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1.
A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy
Park SJ, Seol A, Lee N, Lee S, Kim HS
Scientific reports. 2021;11(1):8495
Abstract
The preservation of ovarian reserve during laparoendoscopic single-site (LESS) ovarian cystectomy is crucial for reproductive-age women. This study was a single-blinded, single-center, and randomized controlled trial to evaluate the effect of hemostatic agents on the preservation of ovarian reserve and hemostasis during LESS ovarian cystectomy. Patients with unilateral ovarian cyst were randomized to the hemostatic agent and coagulation groups according to the hemostasis method. Afterwards, the patients underwent LESS ovarian cystectomy, and hemostasis was performed after ovarian cyst excision according to the assigned hemostasis method. If hemostasis was not completed within 10 min. After discharge, the patients were followed until 3 months after surgery. We compared the hemoglobin, anti-Müllerian hormone (AMH) levels, and ovarian volumes before surgery, and 2 days, 1 week, and 3 months after surgery (3 M-POST), and the decline ratio between the two groups. The decline ratio of serum AMH levels was greater at 3 M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], - 36.7 vs. - 13.3%; per-protocol [PP], - 36.8 vs. - 13.3%; P < 0.05). Notably, the difference of the decline ratio of serum AMH levels was only shown in endometriosis patients (median; ITT, - 50.7 vs. - 14.4%; PP, - 50.7% vs. - 14.4%; P < 0.05), while there was no difference in non-endometriosis patients. In conclusion, Hemostatic agents may be non-inferior to bipolar coagulation for preserving ovarian reserve and hemostasis during LESS ovarian cystectomy, in particular, for endometriosis patients. (Trial registry: ClinicalTrials.gov Identifier NCT03374397).
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Reactive Oxygen Species Scavenger in Acute Intracerebral Hemorrhage Patients: A Multicenter, Randomized Controlled Trial
Kim M, Byun J, Chung Y, Lee SU, Park JE, Park W, Park JC, Ahn JS, Lee S
Stroke. 2021;:Strokeaha120032266
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Abstract
BACKGROUND AND PURPOSE Patients with intracerebral hemorrhage (ICH) have oxidative stress. Oxidative stress contributes to the development and progression of perihematomal edema (PHE) in brain hemorrhage patients. We hypothesized that reactive oxygen species (ROS) scavengers might have a neuroprotective role in the acute period of patients with ICH. METHODS This prospective, multicenter, single-blind, randomized study was conducted between June 2017 and October 2019. Intracranial bleeding, including spontaneous ICH, secondary ICH due to vascular anomalies, venous thrombosis, neoplasms, or hemorrhagic infarction, were included in our study. These ROS scavengers were given for 14 days with a dose of N-acetylcysteine 2000 mg/d and selenium 1600 µg/d intravenously. Other patients received a placebo. The primary outcome was hemorrhage and PHE volume changes in 2-week follow-up computed tomography between ROS scavenger versus placebo groups. RESULTS In total, 448 patients were enrolled with 123 patients remaining after applying the inclusion and exclusion criteria. There were no significant differences in baseline characteristics between the ROS scavenger (n=57) and placebo (n=66) groups. No significant differences in baseline hematoma and PHE volumes were observed but 2 weeks follow-up computed tomography showed significant differences in PHE volume (21.90±17.63 versus 30.66±32.35, P<0.01) and PHE ratio (1.19±0.73 versus 2.05±1.27, P<0.01). Among clinical factors, time to reach target Richmond Agitation Sedation Scale (5.98 hours [95% CI, 4.82-7.241 versus 8.42 hours], [95% CI, 6.57-10.77], P<0.01) and the length of intensive care unit stays (6.46 days [95% CI, 2.38-10.55 versus 12.66 days], [95% CI, 8.47-16.85], P<0.01) were significantly shortened among patients who received ROS scavengers than among patients who did not receive ROS scavenger. CONCLUSIONS ROS scavenger showed a significantly reduced PHE volume, time to reach target Richmond Agitation Sedation Scale, and shortened length of intensive care unit stay in patients with acute ICH. Early and high doses of ROS scavengers in a combination regimen may have played a key role in obtaining a favorable outcome in our study.
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The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil((R))) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial
Kwon J, Shin SH, Lee S, Park G, Park Y, Lee SJ, Lee W, Song KB, Hwang DW, Kim SC, et al
World journal of surgery. 2019
Abstract
BACKGROUND Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF. METHODS This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis. RESULTS A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084). CONCLUSIONS Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).
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Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for the treatment of preoperative anemia in patients with menorrhagia: An open-label, multicenter, randomized study
Lee S, Ryu KJ, Lee ES, Lee KH, Lee JJ, Kim T
The journal of obstetrics and gynaecology research. 2019;45(4):858-864
Abstract
AIM: To compare ferric carboxymaltose (FCM) with iron sucrose (IS) for the effective and timely treatment of preoperative iron deficiency anemia (IDA) in women with menorrhagia. METHODS This open-label, multicenter, two-arm study randomized patients to receive either a single dose of FCM or multiple doses of IS. The primary endpoint was the proportion of patients who achieved hemoglobin (Hb) levels ≥10 g/dL within 2 weeks after the first administration. Secondary endpoints included mean Hb levels, time to reach Hb ≥10 g/dL and quality of life (QoL). RESULTS In total, 101 patients (FCM n = 52; IS n = 49) were randomized to the study treatments. FCM was as effective as IS in achieving Hb ≥10 g/dL within 2 weeks after the first administration (78.8% vs 72.3%). The time to reach Hb ≥10 g/dL was significantly shorter in the FCM group than in the IS group (7.7 days vs 10.5 days). Mean Hb levels were higher in the FCM-treated patients than in the IS-treated patients with borderline significance. QoL scores did not differ between the two groups. CONCLUSION Ferric carboxymaltose is as effective as IS in correcting preoperative IDA among patients with menorrhagia. The added benefits of FCM over IS included significant rapid correction of IDA, replenishment of iron stores and reduced hospital visits.
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Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial
Fergusson DA, Hébert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, et al
JAMA: the Journal of the American Medical Association. 2012;308((14):):1443-51.
Abstract
CONTEXT Even though red blood cells (RBCs) are lifesaving in neonatal intensivecare, transfusing older RBCs may result in higher rates of organ dysfunction,nosocomial infection, and length of hospital stay. OBJECTIVE To determine if RBCs stored for 7 days or less compared with usual standards decreased rates ofmajor nosocomial infection and organ dysfunction in neonatal intensive care unitpatients requiring at least 1 RBC transfusion. DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized controlled trial in 377 premature infants with birthweights less than 1250 g admitted to 6 Canadian tertiary neonatal intensive careunits between May 2006 and June 2011. INTERVENTION Patients were randomlyassigned to receive transfusion of RBCs stored 7 days or less (n = 188) vsstandard-issue RBCs in accordance with standard blood bank practice (n = 189). MAIN OUTCOME MEASURES The primary outcome was a composite measure of majorneonatal morbidities, including necrotizing enterocolitis, retinopathy ofprematurity, bronchopulmonary dysplasia, and intraventricular hemorrhage, as wellas death. The primary outcome was measured within the entire period of neonatalintensive care unit stay up to 90 days after randomization. The rate ofnosocomial infection was a secondary outcome. RESULTS The mean age of transfusedblood was 5.1 (SD, 2.0) days in the fresh RBC group and 14.6 (SD, 8.3) days inthe standard group. Among neonates in the fresh RBC group, 99 (52.7%) had theprimary outcome compared with 100 (52.9%) in the standard RBC group (relativerisk, 1.00; 95% CI, 0.82-1.21). The rate of clinically suspected infection in thefresh RBC group was 77.7% (n = 146) compared with 77.2% (n = 146) in the standardRBC group (relative risk, 1.01; 95% CI, 0.90-1.12), and the rate of positivecultures was 67.5% (n = 127) in the fresh RBC group compared with 64.0% (n = 121)in the standard RBC group (relative risk, 1.06; 95% CI, 0.91-1.22). CONCLUSION In this trial, the use of fresh RBCs compared with standard blood bank practicedid not improve outcomes in premature, very low-birth-weight infants requiring atransfusion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00326924;Current Controlled Trials Identifier: ISRCTN65939658.
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The effect of tranexamic acid used for spine surgery on blood loss and transfused volume Korean
Yoo TJ, Jeon SG, Lee S, Kim K-M, Yon JH, Hong KH
Anesthesia and Pain Medicine. 2009;4((02):):106-112.
Abstract
Background:In this randomized controlled study, we evaluate the effect of tranexamic acid on perioperative blood loss and transfused volume in patients undergoing spine surgery. Methods: We enrolled and randomly allocated 40 patients scheduled for spine surgery under general anesthesia to either tranexamic group or control group.Tranexamic acid was given to tranexamic group with loading dose 10 mg/kg for 15 minutes followed by continuous infusion at the rate of 1 mg/kg/h.In control group, equivalent volume of normal saline was given with the same manner and rate, until the end of procedure. We examined the total blood loss and transfused volume perioperatively. Also we evaluated hemoglobin, platelet, prothrombin time, partial thromboplastin time and thromboelastography before and after surgery. Results: The groups did not differ significantly. Intraoperative blood loss was 1,130.0 ± 563.9 (mean ± SD) ml in control group and 1,061.5 ± 509.7 ml in tranexamic group.Blood loss at postoperative 12 h and 24 h were 392.0 ± 222.0 ml, 466.0 ± 323.2 ml in control group and 158.5 ± 100.6 ml, 470.2 ± 232.7 ml in tranexamic group respectively.Transfused volumes at intraoperative and postoperative period were differing significantly (1,300.0 ± 7 09.3 ml, 800.0 ± 343.3 ml in control group compared to 1,020.0 ± 476.3 ml, 340.0 ± 325.0 ml in tranexamic group). Conclusions: Loading dose of 10 mg/kg tranexamic acid and followed infusion at 1 mg/kg/h reduce perioperative blood trans-fused volume during spinal surgery.
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The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design
Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, et al
Transfusion Medicine Reviews. 2009;23((1):):55-61.
Abstract
Despite recent trends in decreasing transfusion thresholds and the development of technologies designed to avoid allogeneic exposure, allogeneic red blood cell (RBC) transfusions remain an important supportive and life-saving measure for neonatal intensive care patients experiencing illness and anemia. Reluctantly, a number of laboratory and observational studies have indicated that the amount of time RBCs are stored can affect oxygen delivery to tissues. Consequently, older RBCs may result in higher rates of organ dysfunction, nosocomial infection, and lengths of stay. Because of such harmful effects, an evaluation of the association between age of blood and nosocomial infection and organ dysfunction is warranted. The aim of the study was to determine if RBCs stored for 7 days or less (fresh RBCs) compared to current standard transfusion practice decreases major nosocomial infection and organ dysfunction in neonates admitted to the neonatal intensive care unit and requiring at least one RBC transfusion. This study is a double-blind, multicenter, randomized controlled trial design. The trial will be an effectiveness study evaluating the effectiveness of stored vs fresh RBCs in neonates requiring transfusion. Neonatal patients requiring at least one unit of RBCs will be randomized to receive either (1) RBCs stored no longer than 7 days or (2) standard practice. The study was conducted in Canadian university-affiliated level III (tertiary) neonatal intensive care units. The primary outcome for this study will be a composite measure of major neonatal morbidities (necrotizing enterocolitis, retinopathy of prematurity, bronchopulmonary dysplasia, intraventricular hemorrhage, and mortality). Secondary outcomes include individual items of the composite measure and nosocomial infection (bacteremia, septic shock, and pneumonia). The sample size calculations have been estimated based on the formula for 2 independent proportions using an alpha of . 05, a (1-beta) of . 80, and a 10% noncompliance factor. The baseline rate for our composite measure is estimated to be 65% as indicated by the literature. Assuming a 15% absolute risk reduction with the use of RBCs stored 7 days or less, our estimated total sample size required will be 450 (225 patients per treatment arm). The Age of Red Blood Cells in Premature Infants (ARIPI) trial is registered at the US National Institutes of Health (ClinicalTrials. gov) no. NCT00326924 and current controlled trials ISRCTN65939658.
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Efficacy of Crosseal fibrin sealant (human) in rhytidectomy
Lee S, Pham AM, Pryor SG, Tollefson T, Sykes JM
Archives of Facial Plastic Surgery. 2009;11((1):):29-33.
Abstract
OBJECTIVE To examine the potential efficacy of Crosseal (the human protein, bovine component-free fibrin sealant) (OMRIX Biopharmaceuticals, Ltd, Brussels, Belgium) to reduce ecchymoses and hematoma formation in patients undergoing rhytidectomy. METHODS Before initiation of the study, approval was obtained from the US Food and Drug Administration for an Investigational New Drug Application and off-label use of Crosseal and from the Institutional Review Board of the University of California, Davis. Patients undergoing rhytidectomy with or without concomitant procedures were voluntarily enrolled without compensation in the study (N = 9). Patients were randomized according to which side of the rhytidectomy the tissue sealant was placed. In all patients in the study, 1 side of the rhytidectomy was treated with Crosseal; the other, untreated side was used as a control. Before closure of the skin, 2 mL of Crosseal was sprayed through a pressure regulator under the skin flap of the dissected area of the rhytidectomy only on 1 side. The skin was pretrimmed before placement and closed in standard fashion. A pressure dressing was left in place for 3 days before removal. Nine patients were originally enrolled in the study. On postoperative days 3 and 7, photographs were taken of the patients. The photographs were judged by 5 independent reviewers who were blinded as to which side had been treated with Crosseal. The judges rated the degree of ecchymoses on a scale of 1 (minimal) to 10 (severe) and were asked their opinion as to which side of the facelift had been treated with Crosseal. These results were compared using statistical analysis. Also on days 3 and 7, patients were examined for seroma or hematoma formation on each side of the face. RESULTS Our study demonstrated efficacy of Crosseal in reducing ecchymoses and swelling in all patients. The mean score for ecchymosis on the Crosseal-treated side was 4. 5 and on the untreated (control) side was 6. 2 (P < . 01, Wilcoxon rank sum test). The rate of hematoma or seroma formation was 22% (2 of 9 patients) for the untreated side vs 0% (0 of 9 patients) for the treated side. This did not reach statistical significance (P = . 43, Fisher exact test). Small hematomas developed in 2 patients on the control side, which were needle aspirated. There were no known long-term complications from either the use of Crosseal or the rhytidectomy. CONCLUSION Crosseal is efficacious in reducing ecchymoses after rhytidectomy.