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Changes in the body composition after laparoscopic gastric plication: a short-term prospective case series
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Surgery for Obesity and Related Diseases ] (2015) 00–00
Original article
Changes in the body composition after laparoscopic gastric plication: a short-term prospective case series Hamed Vahidi, M.D., M.P.H., Atieh Talebpour, M.D., Omidreza Tabatabaie, M.D., M.P.H., Mohammad Talebpour, M.D.* Laparoscopic Surgery Ward, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Received May 1, 2015; accepted July 21, 2015
Abstract
Background: While laparoscopic gastric plication (LGP) results in a rapid weight loss in the first postoperative months, changes in body composition after LGP have not been studied previously. Objective: To evaluate the body composition after LGP. Setting: A tertiary referral hospital. Method: This is a consecutive case series. Body composition was measured using bioimpedance analysis with a Tanita BC-418 by 1 nutritionist. Weight, fat mass (FM), fat-free mass (FFM), and total body water (TBW) were measured at baseline and at 1, 3, and 6 months postoperative. Results: Sixteen consecutive patients underwent LGP. No intraoperative or major postoperative complications occurred during the follow-up period. No patient was lost to follow-up at any point during the study period. Mean postoperative total weight loss was 31 kg after 6 months, of which 25.5 kg (83%) was due to FM reduction. %FM was decreased by 15% after 6 months, whereas %TBW increased by 11%. Conclusions: Most of the weight loss caused by LGP is attributable to FM loss, and FFM loss is minimal after LGP. Therefore, LGP shifts body composition toward normal. (Surg Obes Relat Dis 2015;]:00–00.) r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Bariatric surgery; Gastric plication; Body composition; Bioimpedance analysis
Obesity is a major public health problem that has been on the rise for the past decades [1]. Traditionally, dietary and lifestyle changes were considered the mainstay of therapy, albeit efficacy of such nonsurgical interventions is limited [2,3]. Consequently, bariatric surgery has gradually emerged as an effective, sustainable, and relatively welltolerated method for weight reduction in severely obese patients [4,5]. Initial development of laparoscopic gastric plication (LGP) as bariatric procedure started in 2000. It was subsequently introduced in 2007 as a restrictive bariatric *
Correspondence: Mohammad Talebpour, M.D., Laparoscopic Surgery Ward, Sina Hospital, Hasan Abad Square, Tehran, Iran. E-mail: [email protected]
technique [6]. Later studies by the same team as well as other research groups had satisfactory efficacy for LGP compared with other restrictive modalities [6–8]. Furthermore, LGP is regarded as one of the least invasive bariatric procedures, since it does not involve any resection of the gastric mucosa and intestinal rearrangement of the gastrointestinal tract. In addition, foreign materials are not used in LGP, and it is a reversible bariatric surgery [9]. Patients experience a rapid weight loss after bariatric surgery, especially during the first postoperative months [8– 10]. Furthermore, restrictive bariatric techniques result in early satiety and reduced calorie and protein intake, which could theoretically predispose patients to malnutrition and wasting [11]. The ideal objective of any bariatric procedure is to reduce the body fat mass (FM) while preserving the
http://dx.doi.org/10.1016/j.soard.2015.08.504 1550-7289/r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
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H. Vahidi et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
body fat-free mass (FFM). However, weight reduction has been reported mostly as changes in body mass index (BMI) and weight. Although BMI is measured easily and is widely applicable, it is a function of total weight and cannot differentiate between a reduction in FFM or FM. Body composition analyses could be used to address this problem, although they are not as readily available as BMI [12]. LGP is a relatively new technique, and its effects on body composition have not been studied adequately, which is especially important during the first months after LGP when patients are experiencing rapid weight loss. Therefore, we conducted this study to determine the changes in the patients’ body composition during the first 6 months after LGP. Methods Study design and population This was a prospective longitudinal case series. The study was approved by the Institutional Review Board. Patients were referred to the bariatric clinic for LGP and were given information regarding LGP as well as other bariatric techniques and nonsurgical therapies. Informed consent was obtained from all the participants before they could be considered eligible. All patients who met the inclusion and exclusion criteria were enrolled consecutively. Inclusion criteria were BMI Z40 kg/m2 or BMI Z35 kg/m2 in the presence of at least 1 major obesity-related co-morbidity, such as type 2 diabetes mellitus, dyslipidemia, or sleep apnea [13]. Exclusion criteria were psychological conditions that could impair patients’ decision making capabilities (defined by a psychiatrist), age o18 years, endocrine disorders causing obesity such as Cushing’s syndrome, and congestive heart failure. All patients underwent a multidisciplinary preoperative workup, including psychiatry, cardiology, endocrinology, and anesthesiology consults, before the operation.
[6,8,10]. Patients were monitored in the hospital for signs of dehydration during the first postoperative 48 hours and were then discharged if they could tolerate adequate oral fluid intake (2 L). Outcome measurements The primary outcomes of this study were fat mass (FM), FFM, and total body water (TBW), measured by bioelectric impedance analysis (BIA). %FM, %FFM, and %TBW were calculated as well, by dividing FM, FFM, and TBW by weight, respectively. Baseline measurements were performed preoperatively and were repeated after the procedure at 1, 3, and 6 months. Excess weight loss percent (%EBWL) was calculated, with the calculation of ideal weight corresponding to a BMI of 25 kg/m2. Patients were instructed not to exercise for 12 hours and not to eat or drink for 3 hours before the measurements. All measurements were done using Tanita BC-418 (Tanita Corporation of America, Arlington Heights, IL) by a nutritionist during afternoon hours. Analysis Sample size was estimated by G power with 95% power a priori, assuming a large effect size (Cohen’s d = 1) based on the previous studies [8–10,15]. Statistical analyses were performed using Statistical Package of Social Science software (SPSS version 20, IBM, Armonk, NY, USA). Shapiro-Wilk analysis was performed to test distributions normality. Repeated measures of ANOVA were used to test the significance within variable changes in the body composition over time. Mauchly's sphericity test was performed, and Greenhouse-Geisser correction was implemented in cases of violation of the sphericity assumption.
Intervention
Results
All procedures were performed by a surgeon who was proficient in LGP in a tertiary referral academic hospital. Technical details of the procedure have been described previously [8,10,14]. In essence, the greater curvature of the stomach was dissected from the pylorus up to 2 cm proximal to the angle of His, thus preserving the anatomy of the angle. Thereafter, a 2-row plication of the greater curvature was performed from the fundus to the antrum using 2-0 polypropylene or nylon, resulting in invagination of the gastric mucosa and restriction of the total gastric volume to about 50 mL.
Sixteen consecutive patients who met inclusion and exclusion criteria underwent LGP. No intraoperative complication occurred, and all procedures were completed laparoscopically. No major complication occurred during the study period. There was no loss to follow-up at any point during follow-up. Baseline characteristics and preoperative co-morbidities are presented in Table 1. Mean BMI at baseline and at 6 months postoperative was 40 and 28.5, respectively (95% CI of change: 8–15 kg). Excess weight loss percent (%EBWL) was 77% (SD ¼ 13). Mean postoperative weight loss was 31 kg after 6 months, of which 25.5 kg (83%) was due to FM reduction. Changes in weight, FM, and FFM are illustrated in Fig. 1. Overall, %FM decreased by 15% 6 months after LGP, while %TBW increased by 11%. Changes in BMI, %FM, %FFM, and %TBW are depicted in Fig. 2.
Postoperative care Nausea, heartburn, and occasional vomiting were anticipated and were treated with pantoprazole and promethazine
131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 T1176 177 178 179 180 181 F1182 183 184 F2185
Body Composition after Laparoscopic Gastric Placation / Surgery for Obesity and Related Diseases ] (2015) 00–00 Table 1 Baseline characteristics and co-morbid conditions of the study population Number (%) Age (SD) Female (%) Caucasian race (%) Sleep apnea (%) Diabetes mellitus (%) Smoking (%) Gastroesophageal reflux (%) Hypertension (%) Hyperlipidemia (%)
16 38 (11) 12 (75%) 16 (100%) 1 (6%) 3 (19%) 1 (6%) 1 (6%) 4 (25%) 3 (19%)
Discussion Although obesity is considered a multifactorial and complex disease, it is known that adiposity and excess fat mass play a pivotal role in its pathophysiology [16–18]. Bariatric surgery is emerging as a sustainable, effective, and well-tolerated therapy for obesity and its related disorders, notably diabetes mellitus. Previous studies suggest that the beneficial effects of the bariatric procedures, especially metabolic disorders, are a result of a decrease in FM [18– 20]. Conversely, FFM is thought to be positively related to basal energy expenditure and insulin resistance. FFM loss is considered as a sign of malnutrition, especially protein malnutrition, and is therefore undesirable [21]. Nonetheless, different weight loss approaches are associated with FFM loss to various extents, and any weight loss appears to be accompanied by a loss of FFM. There are different modalities available for evaluation of the body composition. BIA and dual X-ray absorptiometry (DEXA) are 2 widely used and studied methods. Some studies have raised concern regarding the validity of BIA compared with DEXA. BIA has been reported to underestimate FM systematically in patients with very high BMIs [22]. However, subsequent studies in bariatric surgery
patients have concluded that BIA could be used reliably in repeated measure models to detect change [23]. Furthermore, many bariatric surgery patients are women in childbearing age, which make repeated measures with DEXA harmful to a potential fetus. Tanita BC-418, which we used for this study, was calibrated for high and low BMIs by the manufacturer based on DEXA measurements. Previous data have shown a trend of abrupt weight loss after LGP during the first postoperative months, followed by a plateau in the subsequent years [6,8]. Since LGP is a restrictive technique, any weight loss is thought to be associated with a decrease in the patients’ intake. Therefore, a steep decline in the patients’ weight is especially alarming in relation to malnutrition and excessive FFM loss. Equally, once the patients’ weight reaches a plateau due to an increase in the functional intraluminal space 6 months after LGP [8], malnutrition and FFM loss would be less probable. This study shows the changes in the body composition in the first 6 months after LGP. Our study found that weight, BMI, and FM decrease rapidly and simultaneously after LGP, while FFM and TBW had only a modest decline with no abrupt changes (Fig. 1). Strain et al. examined the effects of various malabsorptive bariatric techniques (Roux-en-Y gastric bypass and biliopancreatic diversion/duodenal switch) on body composition [21]. They reported a 16% decrease in %FM 1 year after the surgery, which is comparable to our results at 6 months. They also reported a 10%–20% reduction in FFM. Nicolleti et al. followed Roux-en-Y gastric bypass patients for 4 years and performed BIA at 1-year intervals. They reported a 15% reduction in %FM at one year, as well [11]. Fewer studies have assessed body composition changes after restrictive bariatric procedures. Friedrich et al. compared sleeve gastrectomy and multidisciplinary weight loss programs [24]. They reported a 5% decrease in %FM at 6 months and 12% at 1 year, which is less than the reduction in %FM
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W E B 4 C / F P O
FFM
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preoperave 16/16 1 Month 16/16
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3 Month 16/16
6 Month 16/16
Fig. 1. Changes in weight (BW), body fat mass (FM), and fat-free mass (FFM [kg]). †Values are derived from repeated measures ANOVA.
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%FM %FFM
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preoperave 16/16
1month 16/16
3month 16/16
6month 16/16
Fig. 2. Changes in BMI, %FM, %TBW, and %FFM. Data are derived from repeated measures ANOVA. BMI ¼ body mass index (kg/m2); %FM ¼ body fat mass percent (100 FM/weight); %FFM ¼ body fat-free mass percent (100 FFM/weight); %TBW ¼ total body water percent (100 TBW/weight).
seen in our LGP results and the studies on Roux-en-Y gastric bypass patients. However, because of the differences in baseline characteristics of study populations, direct comparisons between these studies should be interpreted cautiously. Other approaches to minimize FFM loss, such as increasing daily protein intake after bariatric surgery, have been tried as well with nonconclusive results. For instance, Moize et al. reported that increasing daily protein intake could decrease FFM loss after bariatric surgery [25], while Azagury et al. found that such interventions do not result in significant FFM retention [26]. Our study found that the body composition changes toward normal 6 months after LGP. This is supported by the fact that most of the weight loss after LGP could be attributed to FM reduction (Figs. 1 and 2). Furthermore, while there is no consensus on how much FFM loss is acceptable in weight loss interventions, it appears to accompany any form of weight reduction, possibly due to a reduction in the supporting structures of the adipose tissues. Nonetheless, our LGP series found similar and even superior FFM retention compared with the previous research on both restrictive and malabsorptive techniques [21,24]. However, this is a preliminary study, and the results could not be compared with other studies accurately. Therefore, future clinical trials are needed to compare LGP with other bariatric procedures regarding the postoperative changes in the body composition. This study has some limitations. The follow-up duration of 6 months does not give any information relating to the changes of the body composition beyond that period. Even so, the objective of the study was to assess the changes in the body composition during the most severe phase of weight loss to see if excessive FFM loss would occur at any time during that period. So while we encourage further research with longer follow-ups, this was beyond the scope of our current research. Furthermore, although our results are statistically significant, the sample size of 16 patients may seem insufficient to generalize the results of this study to other populations readily. However, the sample size was
calculated a priori, and a design with repeated measures to maximize the statistical power was implemented. Therefore, our study was too underpowered to justify assessment of subtler variables, such as postoperative changes in the insulin level, insulin sensitivity, and albumin level. Moreover, our small sample size excluded the possibility of a gender-stratified analysis, which could have been informative. Finally, LGP is a novel technique with a prolonged learning curve, so reproducibility and comparability of the technique are of concern in this field. This should be remedied by more interaction between the surgeons performing LGP for a more uniform technique. Conclusions LGP causes a rapid decline in FM, %FM, and BMI with only a modest reduction of FFM and TBW and an increase of %FFM and %TBW 6 months after the operation. Therefore, LGP shifts the body composition toward normal in morbidly obese patients. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Ng M, Fleming T, Robinson M, et al. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. Epub 2014 May 29. [2] Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev 2014;8:Cd003641. [3] Courcoulas AP, Yanovski SZ, Bonds D, et al. Long-term Outcomes of Bariatric Surgery: A National Institutes of Health Symposium. JAMA Surg 2014;149(12):1323–9. [4] Gilbert EW, Wolfe BM. Bariatric surgery for the management of obesity: state of the field. Plast Reconstr Surg 2012;130(4):948–54. [5] Chang SH, Stoll CR, Song J, et al. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003–2012. JAMA Surg 2014;149(3):275–87.
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[6] Talebpour M, Amoli BS. Laparoscopic total gastric vertical plication in morbid obesity. J Laparoendosc Adv Surg Tech A 2007;17 (6):793–8. [7] Abdelbaki TN, Sharaan M, Abdel-Baki NA, Katri K. Laparoscopic gastric greater curvature plication versus laparoscopic sleeve gastrectomy: early outcome in 140 patients. Surg Obes Relat Dis 2014;10 (6):1141–6. [8] Talebpour M, Motamedi SM, Talebpour A, Vahidi H. Twelve year experience of laparoscopic gastric plication in morbid obesity: development of the technique and patient outcomes. Ann Surg Innov Res 2012;6(1):7. [9] Abdelbaki TN, Huang CK, Ramos A, et al. Gastric plication for morbid obesity: a systematic review. Obes Surg 2012;22(10):1633–9. [10] Niazi M, Maleki AR, Talebpour M. Short-term outcomes of laparoscopic gastric plication in morbidly obese patients: importance of postoperative follow-up. Obes Surg 2013;23(1):87–92. [11] Nicoletti CF, Camelo JS Jr., dos Santos JE, et al. Bioelectrical impedance vector analysis in obese women before and after bariatric surgery: changes in body composition. Nutrition 2014;30(5):569–74. [12] Thomson R, Brinkworth GD, Buckley JD, Noakes M, Clifton PM. Good agreement between bioelectrical impedance and dual-energy Xray absorptiometry for estimating changes in body composition during weight loss in overweight young women. Clin Nutr 2007;26 (6):771–7. [13] NIH conference. Gastrointestinal surgery for severe obesity. Consensus Development Conference Panel. Ann Int Med 1991;115 (12):956–61. [14] Zeinoddini A, Heidari R, Talebpour M. Laparoscopic gastric plication in morbidly obese adolescents: a prospective study. Surg Obes Relat Dis 2014;10(6):1135–9. [15] Faul F, Erdfelder E, Lang A-G, Buchner A. G* Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39(2):175–91. [16] Frayn KN. Adipose tissue and the insulin resistance syndrome. Proc Nutr Soc 2001;60(3):375–80.
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[17] Kahn SE, Cooper ME, Del Prato S. Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present, and future. Lancet 2014;383(9922):1068–83. [18] Fornari R, Francomano D, Greco EA, et al. Lean mass in obese adult subjects correlates with higher levels of vitamin D, insulin sensitivity and lower inflammation. J Endocrinol Invest. Epub 2014 Oct 29. [19] Dixon JB, le Roux CW, Rubino F, Zimmet P. Bariatric surgery for type 2 diabetes. Lancet 2012;379(9833):2300–11. [20] Frachetti KJ, Goldfine AB. Bariatric surgery for diabetes management. Curr Opin Endocrinol Diabetes Obes 2009;16(2):119–24. [21] Strain GW, Gagner M, Pomp A, et al. Comparison of fat-free mass in super obesity (BMI Z 50 kg/m2) and morbid obesity (BMI o 50 kg/ m2) in response to different weight loss surgeries. Surg Obes Relat Dis 2012;8(3):255–9. [22] Volgyi E, Tylavsky FA, Lyytikainen A, et al. Assessing body composition with DXA and bioimpedance: effects of obesity, physical activity, and age. Obesity (Silver Spring) 2008;16 (3):700–5. [23] Savastano S, Belfiore A, Di Somma C, et al. Validity of bioelectrical impedance analysis to estimate body composition changes after bariatric surgery in premenopausal morbidly women. Obes Surg 2010;20(3):332–9. [24] Friedrich AE, Damms-Machado A, Meile T, et al. Laparoscopic sleeve gastrectomy compared to a multidisciplinary weight loss program for obesity–effects on body composition and protein status. Obes Surg 2013;23(12):1957–65. [25] Moize V, Andreu A, Rodriguez L, et al. Protein intake and lean tissue mass retention following bariatric surgery. Clin Nutr 2013;32 (4):550–5. [26] Azagury DE, Ris F, Pichard C, et al. Does perioperative nutrition and oral carbohydrate load sustainably preserve muscle mass after bariatric surgery? A randomized control trial. Surg Obes Relat Dis. Epub 2014 Oct 22.
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Surgery for Obesity and Related Diseases ] (2015) 00–00
Original article
Changes in the body composition after laparoscopic gastric plication: a short-term prospective case series Hamed Vahidi, M.D., M.P.H., Atieh Talebpour, M.D., Omidreza Tabatabaie, M.D., M.P.H., Mohammad Talebpour, M.D.* Laparoscopic Surgery Ward, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Received May 1, 2015; accepted July 21, 2015
Abstract
Background: While laparoscopic gastric plication (LGP) results in a rapid weight loss in the first postoperative months, changes in body composition after LGP have not been studied previously. Objective: To evaluate the body composition after LGP. Setting: A tertiary referral hospital. Method: This is a consecutive case series. Body composition was measured using bioimpedance analysis with a Tanita BC-418 by 1 nutritionist. Weight, fat mass (FM), fat-free mass (FFM), and total body water (TBW) were measured at baseline and at 1, 3, and 6 months postoperative. Results: Sixteen consecutive patients underwent LGP. No intraoperative or major postoperative complications occurred during the follow-up period. No patient was lost to follow-up at any point during the study period. Mean postoperative total weight loss was 31 kg after 6 months, of which 25.5 kg (83%) was due to FM reduction. %FM was decreased by 15% after 6 months, whereas %TBW increased by 11%. Conclusions: Most of the weight loss caused by LGP is attributable to FM loss, and FFM loss is minimal after LGP. Therefore, LGP shifts body composition toward normal. (Surg Obes Relat Dis 2015;]:00–00.) r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Bariatric surgery; Gastric plication; Body composition; Bioimpedance analysis
Obesity is a major public health problem that has been on the rise for the past decades [1]. Traditionally, dietary and lifestyle changes were considered the mainstay of therapy, albeit efficacy of such nonsurgical interventions is limited [2,3]. Consequently, bariatric surgery has gradually emerged as an effective, sustainable, and relatively welltolerated method for weight reduction in severely obese patients [4,5]. Initial development of laparoscopic gastric plication (LGP) as bariatric procedure started in 2000. It was subsequently introduced in 2007 as a restrictive bariatric *
Correspondence: Mohammad Talebpour, M.D., Laparoscopic Surgery Ward, Sina Hospital, Hasan Abad Square, Tehran, Iran. E-mail: [email protected]
technique [6]. Later studies by the same team as well as other research groups had satisfactory efficacy for LGP compared with other restrictive modalities [6–8]. Furthermore, LGP is regarded as one of the least invasive bariatric procedures, since it does not involve any resection of the gastric mucosa and intestinal rearrangement of the gastrointestinal tract. In addition, foreign materials are not used in LGP, and it is a reversible bariatric surgery [9]. Patients experience a rapid weight loss after bariatric surgery, especially during the first postoperative months [8– 10]. Furthermore, restrictive bariatric techniques result in early satiety and reduced calorie and protein intake, which could theoretically predispose patients to malnutrition and wasting [11]. The ideal objective of any bariatric procedure is to reduce the body fat mass (FM) while preserving the
http://dx.doi.org/10.1016/j.soard.2015.08.504 1550-7289/r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.
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H. Vahidi et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
body fat-free mass (FFM). However, weight reduction has been reported mostly as changes in body mass index (BMI) and weight. Although BMI is measured easily and is widely applicable, it is a function of total weight and cannot differentiate between a reduction in FFM or FM. Body composition analyses could be used to address this problem, although they are not as readily available as BMI [12]. LGP is a relatively new technique, and its effects on body composition have not been studied adequately, which is especially important during the first months after LGP when patients are experiencing rapid weight loss. Therefore, we conducted this study to determine the changes in the patients’ body composition during the first 6 months after LGP. Methods Study design and population This was a prospective longitudinal case series. The study was approved by the Institutional Review Board. Patients were referred to the bariatric clinic for LGP and were given information regarding LGP as well as other bariatric techniques and nonsurgical therapies. Informed consent was obtained from all the participants before they could be considered eligible. All patients who met the inclusion and exclusion criteria were enrolled consecutively. Inclusion criteria were BMI Z40 kg/m2 or BMI Z35 kg/m2 in the presence of at least 1 major obesity-related co-morbidity, such as type 2 diabetes mellitus, dyslipidemia, or sleep apnea [13]. Exclusion criteria were psychological conditions that could impair patients’ decision making capabilities (defined by a psychiatrist), age o18 years, endocrine disorders causing obesity such as Cushing’s syndrome, and congestive heart failure. All patients underwent a multidisciplinary preoperative workup, including psychiatry, cardiology, endocrinology, and anesthesiology consults, before the operation.
[6,8,10]. Patients were monitored in the hospital for signs of dehydration during the first postoperative 48 hours and were then discharged if they could tolerate adequate oral fluid intake (2 L). Outcome measurements The primary outcomes of this study were fat mass (FM), FFM, and total body water (TBW), measured by bioelectric impedance analysis (BIA). %FM, %FFM, and %TBW were calculated as well, by dividing FM, FFM, and TBW by weight, respectively. Baseline measurements were performed preoperatively and were repeated after the procedure at 1, 3, and 6 months. Excess weight loss percent (%EBWL) was calculated, with the calculation of ideal weight corresponding to a BMI of 25 kg/m2. Patients were instructed not to exercise for 12 hours and not to eat or drink for 3 hours before the measurements. All measurements were done using Tanita BC-418 (Tanita Corporation of America, Arlington Heights, IL) by a nutritionist during afternoon hours. Analysis Sample size was estimated by G power with 95% power a priori, assuming a large effect size (Cohen’s d = 1) based on the previous studies [8–10,15]. Statistical analyses were performed using Statistical Package of Social Science software (SPSS version 20, IBM, Armonk, NY, USA). Shapiro-Wilk analysis was performed to test distributions normality. Repeated measures of ANOVA were used to test the significance within variable changes in the body composition over time. Mauchly's sphericity test was performed, and Greenhouse-Geisser correction was implemented in cases of violation of the sphericity assumption.
Intervention
Results
All procedures were performed by a surgeon who was proficient in LGP in a tertiary referral academic hospital. Technical details of the procedure have been described previously [8,10,14]. In essence, the greater curvature of the stomach was dissected from the pylorus up to 2 cm proximal to the angle of His, thus preserving the anatomy of the angle. Thereafter, a 2-row plication of the greater curvature was performed from the fundus to the antrum using 2-0 polypropylene or nylon, resulting in invagination of the gastric mucosa and restriction of the total gastric volume to about 50 mL.
Sixteen consecutive patients who met inclusion and exclusion criteria underwent LGP. No intraoperative complication occurred, and all procedures were completed laparoscopically. No major complication occurred during the study period. There was no loss to follow-up at any point during follow-up. Baseline characteristics and preoperative co-morbidities are presented in Table 1. Mean BMI at baseline and at 6 months postoperative was 40 and 28.5, respectively (95% CI of change: 8–15 kg). Excess weight loss percent (%EBWL) was 77% (SD ¼ 13). Mean postoperative weight loss was 31 kg after 6 months, of which 25.5 kg (83%) was due to FM reduction. Changes in weight, FM, and FFM are illustrated in Fig. 1. Overall, %FM decreased by 15% 6 months after LGP, while %TBW increased by 11%. Changes in BMI, %FM, %FFM, and %TBW are depicted in Fig. 2.
Postoperative care Nausea, heartburn, and occasional vomiting were anticipated and were treated with pantoprazole and promethazine
131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 T1176 177 178 179 180 181 F1182 183 184 F2185
Body Composition after Laparoscopic Gastric Placation / Surgery for Obesity and Related Diseases ] (2015) 00–00 Table 1 Baseline characteristics and co-morbid conditions of the study population Number (%) Age (SD) Female (%) Caucasian race (%) Sleep apnea (%) Diabetes mellitus (%) Smoking (%) Gastroesophageal reflux (%) Hypertension (%) Hyperlipidemia (%)
16 38 (11) 12 (75%) 16 (100%) 1 (6%) 3 (19%) 1 (6%) 1 (6%) 4 (25%) 3 (19%)
Discussion Although obesity is considered a multifactorial and complex disease, it is known that adiposity and excess fat mass play a pivotal role in its pathophysiology [16–18]. Bariatric surgery is emerging as a sustainable, effective, and well-tolerated therapy for obesity and its related disorders, notably diabetes mellitus. Previous studies suggest that the beneficial effects of the bariatric procedures, especially metabolic disorders, are a result of a decrease in FM [18– 20]. Conversely, FFM is thought to be positively related to basal energy expenditure and insulin resistance. FFM loss is considered as a sign of malnutrition, especially protein malnutrition, and is therefore undesirable [21]. Nonetheless, different weight loss approaches are associated with FFM loss to various extents, and any weight loss appears to be accompanied by a loss of FFM. There are different modalities available for evaluation of the body composition. BIA and dual X-ray absorptiometry (DEXA) are 2 widely used and studied methods. Some studies have raised concern regarding the validity of BIA compared with DEXA. BIA has been reported to underestimate FM systematically in patients with very high BMIs [22]. However, subsequent studies in bariatric surgery
patients have concluded that BIA could be used reliably in repeated measure models to detect change [23]. Furthermore, many bariatric surgery patients are women in childbearing age, which make repeated measures with DEXA harmful to a potential fetus. Tanita BC-418, which we used for this study, was calibrated for high and low BMIs by the manufacturer based on DEXA measurements. Previous data have shown a trend of abrupt weight loss after LGP during the first postoperative months, followed by a plateau in the subsequent years [6,8]. Since LGP is a restrictive technique, any weight loss is thought to be associated with a decrease in the patients’ intake. Therefore, a steep decline in the patients’ weight is especially alarming in relation to malnutrition and excessive FFM loss. Equally, once the patients’ weight reaches a plateau due to an increase in the functional intraluminal space 6 months after LGP [8], malnutrition and FFM loss would be less probable. This study shows the changes in the body composition in the first 6 months after LGP. Our study found that weight, BMI, and FM decrease rapidly and simultaneously after LGP, while FFM and TBW had only a modest decline with no abrupt changes (Fig. 1). Strain et al. examined the effects of various malabsorptive bariatric techniques (Roux-en-Y gastric bypass and biliopancreatic diversion/duodenal switch) on body composition [21]. They reported a 16% decrease in %FM 1 year after the surgery, which is comparable to our results at 6 months. They also reported a 10%–20% reduction in FFM. Nicolleti et al. followed Roux-en-Y gastric bypass patients for 4 years and performed BIA at 1-year intervals. They reported a 15% reduction in %FM at one year, as well [11]. Fewer studies have assessed body composition changes after restrictive bariatric procedures. Friedrich et al. compared sleeve gastrectomy and multidisciplinary weight loss programs [24]. They reported a 5% decrease in %FM at 6 months and 12% at 1 year, which is less than the reduction in %FM
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Fig. 1. Changes in weight (BW), body fat mass (FM), and fat-free mass (FFM [kg]). †Values are derived from repeated measures ANOVA.
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Fig. 2. Changes in BMI, %FM, %TBW, and %FFM. Data are derived from repeated measures ANOVA. BMI ¼ body mass index (kg/m2); %FM ¼ body fat mass percent (100 FM/weight); %FFM ¼ body fat-free mass percent (100 FFM/weight); %TBW ¼ total body water percent (100 TBW/weight).
seen in our LGP results and the studies on Roux-en-Y gastric bypass patients. However, because of the differences in baseline characteristics of study populations, direct comparisons between these studies should be interpreted cautiously. Other approaches to minimize FFM loss, such as increasing daily protein intake after bariatric surgery, have been tried as well with nonconclusive results. For instance, Moize et al. reported that increasing daily protein intake could decrease FFM loss after bariatric surgery [25], while Azagury et al. found that such interventions do not result in significant FFM retention [26]. Our study found that the body composition changes toward normal 6 months after LGP. This is supported by the fact that most of the weight loss after LGP could be attributed to FM reduction (Figs. 1 and 2). Furthermore, while there is no consensus on how much FFM loss is acceptable in weight loss interventions, it appears to accompany any form of weight reduction, possibly due to a reduction in the supporting structures of the adipose tissues. Nonetheless, our LGP series found similar and even superior FFM retention compared with the previous research on both restrictive and malabsorptive techniques [21,24]. However, this is a preliminary study, and the results could not be compared with other studies accurately. Therefore, future clinical trials are needed to compare LGP with other bariatric procedures regarding the postoperative changes in the body composition. This study has some limitations. The follow-up duration of 6 months does not give any information relating to the changes of the body composition beyond that period. Even so, the objective of the study was to assess the changes in the body composition during the most severe phase of weight loss to see if excessive FFM loss would occur at any time during that period. So while we encourage further research with longer follow-ups, this was beyond the scope of our current research. Furthermore, although our results are statistically significant, the sample size of 16 patients may seem insufficient to generalize the results of this study to other populations readily. However, the sample size was
calculated a priori, and a design with repeated measures to maximize the statistical power was implemented. Therefore, our study was too underpowered to justify assessment of subtler variables, such as postoperative changes in the insulin level, insulin sensitivity, and albumin level. Moreover, our small sample size excluded the possibility of a gender-stratified analysis, which could have been informative. Finally, LGP is a novel technique with a prolonged learning curve, so reproducibility and comparability of the technique are of concern in this field. This should be remedied by more interaction between the surgeons performing LGP for a more uniform technique. Conclusions LGP causes a rapid decline in FM, %FM, and BMI with only a modest reduction of FFM and TBW and an increase of %FFM and %TBW 6 months after the operation. Therefore, LGP shifts the body composition toward normal in morbidly obese patients. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Ng M, Fleming T, Robinson M, et al. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. Epub 2014 May 29. [2] Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev 2014;8:Cd003641. [3] Courcoulas AP, Yanovski SZ, Bonds D, et al. Long-term Outcomes of Bariatric Surgery: A National Institutes of Health Symposium. JAMA Surg 2014;149(12):1323–9. [4] Gilbert EW, Wolfe BM. Bariatric surgery for the management of obesity: state of the field. Plast Reconstr Surg 2012;130(4):948–54. [5] Chang SH, Stoll CR, Song J, et al. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003–2012. JAMA Surg 2014;149(3):275–87.
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