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Long-term quality of life and nutrition status of the aboral pouch reconstruction after total gastrectomy for gastric cancer: a prospective multicenter observational study (CCOG1505).
Tanaka, C, Kanda, M, Murotani, K, Yoshikawa, T, Cho, H, Ito, Y, Matsui, T, Nakayama, H, Yamada, T, Kobayashi, D, et al
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 2019;(3):607-616
Abstract
BACKGROUND Several efforts have been made to alleviate harms and symptoms after gastrectomy for gastric cancer. We previously conducted a randomized controlled trial (CCOG1101) to compare quality of life (QOL) and nutritional status between Roux-en-Y (RY) and aboral pouch (AP) reconstructions for up to 1 year after total gastrectomy. However, long-term outcomes after AP reconstruction remain unclear. METHODS A prospective multicenter observational study was conducted to compare QOL, body composition, and nutritional indicators between the RY and AP reconstructions at 5 years after surgery among patients who were enrolled in the CCOG1101 trial. QOL was assessed by the PGSAS-37 questionnaires as well as the EORTC QLQ-C30 and STO22. RESULTS Sixty patients (31 for RY and 29 for AP) were recruited for analysis. There were no significant differences in baseline and perioperative characteristics between the two groups. No significant differences were found in the EORTC QLQ-C30 global health status and functional scales. Regarding symptom scales in the QLQ-C30 and STO22, a more favorable score for the diarrhea scale was observed in the AP group. Diarrhea was also the only item in the PGSAS-37 questionnaires in which significant benefit of AP was observed. Body weight and lean body mass continued to decrease throughout the postoperative 5 years in both groups. None of the conventional nutritional indicators using the serum samples showed significant difference between the two groups. CONCLUSIONS Long-term observation suggested little benefit of AP reconstruction after total gastrectomy other than in alleviating diarrhea.
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Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).
Matsushita, H, Tanaka, C, Murotani, K, Misawa, K, Ito, S, Ito, Y, Kanda, M, Mochizuki, Y, Ishigure, K, Yaguchi, T, et al
Digestive surgery. 2018;(1):11-18
Abstract
BACKGROUND Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). METHODS Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. RESULTS Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. CONCLUSIONS Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC.
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Inadequate protein intake after laparoscopic sleeve gastrectomy surgery is associated with a greater fat free mass loss.
Sherf Dagan, S, Tovim, TB, Keidar, A, Raziel, A, Shibolet, O, Zelber-Sagi, S
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2017;(1):101-109
Abstract
BACKGROUND Low postoperative protein intake may represent a modifiable risk factor that leads to fat free mass (FFM) loss postlaparoscopic sleeve gastrectomy (LSG), but data concerning this phenomenon is scarce. OBJECTIVES To evaluate the association between daily protein intake and relative FFM loss at 6 (M6) and 12 (M12) months after LSG surgery. SETTINGS Private hospital and university hospital. METHODS A prospective cohort study with 12 months follow-up of 77 patients who underwent LSG surgery. Anthropometrics including body composition analysis measured by multifrequency bioelectrical impedance analysis, 3-day food diaries, food intolerance, and habitual physical activity were evaluated at baseline and at M3, M6, and M12. RESULTS Repeated body composition measurements and food diary were available for 77 patients (45 women) at M6 and for 68 patients at M12. Mean age was 42.7±9.4 years and mean preoperative body mass index was 42.2±4.8 kg/m2. A protein intake of≥60 g/d was achieved in 13.3%, 32.5% and 39.7% of the study participants at M3, M6 and M12, respectively. FFM significantly decreased at M6 and stabilized at M12. Protein intake of≥60 g/d was associated with a significantly lower relative FFM loss at M6 among women (8.9±6.5% versus 12.4±4.1%; P = .039) and this trend was also reported among men (9.5±5.5% versus 13.4±6.0%; P = .068). A logistic regression for the prediction of FFM loss of≥10% at M6, indicated that protein intake≥60 g/d is a strong protective factor (odds ratio = 0.29, 95% confidence interval .09-.96, P = .043). CONCLUSION Our study supports the currently recommended protein intake goal of≥60 g/d as an efficient strategy for better preservation of FFM post-LSG.
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Do sleeve gastrectomy and gastric bypass influence treatment with proton pump inhibitors 4 years after surgery? A nationwide cohort.
Thereaux, J, Lesuffleur, T, Czernichow, S, Basdevant, A, Msika, S, Nocca, D, Millat, B, Fagot-Campagna, A
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2017;(6):951-959
Abstract
BACKGROUND Gastroesophageal reflux disease (GERD) is a common obesity-related co-morbidity that routinely is treated by continuous proton pump inhibitor (PPI) therapy. A number of concerns have been raised regarding the risk of de novo GERD or exacerbation of preexisting GERD after sleeve gastrectomy (SG). OBJECTIVE To assess PPI use at 4 years after bariatric surgery. SETTING French National Health Insurance. METHODS Data were extracted from the French National Health Insurance database. All adult obese patients who had undergone gastric bypass (GBP) (n = 8250) or SG (n = 11,923) in 2011 in France were included. Patients were considered to be on continuous PPI therapy when PPIs were dispensed≥6 times per year. Logistic regression models were used to compute odds ratios for potential risk factors for PPI reimbursement 4 years after surgery. RESULTS Overall, continuous use of PPIs increased from baseline to 4 years after SG and GBP, from 10.9% to 26.5% (P<.001) and from 11.4% to 21.9% (P<.001), respectively. Among patients who underwent PPI therapy before surgery, those who had undergone SG were more likely to continue PPI therapy 4 years after surgery compared with those who underwent GBP (72.7% versus 59.2%; P<.001). In multivariate analyses, the major risk factors for persistent continuous PPI treatment 4 years after surgery were the following: SG (odds ratio [OR] = 1.87; 95% confidence interval [CI] 1.55-2.25), higher body mass index (OR 1.85; 95% CI 1.35-2.5), and preoperative antidepressant treatment (OR 1.89; 95% CI 1.56-2.29). CONCLUSION At a nationwide scale, continuous PPI treatment is used by 1 of 10 obese patients before bariatric surgery, but by 1 of 4 patients 4 years after surgery. SG compared with GBP, higher body mass index, and other coexisting conditions are the 3 major risk factors for medium-term continuous PPI therapy.
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Randomized clinical trial comparing standard diet with perioperative oral immunonutrition in total gastrectomy for gastric cancer.
Ida, S, Hiki, N, Cho, H, Sakamaki, K, Ito, S, Fujitani, K, Takiguchi, N, Kawashima, Y, Nishikawa, K, Sasako, M, et al
The British journal of surgery. 2017;(4):377-383
Abstract
BACKGROUND Total gastrectomy for gastric cancer is associated with excessive weight loss and decreased calorie intake. Nutritional support using eicosapentaenoic acid modulates immune function and limits catabolism in patients with advanced cancer, but its impact in the perioperative period is unclear. METHODS This was a randomized phase III clinical trial of addition of eicosapentaenoic acid-rich nutrition to a standard diet in patients having total gastrectomy for gastric cancer. Patients were randomized to either a standard diet or standard diet with oral supplementation of an eicosapentaenoic acid (ProSure®), comprising 600 kcal with 2·2 g eicosapentaenoic acid, for 7 days before and 21 days after surgery. The primary endpoint was percentage bodyweight loss at 1 and 3 months after surgery. RESULTS Of 127 eligible patients, 126 were randomized; 124 patients (61 standard diet, 63 supplemented diet) were analysed for safety and 123 (60 standard diet, 63 supplemented diet) for efficacy. Across both groups, all but three patients underwent total gastrectomy with Roux-en-Y reconstruction. Background factors were well balanced between the groups. Median compliance with the supplement in the immunonutrition group was 100 per cent before and 54 per cent after surgery. The surgical morbidity rate was 13 per cent in patients who received a standard diet and 14 per cent among those with a supplemented diet. Median bodyweight loss at 1 month after gastrectomy was 8·7 per cent without dietary supplementation and 8·5 per cent with eicosapentaenoic acid enrichment (P = 0·818, adjusted P = 1·000). Similarly, there was no difference between groups in percentage bodyweight loss at 3 months (P = 0·529, adjusted P = 1·000). CONCLUSION Immunonutrition based on an eicosapentaenoic acid-enriched oral diet did not reduce bodyweight loss after total gastrectomy for gastric cancer compared with a standard diet. Registration number: UMIN000006380 ( http://www.umin.ac.jp/).
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Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.
Kim, YW, Bae, JM, Park, YK, Yang, HK, Yu, W, Yook, JH, Noh, SH, Han, M, Ryu, KW, Sohn, TS, et al
JAMA. 2017;(20):2097-2104
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Abstract
IMPORTANCE Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. OBJECTIVE To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. INTERVENTIONS Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. RESULTS Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. CONCLUSION AND RELEVANCE Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01725789.
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Multi-institutional prospective feasibility study to explore tolerability and efficacy of oral nutritional supplements for patients with gastric cancer undergoing gastrectomy (CCOG1301).
Kobayashi, D, Ishigure, K, Mochizuki, Y, Nakayama, H, Sakai, M, Ito, S, Kojima, H, Kajikawa, M, Ando, M, Kodera, Y
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 2017;(4):718-727
Abstract
BACKGROUND Postoperative malnutrition after gastrectomy is deemed inevitable, which could have prejudicial influence on survival for gastric cancer patients. A prospective feasibility study was conducted to evaluate the efficacy of postoperative oral nutritional supplements. METHODS Stage I-III gastric cancer patients who underwent distal or total gastrectomy received oral administration of Racol® NF (Otsuka Pharmaceutical Factory, Japan), a liquid enteral nutritional formula, as a supplement to regular meals. Racol® NF administration at a recommended dosage of 400 kcal/400 ml per day was started within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was ratio of the weight loss at 3 months postoperatively to the preoperative body weight (body weight loss ratio). Secondary end points were the adherence to Racol® NF therapy and changes in body composition. RESULTS One hundred eighteen patients were registered before surgery, 82 of whom were eligible for efficacy analyses. The average rate of body weight loss after 3 months postoperatively was 8.3%. The mean daily intake of Racol® NF was 211 ml. There was a significant correlation between adherence to Racol® NF therapy and body weight loss ratio (P < 0.001). Adherence to Racol® NF therapy was the only factor that correlated with the body weight loss ratio among all clinical characteristics by the multiple linear regression analysis (P = 0.007). CONCLUSIONS Oral nutritional supplementation with Racol® NF led to a significant reduction in body weight loss for gastrectomized patients who tolerated more than 200 ml of the nutrient per day compared with those who could not tolerate this amount.
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Randomized controlled trial comparing laparoscopic greater curvature plication versus laparoscopic sleeve gastrectomy.
Grubnik, VV, Ospanov, OB, Namaeva, KA, Medvedev, OV, Kresyun, MS
Surgical endoscopy. 2016;(6):2186-91
Abstract
BACKGROUND Laparoscopic greater curvature plication (LGCP) is a new restrictive bariatric procedure, which has a similar restrictive mechanism like laparoscopic sleeve gastrectomy (LSG) without potential risk of leak. Aim of the study was to compare 2-year outcomes of LSG and LGCP. METHODS Multicenter prospective randomized trial was started in 2010. A total of 54 patients with morbid obesity were allocated either to LGCP group (n = 25) or LSG group (n = 27). Main exclusion criteria were: ASA > III, age > 75 and BMI > 65 kg/m(2). There were 40 women and 12 men, and the mean age was 42.6 ± 6.8 years (range 35-62). Data on the operation time, complications, hospital stay, body mass index loss, percentage of excess weight loss (%EWL), loss of appetite and improvement in comorbidities were collected during the follow-up examinations. RESULTS All procedures were completed laparoscopically. The mean operative time was 92.0 ± 15 min for LSG and 73 ± 19 min for LGCP (p > 0.05). The mean hospital stay was 4.0 ± 1.9 days in the LSG group and 3.8 ± 1.7 days in LGCP group (p > 0.05). One year after surgery, the mean %EWL was 59.5 ± 15.4 % in LSG group and 45.8 ± 17 % in LGCP group (p > 0.05). After 2 years, mean %EWL was 78.9 ± 20 % in the LSG group and 42.4 ± 18 % in the LGCP group (p < 0.01). After 3 years, mean %EWL was 72.8 ± 22 in the LSG group and only 20.5 ± 23.9 in the LGCP group (p < 0.01). Loss of feeling of hunger after 2 years was 25 % in LGCP group and 76.9 % in the LSG group (p < 0.05). The comorbidities including diabetes, sleep apnea and hypertension were markedly improved in the both groups after surgery. CONCLUSION The short-term outcomes demonstrated equal effectiveness of the both procedures, but 2-year follow-up showed that LGCP is worse than LSG as a restrictive procedure for weight loss.
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Laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass lead to equal changes in body composition and energy metabolism 17 months postoperatively: a prospective randomized trial.
Schneider, J, Peterli, R, Gass, M, Slawik, M, Peters, T, Wölnerhanssen, BK
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2016;(3):563-570
Abstract
BACKGROUND Weight loss is the sum of fat and lean mass loss. The aim of this study was to examine whether there are differences between 2 surgical procedures, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), in terms of their effect on body composition and energy metabolism. In addition, the predictive value of preoperative body composition and energy metabolism on postoperative outcome was evaluated. SETTING All procedures were performed by the same surgeon (RP) at the St. Claraspital Basel in Switzerland. Calorimetry and DEXA were carried out at the same institution (Interdisciplinary Center of Nutritional and Metabolic Diseases, St. Claraspital Basel). METHODS Forty-two morbidly obese, mainly female (85%), nondiabetic and diabetic (50%) patients (body mass index [BMI]: 43.9 kg/m(2)±1.3) before and 17±5.6 months after LSG (n = 23) and LRYGB (n = 19) were examined. Body composition was analyzed by dual-energy X-ray absorptiometry (DEXA) and resting energy expenditure (REE); fat and carbohydrate oxidation was determined by indirect calorimetry. RESULTS Follow-up was 100%. Excessive BMI loss (EBMIL) was 64.4% in the LSG group and 76.4% in the LRYGB group (P<.046). In both groups total fat and muscle mass decreased significantly compared with baseline (P<.001) and the percentage of muscle mass per kilogram of weight increased postoperatively (results not significant). REE decreased (P<.001) and REE per kilogram of weight increased significantly (P<.003) compared with baseline. Carbohydrate oxidation remained stable in both groups, and fat oxidation decreased significantly (P<.001) compared with baseline. In diabetic patients compared with nondiabetic patients there were no statistically significant differences in REE, substrate oxidation, or reduction in truncal fat. Postoperatively, lean mass was higher in diabetic patients (P = .037). Preoperative indirect calorimetry and DEXA results were of no predictive value for outcome. CONCLUSION Changes in REE and body composition were equal after both procedures in a bariatric population mainly consisting of women. No predictors for amount of weight loss could be found.
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Factors affecting the quality of life of patients after gastrectomy as assessed using the newly developed PGSAS-45 scale: A nationwide multi-institutional study.
Nakada, K, Takahashi, M, Ikeda, M, Kinami, S, Yoshida, M, Uenosono, Y, Kawashima, Y, Nakao, S, Oshio, A, Suzukamo, Y, et al
World journal of gastroenterology. 2016;(40):8978-8990
Abstract
AIM: To identify certain clinical factors other than the type of gastrectomy which affect the postoperative quality of life (QOL) of patients after gastrectomy. METHODS The postgastrectomy syndrome assessment scale (PGSAS)-45 was designed to assess the severity of symptoms, the living status and the QOL of gastrectomized patients. It consists of 45 items, of which 22 are original items while 23 were retrieved from the SF-8 and Gastrointestinal Symptoms Rating Scale questionnaires with permission. A nationwide surveillance study to validate PGSAS was conducted and 2368 gastric cancer patients who underwent various types of gastrectomy at 52 medical institutions were enrolled. Of these, 1777 patients who underwent total gastrectomy (TG) reconstructed with Roux-Y (n = 393), distal gastrectomy (DG) reconstructed with Billroth-I (n = 909), or DG reconstructed with Roux-Y (n = 475) were evaluated in the current study. The influence of the type of gastrectomy and other clinical factors such as age, sex, duration after surgery, the symptom severity, the degree of weight loss, dietary intake, and the ability for working on the postoperative QOL (i.e., dissatisfaction for daily life subscale, physical component summary and mental component summary of the SF-8) were examined by multiple regression analysis (MRA). In addition, importance of various symptoms such as esophageal reflux, abdominal pain, meal-related distress, indigestion, diarrhea, constipation and dumping on the postoperative living status and QOL were also appraised by MRA. RESULTS The postoperative QOL were significantly deteriorated in patients who underwent TG compared to those after DG. However, the extent of gastrectomy was not an influential factor on patients' QOL when adjusted by the MRA. Among various clinical factors, the symptom severity, ability for working, and necessity for additional meals were the most influential factors to the postoperative QOL. As for the individual symptoms, meal-related distress, dumping, abdominal pain, and esophageal reflux significantly affected the postoperative QOL in that order, while the influence of indigestion, diarrhea and constipation was insignificant. CONCLUSION Several clinical factors such as the symptom severity (especially in meal-related distress and dumping), ability for working and necessity for additional meals were the main factors which affected the patients' well-being after gastrectomy.