Efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: A multicenter, randomized controlled clinical trial
Choi JH, Cho IR, Lee SH, Kim JS, Park N, Lee MW, Jang DK, Paik WH, Ahn DW, Ryu JK, et al
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2023
BACKGROUND Endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (EST) or endoscopic papillectomy (EP). AIMS In this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-EST or post-EP bleeding. METHODS A randomized trial was conducted from November 2020 to December 2021 at two tertiary centers in South Korea. Patients who experienced bleeding immediately after EST or EP were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray. RESULTS A total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group. Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs. 85.4%; P = 0.026). ). In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs. 7.3%; P = 0.329). The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ± 1.94 vs. 1.76 ± 0.99 min; P < 0.001), and no differences were observed in the adverse events. CONCLUSIONS The novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after EST or EP. (Registered in Clinical Research Information Service: KCT0005607).
The effect of fibrin glue on the quantity of drainage after thyroidectomy: a randomized controlled pilot trial
Ha EJ, Lee J
Annals of surgical treatment and research. 2022;102(4):177-184
PURPOSE A seroma is a collection of exudates after surgical trauma in wound healing. Fibrin glue is used to prevent seroma by reducing the generation of exudate. However, the impact of fibrin glue on the prevention of seroma remains debatable. Therefore, we conducted a randomized controlled pilot trial to investigate the effect of the amount of fibrin glue used on the generation of exudate after thyroidectomy and the sample size of future definitive trials. METHODS Between February and December 2020, 41 patients were enrolled; 21 patients in the low fibrin group and 20 in the high fibrin group. Stratified randomization was performed based on sex, body mass index, and thyroiditis. All patients underwent total thyroidectomy and bilateral central compartment dissection. In the low and high fibrin groups, 2 mL and 6 mL of fibrin glue were applied to patients, respectively. RESULTS Both the total drain volume and flow rate during the first 12 hours were lower in the high fibrin group than in the low fibrin group (65.0 mL vs. 47.6 mL, P = 0.008 and 2.7 mL/hr vs. 1.8 mL/hr, P = 0.002, respectively). The calculated sample size for future randomized controlled trial was 32 patients (α = 0.05, power = 0.8), and the power of this trial was 0.91 with µ(1) = 2.7, µ(2) = 1.8, σ = 0.9, and α = 0.05 (µ = mean, σ = standard deviation). CONCLUSION Six milliliters of fibrin glue could reduce total drain volume and flow rate of exudate after thyroidectomy. Therefore, applying an appropriate amount of fibrin glue after thyroidectomy may reduce postoperative seroma.
Comparison of a Hemostatic Powder and Standard Treatment in the Control of Active Bleeding From Upper Nonvariceal Lesions : A Multicenter, Noninferiority, Randomized Trial
Lau JYW, Pittayanon R, Kwek A, Tang RS, Chan H, Rerknimitr R, Lee J, Ang TL, Suen BY, Yu YY, et al
Annals of internal medicine. 2021
BACKGROUND The effectiveness of the hemostatic powder TC-325 as a single endoscopic treatment for acute nonvariceal upper gastrointestinal bleeding is uncertain. OBJECTIVE To compare TC-325 with standard endoscopic hemostatic treatments in the control of active bleeding from nonvariceal upper gastrointestinal causes. DESIGN One-sided, noninferiority, randomized, controlled trial. (ClinicalTrials.gov: NCT02534571). SETTING University teaching hospitals in the Asia-Pacific region. PATIENTS 224 adult patients with acute bleeding from a nonvariceal cause on upper gastrointestinal endoscopy. INTERVENTION TC-325 (n = 111) or standard hemostatic treatment (n = 113). MEASUREMENTS The primary outcome was control of bleeding within 30 days. Other outcomes included failure to control bleeding during index endoscopy, recurrent bleeding after initial hemostasis, further interventions, blood transfusion, hospitalization, and death. RESULTS 224 patients were enrolled (136 with gastroduodenal ulcers [60.7%], 33 with tumors [14.7%], and 55 with other causes of bleeding [24.6%]). Bleeding was controlled within 30 days in 100 of 111 patients (90.1%) in the TC-325 group and 92 of 113 (81.4%) in the standard treatment group (risk difference, 8.7 percentage points [1-sided 95% CI, 0.95 percentage point]). There were fewer failures of hemostasis during index endoscopy with TC-325 (3 [2.7%] vs. 11 [9.7%]; odds ratio, 0.26 [CI, 0.07 to 0.95]). Recurrent bleeding within 30 days did not differ between groups (9 [8.1%] vs. 10 [8.8%]). The need for further interventions also did not differ between groups (further endoscopic treatment: 8 [7.2%] vs. 10 [8.8%]; angiography: 2 [1.8%] vs. 4 [3.5%]; surgery: 1 [0.9%] vs. 0). There were 14 deaths in each group (12.6% vs. 12.4%). LIMITATION Clinicians were not blinded to treatment. CONCLUSION TC-325 is not inferior to standard treatment in the endoscopic control of bleeding from nonvariceal upper gastrointestinal causes. PRIMARY FUNDING SOURCE General Research Fund to the University Grants Committee, Hong Kong SAR Government.
Platelet Transfusion in Cardiac Surgery: A Systematic Review and Meta-Analysis
Yanagawa B, Ribeiro R, Lee J, Mazer CD, Cheng D, Martin J, Verma S, Friedrich JO
Ann Thorac Surg. 2020
BACKGROUND Blood transfusion is a well-established independent risk factor for mortality in patients undergoing cardiac surgery but the impact of platelet transfusion is less clear. We performed a systematic review and meta-analysis of observational studies comparing outcomes of patients who received platelet transfusion following cardiac surgery. METHODS We searched MEDLINE and EMBASE databases to January 2019 for studies comparing peri-operative outcomes in patients undergoing cardiac surgery with and without platelet transfusion. RESULTS There were 9 observational studies reporting on 101,511 patients: 12% with and 88% without platelet transfusion. In unmatched/unadjusted studies, patients who received platelet transfusion were older with greater incidence of renal, peripheral and cerebrovascular disease, myocardial infarction, left ventricular dysfunction, and anemia. They were more likely to have non-elective, combined surgery; pre-operative hemodynamic instability and endocarditis; and more likely to be on clopidogrel preoperatively. Perioperative complications were significantly increased without adjusting for these baseline differences. After pooling only matched/adjusted data, differences were not found in patients who did vs did not receive platelets for operative mortality (risk ratio [RR] 1.26, 95%CI:0.69-2.32, p=0.46, 5 studies), stroke (RR 0.94, 95%CI:0.62-1.45, p=0.79, 5 studies), myocardial infarction (RR1.29, 95%CI:0.95-1.77, p=0.11, 3 studies), reoperation for bleeding (RR1.20, 95%CI:0.46-3.18, p=0.71, 3 studies), infection (RR1.02, 95%CI:0.86-1.20, p=0.85, 6 studies), and peri-operative dialysis (RR0.91, 95%CI:0.63-1.32, p=0.62, 3 studies). CONCLUSIONS After accounting for baseline differences, platelet transfusion was not linked with perioperative complications in cardiac surgery patients. Given the small number of observational studies, these findings should be considered hypothesis generating.
Impact of Dexmedetomidine on Tourniquet-Induced Systemic Effects in Total Knee Arthroplasty under Spinal Anesthesia: a Prospective Randomized, Double-Blinded Study
Lee C, Lee C, So C, Lee J, Choi I, Ma X, Hwang J
BioMed research international. 2020;2020:4208597
BACKGROUND Clinical studies on the impact of dexmedetomidine on tourniquet-induced systemic effects have been inconsistent. We investigated the impact of dexmedetomidine on tourniquet-induced systemic effects in total knee arthroplasty. METHODS Eighty patients were randomly assigned to either control (CON) or dexmedetomidine (DEX) group. The DEX group received an intravenous loading dose of 0.5 μg/kg DEX over 10 minutes, followed by a continuous infusion of 0.5 μg/kg/h from 10 minutes before the start of surgery until completion. The CON group received the same calculated volume of normal saline. Pain outcomes and metabolic and coagulative changes after tourniquet application and after tourniquet release were investigated. RESULTS The frequency of fentanyl administration postoperatively, patient-controlled analgesia (PCA) volume at 24 hours postoperatively, total PCA volume consumed in 48 hours postoperatively, and VAS score for pain at 24 and 48 hours postoperatively were significantly lower in the DEX group than in the CON group. Ten minutes after the tourniquet release, the DEX group showed significantly higher pH and lower lactate level than those in the CON group. Antithrombin III activity and body temperature 10 minutes after tourniquet release were significantly lower in the DEX group than in the CON group. Ca(2+), K(+), HCO(3) (-), base excess, and PCO(2) levels 10 minutes after tourniquet release were not significantly different between the two groups. CONCLUSION We showed that DEX attenuated pain and hemodynamic, metabolic, and coagulative effects induced by the tourniquet. However, these metabolic and coagulative changes were within normal limits. Therefore, DEX could be used as an analgesic adjuvant, but should not be considered for routine use to prevent the systemic effects induced by tourniquet use.
The Efficacy of Hypotensive Agents on Intraoperative Bleeding and Recovery Following General Anesthesia for Nasal Surgery: A Network Meta-Analysis
Kim DH, Lee J, Kim SW, Hwang SH
Clinical and experimental otorhinolaryngology. 2020
OBJECTIVES A systematic review of the literature was conducted to evaluate hypotensive agents in terms of their adverse effects and associations with perioperative morbidity in patients undergoing nasal surgery. METHODS Two authors independently searched databases (Medline, Scopus, and Cochrane databases) up to February 2020 for randomized controlled trials comparing the perioperative administration of a hypotensive agent with a placebo or other agent. The outcomes of interest for this analysis were intraoperative morbidity, operative time, intraoperative bleeding, hypotension, postoperative nausea/vomiting, and postoperative pain. Both a standard pairwise meta-analysis and network meta-analysis were conducted. RESULTS Our analysis was based on 37 trials. Treatment networks consisting of six interventions (placebo, clonidine, dexmedetomidine, beta-blockers, opioids, and nitroglycerine) were defined for the network meta-analysis. Dexmedetomidine resulted in the greatest differences in intraoperative bleeding (-0.971; 95% confidence interval [CI], -1.161 to -0.781), intraoperative fentanyl administration (-3.683; 95% CI, -4.848 to -2.518), and postoperative pain (-2.065; 95% CI, -3.170 to -0.960) compared with placebo. The greatest difference in operative time compared with placebo was achieved with clonidine (-0.699; 95% CI, -0.977 to -0.421). All other agents also had beneficial effects on the measured outcomes. Dexmedetomidine was less likely than other agents to cause adverse effects. CONCLUSION This study demonstrated the superiority of the systemic use of dexmedetomidine as a perioperative hypotensive agent compared with the other five tested agents. However, the other agents were also superior to placebo in improving operative time, intraoperative bleeding, and postoperative pain.
Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline
Scott A, LaPrade RF, Harmon KG, Filardo G, Kon E, Della Villa S, Bahr R, Moksnes H, Torgalsen T, Lee J, et al
The American journal of sports medicine. 2019;:363546519837954
BACKGROUND A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. PURPOSE/HYPOTHESIS To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures-Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change-were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients' global rating of change. RESULTS Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P-58 (29), 71 (20), and 80 (18); pain-4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change-4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). CONCLUSION Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. REGISTRATION NCT02116946 (ClinicalTrials.gov identifier).
Comparison of manual compression and vascular hemostasis devices after coronary angiography or percutaneous coronary intervention through femoral artery access: a meta-analysis of randomized controlled trials
Dahal K, Rijal J, Shahukhal R, Sharma S, Watti H, Azrin M, Katikaneni P, Jimenez E, Tandon N, Modi K, et al
Cardiovascular Revascularization Medicine : Including Molecular Interventions. 2017;19((2):):151-162
OBJECTIVES To compare the efficacy and safety of manual compression (MC) with vascular hemostasis devices (VHD) in patients undergoing coronary angiography (CA) or percutaneous coronary intervention (PCI) through femoral artery access. INTRODUCTION The use of femoral artery access for coronary procedures may result in access-related complications, prolonged immobility and discomfort for the patients. MC results in longer time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to VHDs but its role in access-related complications remains unclear in patients undergoing coronary procedures. METHODS We searched MEDLINE, EMBASE, Cochrane CENTRAL and relevant references for English language randomized controlled trials (RCT) from inception through September 30, 2016. We performed the meta-analysis using random effects model. The outcomes were time-to-hemostasis, time-to-ambulation, major bleeding, large hematoma >5cm, pseudoaneurysm and other adverse events. RESULTS The electronic database search resulted in a total of 44 RCTs with a total of 18,802 patients for analysis. MC, compared to VHD resulted in longer TTH [mean difference (MD): 11.21min; 95% confidence interval (CI) 8.13-14.29; P<0.00001] and TTA [standardized mean difference: 1.2 (0.79-1.62); P<0.00001] along with excess risk of hematoma >5cm formation [risk ratio (RR): 1.38 (1.15-1.67); P=0.0008]. MC resulted in similar risk of major bleeding [1.01 (0.64-1.60); P=0.95] pseudoaneurysm [0.99 (0.75-1.29); P=0.92], infections [0.52 (0.25-1.10); P=0.09], need of surgery [0.60 (0.29-1.22); P=0.16), AV fistula [0.93 (0.68-1.27); P=0.63] and ipsilateral leg ischemia [0.95 (0.57-1.60); P=0.86] compared to VHD. CONCLUSION Manual compression increase time-to-hemostasis, time-to-ambulation and risk of hematoma formation compared vascular hemostasis devices.
Breastfeeding or nipple stimulation for reducing postpartum haemorrhage in the third stage of labour
Abedi P, Jahanfar S, Namvar F, Lee J
The Cochrane Database of Systematic Reviews. 2016;((1)):CD010845.
BACKGROUND Oxytocin and prostaglandin are hormones responsible for uterine contraction during the third stage of labour. Receptors in the uterine muscles are stimulated by exogenous or endogenous oxytocin leading to uterine contractions. Nipple stimulation or breastfeeding are stimuli that can lead to the secretion of oxytocin and consequent uterine contractions. Consequently, uterine contractions can reduce bleeding during the third stage of labour. OBJECTIVES To investigate the effects of breastfeeding or nipple stimulation on postpartum haemorrhage (PPH) during the third stage of labour. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 July 2015) and reference lists of retrieved studies. SELECTION CRITERIA Randomised and quasi-randomised controlled trials comparing breast stimulation, breastfeeding or suckling for PPH in the third stage of labour were selected for this review. DATA COLLECTION AND ANALYSIS Two review authors independently assessed studies for inclusion in terms of risk of bias and independently extracted data. Disagreements were resolved by a third review author. MAIN RESULTS We included four trials (4608 women), but only two studies contributed data to the review's analyses (n = 4472). The studies contributing data were assessed as of high risk of bias overall. One of these studies was cluster-randomised and conducted in a low-income country and the other study was carried out in a high-income country. All four included studies assessed blood loss in the third stage of labour. Birth attendants estimated blood loss in two trials. The third trial assessed the hematocrit level on the second day postpartum to determine the effect of the bleeding. The fourth study measured PPH ≥ 500 mL. Nipple stimulation versus no treatmentOne study (4385 women) compared the effect of suckling versus no treatment. Blood loss was not measured in 114 women (59 in control group and 55 in suckling group). After excluding twin pregnancies, stillbirths and neonatal deaths, the main analyses for this trial were performed on 4227 vaginal deliveries. In terms of maternal death or severe morbidity, one maternal death occurred in the suckling group due to retained placenta (risk ratio (RR) 3.03, 95% confidence interval (CI) 0.12 to 74.26; one study, participants = 4227; very low quality evidence); severe morbidity was not mentioned. Severe PPH (≥ 1000 mL) was not reported in this study.The incidence of PPH (≥ 500 mL) was similar in the suckling and no treatment groups (RR 0.95, 95% CI 0.77 to 1.16; one study, participants = 4227; moderate quality). There were no group differences between nipple stimulation and no treatment regarding blood loss in the third stage of labour (mean difference (MD) 2.00, 95% CI -7.39 to 11.39; one study, participants = 4227; low quality). The rates of retained placenta were similar (RR 1.01, 95% CI 0.14 to 7.16; one study, participants = 4227; very low quality evidence), as were perinatal deaths (RR 1.06, 95% CI 0.57 to 1.98; one study, participants = 4271; low quality), and maternal readmission to hospital (RR 1.01, 95% CI 0.14 to 7.16; one study, participants = 4227; very low quality). We downgraded the evidence for this comparison for risk of bias concerns in the one included trial (inappropriate analyses for cluster design) and for imprecision (wide CIs crossing the line of no difference and, for some outcomes, few events).Many maternal secondary outcomes (including side effects) were not reported. Similarly, most neonatal secondary outcomes were not reported. Nipple stimulation versus oxytocinAnother study compared the effect of nipple stimulation (via a breast pump) with oxytocin. Eighty-seven women were recruited but only 85 women were analysed. Severe PPH ≥ 1000 mL and maternal death or severe morbidity were not reported.There was no clear effect of nipple stimulation on blood loss (MD 15.00, 95% CI -24.50 to 54.50; one study, participants = 85; low quality evidence), or on postnatal anaemia compared to the oxytocin group (MD -
Topical versus intravenous administration of tranexamic acid in primary total hip arthroplasty: a systematic review and meta-analysis of randomized controlled trials
Hanna SA, Prasad A, Lee J, Achan P
Orthopedic Reviews. 2016;8((3)):6792.
Tranexamic acid (TA) is widely used by orthopedic surgeons to decrease blood loss and the need for transfusion following total hip arthroplasty (THA). Although both intravenous and topical applications are described in the literature, there remains no consensus regarding the optimal regimen, dosage and method of delivery of TA during THA. In addition, concerns still exist regarding the risk of thromboembolic events with intravenous administration. The purpose of this meta-analysis was to compare the efficacy and safety of topical versus intravenous administration of TA in THA. A systemic review of the electronic databases PubMed, CENTRAL, EMBASE and Google Scholar was undertaken to identify all randomized controlled trials (RCTs) comparing the topical and intravenous administration of TA during THA, in terms of total blood loss, rate of blood transfusion and incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE) post-operatively. A meta-analysis was performed to evaluate and compare the efficacy and safety of both methods of administration. Of 248 potentially relevant papers, three RCTs comprising (482) were eligible for data extraction and meta-analysis. The results showed a slightly higher amount of blood loss [Mean Difference (MD) - 46.37, P=0.12, 95% confidence interval (CI) - 12.54 to 105.29] and rate of transfusion (Risk Ratio 1.30, P=0.39, 95%CI 0.71 to 2.37) postoperatively in the topical TA group, but both did not reach statistical significance. There were 3 cases (1.2%) of DVT/PE in the intravenous group and one case (0.4%) in the topical group. Topical TA is an effective and safe method to reduce blood loss and the rate of transfusion following primary THA. It has comparative effectiveness to IV administration with slightly less post-operative thromboembolic complications. Larger and better-designed RCTs are required to establish the optimum dosage and regimen for topical use.