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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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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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Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.
Adams, LB, Chang, C, Pope, J, Kim, Y, Liu, P, Yates, A
Obesity surgery. 2016;(5):990-4
Abstract
BACKGROUND Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. METHODS Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. RESULTS Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. CONCLUSIONS The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.