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Prehabilitation Telemedicine in Neoadjuvant Surgical Oncology Patients During the Novel COVID-19 Coronavirus Pandemic.
Sell, NM, Silver, JK, Rando, S, Draviam, AC, Mina, DS, Qadan, M
Annals of surgery. 2020;(2):e81-e83
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A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, vs 4L Polyethylene Glycol-Electrolyte Solution.
Bachwich, DR, Lewis, JD, Kowal, VO, Jacobson, BC, Calderwood, AH, Kochman, ML
Clinical and translational gastroenterology. 2020;(12):e00264
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INTRODUCTION DCL-101, a novel Pill Prep, is compositionally identical to standard 4L polyethylene glycol-electrolyte solution (PEG-ELS) and delivers the salt encapsulated, with PEG 3350 coadministered as a taste-free oral solution. The aim of this study was to compare the safety, taste, and tolerability of DCL-101 with 4L PEG-ELS in outpatients preparing for colonoscopy, with a secondary objective to assess efficacy. METHODS This was a multicenter, randomized, investigator-blinded, phase 2 clinical trial of 45 adult patients undergoing outpatient colonoscopy. Patients were randomized 2:1 to either DCL-101 (3L in cohort 1; 4L in cohort 2) or 4L PEG-ELS, each administered with split dosing. Safety was assessed over 3 post-treatment clinic visits. Tolerability was measured using the Lawrance Bowel-Preparation Tolerability Questionnaire and the Mayo Clinic Bowel Prep Tolerability Questionnaire. Efficacy was determined by expert central readers, blinded to treatment, using the Ottawa Bowel Preparation Quality Scale, Boston Bowel Preparation Scale, and Aronchick scale. RESULTS Both DCL-101 doses had superior taste and tolerability relative to 4L PEG-ELS. All adverse events were grade 1 with no significant differences in adverse events among the 3 regimens. There were no significant differences in efficacy among the 3 treatments as defined by the centrally read Ottawa Bowel Preparation Quality Scale, Boston Bowel Preparation Scale, or Aronchick scores. There were no inadequate preps as judged by the site endoscopist. DISCUSSION DCL-101 Pill Prep is a novel strategy that vastly improves the taste and tolerability of PEG-ELS solutions with safety and efficacy comparable with split-dose 4L PEG-ELS solutions.
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Improving growth of infants with congenital heart disease using a consensus-based nutritional pathway.
Marino, LV, Johnson, MJ, Davies, NJ, Kidd, CS, Fienberg, J, Richens, T, Bharucha, T, Beattie, RM, Darlington, AE
Clinical nutrition (Edinburgh, Scotland). 2020;(8):2455-2462
Abstract
OBJECTIVE Infants with congenital heart disease (CHD) often experience growth failure prior to surgery, which is associated with increased paediatric-intensive-care unit length of stay (PICU-LOS) and post-operative complications. This study assessed the impact of a pre-operative, consensus-based nutritional pathway (including support from a multi-disciplinary team) on growth and clinical outcome. DESIGN Single-centre prospective pilot study. SETTING Tertiary paediatric cardiology surgical centre. PATIENTS Infants with CHD. INTERVENTION Infants with CHD were followed for up to 4-months-of-age before cardiac surgery and then to 12-months-of-age following the implementation of the consensus-based nutritional-pathway (Intervention group: November 2017-August 2018), with outcomes compared to a historic control group. The nutrition pathway involved a dietitian contacting parents of infants with the highest risk of growth failure weekly; reviewing weight gain and providing feeding support. MAIN OUTCOME MEASURE Growth (weight-for-age, WAZ, and height-for-age-z-score, HAZ) at 4 and 12 months-of-age. RESULTS 44 infants in the intervention group were compared to 38 in the control group. Median (inter quartile range) change in WAZ from birth to 4 months-of-age (-0.9 (-1.5, 0.7)) and from birth to 12 months-of-age (-0.09 (-1.3, 1.1)) in the intervention group compared to the control group (-1.5 (-2.0, -0.4) (p = 0.04)) at 4 months-of age and at 12 months-of-age (-0.4 (1.9, 0.2) (p = 0.03)). HAZ at 4 months-of-age was -0.7 (-1.4, -0.1) vs. -1.0 (-1.9, -0.3) (p = 0.6) in the intervention and control groups respectively, and at 12 months-of-age HAZ was -0.7 (-1.9, -0.07) in the intervention group vs.-1.6 (-2.6, -0.4) in the control group (p = 0.04). Duration of PICU-LOS was 8.2 ± 11.6 days intervention vs. 18.3 ± 24.0 days control (p = 0.006). CONCLUSION Overall weight was well maintained and growth improved in infants who followed the pre-operative nutritional-pathway. The duration of PICU-LOS was significantly lower in the intervention group, which may be due to improved nutritional status, although this requires further investigation.
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Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study.
Åhsberg, K, Gardfjell, A, Nimeus, E, Rasmussen, R, Behmer, C, Zackrisson, S, Ryden, L
World journal of surgical oncology. 2020;(1):100
Abstract
OBJECTIVES The aim of this feasibility study was to evaluate the added value of contrast-enhanced mammography (CEM) in preoperative staging of malignant breast lesions, beyond standard assessment with digital mammography and ultrasound, as a base for a future prospective randomized trial. MATERIALS AND METHODS Forty-seven patients, with confirmed or strongly suspected malignant breast lesions after standard assessment (digital mammography (DM) and ultrasound (US)), scheduled for primary surgery, were invited to undergo CEM as an additional preoperative procedure. The primary endpoint was change in treatment due to CEM findings, defined as mastectomy instead of partial mastectomy or contrariwise, bilateral surgery instead of unilateral or neoadjuvant treatment instead of primary surgery. Accuracy in tumour extent estimation compared to histopathology was evaluated by Bland-Altman statistics. Number of extra biopsies and adverse events were recorded. RESULTS In 10/47 patients (21%), findings from CEM affected the primary treatment. Agreement with histopathology regarding extent estimation was better for CEM (mean difference - 1.36, SD ± 18.45) in comparison with DM (- 4.18, SD ± 26.20) and US (- 8.36, SD ± 24.30). Additional biopsies were taken from 19 lesions in 13 patients. Nine biopsies showed malignant outcome. No major adverse events occurred. CONCLUSION The feasibility of preoperative additional CEM was found to be satisfactory without any serious negative effects. Results imply an added value of CEM in preoperative staging of breast cancer. Further evaluation in larger prospective randomized trials is needed. TRIAL REGISTRATION ClinicalTrials.gov, NCT03402529. Registered 18 January 2018-retrospectively registered.
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A multicomponent prehabilitation pathway to reduce the incidence of delirium in elderly patients in need of major abdominal surgery: study protocol for a before-and-after study.
Janssen, TL, Mosk, CA, van Hoof-de Lepper, CCHA, Wielders, D, Seerden, TCJ, Steyerberg, EW, van Gammeren, AJ, de Lange, DC, van Alphen, R, van der Zee, M, et al
BMC geriatrics. 2019;(1):87
Abstract
BACKGROUND Due to the increase in elderly patients who undergo major abdominal surgery there is a subsequent increase in postoperative complications, prolonged hospital stays, health-care costs and mortality rates. Delirium is a frequent and severe complication in the 'frail' elderly patient. Different preoperative approaches have been suggested to decrease incidence of delirium by improving patients' baseline health. Studies implementing these approaches are often heterogeneous, have a small sample and do not provide high-quality or successful strategies. The aim of this study is to prevent postoperative delirium and other complications by implementing a unique multicomponent and multidisciplinary prehabilitation program. METHODS This is a single-center controlled before-and-after study. Patients aged ≥70 years in need of surgery for colorectal cancer or an abdominal aortic aneurysm are considered eligible. Baseline characteristics (such as factors of frailty, physical condition and nutritional state) are collected prospectively. During 5 weeks prior to surgery, patients will follow a prehabilitation program to optimize overall health, which includes home-based exercises, dietary advice and intravenous iron infusion in case of anaemia. In case of frailty, a geriatrician will perform a comprehensive geriatric assessment and provide additional preoperative interventions when deemed necessary. The primary outcome is incidence of delirium. Secondary outcomes are length of hospital stay, complication rate, institutionalization, 30-day, 6- and 12-month mortality, mental health and quality of life. Results will be compared to a retrospective control group, meeting the same inclusion and exclusion criteria, operated on between January 2013 and October 2015. Inclusion of the prehabilitation cohort started in November 2015; data collection is ongoing. DISCUSSION This is the first study to investigate the effect of prehabilitation on postoperative delirium. The aim is to provide evidence, based on a large sample size, for a standardized multicomponent strategy to improve patients' preoperative physical and nutritional status in order to prevent postoperative delirium and other complications. A multimodal intervention was implemented, combining physical, nutritional, mental and hematinic optimization. This research involves a large cohort, including patients most at risk for postoperative adverse outcomes. TRIAL REGISTRATION The protocol is retrospectively registered at the Netherlands National Trial Register (NTR) number: NTR5932 . Date of registration: 05-04-2016.
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Clinical Effectiveness of Intravenous Exenatide Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial.
Besch, G, Perrotti, A, Mauny, F, Puyraveau, M, Baltres, M, Flicoteaux, G, Salomon du Mont, L, Barrucand, B, Samain, E, Chocron, S, et al
Anesthesiology. 2017;(5):775-787
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BACKGROUND We aimed to assess the clinical effectiveness of intravenous exenatide compared to insulin in perioperative blood glucose control in coronary artery bypass grafting surgery patients. METHODS Patients more than 18 yr old admitted for elective coronary artery bypass grafting were included in a phase II/III nonblinded randomized superiority trial. Current insulin use and creatinine clearance of less than 60 ml/min were exclusion criteria. Two groups were compared: the exenatide group, receiving exenatide (1-h bolus of 0.05 µg/min followed by a constant infusion of 0.025 µg/min), and the control group, receiving insulin therapy. The blood glucose target range was 100 to 139 mg/dl. The primary outcome was the proportion of patients who spent at least 50% of the study period within the target range. The consumption of insulin (Cinsulin) and the time to start insulin (Tinsulin) were compared between the two groups. RESULTS In total, 53 and 51 patients were included and analyzed in the exenatide and control groups, respectively (age: 70 ± 9 vs. 68 ± 11 yr; diabetes mellitus: 12 [23%] vs. 10 [20%]). The primary outcome was observed in 38 (72%) patients in the exenatide group and in 41 (80%) patients in the control group (odds ratio [95% CI] = 0.85 [0.34 to 2.11]; P = 0.30). Cinsulin was significantly lower (60 [40 to 80] vs. 92 [63 to 121] U, P < 0.001), and Tinsulin was significantly longer (12 [7 to 16] vs. 7 [5 to 10] h, P = 0.02) in the exenatide group. CONCLUSIONS Exenatide alone at the dose used was not enough to achieve adequate blood glucose control in coronary artery bypass grafting patients, but it reduces overall consumption of insulin and increases the time to initiation of insulin.
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Serum concentrations of antibiotics during severe invasive surgery such as esophagectomy for esophageal cancer.
Owaki, T, Okumura, H, Uchikado, Y, Sasaki, K, Matsumoto, M, Omoto, I, Setoyama, T, Kita, Y, Sakurai, T, Matsushita, D, et al
International surgery. 2013;(1):1-5
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This study was performed to confirm the antibiotic regimen during a severe invasive surgery, such as esophagectomy, with a long procedure and a large amount of normal volumes of infusion. Ten patients with esophageal cancer were enrolled in this study, and cefmetazole sodium concentrations in serum were measured during esophagectomy. The ranges of minimum inhibitory concentrations for 90% of isolates of cefmetazole sodium for microorganisms in our institutions for 8 years were investigated. The maximum concentration was 83.9 μg/mL just after the completion of infusion, and its half-life was 1.5 hours. Serum concentration of cefmetazole sodium was kept above 16 μg/mL for 4 hours during esophagectomy. It was kept above 32 μg/mL for 2.5 hours after injection. There are almost no differences in the pharmacokinetics of cefmetazole sodium between common use and during esophagectomy. In addition, additive infusion of antibiotics 4 hours after the first infusion was recommended during esophagectomy.
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Pre-operative atorvastatin therapy to decrease the systemic inflammatory response after coronary artery bypass grafting.
Dereli, Y, Ege, E, Kurban, S, Narin, C, Sarigül, A, Yeniterzi, M
The Journal of international medical research. 2008;(6):1248-54
Abstract
The effect of pre-operative atorvastatin on systemic inflammatory response syndrome (SIRS), often seen after coronary artery bypass grafting (CABG) was evaluated in 40 patients undergoing elective CABG. Patients were divided into two groups: group I (pre-operative LDL cholesterol > or = 100 mg/dl; n = 20) received 20 mg/day atorvastatin for at least 15 days pre-operatively; group II (pre-operative LDL cholesterol < 100 mg/dl; n = 20) did not receive antihyperlipidaemic agents. All patients underwent CABG with cardiopulmonary bypass. Blood samples were taken pre-operatively and 24 h post-operatively. There were no significant differences between the two groups in terms of demographic, pre-operative or operative parameters. At 24 h post-operatively, median high-sensitivity C-reactive protein and mean interleukin-6 levels were significantly lower in group I compared with group II. There were no other significant differences in post-operative parameters between the two groups, except for duration of stay in the intensive care unit, which was shorter in group I patients. In conclusion, pre-operative atorvastatin treatment in patients undergoing elective CABG decreased inflammation parameters and could be effective in preventing SIRS.
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Coenzyme Q10 therapy before cardiac surgery improves mitochondrial function and in vitro contractility of myocardial tissue.
Rosenfeldt, F, Marasco, S, Lyon, W, Wowk, M, Sheeran, F, Bailey, M, Esmore, D, Davis, B, Pick, A, Rabinov, M, et al
The Journal of thoracic and cardiovascular surgery. 2005;(1):25-32
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OBJECTIVES Previous clinical trials suggest that coenzyme Q(10) might afford myocardial protection during cardiac surgery. We sought to measure the effect of coenzyme Q(10) therapy on coenzyme Q(10) levels in serum, atrial trabeculae, and mitochondria; to assess the effect of coenzyme Q(10) on mitochondrial function; to test the effect of coenzyme Q(10) in protecting cardiac myocardium against a standard hypoxia-reoxygentation stress in vitro; and to determine whether coenzyme Q(10) therapy improves recovery of the heart after cardiac surgery. METHODS Patients undergoing elective cardiac surgery were randomized to receive oral coenzyme Q(10) (300 mg/d) or placebo for 2 weeks preoperatively. Pectinate trabeculae from right atrial appendages were excised, and mitochondria were isolated and studied. Trabeculae were subjected to 30 minutes of hypoxia, and contractile recovery was measured. Postoperative cardiac function and troponin I release were assessed. RESULTS Patients receiving coenzyme Q(10) (n = 62) had increased coenzyme Q(10) levels in serum (P = .001), atrial trabeculae (P = .0001), and isolated mitochondria (P = .0002) compared with levels seen in patients receiving placebo (n = 59). Mitochondrial respiration (adenosine diphosphate/oxygen ratio) was more efficient (P = .012), and mitochondrial malondialdehyde content was lower (P = .002) with coenzyme Q(10) than with placebo. After 30 minutes of hypoxia in vitro, pectinate trabeculae isolated from patients receiving coenzyme Q(10) exhibited a greater recovery of developed force compared with those in patients receiving placebo (46.3% +/- 4.3% vs 64.0% +/- 2.9%, P = .001). There was no between-treatment difference in preoperative or postoperative hemodynamics or in release of troponin I. CONCLUSIONS Preoperative oral coenzyme Q(10) therapy in patients undergoing cardiac surgery increases myocardial and cardiac mitochondrial coenzyme Q(10) levels, improves mitochondrial efficiency, and increases myocardial tolerance to in vitro hypoxia-reoxygenation stress.
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Randomised clinical trial of synbiotic therapy in elective surgical patients.
Anderson, AD, McNaught, CE, Jain, PK, MacFie, J
Gut. 2004;(2):241-5
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BACKGROUND It is possible to manipulate the composition of the gastrointestinal microflora by administration of pre- and probiotics. This may help to preserve gut barrier function and reduce the incidence of septic morbidity. AIMS To assess the effects of a combination of pre- and probiotics (synbiotic) on bacterial translocation, gastric colonisation, systemic inflammation, and septic morbidity in elective surgical patients. PATIENTS Patients were enrolled two weeks prior to elective abdominal surgery. Seventy two patients were randomised to the synbiotic group and 65 to the placebo group. Patients were well matched regarding age and sex distribution, diagnoses, and POSSUM scores. METHODS Patients in the synbiotic group received a two week preoperative course of Lactobacillus acidophilus La5, Bifidobacterium lactis Bb-12, Streptococcus thermophilus, and Lactobacillus bulgaricus, together with the prebiotic oligofructose. Patients in the placebo group received placebo capsules and sucrose powder. At surgery, a nasogastric aspirate, mesenteric lymph node, and scrapings of the terminal ileum were harvested for microbiological analysis. Serum was collected preoperatively and on postoperative days 1 and 7 for measurement of C reactive protein, interleukin 6, and antiendotoxin antibodies. Septic morbidity and mortality were recorded. RESULTS There were no significant differences between the synbiotic and control groups in bacterial translocation (12.1% v 10.7%; p = 0.808, chi(2)), gastric colonisation (41% v 44%; p = 0.719), systemic inflammation, or septic complications (32% v 31%; p = 0.882). CONCLUSIONS In this study, synbiotics had no measurable effect on gut barrier function in elective surgical patients. Further studies investigating the place of pre- and probiotics in clinical practice are required.