Efficacy of perioperative immunonutrition in visceral surgery: an umbrella review protocol.
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ABSTRACT: Introduction
Immunonutrition (IN) is generally used before major visceral surgery with the intent to reduce postoperative complications, especially infectious ones. However, the conclusions of published meta-analyses are conflicting. The purpose of this review is to synthesise the data of published systematic reviews on the effectiveness of IN.Methods and analysis
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols guidelines. This is an umbrella review of systematic reviews comparing IN (delivered orally 5-7 days preoperatively) with normal diet or isocaloric isonitrogenous feeding before visceral surgery performed on any of several viscera (colorectum, stomach, pancreas, liver, oesophagus). We search the systematic reviews included in the main bibliographic databases. To assess the efficacy of IN, several outcomes will be considered: the main outcome is infectious complications (surgical site infections, pulmonary infections or urinary infections) and secondary outcomes are overall morbidity, hospital length of stay and mortality. Identified reviews will be screened by two independent assessors. The methodological quality of relevant included reviews will be assessed using A MeaSurement Tool to Assess systematic Reviews (AMSTAR) instrument. The data extracted from included reviews will be synthesised using the r-Metafor package considering separate groups according to the viscus of interest. Publication bias will be evaluated, and subgroup analyses will be performed according to the quality of studies and preoperative nutritional status.Ethics and dissemination
An umbrella review based on published data from systematic reviews needs no ethical approval. Furthermore, no patient will be involved in the review. Once terminated, the review will be submitted for publication in an open access journal to ensure wide dissemination of the findings.Prospero registration number
CRD42021255177.
SUBMITTER: Slim K
PROVIDER: S-EPMC8438883 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION:Aliskiren is a newly developed medicine. As one of the effective renin-angiotensin-aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy. METHODS AND ANALYSIS:A comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger's test to evaluate if the reporting bias existed. ETHICS AND DISSEMINATION:Ethical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion. PROSPERO REGISTRATION NUMBER:CRD42019142141.
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Project description:BackgroundInfectious complications occur in 4-22 per cent of patients undergoing surgical resection of malignant solid tumours. Improving the patient's immune system in relation to oncological surgery with immunonutrition may play an important role in reducing postoperative infections. A meta-analysis was undertaken to evaluate the potential clinical benefits of immunonutrition on postoperative infections and 30-day mortality in patients undergoing oncological surgery.MethodsPubMed, Embase and Cochrane Library databases were searched to identify eligible studies. Eligible studies had to include patients undergoing elective curative surgery for a solid malignant tumour and receiving immunonutrition orally before surgery, including patients who continued immunonutrition into the postoperative period. The main outcome was overall infectious complications; secondary outcomes were surgical-site infection (SSI) and 30-day mortality, described by relative risk (RR) with trial sequential analysis (TSA). Risk of bias was assessed according to Cochrane methodology.ResultsSome 22 RCTs with 2159 participants were eligible for meta-analysis. Compared with the control group, immunonutrition reduced overall infectious complications (RR 0·58, 95 per cent c.i. 0·48 to 0·70; I2 = 7 per cent; TSA-adjusted 95 per cent c.i. 0·28 to 1·21) and SSI (RR 0·65, 95 per cent c.i. 0·50 to 0·85; I2 = 0 per cent; TSA-adjusted 95 per cent c.i. 0·21 to 2·04). Thirty-day mortality was not altered by immunonutrition (RR 0·69, 0·33 to 1·40; I2 = 0 per cent).ConclusionImmunonutrition reduced overall infectious complications, even after controlling for random error, and also reduced SSI. The quality of evidence was moderate, and mortality was not affected by immunonutrition (low quality). Oral immunonutrition merits consideration as a means of reducing overall infectious complications after cancer surgery.
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Project description:Enhanced recovery after surgery (ERAS) programs are aimed at minimizing postoperative stress and accelerating postoperative recovery by implementing multiple perioperative principles. "Early mobilization" is one such principle, but the quality of assessment and monitoring is poor, and evidence of improved outcome is lacking. Activity trackers allow precise monitoring and automatic feedback to the patients to enhance their motivation for early mobilization. The aim of the study is to monitor and increase the postoperative mobilization of patients by giving them continuous automatic feedback in the form of a step count using activity-tracking wristbands.Patients undergoing elective open and laparoscopic surgery of the colon, rectum, stomach, pancreas, and liver for any indication will be included. Further inclusion criteria are age between 18 and 75 years, American Society of Anesthesiologists Physical Status class less than IV, and a signed informed consent form. Patients will be stratified into two subgroups, laparoscopic and open surgery, and will be randomized 1:1 for automatic feedback of their step count using an activity tracker wristband. The control group will have no automatic feedback. The sample size (n = 30 patients in each of the four groups, overall n = 120) is calculated on the basis of an assumed difference in step count of 250 steps daily (intervention group versus control group). The primary study endpoint is the average step count during the first 5 postoperative days; secondary endpoints are the percentage of patients in the two groups who master the predefined mobilization (step count) targets, assessment of additional activity data obtained from the devices, assessment of preoperative mobility, length of hospital and intensive care unit stays, number of patients who receive physiotherapy, 30-day mortality, and overall 30-day morbidity.Early mobilization is a key element of ERAS. However, enhanced early mobilization is difficult to define, to assess objectively, and to implement in clinical practice. Consequently, there is a discrepancy between ERAS targets and actual practice, especially in patients undergoing major visceral surgery. This study is the first randomized controlled trial investigating the use and feasibility of activity tracking to monitor and enhance postoperative early mobilization.ClinicalTrials.gov identifier: NCT02834338 . Registered on 15 June 2016.
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Project description:INTRODUCTION:There is limited published literature exploring how the personality traits of surgeons may influence preoperative decision making, particularly in the context of visceral/abdominal surgery. Multiple validated personality scoring systems exist and have been used to describe surgeon personalities previously. The degree to which each trait is expressed by abdominal surgeons is neither currently known, nor the impact of these traits on postoperative outcomes. The protocol has been written in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist. METHODS AND ANALYSIS:The search strategy has been developed by a Health Scientist Librarian in collaboration with the review team. The search was conducted on 1st October 2019.Database subject headings and text words relating to 'abdominal/general surgeons', 'personality', 'postoperative outcomes' and 'decision making' formed the basis of our literature search strategy; the MEDLINE, EMBASE, PsycInfo and Cochrane databases will be searched. Three reviewers will independently screen and appraise articles, with a fourth reviewer utilised if disagreements arise.A systematic narrative synthesis will be performed, with information presented in text and table format. These will summarise the findings and characteristics of any included studies. Using guidance from the Centre for Reviews and Dissemination, the reviewers will describe the potential relationship and findings between studies using the narrative synthesis. Studies will only be reported if they are felt to have low or mid-levels of bias. Studies felt to display high levels of bias will be excluded. ETHICS AND DISSEMINATION:This study does not require ethical approval. The formal systematic review will be submitted for peer reviewed publication and presented at relevant conferences. The methods may inform future reviews in other surgical specialties regarding surgeon personality. PROSPERO REGISTRATION NUMBER:CRD42019151375.
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Project description:Perioperative anemia frequently occurs in patients undergoing orthopedic surgery. We aimed to evaluate the efficacy of perioperative intravenous iron therapy (IVIT) on transfusion and recovery profiles during orthopedic surgery. We searched PubMed, Embase, Cochrane, and Google Scholar for eligible clinical trials (randomized controlled trials, RCTs; case-control studies, CCSs) in comparing IVIT and no iron therapy, up to September 2018. Primary outcomes were the effects of IVIT on the proportion of patients transfused and units of red blood cells (RBCs) transfused perioperatively. Secondary outcomes were the effects of IVIT on recovery profiles, such as length of hospital stay (LOS), post-operative infection, and mortality. Subgroup analysis was performed based on iron dose (low: ≤ 300 mg, high: > 400 mg), IVIT period (pre-operative, post-operative, perioperative), and study design. We identified 12 clinical trials (4 RCTs with 616 patients and 8 CCSs with 1,253 patients). IVIT significantly reduced the proportion of patients transfused by 31% (RR, 0.69; P = 0.0002), and units of RBCs transfused by 0.34 units/person (MD, -0.34; P = 0.0007). For subgroup analysis by iron dose, low- or high-dose IVIT significantly reduced the proportion of patients transfused (RR, 0.73, P = 0.005; RR, 0.68, P = 0.008), and RBC units transfused (MD, -0.47, P < 0.0001; MD, -0.28, P = 0.04). For subgroup analysis by period, IVIT administered post-operatively significantly reduced the proportion of patients transfused (post-operative: RR, 0.60, P = 0.002; pre-operative: RR, 0.74, P = 0.06) and RBC units transfused (post-operative: MD, -0.44, P <0.00001; pre-operative: MD, -0.29, P = 0.06). For subgroup analysis by study design, IVIT decreased the proportion of patients transfused and RBC units transfused in the group of CCSs, but IVIT in the group of RCTs did not. IVIT significantly shortened LOS by 1.6 days (P = 0.0006) and reduced post-operative infections by 33% (P = 0.01). IVIT did not change mortality. Perioperative IVIT during orthopedic surgery, especially post-operatively, appears to reduce the proportion of patients transfused and units of RBCs transfused, with shorter LOS and decreased infection rate, but no change in mortality rate. These were only found in CCSs and not in RCTs due to the relatively small number of RCTs with low to high risk of bias.
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Project description:INTRODUCTION:Perioperative benzodiazepines are used because of their anxiolytic, sedative and amnestic effects. Evidence has demonstrated an association of benzodiazepines with adverse neuropsychiatric effects. Nonetheless, because of their potential benefits, perioperative benzodiazepines continue to be used routinely. We seek to evaluate the body of evidence of the risks and benefits of benzodiazepine use during the perioperative period. METHODS AND ANALYSIS:We will search Cochrane CENTRAL, MEDLINE, EMBASE, PsychINFO, CINAHL and Web of Science from inception to March 2019 for randomised controlled trials (RCTs) and observational studies evaluating the administration of benzodiazepine medications as compared with all other medications (or nothing) in patients undergoing cardiac and non-cardiac surgery. We will exclude studies assessing the use of benzodiazepines for procedural sedation or day surgery. We will examine the impact of giving these medications before, during and after surgery. Outcomes of interest include the incidence of delirium, duration of delirium, postprocedure cognitive change, the incidence of intraoperative awareness, patient satisfaction/quality of life/quality of recovery, length-of-stay (LOS) in the intensive care unit (ICU), hospital LOS and in-hospital mortality.Reviewers will screen references and assess eligibility using predefined criteria independently and in duplicate. Two reviewers will independently collect data using prepiloted forms. We will present results separately for RCTs and observational studies. We will pool data using a random effect model and present results as relative risk with 95% CIs for dichotomous outcomes and mean difference with 95%?CI for continuous outcomes. We will pool adjusted ORs for observational studies. We will assess risk of bias for individual studies using the Cochrane Collaboration tool for RCTs. For observational studies, we will use tools designed by the Clinical Advances through Research and Information Translation group. Quality of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION:This systematic review involves no patient contact and no interaction with healthcare providers or systems. As such, we did not seek ethics board approval. We will disseminate the findings of our systematic review through the presentation at peer-reviewed conferences and by seeking publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42019128144.
| S-EPMC6924818 | biostudies-literature
Project description:IntroductionVision impairment and eye disease are major global health concerns and have been associated with increased morbidity and mortality, and lower quality of life. Quality of life, whether generic, vision-specific or disease-specific, is an important measure of the impact of eye health on people's daily activities, well-being and visual function, and is increasingly used to evaluate the impact of ophthalmic interventions and new devices. While many studies and reviews have examined the relationship between vision or eye health and quality of life across different contexts, there has yet to be a synthesis of the impact of vision impairment, eye disease and ophthalmic interventions on quality of life globally and across the lifespan.Methods and analysisAn umbrella review of systematic reviews will be conducted to address these two questions: (1) What is the association of vision impairment and eye disease with quality of life? (2) What is the impact of ophthalmic interventions on quality of life? A search of related literature will be performed on the 11 February 2020 in Medline Ovid, Embase.com, Cochrane Database of Systematic Reviews, Proquest Dissertations and Theses Global, and the grey literature, and repeated at the synthesis stage. Title/abstract and full-text screening, methodological quality assessment and data extraction will be conducted by reviewers working independently and in duplicate. Assessment of methodological quality and data extraction will be performed using Joanna Briggs Institute standard forms. Findings from the systematic reviews and their methodological quality will be summarised qualitatively in the text and using tables.Ethics and disseminationNo ethical approval is required. Results of this umbrella review will be published in a peer-reviewed journal and summarised in the Lancet Global Health Commission on Global Eye Health.Trial registration numberThis protocol was registered in the Open Science Framework Registries (https://osf.io/qhv9g/).
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Project description:BackgroundImmunonutrition is assumed to enhance immune system function. In surgical patients, it is supposed to reduce postoperative complications. However, results of recent clinical trials have been puzzling and have not supported this theory.AimThe aim of our study was to evaluate the value of enteral and parenteral postoperative immunonutrition.MethodsAfter initial evaluation of 969 patients, the intent-to-treat analysis included 776 patients (female 407, male 466, mean age 61.1 years) undergoing gastric or pancreatic resections between 2001 and 2009. All patients were randomly assigned after surgery to one of the following groups: standard enteral nutrition (SEN), immunomodulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), or immunomodulating parenteral nutrition (IMPN). All malnourished patients received preoperative parenteral nutrition. Number and type of postoperative complications, length of hospitalization (length of stay [LOS]), and vital organ function were assessed.ResultsNo statistically significant differences were observed in well-nourished patients, during either enteral or parenteral intervention, independent of the type of intervention (standard or immunomodulating). However, analysis of the malnourished group revealed the positive impact of enteral immunonutrition on reduction of postoperative complications (28.3 vs. 39.2 %, respectively; p = 0.043) and LOS (17.1 and 13.1 days, respectively; p < 0.05) compared with a standard enteral diet. The cross-analysis of SEN, IMEN, SPN, and IMPN was insignificant.ConclusionsThe type of postoperative nutrition was of no importance in well-nourished patients. However, in malnourished patients, enteral immunonutrition helped to improve treatment outcome. These findings suggest its use as a method of choice during the postoperative period.
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Project description:IntroductionSeveral systematic reviews and meta-analysis indicate that acupuncture and related therapies may be a valuable adjunctive technique to pharmacological interventions for pain management of postherpetic neuralgia (PHN). However, the robustness of the results of these studies has not been evaluated. The aim of this proposed umbrella review is to provide more reliable evidence of the effectiveness of acupuncture therapy for PHN based on medical references for healthcare decision makers.Methods and analysisPubMed, EMBASE, The Cochrane Library, Web of Science, Chinese BioMedical Literature Database, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure and Wan fang Database will be used to retrieve reviews. The time of publication will be limited from inception to March 2021. Two reviewers will screen all retrieved articles independently to identify their eligibility and extract the data. The quality will be assessed independently by two trained reviewers using Assessment of Multiple Systematic Reviews-2 for methodological quality, Risk of Bias in Systematic Review for level of bias, Preferred Reporting Items for Systematic Reviews and Meta-Analysis for reporting quality and Grading of Recommendations Assessment, Development and Evaluation for the quality of evidence. Any disagreements will be settled by discussion or the involvement of a third reviewer.Ethics and disseminationThe protocol of this review does not require ethical approval because the research will be based on publicly available data. The findings will be disseminated through publication in peer-reviewed international journals or presentation in academic conference.Prospero registration numberCRD42020173341.Reporting checklistPRISMA-P, 2015.
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