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Computational modelling of self-reported dietary carbohydrate intake on glucose concentrations in patients undergoing Roux-en-Y gastric bypass versus one-anastomosis gastric bypass.
Ashrafi, RA, Ahola, AJ, Rosengård-Bärlund, M, Saarinen, T, Heinonen, S, Juuti, A, Marttinen, P, Pietiläinen, KH
Annals of medicine. 2021;(1):1885-1895
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Abstract
OBJECTIVES Our aim was to investigate in a real-life setting the use of machine learning for modelling the postprandial glucose concentrations in morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) or one-anastomosis gastric bypass (OAGB). METHODS As part of the prospective randomized open-label trial (RYSA), data from obese (BMI ≥35 kg/m2) non-diabetic adult participants were included. Glucose concentrations, measured with FreeStyle Libre, were recorded over 14 preoperative and 14 postoperative days. During these periods, 3-day food intake was self-reported. A machine learning model was applied to estimate glycaemic responses to the reported carbohydrate intakes before and after the bariatric surgeries. RESULTS Altogether, 10 participants underwent RYGB and 7 participants OAGB surgeries. The glucose concentrations and carbohydrate intakes were reduced postoperatively in both groups. The relative time spent in hypoglycaemia increased regardless of the operation (RYGB, from 9.2 to 28.2%; OAGB, from 1.8 to 37.7%). Postoperatively, we observed an increase in the height of the fitted response curve and a reduction in its width, suggesting that the same amount of carbohydrates caused a larger increase in the postprandial glucose response and that the clearance of the meal-derived blood glucose was faster, with no clinically meaningful differences between the surgeries. CONCLUSIONS A detailed analysis of the glycaemic responses using food diaries has previously been difficult because of the noisy meal data. The utilized machine learning model resolved this by modelling the uncertainty in meal times. Such an approach is likely also applicable in other applications involving dietary data. A marked reduction in overall glycaemia, increase in postprandial glucose response, and rapid glucose clearance from the circulation immediately after surgery are evident after both RYGB and OAGB. Whether nondiabetic individuals would benefit from monitoring the post-surgery hypoglycaemias and the potential to prevent them by dietary means should be investigated.KEY MESSAGESThe use of a novel machine learning model was applicable for combining patient-reported data and time-series data in this clinical study.Marked increase in postprandial glucose concentrations and rapid glucose clearance were observed after both Roux-en-Y gastric bypass and one-anastomosis gastric bypass surgeries.Whether nondiabetic individuals would benefit from monitoring the post-surgery hypoglycaemias and the potential to prevent them by dietary means should be investigated.
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Randomized Comparison of Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis After Esophagectomy.
Yano, M, Sugimura, K, Miyata, H, Motoori, M, Tanaka, K, Omori, T, Ohue, M, Sakon, M
Annals of surgery. 2020;(1):48-54
Abstract
OBJECTIVE This prospective randomized phase-II trial examined whether gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY) minimized gastroduodenal reflux and delayed gastric emptying compared with standard gastric reconstruction. SUMMARY BACKGROUND DATA There is no established standard surgical procedure to prevent both gastroduodenal reflux and delayed gastric emptying simultaneously. METHODS Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction were randomly allocated to standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY (n = 29) groups. Primary endpoint was quality of life assessed by DAUGS-32 score 1 year after surgery. Secondary endpoints were the extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status. RESULTS Preoperative clinicopathological characteristics and postoperative morbidity did not differ significantly between groups. However, operation time and blood loss volume were significantly higher in the RY group. Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group. Postoperative endoscopic examination showed residual gastric content in 7 of 17 patients in the non-RY group but in none in the RY group (P = 0.012). Quality of life was significantly favorable in the RY group with regard to reflux symptoms and food passage dysfunction. Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts were not significantly different between groups. CONCLUSION Gastric reconstruction with duodenal diversion plus RY is effective in improving both gastroduodenal reflux and delayed gastric emptying.
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Functional jejunal interposition versus Roux-en-Y anastomosis after total gastrectomy for gastric cancer: A prospective randomized clinical trial.
Wang, H, Hu, X, Chen, S, Xiang, J, Yang, Z, Zhou, Z, Chen, Y, Lin, Y, Chen, Y, Peng, J
Surgical oncology. 2020;:236-244
Abstract
BACKGROUND Nutritional status and quality of life deteriorate significantly after total gastrectomy for patients with gastric cancer. The numerous types of reconstruction proposed by medical researchers around the world have limited effect. This prospective, randomized clinical trial compared functional jejunal interposition with Roux-en-Y anastomosis to identify the optimal reconstruction procedure. METHODS This was a multi-center, prospective, randomized control trial. The enrolled patients were randomly assigned into the functional jejunal interposition group and the Roux-en-Y group. All patients were followed up at regular intervals after surgery. The endpoints were postoperative nutritional status, quality of life, and long-term postoperative complications. RESULTS A total of 113 patients were enrolled from August 2012 to September 2017. Until March 2018, the median follow-up period was 18 months. At 12 months after surgery, food intake per meal (P = 0.021), Prognosis Nutritional Index (P = 0.015), weight loss (P = 0.019), and Gastrointestinal Symptom Rating Scale score (P = 0.015) of the functional jejunal interposition group were significantly worse than those of the Roux-en-Y group. There was no significant difference in operative time, intraoperative blood loss, perioperative complications, time of first flatus and defecation after surgery, postoperative plasma nutritional parameters, Visick score, Eastern Cooperative Group physical condition score, and survival rate. CONCLUSION For patients with long-term survival after total gastrectomy for gastric cancer, the Roux-en-Y anastomosis is a better choice compared with functional jejunal interposition.
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Impact of enhanced recovery after surgery on postoperative rehabilitation, inflammation, and immunity in gastric carcinoma patients: a randomized clinical trial.
Wang, WK, Tu, CY, Shao, CX, Chen, W, Zhou, QY, Zhu, JD, Xu, HT
Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas. 2019;(5):e8265
Abstract
We determined the effects of enhanced recovery after surgery (ERAS) in patients undergoing radical surgery for gastric carcinoma. Sixty patients undergoing radical gastrectomy for gastric carcinoma in Lishui Hospital between March and October 2016 were randomized to receive either ERAS (30 patients) or conventional care (30 patients, controls). Clinical, economic, and laboratory indices were analyzed. ERAS patients showed faster recovery and shorter postoperative hospital stays than the controls (P<0.05). Some clinical indices (i.e., time to first flatus and defecation, time to removal of drainage tubes, time to resumption of oral feeding, time to postoperative mobilization, and postoperative complications) were significantly better in ERAS patients than in controls. Duration of postoperative infusion was lower in ERAS patients than in controls (P<0.05). In ERAS patients, serum albumin and prealbumin were higher on postoperative day 7, C-reactive protein was lower on postoperative days 3 and 7, and neutrophil count was lower on postoperative day 3 compared to the values in controls (P<0.05 for all). IgM levels were higher in ERAS patients on postoperative days 3 and 7 (P<0.05), while IgG levels were higher on postoperative day 3 (P<0.05). Total T lymphocytes were higher in ERAS patients on postoperative day 3, while helper T cells and CD4+/CD8+ ratio were higher on postoperative days 3 and 7 (P<0.05 for all). In gastric carcinoma patients, ERAS may reduce perioperative inflammation, improve immunity and postoperative nutrition, shorten hospitalization, and enhance rehabilitation.
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Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial.
Hofsø, D, Fatima, F, Borgeraas, H, Birkeland, KI, Gulseth, HL, Hertel, JK, Johnson, LK, Lindberg, M, Nordstrand, N, Cvancarova Småstuen, M, et al
The lancet. Diabetes & endocrinology. 2019;(12):912-924
Abstract
BACKGROUND For patients with obesity and type 2 diabetes, weight loss improves insulin sensitivity and β-cell function, and can induce remission of diabetes. The comparative efficacy of various bariatric procedures for the remission of type 2 diabetes has not been fully elucidated. We aimed to compare the effects of the two most common bariatric procedures, gastric bypass and sleeve gastrectomy, on remission of diabetes and β-cell function. METHODS We conducted a single-centre, triple-blind, randomised trial at Vestfold Hospital Trust (Tønsberg, Norway), in which patients (aged ≥18 years) with type 2 diabetes and obesity were randomly assigned (1:1) to receive gastric bypass or sleeve gastrectomy (the Oseberg study). Randomisation was performed with a computerised random number generator and a block size of 10. Treatment allocation was masked from participants, study personnel, and outcome assessors and was concealed with sealed opaque envelopes. Surgeons used identical skin incisions during both surgeries and were not involved in patient follow-up. The primary clinical outcome was the proportion of participants with complete remission of type 2 diabetes (HbA1c of ≤6·0% [42 mmol/mol] without the use of glucose-lowering medication) at 1 year after surgery. The primary physiological outcome was disposition index (a measure of β-cell function) at 1 year after surgery, as assessed by an intravenous glucose tolerance test. Primary outcomes were analysed in the intention-to-treat and per-protocol populations. This trial is ongoing and closed to recruitment, and is registered with ClinicalTrials.gov, NCT01778738. FINDINGS Between Oct 15, 2012, and Sept 1, 2017, 1305 patients who were preparing for bariatric surgery were screened, of whom 319 consecutive patients with type 2 diabetes were assessed for eligibility. 109 patients were enrolled and randomly assigned to gastric bypass (n=54) or sleeve gastrectomy (n=55). 107 (98%) of 109 patients completed 1-year follow-up, with one patient in each group withdrawing after surgery (per-protocol population). In the intention-to-treat population, diabetes remission rates were higher in the gastric bypass group than in the sleeve gastrectomy group (risk difference 27% [95% CI 10 to 44]; relative risk [RR] 1·57 [1·14 to 2·16], p=0·0054); results were similar in the per-protocol population (risk difference 27% [95% CI 10 to 45]; RR 1·57 [1·14 to 2·15], p=0·0036). In the intention-to-treat population, disposition index increased in both groups (between-group difference 55 [-111 to 220], p=0·52); results were similar in the per-protocol population (between-group difference 21 [-214 to 256], p=0.86). In the gastric bypass group, ten of 54 participants had early complications and 17 of 53 had late side-effects. In the sleeve gastrectomy group, eight of 55 participants had early complications and 22 of 54 had late side-effects. No deaths occurred in either group. INTERPRETATION Gastric bypass was found to be superior to sleeve gastrectomy for remission of type 2 diabetes at 1 year after surgery, and the two procedures had a similar beneficial effect on β-cell function. The use of gastric bypass as the preferred bariatric procedure for patients with obesity and type 2 diabetes could improve diabetes care and reduce related societal costs. FUNDING Morbid Obesity Centre, Vestfold Hospital Trust.
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Effects of different doses of magnesium sulfate on pneumoperitoneum-related hemodynamic changes in patients undergoing gastrointestinal laparoscopy: a randomized, double-blind, controlled trial.
Tan, W, Qian, DC, Zheng, MM, Lu, X, Han, Y, Qi, DY
BMC anesthesiology. 2019;(1):237
Abstract
BACKGROUND The infusion of magnesium sulfate is well known to reduce arterial pressure and attenuate hemodynamic response to pneumoperitoneum. This study aimed to investigate whether different doses of magnesium sulfate can effectively attenuate the pneumoperitoneum-related hemodynamic changes and the release of vasopressin in patients undergoing laparoscopic gastrointestinal surgery. METHODS Sixty-nine patients undergoing laparoscopic partial gastrectomy were randomized into three groups: group L received magnesium sulfate 30 mg/kg loading dose and 15 mg/kg/h continuous maintenance infusion for 1 h; group H received magnesium sulfate 50 mg/kg followed by 30 mg/kg/h for 1 h; and group S (control group) received same volume 0.9% saline infusion, immediately before the induction of pneumoperitoneum. Systemic vascular resistance (SVR), cardiac output (CO), mean arterial pressure (MAP), heart rate (HR), central venous pressure (CVP), serum vasopressin and magnesium concentrations were measured. The extubation time, visual analogue scale were also assessed. The primary outcome is the difference in SVR between different groups. The secondary outcome is the differences of other indicators between groups, such as CO, MAP, HR, CVP, vasopressin and postoperative pain score. RESULTS Pneumoperitoneum instantly resulted in a significant reduction of cardiac output and an increase in mean arterial pressure, systemic vascular resistance, central venous pressure and heart rate in the control group (P < 0.01). The mean arterial pressure (T2 - T4), systemic vascular resistance (T2 - T3), central venous pressure(T3-T5) and the level of serum vasopressin were significantly lower (P < 0.05) and the cardiac output (T2 - T3) was significantly higher (P < 0.05) in group H than those in the control group. The mean arterial pressure (T4), systemic vascular resistance (T2), and central venous pressure(T3-T4) were significantly lower in group H than those in group L (P < 0.05). Furthermore, the visual analog scales at 5 min and 20 min, the level of vasopressin, and the dose of remifentanil were significantly decreased in group H compared to the control group and group L (P < 0.01). CONCLUSION Magnesium sulfate could safely and effectively attenuate the pneumoperitoneum-related hemodynamic instability during gastrointestinal laparoscopy and improve postoperative pain at serum magnesium concentrations above 2 mmol/L. TRIAL REGISTRATION The study was retrospectively registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IPD-17011145, principal investigator: D.Y. Q., date of registration: April 13, 2017.
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Continuous administration of ramosetron with patient-controlled analgesia after laparoscopic distal gastrectomy does not delay postoperative bowel function recovery: A prospective, randomized, double-blinded study.
Jung, HS, Huh, J, Kim, Y, Hong, SH, Lee, J
Medicine. 2018;(31):e11503
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Abstract
BACKGROUND Currently, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are indicated to slow gastrointestinal motility in the diarrhea-predominant subtype of irritable bowel syndrome. They are commonly used to prevent or treat postoperative nausea and vomiting (PONV) and opioid-induced nausea and vomiting (OINV). We conducted a prospective, randomized, double-blinded study to investigate whether the continuous administration of ramosetron, a selective 5-HT3 receptor antagonist, for preventing PONV and/or OINV after laparoscopic distal gastrectomy (LDG) might influence bowel function recovery. METHODS Patients scheduled to undergo LDG were randomly assigned to 1 of 3 treatment regimens: no prophylactic ramosetron (Group C); ramosetron 0.6 mg added to 2-day intravenous patient-controlled analgesia (IV-PCA) (Group R0.6); and ramosetron 1.2 mg added to 2-day IV-PCA (Group R1.2). Postoperative recovery profiles of bowel function, incidence of postoperative nausea/vomiting and pain, and perioperative data that affected bowel function recovery were evaluated. RESULTS Seventy-three patients completed the study protocol. Parameters associated with postoperative recovery of bowel function, such as time to first flatus, time to first bowel movement, time to first defecation, and time to commencement of soft diet, were not significantly different between the 3 groups. The incidence of nausea 2 to 24 hours after surgery was significantly lower in Group R0.6 (20.0%) and Group R1.2 (12.5%) than in Group C (45.8%) (P < .022). The ratio of complete response 2 to 24 hours after surgery was significantly higher in Group R0.6 (80.0%) and Group R1.2 (87.5%) than in Group C (54.2%) (P < .022). The incidence of retching 24 to 48 hours after surgery was significantly lower in Group R0.6 (0.0%) and Group R1.2 (4.2%) than in Group C (16.7%) (P < .043). CONCLUSION Continuous administration of ramosetron with patient-controlled analgesia to prevent PONV and OINV after LDG did not delay postoperative bowel function recovery.
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Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial.
Kang, SH, Lee, Y, Min, SH, Park, YS, Ahn, SH, Park, DJ, Kim, HH
Annals of surgical oncology. 2018;(11):3231-3238
Abstract
BACKGROUND The application of ERAS protocol has widely gained acceptance after gastrointestinal surgery. Well-designed, randomized, control trials are needed to evaluate fully its safety and efficacy in the field of gastric cancer. This study aims to compare the enhanced recovery after surgery (ERAS) protocol and the conventional perioperative care program after totally laparoscopic distal gastrectomy (TLDG) in gastric cancer. METHODS Patients with gastric cancer indicated for TLDG were randomly assigned to either the ERAS group or the conventional group. The ERAS protocol included short fasting time, fluid restriction, early oral feeding, immediate mobilization, and use of epidural patient-controlled analgesia. Primary endpoint was recovery time, which was defined with the criteria of tolerable diet, safe ambulation, no requirement of additional analgesics, and afebrile state. Hospital stay, pain score, complications, and readmission rate were secondary endpoints. RESULTS A total of 97 patients who underwent TLDG from October 2012 to August 2014 were enrolled (ERAS = 46, conventional = 51). The ERAS group had faster recovery time (111.6 ± 34.3 vs. 126.7 ± 30.7 h; p = 0.026) and significantly less pain through postoperative days 1-4. Possible hospital stay also was faster in the ERAS group (5.0 ± 1.9 vs. 5.7 ± 1.6 days, p = 0.038), but there was no difference in actual hospital stay. No difference was found in complication, and there was no mortality or readmission in both groups. CONCLUSIONS ERAS is safe and enhances postoperative recovery after TLDG in gastric cancer. TRIAL REGISTRATION The trial was registered in ClinicalTrials.gov (NCT01938313).
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Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report.
Lu, J, Zheng, CH, Zheng, HL, Li, P, Xie, JW, Wang, JB, Lin, JX, Chen, QY, Cao, LL, Lin, M, et al
Surgical endoscopy. 2017;(7):2939-2945
Abstract
OBJECTIVE In this study, we evaluated the short-term outcomes following three-dimensional (3D) or two-dimensional (2D) laparoscopic surgery for patients with gastric cancer. BACKGROUND There is a lack of prospective evidence regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for patients with gastric cancer. Therefore, we conducted a phase III single-center, prospective, randomized, controlled trial to compare 3D and 2D laparoscopic surgery for patients with gastric cancer. METHODS We compared operation time, intraoperative blood loss, number of lymph node dissections, morbidity, and mortality between the 3D and 2D groups following laparoscopic surgery for gastric cancer. The study is registered at ClinicalTrials.gov with ID number NCT02327481. RESULTS A total of 228 patients were randomized (3D group 115 cases; 2D group 113 cases) between January 1, 2015 and September 1, 2015. Seven patients who underwent exploratory operations were excluded. Finally, a total of 221 patients were analyzed (3D group 109 cases, 2D group 112 cases). There were no significant differences between the two groups regarding the clinical pathological characteristics, operating time (3D vs. 2D, 184 ± 36 vs. 178 ± 37 min, P = 0.288), number of lymph node dissections (36 ± 14 vs. 37 ± 13, P = 0.698), time to first ambulation (2.27 ± 1.60 vs. 2.04 ± 0.84, P = 0.18), flatus (3.89 ± 1.49 vs. 3.69 ± 1.12, P = 0.255), liquid diet (4.88 ± 1.88 vs. 4.79 ± 1.57, P = 0.684), or duration of postoperative hospital stay (12.52 ± 4.83 vs. 12.63 ± 7.32, P = 0.903). The postoperative complication rates of the 3D and 2D groups were 18.3 and 16.1%, respectively, P = 0.723. No patients died during the postoperative hospital stay. However, the intraoperative blood loss in the 3D group was significantly lower than the 2D group (58 ± 75 vs. 78 ± 72 ml, P = 0.047). CONCLUSION There was no significant difference in operation time and number of lymph node harvested between the 3D and 2D groups; however, 3D laparoscopic surgery may reduce the intraoperative blood loss compared to 2D procedure. Therefore, we conclude that this trial is safe and is thus ongoing.
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Predictive Value of Gut Peptides in T2D Remission: Randomized Controlled Trial Comparing Metabolic Gastric Bypass, Sleeve Gastrectomy and Greater Curvature Plication.
Casajoana, A, Pujol, J, Garcia, A, Elvira, J, Virgili, N, de Oca, FJ, Duran, X, Fernández-Veledo, S, Vendrell, J, Vilarrasa, N
Obesity surgery. 2017;(9):2235-2245
Abstract
BACKGROUND Our aim was to determine the predictive value of gut hormone changes for the improvement of type 2 diabetes (T2D) following metabolic Roux-en-Y gastric bypass (mRYGB), sleeve gastrectomy (SG), and greater curvature plication (GCP) in a randomized controlled trial. Contradictory results have been obtained regarding the role of gastrointestinal hormones (in particular GLP-1) in beneficial metabolic bariatric surgery outcomes. METHODS Forty-five patients with T2D (mean BMI 39.4 ± 1.9 kg/m2) were randomly assigned to mRYGB, SG, or GCP. Anthropometric and biochemical parameters, fasting concentrations of PYY, ghrelin, glucagon, and area under the curve (AUC) of GLP-1 after a standard meal test were determined prior to and at months 1 and 12 after surgery. RESULTS Twelve months after surgery, total weight loss percentage was higher and HbA1c lower in the mRYGB group than in the SG and GCP groups (-35.2 ± 8.1 and 5.1 ± 0.6% vs. -27.8 ± 5.4 and 6.2 ± 0.8% vs. -20.5 ± 6.8 and 6.6 ± 1.3%; p = 0.007 and p < 0.001, respectively). Moreover, GLP-1 AUC at months 1 and 12 was greater and T2D remission was higher in mRYGB (80 vs. 53.3 vs. 20%, p < 0.001). Insulin treatment (odds ratio (OR) 0.025, p = 0.018) and the increase in GLP-1 AUC from baseline to month 1 (OR 1.021, p = 0.013) were associated with T2D remission. CONCLUSIONS mRYGB achieves a superior rate of weight loss and T2D remission at month 12. Enhanced GLP-1 secretion 1 month after surgery was a determinant of glucose metabolism improvement. Registration number ( http://www.clinicaltrials.gov ): NCT14104758.