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    Ignace Janssen

    Objective. To investigate whether laparoscopic adhesiolysis leads to pain relief and an improved quality of life in patients with adhesions and chronic abdominal pain. Design. Double-blind, randomised multicentre trial. Method. Patients... more
    Objective. To investigate whether laparoscopic adhesiolysis leads to pain relief and an improved quality of life in patients with adhesions and chronic abdominal pain. Design. Double-blind, randomised multicentre trial. Method. Patients underwent diagnostic laparoscopy if they had chronic abdominal pain attributable to adhesions. If adhesions were confirmed during diagnostic laparoscopy then the patients were randomly assigned to either laparoscopic adhesiolysis or no treatment. Only surgeons knew the randomisation choice. Follow-up assessors for both treatment and outcome were unaware of this randomisation. The pain was assessed 3, 6 and 12 months postoperatively using a visual analogous scale (VAS), the pain change score, and the medication used. The quality of life score was also determined after 6 and 12 months. Results. One hundred of the II6 patients included for diagnostic laparoscopy were randomised, 52 for laparoscopic adhesiolysis and 48 for no treatment. The treatment gro...
    BACKGROUND Bariatric surgery among patients with obesity and type 2 diabetes (T2D) can induce complete remission. However, it remains unclear whether sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) has better T2D remission... more
    BACKGROUND Bariatric surgery among patients with obesity and type 2 diabetes (T2D) can induce complete remission. However, it remains unclear whether sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) has better T2D remission within a population-based daily practice. OBJECTIVES To compare patients undergoing RYGB and SG on the extent of T2D remission at the 1-year follow-up. SETTING Nationwide, population-based study including all 18 hospitals in the Netherlands providing metabolic and bariatric surgery. METHODS Patients undergoing RYGB and SG between October 2015 and October 2018 with 1 year of complete follow-up data were selected from the mandatory nationwide Dutch Audit for Treatment of Obesity (DATO). The primary outcome is T2D remission within 1 year. Secondary outcomes include ≥20% total weight loss (TWL), obesity-related co-morbidity reduction, and postoperative complications with a Clavien-Dindo (CD) grade ≥III within 30 days. We compared T2D remission between RYGB and SG groups using propensity score matching to adjust for confounding by indication. RESULTS A total of 5015 patients were identified from the DATO, and 4132 (82.4%) had completed a 1-year follow-up visit. There were 3350 (66.8%) patients with a valid T2D status who were included in the analysis (RYGB = 2623; SG = 727). RYGB patients had a lower body mass index than SG patients, but were more often female, with higher gastroesophageal reflux disease and dyslipidemia rates. After adjusting for these confounders, RYGB patients had increased odds of achieving T2D remission (odds ratio [OR], 1.54; 95% confidence interval [CI], 1.14-2.1; P < .01). Groups were balanced after matching 695 patients in each group. After matching, RYGB patients still had better odds of T2D remission (OR, 1.91; 95% CI, 1.27-2.88; P < .01). Also, significantly more RYGB patients had ≥20%TWL (OR, 2.71; 95% CI, 1.96-3.75; P < .01) and RYGB patients had higher dyslipidemia remission rates (OR, 1.96; 95% CI, 1.39-2.76; P < .01). There were no significant differences in CD ≥III complications. CONCLUSION Using population-based data from the Netherlands, this study shows that RYGB leads to better T2D remission rates at the 1-year follow-up and better metabolic outcomes for patients with obesity and T2D undergoing bariatric surgery in daily practice.
    The prevalence of obesity is increasing worldwide. Its primary treatment consists of lifestyle changes. In severely obese (BMI > 40 kg/m2 or >/= 35 kg/m2 with comorbidity) patients though, bariatric surgery has been found to be the... more
    The prevalence of obesity is increasing worldwide. Its primary treatment consists of lifestyle changes. In severely obese (BMI > 40 kg/m2 or >/= 35 kg/m2 with comorbidity) patients though, bariatric surgery has been found to be the only way to achieve permanent weight loss. Operations such as the placement of a gastric band or a gastric bypass can, however, lead to complications and necessitate secondary interventions.
    BackgroundPathogenic PTEN gene mutations are known to cause PTEN tumor hamartoma syndrome. Recent studies also suggest a role for PTEN mutations in the pathogenesis of obesity. No PTEN mutations have been reported among bariatric surgery... more
    BackgroundPathogenic PTEN gene mutations are known to cause PTEN tumor hamartoma syndrome. Recent studies also suggest a role for PTEN mutations in the pathogenesis of obesity. No PTEN mutations have been reported among bariatric surgery patients and obesity treatment results are unknown. Since preventive screening for associated tumors is offered to patients with molecular proven PTEN hamartoma tumor syndrome, recognition of this condition in the bariatric surgery clinic is important.MethodWe present a patient with morbid obesity who carries a known pathogenic PTEN mutation, identified at the bariatric surgery clinic using an obesity gene panel consisting of 52 obesity–associated genes. We analyzed the weight loss response during the first 3 years after Sleeve Gastrectomy.ResultsAt 1, 2 and 3 years after surgery, the patient achieved a Total Body Weight Loss of 39.4%, 48.8% and 44.9%, respectively. This corresponds to the results of a control group of 18 female patients with normal...
    Morbidly obese patients are at increased risk to develop venous thromboembolism (VTE), especially after bariatric surgery. Adequate postoperative thrombosis prophylaxis is of utmost importance. It is assumed that morbidly obese patients... more
    Morbidly obese patients are at increased risk to develop venous thromboembolism (VTE), especially after bariatric surgery. Adequate postoperative thrombosis prophylaxis is of utmost importance. It is assumed that morbidly obese patients need higher doses of low molecular weight heparin (LMWH) compared to normal-weight patients; however, current guidelines based on relative efficacy in obese populations are lacking. First, we will evaluate the relationship between body weight descriptors and anti-Xa activity prospectively. Second, we will determine the dose-linearity of LMWH in morbidly obese patients. This study was performed in a general hospital specialized in bariatric surgery. Patients were scheduled for a Roux-en-Y gastric bypass with a total bodyweight (TBW) of ≥ 140 kg. Patients (n = 50, 64% female) received a daily postoperative dose of 5700 IU of nadroparin for 4 weeks. Anti-Xa activity was determined 4 h after the last nadroparin administration. To determine the dose linea...
    Background. Calcium malabsorption after bariatric surgery may be harmful to skeletal health and demands for optimal skeletal management. Methods. 103 Patients were evaluated retrospectively at 12 months after surgery. The evaluation... more
    Background. Calcium malabsorption after bariatric surgery may be harmful to skeletal health and demands for optimal skeletal management. Methods. 103 Patients were evaluated retrospectively at 12 months after surgery. The evaluation included a questionnaire about stool frequency and consistency and laboratory assessments. Results. 103 Patients, 27 males and 76 females, were included in the study. 83 Patients had an alimentary limb of 100 cm and 20 patients one of 150 cm. At 12 months after surgery, 77.7% reported changes of bowel habits, albumin adjusted calcium levels were normal in all but 2 patients, and PTH levels were increased in 35%. Correlations between semiquantified bowel scores (fecal scores) and data from the laboratory demonstrated increasing PTH values along with more frequent and softer/watery stools (RR 30.5, CI 6.2-149.2, P < .001). There was a trend for higher PTH levels in patients with an alimentary limb of 150 cm. Normal PTH levels were more frequently found ...
    The global obesity epidemic is also affecting the Netherlands, paralleled by a proportional increase in the number of morbidly obese persons. Bariatric surgery has been included as a treatment for morbid obesity in the Dutch Guideline for... more
    The global obesity epidemic is also affecting the Netherlands, paralleled by a proportional increase in the number of morbidly obese persons. Bariatric surgery has been included as a treatment for morbid obesity in the Dutch Guideline for Obesity (2008). Nonetheless, bariatric surgery is applied in only a limited number of morbidly obese subjects in the Netherlands. Based on the most recent literature and Dutch statistics, this review provides a summary of current knowledge on the impact of obesity on health and health care and highlights the effective role of bariatric surgery in reducing this threat to public health.
    Laparoscopic adjustable gastric band (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most performed procedures worldwide (92 %) nowadays. However, comparative clinical trials are... more
    Laparoscopic adjustable gastric band (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most performed procedures worldwide (92 %) nowadays. However, comparative clinical trials are scarce in literature. The objective of this study was to compare the effectiveness and safety of the three most performed bariatric procedures. A multicenter, retrospective, matched cohort study was conducted. Patients were eligible for analysis when a primary procedure was performed between 2007 and 2010 in one of the two specialized bariatric centers. Primary outcome was weight loss, expressed in the percentage excess weight loss (%EWL). Secondary outcome parameters are hospital stay, complication rate, and revisional surgery. In total, 735 patients, 245 in each group, were included for analysis. The groups were comparable for age and gender after matching. Mean postoperative follow-up was 3.1 ± 1.2 years. LAGB patients showed less %EWL compared to LSG and LRYGB at all postoperative follow-up visits. LRYGB showed a %EWL of 71 ± 20 % compared to LSG (76 ± 23 %; p = 0.008) after 1-year follow-up; thereafter, no significant difference was observed. After 3 years of follow-up, LAGB showed a higher complication rate compared to LSG and LRYGB (p < 0.05). Revisional surgery after LAGB was needed in 21 %, while 9 % of the LSG underwent conversion to RYGB. LRYGB is a safe and effective treatment in morbid obese patients with good long-term outcomes. LSG seems to be an appropriate alternative as a definitive procedure, in terms of weight reduction and complication rate. LAGB is inferior to both LRYGB and LSG.
    Severely obese patients have an increased risk for developing metabolic complications such as type 2 diabetes mellitus (T2DM), dyslipidaemia (DL) and hypertension (HT). The aim of the present study is to research the effect of a primary... more
    Severely obese patients have an increased risk for developing metabolic complications such as type 2 diabetes mellitus (T2DM), dyslipidaemia (DL) and hypertension (HT). The aim of the present study is to research the effect of a primary laparoscopic Roux-en-Y gastric bypass (LRYGB) on T2DM, HT and DL in the long-term. Fifty-two out of 89 (58 %) adult severely obese patients with T2DM who had received a LRYGB between January 2000 and December 2008 were evaluated. Primary outcome of evaluation was remission of T2DM according to the definition of 2009 consensus statement. Complete remission was defined as achievement fasting plasma glucose (FPG) of <5.6 mmol/l (<100.8 mg/dL) and HbA1c <42 mmol/mol…
    To evaluate whether preoperative measurement of fasting plasma C-peptide levels is useful to predict diabetes outcome after Roux-en-Y gastric bypass (RYGB) surgery. Diabetes outcome after RYGB was evaluated in 126 obese patients: 41... more
    To evaluate whether preoperative measurement of fasting plasma C-peptide levels is useful to predict diabetes outcome after Roux-en-Y gastric bypass (RYGB) surgery. Diabetes outcome after RYGB was evaluated in 126 obese patients: 41 non-diabetic controls (NDC), 29 with impaired glucose tolerance (IGT) and 56 had type 2 diabetes mellitus (T2DM). Body weight, fasting plasma glucose, fasting C-peptide levels, and HbA1c were measured at baseline and 3.6 ± 0.16 years after GBS. Complete resolution of diabetes was defined as: fasting glucose <7.0 mmol/l, HbA1c <6.5 %, achieved without anti-diabetic medication. Patients with complete resolution of diabetes had a more recent diagnosis of T2DM, lower preoperative HbA1c levels and lower daily doses of metformin and insulin use. These parameters were related to postoperative HbA1c levels but they failed to mark the specific patients who had not reached complete resolution of T2DM. Fasting preoperative C-peptide levels had better predictive power: 90 % of T2DM patients with preoperative fasting C-peptide levels >1.0 nmol/l achieved a postoperative HbA1c <6.5 %, and 74 % achieved complete resolution of their diabetes. In contrast, none of the T2DM patients with a preoperative fasting C-peptide <1.0 nmol/l attained these goals. A preoperative fasting plasma C-peptide level <1.0 nmol/l in severely obese T2DM patients indicates partial β-cell failure, and is associated with a markedly reduced chance of complete resolution of T2DM after RYGB. We therefore advocate measuring C-peptide levels in all diabetic patients up for bariatric surgery to improve the prediction of outcome.
    Iron, vitamin B12, and folic acid deficiencies are among the most common deficiencies occurring after laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study evaluates the effectiveness of a specially designed multivitamin... more
    Iron, vitamin B12, and folic acid deficiencies are among the most common deficiencies occurring after laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study evaluates the effectiveness of a specially designed multivitamin supplement (WLS Forte, FitForMe, Rotterdam, the Netherlands) specifically developed for LRYGB patients.A triple-blind, randomized, 12-month study was conducted comparing WLS forte with a standard multivitamin supplement (sMVS) containing approximately 100% of the recommended daily allowance (RDA) for iron, vitamin B12, and folic acid. WLS Forte contains vitamin B12 14000% RDA, iron 500% RDA, and folic acid 300% RDA.In total, 148 patients (74 in each group) underwent a LRYGB procedure. Baseline characteristics were similar for both groups. Per protocol analysis demonstrated that sMVS treatment was associated with a decline in ferritin (-24.4 ± 70.1 μg/L) and vitamin B12 (-45.9 ± 150.3 pmol/L) over 12 months, whereas in WLS Forte patients, ferritin remained...
    After Roux-en-Y gastric bypass (RYGB) surgery, patients report a shift in food preferences away from high-energy foods. We aimed to elucidate the potential mechanisms underlying this shift in food preferences by assessing changes in... more
    After Roux-en-Y gastric bypass (RYGB) surgery, patients report a shift in food preferences away from high-energy foods. We aimed to elucidate the potential mechanisms underlying this shift in food preferences by assessing changes in neural responses to food pictures and odors before and after RYGB. Additionally, we investigated whether altered neural responsivity was associated with changes in plasma endocannabinoid and ghrelin concentrations. 19 RYGB patients (4 men; age 41 ± 10 years; BMI 41 ± 1 kg/m before; BMI 36 ± 1 kg/m after) participated in this study. Before and two months after RYGB surgery, they rated their food preferences using the Macronutrient and Taste Preference Ranking Task and BOLD fMRI responses towards pictures and odors of high-, and low-energy foods and non-food items were measured. Blood samples were taken to determine plasma endocannabinoid and ghrelin concentrations pre- and post-surgery. Patients demonstrated a shift in food preferences away from high-fat/...
    The aim of this research was to study the duodenal-jejunal bypass liner (DJBL) treatment for obesity and type 2 diabetes mellitus (T2DM) in patients after dietary treatment in a cross-over design. DJBL treatment has been proven effective... more
    The aim of this research was to study the duodenal-jejunal bypass liner (DJBL) treatment for obesity and type 2 diabetes mellitus (T2DM) in patients after dietary treatment in a cross-over design. DJBL treatment has been proven effective for treatment of obesity and T2DM. However, data on safety and efficacy of a 12-month DJBL treatment is limited. In 2014, our research group reported on a multicenter randomized clinical trial. Patients were randomized to DJBL or dietary treatment (control group). Twenty-eight patients crossed over after their dietary treatment and received up to 12 months of DJBL treatment. Patient visits were conducted at baseline, during DJBL treatment (1 week, 1-6, 9, 12 months) and 6 months after removal of the liner. Patients underwent a standard physical examination, blood sampling, assessment of adverse events, nutritional and diabetes counseling, and a standardized meal tolerance test. Of the 28 patients included in this study, 24 patients completed 6 month...
    After Roux-en-Y gastric bypass (RYGB), patients often develop a vitamin B-12 deficiency. Our objective was to investigate whether oral supplementation increases and normalizes low vitamin B-12 concentrations (vitamin B-12 > 200 pmol/L)... more
    After Roux-en-Y gastric bypass (RYGB), patients often develop a vitamin B-12 deficiency. Our objective was to investigate whether oral supplementation increases and normalizes low vitamin B-12 concentrations (vitamin B-12 > 200 pmol/L) in RYGB patients as compared to intramuscular injections. A randomized controlled trial in RYGB patients with subnormal serum B-12 concentrations was performed. One group (IM B-12) received bimonthly intramuscular hydroxocobalamin injections (2000 µg as loading dose and 1000 µg at follow-up) for 6 mo. The second group (oral B-12) received daily doses of oral methylcobalamin (1000 µg). Serum vitamin B-12 was determined at baseline (T0) and at 2 (T1), 4 (T2), and 6 mo (T3) after start of treatment. Concentrations of the secondary markers methylmalonic acid (MMA) and homocysteine (Hcy) were measured at T0 and T3. Fifty patients were included and randomized, 27 in IM B-12 and 23 in oral B-12. The median vitamin B-12 concentration at T0 was 175 pmol/L (...
    Sleeve gastrectomy (SG) has become the most performed bariatric procedure to induce weight loss worldwide. Unfortunately, a significant portion of patients show insufficient weight loss or weight regain after a few years. To investigate... more
    Sleeve gastrectomy (SG) has become the most performed bariatric procedure to induce weight loss worldwide. Unfortunately, a significant portion of patients show insufficient weight loss or weight regain after a few years. To investigate the effectiveness of the single anastomosis duodenoileal (SADI) bypass versus the Roux-en-Y gastric bypass (RYGB) on health outcomes in morbid obese patients who had undergone SG previously, with up to 2 years of follow-up. From 2007 to 2017, 140 patients received revisional laparoscopic surgery after SG in four specialized Dutch bariatric hospitals. Data was analyzed retrospectively and included comparisons for indication of surgery, vitamin/mineral deficiencies, and complications; divided into short-, medium-term. To compare weight loss, linear regression and linear mixed models were used. Conversion of a SG to SADI was performed in 66 patients and to RYGB in 74 patients. For patients in which additional weight loss was the main indication for surg...
    Inflammatory bowel diseases (IBD) are listed as a contraindication for bariatric surgery in various guidelines due to a theoretical higher complication risk. Therefore, little is known about safety and efficacy of bariatric surgery in IBD... more
    Inflammatory bowel diseases (IBD) are listed as a contraindication for bariatric surgery in various guidelines due to a theoretical higher complication risk. Therefore, little is known about safety and efficacy of bariatric surgery in IBD patients. We assessed the safety and efficacy of bariatric surgery and postoperative quality of life (QoL) in IBD patients. The study was conducted in a large peripheral hospital in the Netherlands. All IBD patients who underwent bariatric surgery in our facility were included. Complications, mortality, reoperations, and micronutrient deficiencies were analyzed. Weight loss was assessed 6, 12, and 24 months after surgery. Postoperative QoL was assessed using a disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). Forty-five patients were included in this study, all diagnosed with IBD (16 ulcerative colitis (UC) and 29 Crohn's disease (CD)) prior to bariatric surgery. Bariatric procedures included Roux-en-Y gastric bypass, sleeve gas...
    The purposes of the study are to outline the complexity of diagnosing internal herniation after Roux-en-Y gastric bypass (RYGB) surgery and to investigate the added value of computed tomography angiography (CTA) for diagnosing internal... more
    The purposes of the study are to outline the complexity of diagnosing internal herniation after Roux-en-Y gastric bypass (RYGB) surgery and to investigate the added value of computed tomography angiography (CTA) for diagnosing internal herniation. A cadaver study was performed to investigate the manifestations of internal hernias and mesenteric vascularization. Furthermore, a prospective, ethics approved study with retrospective interpretation was conducted. Ten patients, clinically suspected for internal herniation, were prospectively included. After informed consent was obtained, these subjects underwent abdominal CT examination, including additional arterial phase CTA. All subjects underwent diagnostic laparoscopy for suspected internal herniation. The CTA was used to create a 3D reconstruction of the mesenteric arteries and surgical staples (3D CTA). The 3D CTA was interpreted, taking into account the presence and type of internal hernia that was found upon laparoscopy. Cadaveri...
    Iron deficiency is one of the most common deficiencies that may occur after Roux-en-Y gastric bypass (RYGB). Little is known about the optimal treatment of post-RYGB iron deficiency. The aim of this study is to evaluate the changes in... more
    Iron deficiency is one of the most common deficiencies that may occur after Roux-en-Y gastric bypass (RYGB). Little is known about the optimal treatment of post-RYGB iron deficiency. The aim of this study is to evaluate the changes in iron absorption characteristics after RYGB for two oral iron formulations, one presented in tablet form and one as in the form of a solution. Iron absorption in 24 obese women was studied before and 1 month after RYGB. Twelve patients were tested with a single dose of 600 mg ferrous fumarate in tablet form (195 mg of elementary iron, group 1), and 12 patients received a single dose of 1390 mg ferrous gluconate as a solution (160 mg of elementary iron, group 2). Serum iron levels were measured before (T) and every hour after ingestion of the supplement (T-T). Before surgery, iron absorption was similar for the two supplements (P = 0.71). However, RYGB was associated with a decrease in fumarate iron absorption (P < 0.001) but did not affect gluconate ...
    Pharmacokinetic data suggest that the risk of metformin-associated lactic acidosis (MALA) may be increased after Roux-en-Y gastric bypass (RYGB) surgery. The aim of this study was to examine the impact of metformin on plasma lactate... more
    Pharmacokinetic data suggest that the risk of metformin-associated lactic acidosis (MALA) may be increased after Roux-en-Y gastric bypass (RYGB) surgery. The aim of this study was to examine the impact of metformin on plasma lactate levels before and after RYGB surgery. Retrospective study of plasma lactate levels before and 3 months after RYGB surgery in patients with type 2 diabetes mellitus (T2DM) not using metformin (MET-0, N = 58), on a stable dose (MET-S, N = 138), or on a decreasing dose (MET-D, N = 85) of metformin. Preoperatively, lactate levels were similar in patients on metformin (1.8 ± 0.05 mmol/L) and those not on metformin (1.7 ± 0.08 mmol/L), P = 0.21. Three months postoperatively, lactate levels had decreased in all groups (P < 0.001) to 1.3 ± 0.07 (SE), 1.4 ± 0.05, and 1.2 ± 0.05 mmol/l in MET-0, MET-S, and MET-D, respectively. Lactate levels differed between the groups (P = 0.03), with the lowest level in MET-D. The number of patients with hyperlactatemia (lact...
    The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that induces weight loss and improves glycemic control in patients with type 2 diabetes mellitus (T2DM). The aim of the current study was to assess the effects of DJBL... more
    The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that induces weight loss and improves glycemic control in patients with type 2 diabetes mellitus (T2DM). The aim of the current study was to assess the effects of DJBL explantation on glycemic control and body weight. This prospective, observational study included only T2DM patients who had the DJBL implanted for at least 6 months, and had a follow-up of at least 12 months after explantation. The primary endpoints were changes in HbA1c and body weight during the 12 months after explantation. Secondary endpoints were: changes in fasting plasma glucose (FPG), blood pressure, and plasma lipid levels. In total 59 patients completed the 12-month follow-up after explantation. During this period body weight increased by 5.6 (6.4) kg (p<0.001) and HbA1 rose from 65 (17) to 70 (20) mmol/mol (p<0.001). However, body weight remained 8.0 (8.6) kg (p<0.001) lower than before implantation, i.e. corresponding to a net total ...
    After Roux-en-Y gastric bypass, calcium and vitamin D deficiencies are frequently reported. In the presence of adequate vitamin D levels, calcium deficiency is caused by a lower efficacy of the intestinal calcium transport. To investigate... more
    After Roux-en-Y gastric bypass, calcium and vitamin D deficiencies are frequently reported. In the presence of adequate vitamin D levels, calcium deficiency is caused by a lower efficacy of the intestinal calcium transport. To investigate whether the use of a simple clinical score quantifying bowel habits (fecal score [FS]) correlates with the degree of secondary hyperparathyroidism that arises to compensate for calcium deficiency postsurgery. Large peripheral hospital. Seventy-five patients supplemented with calcium and vitamin D were prospectively studied before and 6 and 12 months after Roux-en-Y gastric bypass. FS, calcium (mmol/L), phosphate (mmol/L), magnesium (mmol/L), vitamin D (nmol/L), and parathyroid hormone (PTH; pmol/L) were measured in each patient. Mean body mass index was 44.7±5.4 kg/m(2) preoperatively and decreased to 34.3±5.0 kg/m(2) at 6 months and 30.8±4.8 kg/m(2) at 12 months, corresponding to a total weight loss of 23.2±5.9% and 30.9±8.3% respectively. There w...

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