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Hyperoxia and Antioxidants for Myocardial Injury in Noncardiac Surgery: A 2 × 2 Factorial, Blinded, Randomized Clinical Trial.
Holse, C, Aasvang, EK, Vester-Andersen, M, Rasmussen, LS, Wetterslev, J, Christensen, R, Jorgensen, LN, Pedersen, SS, Loft, FC, Troensegaard, H, et al
Anesthesiology. 2022;(3):408-419
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Abstract
BACKGROUND Hyperoxia and oxidative stress may be associated with increased risk of myocardial injury. The authors hypothesized that a perioperative inspiratory oxygen fraction of 0.80 versus 0.30 would increase the degree of myocardial injury within the first 3 days of surgery, and that an antioxidant intervention would reduce degree of myocardial injury versus placebo. METHODS A 2 × 2 factorial, randomized, blinded, multicenter trial enrolled patients older than 45 yr who had cardiovascular risk factors undergoing major noncardiac surgery. Factorial randomization allocated patients to one of two oxygen interventions from intubation and at 2 h after surgery, as well as antioxidant intervention or matching placebo. Antioxidants were 3 g IV vitamin C and 100 mg/kg N-acetylcysteine. The primary outcome was the degree of myocardial injury assessed by the area under the curve for high-sensitive troponin within the first 3 postoperative days. RESULTS The authors randomized 600 participants from April 2018 to January 2020 and analyzed 576 patients for the primary outcome. Baseline and intraoperative characteristics did not differ between groups. The primary outcome was 35 ng · day/l (19 to 58) in the 80% oxygen group; 35 ng · day/l (17 to 56) in the 30% oxygen group; 35 ng · day/l (19 to 54) in the antioxidants group; and 33 ng · day/l (18 to 57) in the placebo group. The median difference between oxygen groups was 1.5 ng · day/l (95% CI, -2.5 to 5.3; P = 0.202) and -0.5 ng · day/l (95% CI, -4.5 to 3.0; P = 0.228) between antioxidant groups. Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79 [95% CI, 0.214 to 2.99]; P = 0.732 for the antioxidants vs. placebo groups). CONCLUSIONS Perioperative interventions with high inspiratory oxygen fraction and antioxidants did not change the degree of myocardial injury within the first 3 days of surgery. This implies safety with 80% oxygen and no cardiovascular benefits of vitamin C and N-acetylcysteine in major noncardiac surgery.
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Perioperative lipid-enriched enteral nutrition versus standard care in patients undergoing elective colorectal surgery (SANICS II): a multicentre, double-blind, randomised controlled trial.
Peters, EG, Smeets, BJJ, Nors, J, Back, CM, Funder, JA, Sommer, T, Laurberg, S, Løve, US, Leclercq, WKG, Slooter, GD, et al
The lancet. Gastroenterology & hepatology. 2018;(4):242-251
Abstract
BACKGROUND Postoperative ileus and anastomotic leakage severely impair recovery after colorectal resection. We investigated the effect of perioperative lipid-enriched enteral nutrition versus standard care on the risk of postoperative ileus, anastomotic leakage, and other clinical outcomes. METHODS We did an international, multicentre, double-blind, randomised, controlled trial of patients (≥18 years) undergoing elective colorectal surgery with primary anastomosis at six clinical centres in the Netherlands and Denmark. Patients were randomly assigned (1:1), stratified by location (colonic and rectal) and type of surgery (laparoscopic and open), via online randomisation software, with block sizes of six, to receive either continuous lipid-enriched enteral tube feeding from 3 h before until 6 h after surgery (intervention) or no perioperative nutrition (control). Surgeons, patients, and researchers were masked to treatment allocation for the entire study period. The primary outcome was postoperative ileus. Secondary outcomes included anastomotic leakage, pneumonia, preoperative gastric volumes, time to functional recovery, length of hospital stay, the need for additional interventions, intensive care unit admission, postoperative inflammatory response, and surgical complications. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02175979, and trialregister.nl, number NTR4670. FINDINGS Between July 28, 2014, and February 20, 2017, 280 patients were randomly assigned, 15 of whom were excluded after random allocation because they fulfilled one or more exclusion criteria. 265 patients received perioperative nutrition (n=132) or standard care (n=133) and were included in the analyses. A postoperative ileus occurred in 37 (28%) patients in the intervention group versus 29 (22%) in the control group (risk ratio [RR] 1·09, 95% CI 0·95-1·25; p=0·24). Anastomotic leakage occurred in 12 (9%) patients in the intervention group versus 11 (8%) in the control group (RR 1·01, 95% CI 0·94-1·09; p=0·81). Pneumonia occurred in ten (8%) patients in the intervention group versus three (2%) in the control group (RR 1·06, 95% CI 1·00-1·12; p=0·051). All other secondary outcomes were similar between groups (all p>0·05). INTERPRETATION Perioperative lipid-enriched enteral nutrition in patients undergoing elective colorectal surgery has no advantage over standard care in terms of postoperative complications. FUNDING Netherlands Organisation for Health Research and Development (ZonMW), Fonds NutsOhra, and Danone Research.
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Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer.
Mudge, LA, Watson, DI, Smithers, BM, Isenring, EA, Smith, L, Jamieson, GG, ,
The British journal of surgery. 2018;(10):1262-1272
Abstract
BACKGROUND Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. METHODS Patients were randomized before oesophagectomy to immunonutrition (IMPACT® ) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. RESULTS Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. CONCLUSION Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 ( https://www.anzctr.org.au).
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Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients.
Choi, JH, Kim, HJ, Lee, BU, Kim, TH, Song, IH
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2017;(1):86-92.e1
Abstract
BACKGROUND & AIMS Vigorous intravenous fluid resuscitation (IVFR) was reported to reduce post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in a pilot study. We performed a randomized, double-blind controlled trial to establish whether periprocedural vigorous IVFR reduces the risk of post-ERCP pancreatitis. METHODS A total of 510 patients with native papilla at 3 tertiary referral centers in Korea were randomly assigned (1:1) to groups given vigorous IVFR (lactated Ringer's solution in an initial bolus of 10 mL/kg before the procedure, 3 mL/kg/h during the procedure, for 8 hours after the procedure, and a post-procedure bolus of 10 mL/kg) or a standard IVFR (lactated Ringer's solution at 1.5 mL/kg/h during and for 8 hours after the procedure). The primary end point of the study was the development of post-ERCP pancreatitis, and the secondary end point was severity of pancreatitis, hyperamylasemia, and fluid overload. RESULTS The main indications for ERCP were choledocholithiasis (58%) and malignant biliary stricture (27%). Post-ERCP pancreatitis developed in 11 patients in the vigorous IVFR group (4.3%) and 25 patients in the standard IVFR group (9.8%) (relative risk, 0.41; 95% CI, 0.20-0.86; P = .016). Moderate or severe acute pancreatitis occurred in a significantly smaller proportion of patients in the vigorous IVFR group (0.4%) than in the standard IVFR group (2.0%; P = .040). One patient in the vigorous IVFR group developed peripheral edema. CONCLUSIONS In a double-blind, randomized controlled trial, we found vigorous periprocedural intravenous hydration with lactated Ringer's solution to reduce the incidence and severity of post-ERCP pancreatitis in average-risk and high-risk cases. IVFR is not associated with increased adverse events. ClinicalTrials.gov number: NCT02308891.
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Perioperative Enteral Immunonutrition Modulates Systemic and Mucosal Immunity and the Inflammatory Response in Patients With Periampullary Cancer Scheduled for Pancreaticoduodenectomy: A Randomized Clinical Trial.
Hamza, N, Darwish, A, O'Reilly, DA, Denton, J, Sheen, AJ, Chang, D, Sherlock, DJ, Ammori, BJ
Pancreas. 2015;(1):41-52
Abstract
OBJECTIVES Nutritional deficiencies and immune dysfunction in cancer patients may contribute to postoperative septic morbidity. This trial compared the effects of perioperative enteral immunonutrition (EIN) versus standard enteral nutrition (SEN) on systemic and mucosal immunity in patients undergoing pancreaticoduodenectomy for periampullary cancer. METHODS Thirty-seven patients were randomized (EIN, n = 17; SEN, n = 20) to receive feed for 14 days preoperatively and 7 days postoperatively. Mediators of systemic immunity (interleukin 1α, tumor necrosis factor α, lymphocytes subsets, and complement components) and of mucosal immunity in duodenal biopsies, nutritional markers and parameters were evaluated. RESULTS The groups were comparable for demographics, the concentrations of mediators of systemic and mucosal immunity at time of recruitment, and for the duration and amount of feed received. Preoperative EIN rather than SEN was associated with significant reductions in plasma tumor necrosis factor α and total hemolytic complement. Enteral immunonutrition-fed patients had significantly higher total lymphocyte count on the third postoperative day and significantly greater rise in CD4/CD8 ratio from day 3 to day 7 postoperatively compared with SEN-fed patients. CONCLUSIONS The perioperative administration of EIN rather than SEN is associated with a favorable modulation of the inflammatory response and enhancement of systemic immunity in patients undergoing pancreaticoduodenectomy for periampullary cancer.
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Positive regulatory effects of perioperative probiotic treatment on postoperative liver complications after colorectal liver metastases surgery: a double-center and double-blind randomized clinical trial.
Liu, Z, Li, C, Huang, M, Tong, C, Zhang, X, Wang, L, Peng, H, Lan, P, Zhang, P, Huang, N, et al
BMC gastroenterology. 2015;:34
Abstract
BACKGROUND Colorectal liver metastases (CLM) occur frequently and postoperative intestinal infection is a common complication. Our previous study showed that probiotics could decrease the rate of infectious complications after colectomy for colorectal cancer. To determine the effects of the perioperative administration of probiotics on serum zonulin levels which is a marker of intestinal permeability and the subsequent impact on postoperative infectious complications in patients with CLM. METHODS 150 patients with CLM were randomly divided into control group (n = 68) and probiotics group (n = 66). Probiotics and placebo were given orally for 6 days preoperatively and 10 days postoperatively to control group and probiotics group respectively. We used the local resection for metastatic tumor ,while for large tumor, the segmental hepatectomy. Postoperative outcome were recorded. Furthermore, complications in patients with normal intestinal barrier function and the relation with serum zonulin were analyzed to evaluate the impact on the liver barrier dysfunction. RESULTS The incidence of infectious complications in the probiotics group was lower than control group. Analysis of CLM patients with normal postoperative intestinal barrier function paralleled with the serum zonulin level. And probiotics could also reduce the concentration of serum zonulin (P = 0.004) and plasma endotoxin (P < 0.001). CONCLUSION Perioperative probiotics treatment could reduce the serum zonulin level, the rate of postoperative septicemia and maintain the liver barrier in patients undergoing CLM surgery. we propose a new model about the regulation of probiotics to liver barrier via clinical regulatory pathway. We recommend the preoperative oral intake of probiotics combined with postoperative continued probiotics treatment in patients who undergo CLM surgery. TRIAL REGISTRATION ChiCTR-TRC- 12002841 . 2012/12/21.
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Reduced infections with perioperative immunonutrition in head and neck cancer: exploratory results of a multicenter, prospective, randomized, double-blind study.
Falewee, MN, Schilf, A, Boufflers, E, Cartier, C, Bachmann, P, Pressoir, M, Banal, A, Michel, C, Ettaiche, M
Clinical nutrition (Edinburgh, Scotland). 2014;(5):776-84
Abstract
BACKGROUND & AIMS Head and neck cancer surgery is affected by complications in 20-60% of cases, with risk factors being malnutrition, alcoholism and immunosuppression due to cancer. The aim of the study was to investigate whether preoperative or perioperative immunonutrition could reduce postoperative infectious complications (IC) and surgical-site infections (SSI) in this population. METHODS This was a multicenter, prospective, randomized, double-blind study. Patients with oropharyngeal and pharyngolaryngeal tumour were randomly allocated to three groups: a) perioperative formula of Impact(®) without immune nutrients, named "reference diet" (group A, control); b) preoperative Impact(®) and "reference diet" postoperatively (group B); c) Impact(®) perioperatively (group C). Products were available in oral and enteral formula and were given 7 days before surgery and for 7-15 days postoperatively. The primary and secondary endpoints were the incidence of IC and SSI, respectively. RESULTS Of 312 randomized patients, 205 were evaluable for ITT analysis. There was no significant difference in IC and SSI. However out of this population, only 64 patients had taken at least 75% of the theoretical intake from surgery to day 10 (per-protocol population). In this condition, a significant difference in IC (OR = 0.24, p = 0.05), SSI (OR = 0.17, p = 0.04) and also in the median length of postoperative stay (18 vs. 25 days, p = 0.05) was demonstrated between groups A and C. CONCLUSIONS In the ITT population, no significant difference in IC, SSI and LOS was demonstrated. Positive exploratory results on the perioperative Impact(®) per-protocol population, encourage further study in head and neck cancer patients. Registered under ClinicalTrials.gov Identifier no. NCT00765440.
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Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis.
Spinelli, A, Bazzi, P, Sacchi, M, Danese, S, Fiorino, G, Malesci, A, Gentilini, L, Poggioli, G, Montorsi, M
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract. 2013;(1):126-32; discussion p.132
Abstract
BACKGROUND Laparoscopy combined with an enhanced recovery pathway (ERP) is widely considered to be the first-choice option for patients with colorectal cancer. However, no previous reports have focused on patients with Crohn's disease (CD) treated by laparoscopy and ERP. METHODS Twenty patients with CD underwent laparoscopic ileocecal resection with an ERP at two institutions. The ERP protocol included no bowel preparation nor fasting, no nasogastric tube, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization, opioid-sparing analgesia and restrictive fluid management. This group was compared with a matched historical control group of 70 CD patients who underwent laparoscopic ileocecal resection treated with conventional care. RESULTS Compliance with the ERP was high (≥80 %) for all items except no drain placement. A significantly earlier return of bowel function (time to first flatus and stool) was observed in the ERP group. Mean postoperative and total length of stay were significantly shorter in the ERP group. Postoperative complications were similar in both groups. CONCLUSIONS This is the first reported experience of laparoscopy with ERP in CD patients and suggests that optimized perioperative care combined with minimally invasive techniques may lead to further improvements in surgical outcomes for CD patients.
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The effects of perioperative probiotic treatment on serum zonulin concentration and subsequent postoperative infectious complications after colorectal cancer surgery: a double-center and double-blind randomized clinical trial.
Liu, ZH, Huang, MJ, Zhang, XW, Wang, L, Huang, NQ, Peng, H, Lan, P, Peng, JS, Yang, Z, Xia, Y, et al
The American journal of clinical nutrition. 2013;(1):117-26
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BACKGROUND Zonulin is a newly discovered protein that has an important role in the regulation of intestinal permeability. Our previous study showed that probiotics can decrease the rate of infectious complications in patients undergoing colectomy for colorectal cancer. OBJECTIVE The objective was to determine the effects of the perioperative administration of probiotics on serum zonulin concentrations and the subsequent effect on postoperative infectious complications in patients undergoing colorectal surgery. DESIGN A total of 150 patients with colorectal carcinoma were randomly assigned to the control group (n = 75), which received placebo, or the probiotics group (n = 75). Both the probiotics and placebo were given orally for 6 d preoperatively and 10 d postoperatively. Outcomes were measured by assessing bacterial translocation, postoperative intestinal permeability, serum zonulin concentrations, duration of postoperative pyrexia, and cumulative duration of antibiotic therapy. The postoperative infection rate, the positive rate of blood microbial DNA, and the incidence of postoperative infectious complications-including septicemia, central line infection, pneumonia, urinary tract infection, and diarrhea-were also assessed. RESULTS The infection rate was lower in the probiotics group than in the control group (P < 0.05). Probiotics decreased the serum zonulin concentration (P < 0.001), duration of postoperative pyrexia, duration of antibiotic therapy, and rate of postoperative infectious complications (all P < 0.05). The p38 mitogen-activated protein kinase signaling pathway was inhibited by probiotics. CONCLUSIONS Perioperative probiotic treatment can reduce the rate of postoperative septicemia and is associated with reduced serum zonulin concentrations in patients undergoing colectomy. We propose a clinical regulatory model that might explain this association. This trial was registered at http://www.chictr.org/en/ as ChiCTR-TRC-00000423.
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A prospective randomized multicenter study of Turkish Society of Urooncology comparing two different mechanical bowel preparation methods for radical cystectomy.
Aslan, G, Baltaci, S, Akdogan, B, Kuyumcuoğlu, U, Kaplan, M, Cal, C, Adsan, O, Turkolmez, K, Ugurlu, O, Ekici, S, et al
Urologic oncology. 2013;(5):664-70
Abstract
OBJECTIVE To investigate the outcomes and complication rates of urinary diversion using mechanical bowel preparation (BP) with 3 day conventional and limited BP method through a standard perioperative care plan. MATERIALS AND METHODS This study was designed as a prospective randomized multicenter trial. All patients were randomized to 2 groups. Patients in standard 3-day BP protocol received diet restriction, oral antibiotics to bowel flora, oral laxatives, and saline enemas over a 3-day period, whereas limited the BP arm received liberal use of liquid diet, sodium phosphate laxative, and self administered enema the day before surgery. All patients received same perioperative treatment protocol. The endpoints for the assessment of outcome were anastomotic leakage, wound infection, wound dehiscence, intraperitoneal abscess, peritonitis, sepsis, ileus, reoperation, and mortality. Bowel function recovery, including time to first bowel movement, time to first oral intake, time to regular oral intake, and length of hospital stay were also assessed. RESULTS Fifty-six patients in 3-day BP and 56 in limited BP arm were evaluable for the study end points. Postoperatively, 1 patient in limited BP and 2 patients in 3-day BP arm died. There was no statistical difference in any of the variables assessed throughout the study, however, a favorable return of bowel function and time to discharge as well as lower complication rate were observed in limited BP group. CONCLUSIONS Regarding all endpoints, including septic and nonseptic complications, current clinical research offers no evidence to show any advantage of 3-day BP over limited BP.