitus (T2DM) and cardiovascular disease [2,3]. The epidemic of obesity is not often appreciated because of the comparatively lower body mass index (BMI) of Asian Indians, which underestimates the relatively high abdominal adiposity [4]. *Reprint requests: Shashank Shah, M.S., Laparo-Obeso Centre, Sasoon Road, Pune, Maharashtra, India. E-mail: [email protected]
Although the outcomes of conservative management for morbid obesity and related conditions such as lifestyle modification and pharmacotherapy remain poor, bariatric surgery studies have reported excellent results in the management of T2DM and the metabolic syndrome, leading to an exponential increase in the number of procedures performed [1]. Although it has been known that restrictive surgical procedures such as laparoscopic adjustable gastric banding, laparoscopic vertical banded gastroplasty, and laparoscopic duodenal switch with sleeve gastrectomy are the procedures of choice across Europe and the United States, studies to date have shown only short-term weight loss in both the obese and the super obese [5–10]. The present study reports the results of a retrospective analysis of the
1550-7289/10/$ – see front matter © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2009.06.008
J. S. Todkar et al. / Surgery for Obesity and Related Diseases 6 (2010) 142–145
long-term effects of LSG performed in Indian subjects with morbid obesity and T2DM. Methods The present study was conducted at Ruby Hall Clinic, Pune, a tertiary care hospital in Western India. The details of morbidly obese patients (BMI ⬎33 kg/m2) who had undergone LSG in the previous 36 months, from January 2004 to December 2005, were collected retrospectively. The number of patients with co-morbid conditions (i.e., T2DM, hypertension, osteoarthritis, sleep apnea, and metabolic syndrome) were gathered to study the improvement/resolution that occurred after LSG. A co-morbidity was considered resolved if the laboratory results were within the normal reference values with no medication. We considered a comorbidity to have improved when the laboratory values were the same as at baseline but without an increase in medication. The Hospital Ethics Committee approved the study, and all patients included in the present study were aware of the information collected and consented to the use of the data. Consecutive patients who had undergone LSG from 2004 to 2005 were selected and followed up for ⱖ36 months after surgery. Data with regard to the percentage of excess weight loss (%EWL) (weight loss/excess weight ⫻100) and changes in co-morbidity status and quality of life (QOL) were assessed at the end of 36 months after surgery. The Bariatric Analysis and Reporting Outcome System (BAROS) scores were classified as excellent (⬎7–9 points), very good (⬎5–7 points), good (⬎3–5 points), fair (⬎1–3 points), and failure (ⱕ1 point). The BAROS is a simple questionnaire that evaluates 3 main categories: %EWL, changes in co-morbidities, and QOL using the Moorehead-Ardelt QOL questionnaire [11]. The Moorehead-Ardelt QOL questionnaire evaluates selfesteem, physical activity, social life, work conditions, and sexual interest/activity. Surgical technique LSG was performed as previously described [12]. In brief, after the induction of anesthesia and endotracheal intubation, the patient was placed on the operating room table in the supine, leg-spread position. The pneumoperitoneum was obtained with a Veress needle. Four to five trocars were inserted in a classic gastric laparoscopy configuration. The liver was cranially retracted, and the gastroesophageal junction was exposed. The gastrocolic ligament was dissected in the vicinity of the stomach to enter the bursa minor. The dissection along the greater curvature started 5 cm from the pylorus and progressed toward the angle of His. A 32F calibration tube was placed transorally along the lesser curvature to perform a controlled vertical gastrectomy. The resection was parallel to the lesser curvature and in contact with the calibration tube. The estimated
143
capacity of the created gastric sleeve was 100 to 150 cm3. To prevent dehiscence of the stapling line from the thick tissue of the stomach, green or gold staplers were used. The stapler line was strengthened with sutures at the junctions. The stapling line was checked for leakage by injecting methylene blue through a gastric tube. A 16-mm tube drain was left in contact with the stomach. All patients received perioperative deep vein thrombosis prophylaxis using low-molecular-weight heparin. At 24 hours after the procedure, a Gastrografin swallow test was performed to exclude fistulas on the stapler line or stenosis. If the test results were negative, the patient was started on a clear liquid diet. Statistical analysis Continuous data are presented as the mean ⫾ standard deviation. Changes in the efficacy parameters from baseline were evaluated using the Student t test. Statistical analysis was conducted using the Statistical Package for Social Sciences for Windows, version 16.0 (SPSS, Chicago, IL). P ⬍.05 was considered significant. Results The mean age of the patients was 44.6 ⫾ 11.9 years, and the BMI was 40.7 ⫾ 6.6 kg/m2. The co-morbid conditions included T2DM in 23 patients, hypertension in 10, osteoarthritis in 7, sleep apnea in 5, and the metabolic syndrome in 3. The baseline demographics and laboratory parameters of the 23 patients satisfying the selection criteria are summarized in Tables 1 and 2, respectively. Significant reductions had occurred in body weight at 36 months after LSG (before LSG 104.1 ⫾ 22.2 kg, after LSG 77.2 ⫾ 16.4 kg, P ⬍.001) and BMI ( before LSG 40.7 ⫾ 6.6 kg/m2, after LSG 30.9 ⫾ 5.4, P ⬍.001). The mean reduction in body weight and BMI was 26.94 kg and 9.82 kg/m2, respectively. The associated improvement in glycemic parameters was ⫺2.7% for the mean hemoglobin A1c, ⫺60 mg/dL for the mean fasting blood glucose, and ⫺82.34 mg/dL for the postprandial blood glucose at 36 months after surgery. Significant improvements were also seen in the
Table 1 Baseline demographic characteristics Baseline demographics
Value
Patients (n) Age (yr) Co-morbidity (n) T2DM Hypertension Osteoarthritis Sleep apnea Metabolic syndrome
23 44.6 ⫾ 11.9
T2DM ⫽ type 2 diabetes mellitus.
23 10 7 5 3
144
J. S. Todkar et al. / Surgery for Obesity and Related Diseases 6 (2010) 142–145 Table 3 Status of co-morbidities 36 months after LSG
Table 2 Baseline laboratory parameters Parameter
Mean ⫾ SD
Weight (kg) BMI (kg/m2) Waist circumference (cm) Hip circumference (cm) Fasting blood glucose (mg/dL) Postprandial blood glucose (mg/dL) HbA1c (%) (n ⫽ 18) Total cholesterol (mg/dL) Serum triglycerides (mg/dL) (n ⫽ 22) HDL (mg/dL) (n ⫽ 21) LDL (mg/dL) (n ⫽ 21) VLDL (mg/dL) (n ⫽ 19)
104.1 ⫾ 22.2 40.7 ⫾ 6.6 118.8 ⫾ 25.2 123.7 ⫾ 25.3 157.4 ⫾ 48.5 205 ⫾ 54.4 9.1 ⫾ 1.2 203.5 ⫾ 48.2 174.8 ⫾ 89.4 45.4 ⫾ 7.8 120.9 ⫾ 37.4 28.6 ⫾ 13.1
SD ⫽ standard deviation; BMI ⫽ body mass index; HbA1c ⫽ hemoglobin A1c; HDL ⫽ high-density lipoprotein; LDL ⫽ low-density lipoprotein; VLDL ⫽ very-low-density lipoprotein.
lipid profile after LSG (Fig. 1). Overall improvement occurred in the status of the co-morbidities after LSG (Table 3). At 36 months after surgery, the %EWL was 74.57%. Of the 23 patients, 16 (69.6%) demonstrated improvement in all co-morbidities and 7 (30.4%) had improvement in ⱖ1 co-morbidity. The %EWL and corresponding BMI are listed in Table 4. All 23 patients reported improvement in their QOL but not equally in all parameters of the questionnaire. For all patients, the BAROS score was good, very good, or excellent (Fig. 2). Discussion Morbid obesity, in which subjects are ⬎200% of their ideal body weight [13] is associated with severe co-morbid diseases such as T2DM, hypertension, hyperlipidemia, and cardiopulmonary failure [14]. Weight gain is a risk factor for impaired glucose tolerance and T2DM, as well as 1 of the common side effects of most antidiabetic agents [15]. In effect, weight gain forms the crux of a vicious circle: weight gain¡insulin resistance¡glucose intolerance¡antidiabetic agents¡weight gain¡insulin resistance. Hence, although aggressive treatment of T2DM has clearly been shown to reduce the related morbidity and mor-
Co-morbidity
T2DM (n ⫽ 22) Hypertension (n ⫽ 10) Osteoarthritis (n ⫽ 7) Sleep apnea (n ⫽ 5) Metabolic syndrome (n ⫽ 3)
Status 36 mo after LSG (n) Resolved*
Stable†
16 7 5 5 3
7 3 2 0 0
LSG ⫽ laparoscopic sleeve gastrectomy; T2DM ⫽ type 2 diabetes mellitus. * Normal reference values with no medication. † Same values as baseline without increase in medication.
tality and improve long-term QOL, the management of T2DM, especially in obese patients, can be a frustrating experience for both patients and treating physicians [16]. Fewer than one half of these patients reach the American Diabetes Associationmandated goal of hemoglobin A1c of ⬍7%. For these patients, bariatric surgery represents the most effective therapy because it can result in significant and durable weight loss, as well as resolution or amelioration of co-morbidities [14]. LSG has recently emerged as a new, restrictive, standalone bariatric procedure [17]. Considering the excellent short-term outcomes and the significant reduction in morbidity and mortality reported in high-risk subjects who underwent LSG as a first-step procedure, several centers are now using LSG as a definitive operation for morbid obesity. Current evidence has shown that the %EWL at 2 years of follow-up is almost comparable for both Roux-en-Y gastric bypass and LSG [6]. In a previous short-term follow-up study, Vidal et al. [18] reported a weight loss of 20.6% from baseline and resolution of T2DM in 51.4% of patients 4 months after LSG. In a 12-month post-LSG follow-up study, the same group reported 63% EWL and resolution of T2DM in 84% of morbidly obese patients with T2DM [19]. Recently, Arias et al. [6] reported 67.9% EWL at 24 months after LSG. In our study, we have reported a 74.57% EWL at the end of 36 months after surgery. No significant adverse events were reported during the 36 months of follow-up. These observations support the long-term effectiveness and safety of LSG. Morbid obesity is associated with co-morbidities such as T2DM, hypertension, cardiopulmonary failure, asthma, pseudo-
Table 4 %EWL and BMI (n ⫽ 23)
Fig. 1. Change in lipid profile at end of 36 months after LSG.
BMI (kg/m2)
%EWL (mean ⫾ SD)
⬍40 (n ⫽ 11) 40–50 (n ⫽ 9) ⬎50 (n ⫽ 3)
67.7 ⫾ 14.2 83 ⫾ 15.5 74.5 ⫾ 19.7
%EWL ⫽ percentage of excess weight loss; BMI ⫽ body mass index.
J. S. Todkar et al. / Surgery for Obesity and Related Diseases 6 (2010) 142–145
145
References
Fig. 2. BAROS scores stratified by proportion of patients at end of 36 months after LSG.
tumor cerebri, infertility, and crippling arthritis [20]. In our study, at baseline, our study population of morbidly obese patients with T2DM had co-morbidities that included hypertension, osteoarthritis, sleep apnea, the metabolic syndrome, and coronary artery disease. After LSG, 16 (69.6%) of the 23 patients had demonstrated significant improvement in all co-morbidities and 7 (30.4%) had had improvement in ⱖ1 co-morbidity. For most of our patients, the co-morbidity was either cured or remained stable for as long as 36 months, implying the possible long-term benefits of LSG in terms of improvement in co-morbid conditions, in addition to weight loss. The BAROS enabled us to assess the extent to which patients were satisfied with the surgery. Compared with other restrictive procedures such as gastric banding, all patients studied reported positive outcomes in the present study (good, very good, or excellent) [21,22]. These results are comparable to a long-term study by Puzziferri et al. [23] that reported ⬎95.5% of 79 patients and ⬎86.6% of 76 patients studied for 3 years felt good, very good, or excellent after Roux-en-Y gastric bypass and open gastric bypass, respectively.
Conclusion To the best of our knowledge, the present study is the first to report the long-term efficacy and safety of LSG among morbidly obese Indian subjects with T2DM. Our data have shown that LSG is a highly effective and safe procedure for achieving weight loss and improvements in co-morbidities and QOL in patients with T2DM and morbid obesity during long-term period. However, evidence from prospective studies with a sufficient sample size is necessary before we can routinely use this procedure for treating morbidly obese patients with T2DM.
[1] Aggarwal R, Hodgson L, Rao C, et al. Surgical management of morbid obesity. Br J Hosp Med (Lond) 2008;69:95–100. [2] Misra A, Khurana L. Obesity and the metabolic syndrome in developing countries. J Clin Endocrinol Metab 2008;93(Suppl 1):S9 –30. [3] Caterson ID. Medical management of obesity and its complications. Ann Acad Med 2009;38:22–7. [4] Yajnik CS. Obesity epidemic in India: intrauterine origins? Proc Nutr Soc 2004;63:387–96. [5] Cummings S, Apovian CM, Khaodhiar L. Obesity surgery: evidence for diabetes prevention/management. J Am Diet Assoc 2008;108(Suppl 1): S40 – 4. [6] Arias E, Martínez PR, Ka Ming Li V, Szomstein S, Rosenthal RJ. Mid-term follow-up after sleeve gastrectomy as a final approach for morbid obesity. Obes Surg 2009;19:544 – 8. [7] Fuks D, Verhaeghe P, Brehant O, et al. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery 2009;145:106 –13. [8] Tagaya N, Kasama K, Kikkawa R, et al. Experience with laparoscopic sleeve gastrectomy for morbid versus super morbid obesity. Obes Surg Epub 2008 Dec 9. [9] Moy J, Pomp A, Dakin G, et al. Laparoscopic sleeve gastrectomy for morbid obesity. Am J Surg 2008;196:e56 –9. [10] Rubin M, Yehoshua RT, Stein M, et al. Laparoscopic sleeve gastrectomy with minimal morbidity: early results in 120 morbidly obese patients. Obes Surg 2008;18:1567–70. [11] Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg 1998;8:487–99. [12] Nocca D, Krawczykowsky D, Bomans B, et al. A prospective multicenter study of 163 sleeve gastrectomies: results at 1 and 2 years. Obes Surg 2008;18:560 –5. [13] Choban PS, Dickerson RN. Morbid obesity and nutrition support: is bigger different? Nutr Clin Pract 2005;20:480 –7. [14] Smith BR, Schauer P, Nguyen NT. Surgical approaches to the treatment of obesity: bariatric surgery. Endocrinol Metab Clin North Am 2008;37:943– 64. [15] Pi-Sunyer FX. The effects of pharmacologic agents for T2DM mellitus on body weight. Postgrad Med 2008;120:5–17. [16] Russel-Jones D. Blood glucose and bodyweight in T2DM—are these compatible treatment targets? Eur Endocrinol 2009;1:31– 4. [17] Deitel M, Crosby RD, Gagner M. The first international consensus summit for sleeve gastrectomy (SG), New York City, 25–27 October 2007. Obes Surg 2008;18:487–96. [18] Vidal J, Ibarzabal A, Nicolau J, et al. Short-term effects of sleeve gastrectomy on T2DM mellitus in severely obese subjects. Obes Surg 2007;17:1069 –74. [19] Vidal J, Ibarzabal A, Romero F, et al. T2DM mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg 2008;18:1077– 82. [20] Pories WJ. Bariatric surgery: risks and rewards. J Clin Endocrinol Metab 2008;93(Suppl 1):S89 –96. [21] Zinzindohoue F, Chevallier JM, Douard R, et al. Laparoscopic gastric banding: a minimally invasive surgical treatment for morbid obesity: prospective study of 500 consecutive patients. Ann Surg 2003;237: 1–9. [22] Martikainen T, Pirinen E, Alhava E, et al. Long-term results, late complications and quality of life in a series of adjustable gastric banding. Obes Surg 2004;14:648 –54. [23] Puzziferri N, Iselin T, Austrheim-Smith BS, Wolfe BM, Nguyen NT. Three-year follow-up of a prospective randomized trial comparing laparoscopic versus open gastric bypass. Ann Surg 2006;243:181– 8.
Original article
Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus Jayashree S. Todkar, M.S., Shashank S. Shah, M.S.*, Poonam S. Shah, M.D., Jayashri Gangwani, B.A.M.S. Laparascopic and Bariatric Surgery, Ruby Hall Clinic, Pune, Maharashtra, India Received May 21, 2009; revised June 21, 2009; accepted June 29, 2009
Abstract
Background: Laparoscopic sleeve gastrectomy (LSG) is becoming popular as a stand-alone procedure for the treatment of morbid obesity and related diseases. This retrospective study presents the outcomes of LSG with regard to weight loss and improvement in co-morbidities and quality of life (QOL) at the end of 3 years after surgery in a tertiary care hospital in Pune, India. Methods: A total of 23 patients with type 2 diabetes mellitus (6 men and 17 women) with morbid obesity (mean body mass index 40.7 ⫾ 6.6 kg/m2) who had undergone LSG from 2004 to 2005 were selected for the present analysis. The percentage of excess weight loss and changes in co-morbidity status and QOL at the end of 3 years were calculated. The patients were simultaneously evaluated using the Bariatric Analysis and Reporting Outcome System scores. P values ⬍.05 were considered significant. Results: At 36 months after surgery, the percentage of excess weight loss was 74.58%, a significant number of patients (16 of 23, P ⬍.05) had had improvement in all co-morbidities, and 7 showed improvement in ⱖ1 co-morbidity. All patients indicated improvement in their QOL but not equally for all parameters included in the questionnaire. The Bariatric Analysis and Reporting Outcome System score was good in 4, very good in 4, and excellent in 15 of the 23 patients. Conclusion: Our data have shown that LSG is a highly effective and safe procedure for achieving weight loss, improving co-morbidities, and improving the QOL in patients with type 2 diabetes mellitus and morbid obesity during a long-term period. (Surg Obes Relat Dis 2010; 6:142–145.) © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Bariatric Analysis and Reporting Outcome System, BAROS; Percentage of excess weight loss; Quality of life; Laparoscopic sleeve gastrectomy; Long-term effects; Morbid obesity
Obesity affects 1.7 million people worldwide [1]. With improvement in the economic status of the general population, even developing countries such as India are experiencing an increased prevalence of obesity and the metabolic syndrome, in turn leading to increased morbidity and mortality from type 2 diabetes mellitus (T2DM) and cardiovascular disease [2,3]. The epidemic of obesity is not often appreciated because of the comparatively lower body mass index (BMI) of Asian Indians, which underestimates the relatively high abdominal adiposity [4]. *Reprint requests: Shashank Shah, M.S., Laparo-Obeso Centre, Sasoon Road, Pune, Maharashtra, India. E-mail: [email protected]
Although the outcomes of conservative management for morbid obesity and related conditions such as lifestyle modification and pharmacotherapy remain poor, bariatric surgery studies have reported excellent results in the management of T2DM and the metabolic syndrome, leading to an exponential increase in the number of procedures performed [1]. Although it has been known that restrictive surgical procedures such as laparoscopic adjustable gastric banding, laparoscopic vertical banded gastroplasty, and laparoscopic duodenal switch with sleeve gastrectomy are the procedures of choice across Europe and the United States, studies to date have shown only short-term weight loss in both the obese and the super obese [5–10]. The present study reports the results of a retrospective analysis of the
1550-7289/10/$ – see front matter © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2009.06.008
J. S. Todkar et al. / Surgery for Obesity and Related Diseases 6 (2010) 142–145
long-term effects of LSG performed in Indian subjects with morbid obesity and T2DM. Methods The present study was conducted at Ruby Hall Clinic, Pune, a tertiary care hospital in Western India. The details of morbidly obese patients (BMI ⬎33 kg/m2) who had undergone LSG in the previous 36 months, from January 2004 to December 2005, were collected retrospectively. The number of patients with co-morbid conditions (i.e., T2DM, hypertension, osteoarthritis, sleep apnea, and metabolic syndrome) were gathered to study the improvement/resolution that occurred after LSG. A co-morbidity was considered resolved if the laboratory results were within the normal reference values with no medication. We considered a comorbidity to have improved when the laboratory values were the same as at baseline but without an increase in medication. The Hospital Ethics Committee approved the study, and all patients included in the present study were aware of the information collected and consented to the use of the data. Consecutive patients who had undergone LSG from 2004 to 2005 were selected and followed up for ⱖ36 months after surgery. Data with regard to the percentage of excess weight loss (%EWL) (weight loss/excess weight ⫻100) and changes in co-morbidity status and quality of life (QOL) were assessed at the end of 36 months after surgery. The Bariatric Analysis and Reporting Outcome System (BAROS) scores were classified as excellent (⬎7–9 points), very good (⬎5–7 points), good (⬎3–5 points), fair (⬎1–3 points), and failure (ⱕ1 point). The BAROS is a simple questionnaire that evaluates 3 main categories: %EWL, changes in co-morbidities, and QOL using the Moorehead-Ardelt QOL questionnaire [11]. The Moorehead-Ardelt QOL questionnaire evaluates selfesteem, physical activity, social life, work conditions, and sexual interest/activity. Surgical technique LSG was performed as previously described [12]. In brief, after the induction of anesthesia and endotracheal intubation, the patient was placed on the operating room table in the supine, leg-spread position. The pneumoperitoneum was obtained with a Veress needle. Four to five trocars were inserted in a classic gastric laparoscopy configuration. The liver was cranially retracted, and the gastroesophageal junction was exposed. The gastrocolic ligament was dissected in the vicinity of the stomach to enter the bursa minor. The dissection along the greater curvature started 5 cm from the pylorus and progressed toward the angle of His. A 32F calibration tube was placed transorally along the lesser curvature to perform a controlled vertical gastrectomy. The resection was parallel to the lesser curvature and in contact with the calibration tube. The estimated
143
capacity of the created gastric sleeve was 100 to 150 cm3. To prevent dehiscence of the stapling line from the thick tissue of the stomach, green or gold staplers were used. The stapler line was strengthened with sutures at the junctions. The stapling line was checked for leakage by injecting methylene blue through a gastric tube. A 16-mm tube drain was left in contact with the stomach. All patients received perioperative deep vein thrombosis prophylaxis using low-molecular-weight heparin. At 24 hours after the procedure, a Gastrografin swallow test was performed to exclude fistulas on the stapler line or stenosis. If the test results were negative, the patient was started on a clear liquid diet. Statistical analysis Continuous data are presented as the mean ⫾ standard deviation. Changes in the efficacy parameters from baseline were evaluated using the Student t test. Statistical analysis was conducted using the Statistical Package for Social Sciences for Windows, version 16.0 (SPSS, Chicago, IL). P ⬍.05 was considered significant. Results The mean age of the patients was 44.6 ⫾ 11.9 years, and the BMI was 40.7 ⫾ 6.6 kg/m2. The co-morbid conditions included T2DM in 23 patients, hypertension in 10, osteoarthritis in 7, sleep apnea in 5, and the metabolic syndrome in 3. The baseline demographics and laboratory parameters of the 23 patients satisfying the selection criteria are summarized in Tables 1 and 2, respectively. Significant reductions had occurred in body weight at 36 months after LSG (before LSG 104.1 ⫾ 22.2 kg, after LSG 77.2 ⫾ 16.4 kg, P ⬍.001) and BMI ( before LSG 40.7 ⫾ 6.6 kg/m2, after LSG 30.9 ⫾ 5.4, P ⬍.001). The mean reduction in body weight and BMI was 26.94 kg and 9.82 kg/m2, respectively. The associated improvement in glycemic parameters was ⫺2.7% for the mean hemoglobin A1c, ⫺60 mg/dL for the mean fasting blood glucose, and ⫺82.34 mg/dL for the postprandial blood glucose at 36 months after surgery. Significant improvements were also seen in the
Table 1 Baseline demographic characteristics Baseline demographics
Value
Patients (n) Age (yr) Co-morbidity (n) T2DM Hypertension Osteoarthritis Sleep apnea Metabolic syndrome
23 44.6 ⫾ 11.9
T2DM ⫽ type 2 diabetes mellitus.
23 10 7 5 3
144
J. S. Todkar et al. / Surgery for Obesity and Related Diseases 6 (2010) 142–145 Table 3 Status of co-morbidities 36 months after LSG
Table 2 Baseline laboratory parameters Parameter
Mean ⫾ SD
Weight (kg) BMI (kg/m2) Waist circumference (cm) Hip circumference (cm) Fasting blood glucose (mg/dL) Postprandial blood glucose (mg/dL) HbA1c (%) (n ⫽ 18) Total cholesterol (mg/dL) Serum triglycerides (mg/dL) (n ⫽ 22) HDL (mg/dL) (n ⫽ 21) LDL (mg/dL) (n ⫽ 21) VLDL (mg/dL) (n ⫽ 19)
104.1 ⫾ 22.2 40.7 ⫾ 6.6 118.8 ⫾ 25.2 123.7 ⫾ 25.3 157.4 ⫾ 48.5 205 ⫾ 54.4 9.1 ⫾ 1.2 203.5 ⫾ 48.2 174.8 ⫾ 89.4 45.4 ⫾ 7.8 120.9 ⫾ 37.4 28.6 ⫾ 13.1
SD ⫽ standard deviation; BMI ⫽ body mass index; HbA1c ⫽ hemoglobin A1c; HDL ⫽ high-density lipoprotein; LDL ⫽ low-density lipoprotein; VLDL ⫽ very-low-density lipoprotein.
lipid profile after LSG (Fig. 1). Overall improvement occurred in the status of the co-morbidities after LSG (Table 3). At 36 months after surgery, the %EWL was 74.57%. Of the 23 patients, 16 (69.6%) demonstrated improvement in all co-morbidities and 7 (30.4%) had improvement in ⱖ1 co-morbidity. The %EWL and corresponding BMI are listed in Table 4. All 23 patients reported improvement in their QOL but not equally in all parameters of the questionnaire. For all patients, the BAROS score was good, very good, or excellent (Fig. 2). Discussion Morbid obesity, in which subjects are ⬎200% of their ideal body weight [13] is associated with severe co-morbid diseases such as T2DM, hypertension, hyperlipidemia, and cardiopulmonary failure [14]. Weight gain is a risk factor for impaired glucose tolerance and T2DM, as well as 1 of the common side effects of most antidiabetic agents [15]. In effect, weight gain forms the crux of a vicious circle: weight gain¡insulin resistance¡glucose intolerance¡antidiabetic agents¡weight gain¡insulin resistance. Hence, although aggressive treatment of T2DM has clearly been shown to reduce the related morbidity and mor-
Co-morbidity
T2DM (n ⫽ 22) Hypertension (n ⫽ 10) Osteoarthritis (n ⫽ 7) Sleep apnea (n ⫽ 5) Metabolic syndrome (n ⫽ 3)
Status 36 mo after LSG (n) Resolved*
Stable†
16 7 5 5 3
7 3 2 0 0
LSG ⫽ laparoscopic sleeve gastrectomy; T2DM ⫽ type 2 diabetes mellitus. * Normal reference values with no medication. † Same values as baseline without increase in medication.
tality and improve long-term QOL, the management of T2DM, especially in obese patients, can be a frustrating experience for both patients and treating physicians [16]. Fewer than one half of these patients reach the American Diabetes Associationmandated goal of hemoglobin A1c of ⬍7%. For these patients, bariatric surgery represents the most effective therapy because it can result in significant and durable weight loss, as well as resolution or amelioration of co-morbidities [14]. LSG has recently emerged as a new, restrictive, standalone bariatric procedure [17]. Considering the excellent short-term outcomes and the significant reduction in morbidity and mortality reported in high-risk subjects who underwent LSG as a first-step procedure, several centers are now using LSG as a definitive operation for morbid obesity. Current evidence has shown that the %EWL at 2 years of follow-up is almost comparable for both Roux-en-Y gastric bypass and LSG [6]. In a previous short-term follow-up study, Vidal et al. [18] reported a weight loss of 20.6% from baseline and resolution of T2DM in 51.4% of patients 4 months after LSG. In a 12-month post-LSG follow-up study, the same group reported 63% EWL and resolution of T2DM in 84% of morbidly obese patients with T2DM [19]. Recently, Arias et al. [6] reported 67.9% EWL at 24 months after LSG. In our study, we have reported a 74.57% EWL at the end of 36 months after surgery. No significant adverse events were reported during the 36 months of follow-up. These observations support the long-term effectiveness and safety of LSG. Morbid obesity is associated with co-morbidities such as T2DM, hypertension, cardiopulmonary failure, asthma, pseudo-
Table 4 %EWL and BMI (n ⫽ 23)
Fig. 1. Change in lipid profile at end of 36 months after LSG.
BMI (kg/m2)
%EWL (mean ⫾ SD)
⬍40 (n ⫽ 11) 40–50 (n ⫽ 9) ⬎50 (n ⫽ 3)
67.7 ⫾ 14.2 83 ⫾ 15.5 74.5 ⫾ 19.7
%EWL ⫽ percentage of excess weight loss; BMI ⫽ body mass index.
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References
Fig. 2. BAROS scores stratified by proportion of patients at end of 36 months after LSG.
tumor cerebri, infertility, and crippling arthritis [20]. In our study, at baseline, our study population of morbidly obese patients with T2DM had co-morbidities that included hypertension, osteoarthritis, sleep apnea, the metabolic syndrome, and coronary artery disease. After LSG, 16 (69.6%) of the 23 patients had demonstrated significant improvement in all co-morbidities and 7 (30.4%) had had improvement in ⱖ1 co-morbidity. For most of our patients, the co-morbidity was either cured or remained stable for as long as 36 months, implying the possible long-term benefits of LSG in terms of improvement in co-morbid conditions, in addition to weight loss. The BAROS enabled us to assess the extent to which patients were satisfied with the surgery. Compared with other restrictive procedures such as gastric banding, all patients studied reported positive outcomes in the present study (good, very good, or excellent) [21,22]. These results are comparable to a long-term study by Puzziferri et al. [23] that reported ⬎95.5% of 79 patients and ⬎86.6% of 76 patients studied for 3 years felt good, very good, or excellent after Roux-en-Y gastric bypass and open gastric bypass, respectively.
Conclusion To the best of our knowledge, the present study is the first to report the long-term efficacy and safety of LSG among morbidly obese Indian subjects with T2DM. Our data have shown that LSG is a highly effective and safe procedure for achieving weight loss and improvements in co-morbidities and QOL in patients with T2DM and morbid obesity during long-term period. However, evidence from prospective studies with a sufficient sample size is necessary before we can routinely use this procedure for treating morbidly obese patients with T2DM.
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