Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2021
Background: There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Methods: Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Results: Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group (P = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Conclusion: Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).
Therapeutic Application of Fibrinogen in Spine Surgery: A Review Article
International journal of spine surgery. 2021
BACKGROUND The aim of this review is to investigate current uses of fibrinogen as a tool to reduce operative and postoperative blood loss in different surgical fields especially orthopedic spine surgery. This is a systematic review. METHODS MEDLINE (via Ovid 1946 to June 1, 2020) and Embase (via Ovid 1947 to June 1, 2020) were searched using the keywords "fibrinogen", "surgery", and "spine" for relevant studies. The search strategy used text words and relevant indexing to identify articles discussing the use of fibrinogen to control surgical blood loss. RESULTS The original literature search yielded 407 articles from which 68 duplications were removed. Three hundred thirty-nine abstracts and titles were screened. Results were separated by surgical specialties. CONCLUSIONS Multiple studies have looked at the role of fibrinogen for acute bleeding in the operative setting. The current evidence regarding the use of fibrinogen concentrate in spine surgery is promising but limited, even though this is a field with the potential for severe hemorrhage. Further trials are required to understand the utility of fibrinogen concentrate as a first-line therapy in spine surgery and to understand the importance of target fibrinogen levels and subsequent dosing and administration to allow recommendations to be made in this field.
Epidemiology and treatment of peripheral neuropathy in systemic sclerosis
The Journal of rheumatology. 2021
OBJECTIVE The epidemiology and treatment of peripheral neuropathy in systemic sclerosis (SSc) is poorly understood. The objectives of this study were to evaluate the incidence, prevalence, risk factors, and treatments of peripheral neuropathy in SSc. METHODS A systematic review of Medline, Embase and CINAHL databases for literature reporting peripheral neuropathy in SSc was performed. Studies evaluating incidence, prevalence, risk factors, and treatments were synthesized. Meta-analysis using a random effects model was used to evaluate the prevalence of peripheral neuropathy. RESULTS 113 studies reported 949 subjects with at least one type of peripheral neuropathy out of 2143 SSc patients studied. The mean age was 48.5 years. The mean time between SSc onset and detection of peripheral neuropathy was 8.85 years. The pooled prevalence of neuropathy was 27.4% (95%CI 22.4% - 32.7%). Risk factors for peripheral neuropathy in SSc included advanced diffuse disease, anticentromere antibodies, calcinosis cutis, ischemia of the vasa nervosum, iron deficiency anemia, metoclopramide, pembrolizumab, silicosis and uremia. There were 73 subjects with successful treatments (n=36 restoring sensation, n=37 restoring motor or sensorimotor function). Treatments included decompression surgery, prednisone, cyclophosphamide, carbamazepine, transcutaneous electrical nerve stimulation, tricyclic antidepressants and IVIG. CONCLUSION All-cause peripheral neuropathy is not uncommon in SSc. Compression neuropathies can be treated with decompression surgery. Observational data reporting immunosuppressive and anticonvulsants to treat peripheral neuropathy in SSc is limited and conflicting. This data provides the signal of effect to justify RCT to evaluate the efficacy of these interventions.
Early and Systematic Administration of Fibrinogen Concentrate in Postpartum Haemorrhage Following Vaginal Delivery: The FIDEL Randomized Controlled Trial
BJOG : an international journal of obstetrics and gynaecology. 2021
OBJECTIVE To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management. DESIGN Multicentre, double-blind, randomized placebo-controlled trial. SETTING 30 French hospitals. POPULATION patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins. METHODS Within 30 min after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo. MAIN OUTCOME MEASURES Failure as composite primary efficacy endpoint: at least 4 g/dL of haemoglobin decrease and/or transfusion of at least 2 units of packed red blood cells within 48h following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures, and maternal morbidity-mortality within 6±2 weeks after delivery. RESULTS 437 patients were included : 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346mL) and plasma fibrinogen (4.1 ± 0.9g/L) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the Fibrinogen and placebo groups, respectively (OR=0.99) after adjustment for centre and baseline plasma fibrinogen; (95%CI: [0.66;1.47]; p=0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/L in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group, versus two in the placebo group. CONCLUSIONS As previous placebo-controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs, and postpartum anaemia, but prevented plasma fibrinogen decrease without any subsequent thromboembolic events.
Patients with persistent post-partum haemorrhage after vaginal delivery enrolled in the FIDEL trial (n= 437).
Fibrinogen concentrate (n= 224).
Placebo (n = 213).
At inclusion, blood loss (877 ± 346mL) and plasma fibrinogen (4.1 ± 0.9g/L) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively after adjustment for centre and baseline plasma fibrinogen. No significant differences in secondary efficacy outcomes were observed. The mean plasma fibrinogen was unchanged in the fibrinogen group and decreased by 0.56 g/L in the placebo group. No thromboembolic or other relevant adverse effects were reported in the fibrinogen group, versus two in the placebo group.
A randomized trial of albumin infusion to prevent intradialytic hypotension in hospitalized hypoalbuminemic patients
Critical care (London, England). 2021;25(1):18
BACKGROUND Intradialytic hypotension (IDH) is a frequent complication of intermittent hemodialysis (IHD), occurring from 15 to 50% of ambulatory sessions, and is more frequent among hospitalized patients with hypoalbuminemia. IDH limits adequate fluid removal and increases the risk for vascular access thrombosis, early hemodialysis (HD) termination, and mortality. Albumin infusion before and during therapy has been used for treating IDH with the varying results. We evaluated the efficacy of albumin infusion in preventing IDH during IHD in hypoalbuminemic inpatients. METHODS A randomized, crossover trial was performed in 65 AKI or ESKD patients with hypoalbuminemia (albumin < 3 g/dl) who required HD during hospitalization. Patients were randomized to receive 100 ml of either 0.9%sodium chloride or 25% albumin intravenously at the initiation of each dialysis. These two solutions were alternated for up to six sessions. Patients' vital signs and ultrafiltration removal rate were recorded every 15 to 30 min during dialysis. IDH was assessed by different definitions reported in the literature. All symptoms associated with a noted hypotensive event as well as interventions during the dialysis were recorded. RESULTS Sixty-five patients were submitted to 249 sessions; the mean age was 58 ([Formula: see text] 12), and 46 (70%) were male with a mean weight of 76 ([Formula: see text] 18) kg. The presence of IDH was lower during albumin sessions based on all definitions. The hypotension risk was significantly decreased based on the Kidney Disease Outcomes Quality Initiative definition; (15% with NS vs. 7% with albumin, p = 0.002). The lowest intradialytic SBP was significantly worse in patients who received 0.9% sodium chloride than albumin (NS 83 vs. albumin 90 mmHg, p = 0.035). Overall ultrafiltration rate was significantly higher in the albumin therapies [NS - 8.25 ml/kg/h (- 11.18 5.80) vs. 8.27 ml/kg/h (- 12.22 to 5.53) with albumin, p = 0.011]. CONCLUSION In hypoalbuminemic patients who need HD, albumin administration before the dialysis results in fewer episodes of hypotension and improves fluid removal. Albumin infusion may be of benefit to improve the safety of HD and achievement of fluid balance in these high-risk patients. ClinicalTrials.gov Identifier: NCT04522635.
Effectiveness of ankle fusion in patients with hemophilia, advanced ankle degeneration, and unbearable pain for whom nonsurgical and surgical treatments have been ineffective
Expert review of hematology. 2021
INTRODUCTION In underdeveloped countries, patients with hemophilia often experience repetitive ankle joint hemorrhages due to a shortage of coagulation factors (factor VIII [FVIII] and factor IX [FIX] for hemophilia A and B, respectively). AREAS COVERED This is a narrative literature review in which we searched the Cochrane Library and MEDLINE for articles related to ankle arthrodesis in patients with hemophilia. The searches covered the period from the databases´ inception to February 28, 2021. In the event of unsuccessful hematologic prophylaxis and conservative measures (e.g., analgesics, cyclooxygenase-2 inhibitors, taping, intra-articular injections of hyaluronic acid and corticosteroids, physical and rehabilitation medicine, orthoses, radiosynovectomy, and joint-preserving surgery (e.g., removal of the distal tibia by open surgery or by arthroscopic surgery, joint debridement by arthroscopic surgery), the only surgical solution is ankle arthrodesis, which does not preserve the ankle joint. EXPERT OPINION Ankle pain is reduced after ankle arthrodesis (75% of patients experience no pain). Approximately 5% of patients require reoperation due to lack of fusion, and deep infection occurs in 2.5%. After tibiotalar fusion, a self-reported activity scale shows that approximately 12% of patients improve, 9% worsen, and 79% show no improvement. The results of ankle arthrodesis therefore appear to be poor.
Evaluation of high-dose aspirin elimination in the treatment of Kawasaki disease in the incidence of coronary artery aneurysm
Annals of pediatric cardiology. 2021;14(2):146-151
BACKGROUND Standard first-step therapy for Kawasaki disease consists of Intravenous immunoglobulin and high dose Aspirin (80-100 mg/kg/day). The standard dose of Intravenous immunoglobulin (2gr/kg) is strongly effective in reducing the risk of coronary arteries abnormalities. So, the proper dose and efficacy of Aspirin to decrease the risk of coronary arteries abnormalities is a controversial issue. In this study, it is tried to assess the result of eliminating high-dose Aspirin in the treatment of the acute phase of Kawasaki and observe the incidence rate of coronary arteries abnormalities when only Intravenous immunoglobulin was administered. METHODS This study is a prospective randomized, open-label, blinded end-points clinical trial performed in Afzalipour hospital in Kerman University of Medical Sciences from September 2017 to September 2018 in 62 patients with typical and atypical Kawasaki disease. The study group received Intravenous immunoglobulin (2 g/kg) and the control group get the same dose of Intravenous immunoglobulin plus Aspirin with the dose of 80-100 mg/Kg/day until they were afebrile for 48 hours. Afterward, both groups received a daily single dose (3-5 mg/kg) of Aspirin for six weeks. Echocardiography was done after two weeks, six weeks, and six months. Internal diameter of the left and right main coronary arteries was measured and then the corresponding Z-score was calculated. RESULTS In the study group, coronary arteries abnormalities decreased from 38.7% in the 2nd week to 16.1% in the 6th month. In the control group, it declined from 54.8% to 22.6%. There was no statistically significant difference between the groups in term of frequency of abnormal coronary arteries at the study period (P=0.151). CONCLUSIONS We concluded that high dose Aspirin does not have a significant role in preventing coronary arteries abnormalities in Kawasaki disease and giving standard 2 gr/kg/day Intravenous immunoglobulin without high-dose Aspirin in acute-phases therapy does not increase the risk of coronary arteries abnormality.
Patient Preferences for Subcutaneous versus Intravenous Administration of Treatment for Chronic Immune System Disorders: A Systematic Review
Patient preference and adherence. 2021;15:811-834
BACKGROUND For many chronic immune system disorders, the available treatments provide several options for route of administration. The objective of this systematic literature review is to inform discussions about therapy choices for individual patients by summarizing the available evidence regarding the preferences of patients with chronic immune system disorders for intravenous (IV) or subcutaneous (SC) administration. METHODS Searches of the MEDLINE, Embase and Cochrane Library databases were conducted using terms designed to capture studies reporting patient preferences between IV and SC therapy published in English. Relevant studies were limited to those in which mode of administration, including treatment frequency and setting, was the main difference between comparators. RESULTS In total, 49 studies were included in the review. Among 18 studies that compared IV and SC immunoglobulin therapy, 16 found patients to prefer the SC administration route. The results of the 31 studies comparing IV infusion and SC injection of non-immunoglobulin therapies were mixed, with patients favoring SC administration in 20, IV infusion in seven, and having no overall preference in four. Patient experience had a strong effect on preferences, with treatment-experienced patients preferring their current administration route in most studies. Patients preferring SC administration tended also to prefer treatment at home, mainly due to the convenience and comfort of home treatment and the avoidance of having to attend hospital. By contrast, patients preferring IV infusion tended to cite the lower treatment frequency and a dislike of self-injecting, and preferred hospital treatment, mainly due to the presence of healthcare professionals and resulting feelings of safety. CONCLUSION In general patients with chronic immune system disorders tend to be more likely to choose SC administration than IV infusion, but preferences may vary according among individuals. These findings may assist discussions around appropriate treatment choices for each patient.
Is Intra-Articular Administration of Fibrinogen Effective in Postoperative Total Knee Arthroplasty Blood Loss? A Randomized Clinical Trial
Anesthesiology and pain medicine. 2021;11(1):e107431
OBJECTIVES The purpose of this study was to evaluate the effect of intra-articular injection of fibrinogen on postoperative bleeding following total knee arthroplasty. METHODS A double-blind randomized clinical trial was conducted on 40 patients aged 40 - 70 years under spinal anesthesia candidate for total knee arthroplasty in Golestan hospital, Ahwaz, Iran, in 2017-2018. Patients were divided into fibrinogen intra-articular injection (n = 20) and control (n = 20) groups. The amounts of blood loss and blood transfusion requirement were recorded. Hemoglobin (Hb), hematocrit (HCT), international normalized ratio (INR), platelet (PLT), prothrombin time (PT), and partial thromboplastin time (PTT) were recorded before and after the surgery. RESULTS There was no significant difference in the average amount of intraoperative blood loss between the groups (P > 0.05). The average amount of blood loss 24 hours after the surgery was significantly lower in the fibrinogen group than in the control group (fibrinogen group 350.61 ± 120.32 cc; control group 540.00 ± 170.21 cc; P = 0.0002). There were significant differences in transfusion between the groups (fibrinogen group 250 ± 20 cc; control group 350 ± 50 cc; P < 0.0001). There was a significant difference between the two groups in 24 h postoperative Hb and HCT (P < 0.001). CONCLUSIONS Intra-articular fibrinogen administration may reduce acute bleeding and can be used as an effective intervention to prevent further bleeding and the need for transfusion in patients undergoing total knee arthroplasty.
Application of Tissue Engineering and Regenerative Medicine in Prelabor Rupture of Membranes: a Review of the Current Evidence
Reproductive sciences (Thousand Oaks, Calif.). 2021
Preterm prelabor rupture of membranes (PPROM) is the main cause of preterm delivery, resulting in increased perinatal morbidity and mortality. Several techniques have been studied for the healing of ruptured membranes, with some success. Before new techniques using tissue/organ engineering are applied in clinical practice, these techniques must be validated in clinical trials. To address this issue, the objective of this study was to summarize the current literature on interventions to seal or heal the amniotic membranes after PPROM. An electronic search was conducted using the keywords "fetal membranes," "premature rupture," "amnion," "tissue engineering," "fibrin tissue adhesive," "regenerative medicine," "tissue adhesive," "wound healing," and "fetoscopy" through the MEDLINE, Embase, and Cochrane CENTRAL databases, with the limitation of English-language studies. Through a review of the identified studies, it was found that spontaneous healing of the fetal membrane has not been successful. Several efforts have been made to seal membranes before or after rupture using different methods, including amniopatches, collagen, tissue patches, fibrin sealant, mussel-mimetic sealant, engineered cell matrix, and immunological supplements. However, most studies have been conducted in ex vivo or in vivo settings, so the safety and applicability of these techniques to spontaneous rupture of membranes in clinical settings have not been sufficiently tested. Overall, the current evidence is limited regarding the safety and effectiveness of interventions against PPROM.