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1.
Complications of revision surgery in case of bleeding after thyroid surgery: A systematic review
Galluzzi F, Garavello W
European annals of otorhinolaryngology, head and neck diseases. 2023
Abstract
OBJECTIVES The aim of this review is to evaluate complications in patients undergoing surgical control of bleeding after thyroid surgery. Secondly, we have analyzed the rate of the main complications. METHODS The databases PubMed and EMBASE were searched for articles regarding complications after revision thyroid surgery for bleeding. A Systematic review methodology based on Preferred Reporting Items for Systematic Reviews and Meta-analysis was performed. RESULTS Nine studies met the inclusion criteria, six are retrospectives and three retrospectives controlled. The overall rate of bleeding after thyroid surgery was 1.38%. In these patients, the most common complication after revision surgery for bleeding is hypoparathyroidism 24.9% (95% CI: 20.7-29.5) followed by recurrent laryngeal nerve injury 8.1% (95% CI: 6.4-10.1) and wound infection 4.5% (95% CI: 2.5-7.6). Tracheostomy and other lethal complications are rarely described. CONCLUSION Although rare, complications after surgical control of bleeding in patients undergoing thyroid surgery can be serious. Therefore, in order to optimize the surgical outcomes, standardized protocol providing early detection and precise hemostasis procedure, is needed. Specific patient-informed consent for this condition should be created.
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2.
Efficacy and safety of tranexamic acid in posterior lumbar interbody fusion: a meta-analysis of randomized controlled trials
Luan H, Liu K, Peng C, Tian Q, Song X
Journal of orthopaedic surgery and research. 2023;18(1):14
Abstract
OBJECTIVE To evaluate the efficacy and safety of tranexamic acid (TXA) in hemostasis in patients undergoing posterior lumbar interbody fusion (PLIF) by meta-analysis. METHODS This study was registered on the International Prospective Register of Systematic Reviews (PROSPERO) (ID: CRD42022354812). The databases PubMed, Cochrane Library, Web of Science, and Embase were searched for randomized controlled trial (RCT) papers on the use of TXA in patients with PLIF from database establishment to August 2022. Two researchers screened the literature, extracted data, evaluated the risk of bias of the included studies, recorded the authors, sample size, type of study design, and TXA dose of each study, and extracted the intraoperative blood loss, number of blood transfusions, total blood loss, drainage volume, operation time, and incidence of deep venous thrombosis in each study. Meta-analysis was performed using RevMan 5.4 software provided by Cochrane Library. RESULTS A total of 14 RCTs with a total of 1681 patients were included in this study, including 836 patients in the TXA group and 845 patients in the control group. The intraoperative blood loss [mean difference (MD) = - 125.97, 95% confidence interval (CI) (- 138.56, - 113.37), P < 0.0001] and less total blood loss [MD = - 204.28, 95% CI (- 227.38, - 181.18), P < 0.00001] in TXA group were lower than the control group. Statistical significance was also observed in postoperative drainage volume [MD = - 115.03, 95% CI (- 123.89, - 106.17), P < 0.00001], operation time [MD = - 8.10, 95% CI (- 14.49, - 1.71), P = 0.01], and blood transfusion rate [odds ratio (OR) = 0.30, 95% CI (0.23, 0.39), P < 0.00001]. However, there was no statistical difference observed in the incidence of deep venous thrombosis [OR = 0.83, 95% CI (0.56, 1.21), P = 0.33]. CONCLUSION The application of TXA in PLIF can reduce intraoperative blood loss, total blood loss, drainage volume, the incidence of transfusion events, and operation time without increasing the risk of deep venous thrombosis.
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3.
A systematic review and meta-analysis of the effects of tranexamic acid in surgical procedure for intracranial meningioma
Wijaya JH, July J, Quintero-Consuegra M, Chadid DP
Journal of neuro-oncology. 2023
Abstract
PURPOSE During intracranial meningioma surgery, surgeons experience considerable blood loss. Tranexamic acid (TXA) is used to minimize blood loss in several neurosurgical settings. However, evidence and trials are lacking. Our objective is to establish the most recent evidence on TXA safety and efficacy in intracranial meningioma surgery. METHODOLOGY Based upon Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the authors collected fully published English literature on the administration of tranexamic acid for patients undergoing intracranial meningioma surgery using the keywords ["tranexamic acid" and "meningioma"] and its synonyms from Cochrane Central Database, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and PubMed. The primary outcome of the current study was total blood loss. The secondary outcomes include individuals requiring blood transfusion, anesthesia duration, surgical duration, and complication rate. Each included studies' quality was assessed using the JADAD scale. RESULTS For qualitative and quantitative data synthesis, we included five RCTs (n = 321) with the mean age was 47.5 ± 11.9 years for the intervention group and 47.2 ± 11.9 years for the control group. Our meta-analysis showed that the administration of TXA is associated with decreased total blood loss of standardized mean difference (SMD) of -1.40 (95% CI [-2.49, -0.31]), anesthetic time SMD -0.36 (95% CI [-0.63, -0.09]), and blood transfusion requirements RR 0.58 (95% CI [0.34, 0.99]). CONCLUSIONS The current study showed that TXA was associated with reduced intraoperative blood loss and intra- and postoperative blood transfusion. However, the studies are small. More RCT studies with a greater sample size are favorable.
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4.
Tranexamic acid use in meningioma surgery - A systematic review and meta-analysis
Clynch AL, Gillespie CS, Richardson GE, Mustafa MA, Islim AI, Keshwara SM, Bakhsh A, Kumar S, Zakaria R, Millward CP, et al
Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 2023;110:53-60
Abstract
Tranexamic Acid (TXA) has been used in medical and surgical practice to reduce haemorrhage. The aim of this review was to evaluate the effect of TXA use on intraoperative and postoperative outcomes of meningioma surgery. A systematic review and meta-analysis was conducted in accordance with the PRISMA statement and registered in PROSPERO (CRD42021292157). Six databases were searched up to November 2021 for phase 2-4 control trials or cohort studies, in the English language, examining TXA use during meningioma surgery. Studies ran outside of dedicated neurosurgical departments or centres were excluded. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Random effects meta-analysis were performed to delineate differences in operative and postoperative outcomes. Four studies (281 patients) were included. TXA use significantly reduced intraoperative blood loss (mean difference 315.7 mls [95% confidence interval [CI] -532.8, -98.5]). Factors not affected by TXA use were transfusion requirement (odds ratio = 0.52; 95% CI 0.27, 0.98), operation time (mean difference = -0.2 h; 95% CI -0.8, 0.4), postoperative seizures (Odds Ratio [OR] = 0.88; 95% CI 0.31, 2.53), hospital stay (mean difference = -1.2; 95% CI -3.4, 0.9) and disability after surgery (OR = 0.50; 95% CI 0.23, 1.06). The key limitations of this review were the small sample size, limited data for secondary outcomes and a lack of standardised method for measuring blood loss. TXA use reduces blood loss in meningioma surgery, but not transfusion requirement or postoperative complications. Larger trials are required to investigate the impact of TXA on patient-reported postoperative outcomes.
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5.
Local Application of Tranexamic Acid in Plastic Surgery Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Wang S, Yang J, Lin L
Aesthetic plastic surgery. 2023
Abstract
BACKGROUND According to recent evidence, the use of local tranexamic acid (TXA) during plastic surgery may lessen blood loss. OBJECTIVES To comprehensively assess the use of local TXA during plastic surgery through a systematic review and meta-analysis of randomized controlled trials addressing these issues. METHODS Four electronic databases, including PubMed, Web of Science, Embase and the Cochrane Library, were searched until December 12, 2022. Following meta-analyses, the mean difference (MD) or standardized mean difference (SMD) for blood loss volume (BLV), ΔHct, ΔHb and operation time were calculated when appropriate. RESULTS Eleven randomized controlled trials were included in the qualitative synthesis, while 8 studies were included in the meta-analysis. Compared with the control group, the local TXA group showed a reduction in blood loss volume of -1.05 (p < 0.00001; 95% CI, -1.72 to -0.38). However, local TXA had a limited effect on reducing ΔHct, ΔHb and operation time. A meta-analysis was not performed because of heterogeneity in other outcomes; however, except for 1 study in which no significant difference was observed on POD 1, all studies showed significantly lower rates of postoperative ecchymosis after surgery, 2 studies showed statistically significant reductions in transfusion risk or volume, and 3 studies reported significantly better surgical field quality in operations with local TXA. In the 2 included studies, the researchers concluded that local treatment does not play a role in relieving postoperative pain. CONCLUSIONS Local TXA is associated with less blood loss, less ecchymosis and better surgical field in plastic surgery patients. LEVEL OF EVIDENCE I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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6.
Hemorrhagic complications in implant surgery: a scoping review of etiology, prevention, and management
La Monaca G, Pranno N, Polimeni A, Annibali S, Di Carlo S, Pompa G, Cristalli MP
The Journal of oral implantology. 2023
Abstract
PURPOSE To provide the most relevant aspects of the etiology, prevention, and management of bleeding in routine implant surgery. MATERIALS AND METHODS A comprehensive and systematic electronic search was conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews databases until Jun 2021. Further references of interest were retrieved from bibliographic lists of the selected articles and the "Related Articles" feature of PubMed. Eligibility criteria were papers about bleeding, hemorrhage or hematoma associated with routine implant surgery on human subjects. RESULTS Twenty reviews and 41 case reports fulfilled eligibility criteria and were included in the scoping review. Involved implants were mandibular in 37 and maxillary in 4 cases. The major number of bleeding complications was in the mandibular canine region. The most injured vessels were sublingual and submental arteries, mainly due to perforation of the lingual cortical plate. Time to bleeding occurred intraoperatively, at suturing, or postoperatively. The most reported clinical manifestations were swelling and elevation of the mouth floor and the tongue with partial or complete airway obstructions. The first aid to manage airway obstruction was intubation and tracheostomy. For active bleeding control, gauze tamponade, manual or digital compression, hemostatic agents and cauterization were applied. When conservative procedures failed, hemorrhage was controlled by intra- or extraoral surgical approaches to ligate injured vessels or by angiographic embolization. CONCLUSIONS The present scoping review provides knowledge and evidence on the most relevant aspects of the etiology, prevention, and management of implant surgery bleeding complications.
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7.
Systematic mapping review of interventions to prevent blood loss, infection and relapse in orthognathic surgery
Bendersky J, Uribe M, Bravo M, Vargas JP, Villanueva J, Urrutia G, Bonfill X
Medicina oral, patologia oral y cirugia bucal. 2023
Abstract
BACKGROUND This systematic mapping review aims to identify, describe, and organize the currently available evidence in systematic reviews (SR) and primary studies regarding orthognathic surgery (OS) co-interventions and surgical modalities, focusing on the outcomes blood loss, infection and relapse. MATERIAL AND METHODS A comprehensive search strategy was performed to identify all SRs, randomized controlled trials and observational studies that evaluate surgical modalities and perioperative co-interventions in OS that evaluate the outcomes blood loss, infection and relapse, regardless of language or publication date. Searches were conducted in MEDLINE, EMBASE, Epistemonikos, Lilacs, Web of Science, and CENTRAL. In addition, grey literature was screened. RESULTS 27 SRs and 150 primary studies fulfilled the inclusion criteria, 91 from SRs, and 59 from our search strategy. Overall, the quality of the SRs was graded as "Critically low," and only two SRs were rated as "High" quality. 11 PICO questions were extracted from SRs and 31 from primary studies, which focused on osteosynthesis methods, surgical cutting devices, use of antibiotics, and induced hypotension. In addition, evidence bubble maps for each outcome were created to analyze in a visual manner the existing evidence. CONCLUSIONS Future primary and secondary high-quality research should be addressed focused on the eight knowledge gaps identified in this mapping review. We concluded that the evidence mapping approach is a practical methodology for organizing the current evidence and identifying knowledge gaps in OS, helping to reduce research waste and canalize future efforts in developing studies for unsolved questions.
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8.
Safety and Efficacy of Tranexamic Acid in Hip Hemiarthroplasty for Fracture Neck Femur: a Systematic Review and Meta-analysis
Tripathy SK, Varghese P, Kumarasamy AKN, Mishra NP, Neradi D, Jain M, Sarkar S, Sen RK
Indian journal of orthopaedics. 2023;57(1):33-43
Abstract
PURPOSE Although numerous systematic reviews and meta-analyses have established the efficacy of tranexamic acid (TXA) in hip fracture surgeries, the included studies in those reviews have included all types of surgical interventions ranging from fixation to arthroplasty. Hip hemiarthroplasty is usually indicated in the elderly patients with femoral neck fracture and these patients have associated severe comorbidities and cognitive impairment. These subsets of patients with femoral neck fracture needs appropriate perioperative care and judicious use of antifibrinolytics. There is no meta-analysis evaluating the safety and efficacy of intravenous TXA in these patients. METHODS Searches of PubMed, Embase and Cochrane Central Register of Controlled Trials databases revealed 102 studies on TXA in hip fracture surgeries. After screening, eight studies were found to be suitable for review. The primary objective of this meta-analysis was to compare blood transfusion rate between TXA vs. control in hip hemiarthroplasty. The secondary objectives were total blood loss, postoperative haemoglobin, surgical duration, length of hospital stay and side effects (VTE, readmission and 30 days mortality). RESULTS There were one RCT, one prospective cohort study and six retrospective studies. All studies recruited the elderly patients. Intravenous (IV) TXA administration resulted in significant reduction in requirement of blood transfusion (12.7% vs. 31.9%; OR 0.28; 95% CI 0.17-0.46; p < 00,001; I (2) = 73%). The TXA group had significantly decreased total blood loss (MD - 100.31; 95% CI - 153.79, - 46.83; p < 0.0002). The postoperative Hb in the TXA group was significantly higher than the control group (MD 0.53; 95% CI 0.35, 0.71; p < 0.00001). There was no significant difference in the incidences of VTE (0.97% vs. 0.73%, OR 1.27; p = 0.81; I (2) = 64%) and readmission rate (9.2% vs. 9.64%; OR 0.79; p = 0.54), but 30-d mortality rate was significantly lower in the TXA group (3.41% vs. 6.04%; OR 0.66; p = 0.03). CONCLUSIONS Intravenous TXA is efficacious in the reduction of blood loss and transfusion need in hip hemiarthroplasty surgery for hip fracture, without increased risk of VTE. The blood conservation protocol led to decreased 30 days mortality in these fragile elderly patients. LEVEL OF EVIDENCE III.
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9.
Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta-analysis
Beverly A, Ong G, Kimber C, Sandercock J, Dorée C, Welton NJ, Wicks P, Estcourt LJ
The Cochrane database of systematic reviews. 2023;2(2):Cd013649
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Abstract
BACKGROUND Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor, with no transfusion requirement, to massive, requiring multiple blood product transfusions. There are a number of drugs, given systemically or applied locally, which may reduce the need for blood transfusion. OBJECTIVES To assess the effectiveness and safety of anti-fibrinolytic and haemostatic drugs and agents in reducing bleeding and the need for blood transfusion in people undergoing major vascular surgery or vascular procedures with a risk of moderate or severe (> 500 mL) blood loss. SEARCH METHODS We searched: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL, and Transfusion Evidence Library. We also searched the WHO ICTRP and ClinicalTrials.gov trial registries for ongoing and unpublished trials. Searches used a combination of MeSH and free text terms from database inception to 31 March 2022, without restriction on language or publication status. SELECTION CRITERIA We included randomised controlled trials (RCTs) in adults of drug treatments to reduce bleeding due to major vascular surgery or vascular procedures with a risk of moderate or severe blood loss, which used placebo, usual care or another drug regimen as control. DATA COLLECTION AND ANALYSIS We used standard Cochrane methods. Our primary outcomes were units of red cells transfused and all-cause mortality. Our secondary outcomes included risk of receiving an allogeneic blood product, risk of reoperation or repeat procedure due to bleeding, risk of a thromboembolic event, risk of a serious adverse event and length of hospital stay. We used GRADE to assess certainty of evidence. MAIN RESULTS We included 22 RCTs with 3393 participants analysed, of which one RCT with 69 participants was reported only in abstract form, with no usable data. Seven RCTs evaluated systemic drug treatments (three aprotinin, two desmopressin, two tranexamic acid) and 15 RCTs evaluated topical drug treatments (drug-containing bioabsorbable dressings or glues), including fibrin, thrombin, collagen, gelatin, synthetic sealants and one investigational new agent. Most trials were conducted in high-income countries and the majority of the trials only included participants undergoing elective surgery. We also identified two ongoing RCTs. We were unable to perform the planned network meta-analysis due to the sparse reporting of outcomes relevant to this review. Systemic drug treatments We identified seven trials of three systemic drugs: aprotinin, desmopressin and tranexamic acid, all with placebo controls. The trials of aprotinin and desmopressin were small with very low-certainty evidence for all of our outcomes. Tranexamic acid versus placebo was the systemic drug comparison with the largest number of participants (2 trials; 1460 participants), both at low risk of bias. The largest of these included a total of 9535 individuals undergoing a number of different higher risk surgeries and reported limited information on the vascular subgroup (1399 participants). Neither trial reported the number of units of red cells transfused per participant up to 30 days. Three outcomes were associated with very low-certainty evidence due to the very wide confidence intervals (CIs) resulting from small study sizes and low number of events. These were: all-cause mortality up to 30 days; number of participants requiring an allogeneic blood transfusion up to 30 days; and risk of requiring a repeat procedure or operation due to bleeding. Tranexamic acid may have no effect on the risk of thromboembolic events up to 30 days (risk ratio (RR) 1.10, 95% CI 0.88 to 1.36; 1 trial, 1360 participants; low-certainty evidence due to imprecision). There is one large ongoing trial (8320 participants) comparing tranexamic acid versus placebo in people undergoing non-cardiac surgery who are at high risk of requiring a red cell transfusion. This aims to complete recruitment in April 2023. This trial has primary outcomes of proportion of participants transfused with red blood cells and incidence of venous thromboembolism (DVT or PE). Topical drug treatments Most trials of topical drug treatments were at high risk of bias due to their open-label design (compared with usual care, or liquids were compared with sponges). All of the trials were small, most were very small, and few reported clinically relevant outcomes in the postoperative period. Fibrin sealant versus usual care was the topical drug comparison with the largest number of participants (5 trials, 784 participants). The five trials that compared fibrin sealant with usual care were all at high risk of bias, due to the open-label trial design with no measures put in place to minimise reporting bias. All of the trials were funded by pharmaceutical companies. None of the five trials reported the number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. The other three outcomes were associated with very low-certainty evidence with wide confidence intervals due to small sample sizes and the low number of events, these were: all-cause mortality up to 30 days; risk of requiring a repeat procedure due to bleeding; and risk of thromboembolic disease up to 30 days. We identified one large trial (500 participants) comparing fibrin sealant versus usual care in participants undergoing abdominal aortic aneurysm repair, which has not yet started recruitment. This trial lists death due to arterial disease and reintervention rates as primary outcomes. AUTHORS' CONCLUSIONS Because of a lack of data, we are uncertain whether any systemic or topical treatments used to reduce bleeding due to major vascular surgery have an effect on: all-cause mortality up to 30 days; risk of requiring a repeat procedure or operation due to bleeding; number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. There may be no effect of tranexamic acid on the risk of thromboembolic events up to 30 days, this is important as there has been concern that this risk may be increased. Trials with sample size targets of thousands of participants and clinically relevant outcomes are needed, and we look forward to seeing the results of the ongoing trials in the future.
PICO Summary
Population
Adults undergoing major vascular surgery or vascular procedures with a risk of moderate or severe blood loss (22 randomised controlled trials, n= 3,393).
Intervention
Drug treatments to reduce bleeding: anti-fibrinolytic and haemostatic drugs and agents.
Comparison
Placebo, usual care or another drug regimen.
Outcome
The primary outcomes were units of red blood cells transfused, all-cause mortality and thromboembolic events. There was too little data for a network meta-analysis. The reporting of outcomes was sparse. There was no evidence of increased risk of thromboembolic events with tranexamic acid [low certainty evidence]. The authors reported a need for larger trials with better reporting of post-surgical outcomes.
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10.
Efficacy and safety of tranexamic acid in elderly patients with femoral neck fracture treated with hip arthroplasty: A systematic review and meta-analysis
Zhao YK, Zhang C, Zhang YW, Li RY, Xie T, Bai LY, Chen H, Rui YF
Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association. 2023
Abstract
BACKGROUND Elderly patients with femoral neck fracture have high perioperative blood loss according to the trauma and hip arthroplasty surgery. Tranexamic acid is a fibrinolytic inhibitor and has been widely used in hip fracture patients to against perioperative anemia. The aim of the present meta-analysis was to evaluate the efficacy and safety of Tranexamic acid (TXA) in elderly patients with femoral neck fracture undergoing hip arthroplasty. METHODS We performed search using Pubmed, EMBASE, Cochrane Reviews, and Web of Science databases to identify all relevant research studies published from inception to June 2022. Randomized controlled studies and high-quality cohort studies that reported the perioperative use of TXA in patients with femoral neck fractures treated with arthroplasty, and made a comparison with the control group were included. Meta-analysis was performed using Review Manager 5.3 to assess the efficacy and safety of TXA. Subgroup analysis was conducted to further investigate the impact caused by surgery types and administration routes on the efficacy and safety outcomes. RESULTS Five randomized controlled trials (RCTs) and eight cohort studies published from January 2015 to June 2022 were included in this meta-analysis. The results showed significant reductions in the rate of allogeneic blood transfusion, total blood loss (TBL) and postoperative hemoglobin (Hb) drop in the TXA group compared with the control group, while no significant difference was found in the intraoperative blood loss, postoperative drainage, hospital length of stay (LOS), re-admission rate, and wound complications between the two groups. The incidence of thromboembolic events and mortality showed no significant difference. Subgroup analysis indicated that surgery types and administration routes did not change the overall tendency. CONCLUSION The current evidence shows that both intravascular administration (IV) and topical administration of TXA can significantly decrease the perioperative transfusion rate and TBL without increasing the risk of thromboembolic complications in elderly patients with femoral neck fracture.