Assuring quality in HPB surgery--efficacy and safety.
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ABSTRACT:
SUBMITTER: Maddern GJ
PROVIDER: S-EPMC2225509 | biostudies-other | 2007
REPOSITORIES: biostudies-other
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Project description:Purpose:To evaluate the clinical outcome following intraoperative transzonular intravitreal injection of triamcinolone acetonide and moxifloxacin in patients undergoing phacoemulsification cataract extraction with intraocular lens (IOL) implantation. Methods:In this prospective, non-randomized, clinical, interventional study, a total of 200 eyes were enrolled. Patients who voluntarily gave their consent after being informed about dropless cataract surgery along with its pros and cons were included. Those who had glaucoma or were known steroid responders as well as those who were lost to follow-up were excluded. 0.1 ml each of moxifloxacin (500 mg) and triamcinolone acetonide (4 mg) were injected transzonularly following IOL implantation in phacoemulsification cataract surgery with the help of 27G curved cannula. Slit-lamp examination was done to detect cells, visual acuity was noted, and intraocular pressure was measured postoperatively on day 1, 7, 30, 60, and 90. Results:Uncorrected visual acuity (UCVA) greater than 6/9 was achieved in 96% of patients at the end of 3 months. The mean IOP was found to be normal in all the cases at every visit. Twenty patients complained of floaters on postoperative day 1 (D1), which decreased to zero after 60 days (D60). None of the patients needed any eye drop during the entire postoperative period. Conclusion:The study demonstrates that this procedure is advantageous and safe.
| S-EPMC7508123 | biostudies-literature
Project description:Assessing the groundwater quality at a Saudi Arabian agricultural site and the occurrence of antibiotic-resistant opportunistic pathogens on irrigated food produce
| PRJEB9501 | ENA
Project description:PURPOSE:To evaluate the predictive factors for safety and efficacy in laser refractive surgery for myopia. SETTING:A singular refractive surgery center, at a University-affiliated tertiary medical center. DESIGN:Retrospective cohort study. METHODS:Study population-A total 8,775 eyes having laser refractive laser procedures for myopia (in4,623 patients). Observation procedures-Using a prospective database of refractive procedures performed over the span of 13 years, variables such as gender, age, type of surgery, date of surgery, pre-operative corneal thickness and Spherical Equivalent (SEQ) were evaluated. Main outcome measures-Proportion of patients with Safety index higher than 0.85 and Efficacy index higher than 0.80. RESULTS:91.9% and 86.0% of all evaluated eyes were above the safety and efficacy cut-off levels, respectively. Younger age was significantly correlated with safety and efficacy indices above the cut-off levels (p<0.001). Male gender was significantly correlated with efficacy above the cut-off level (p<0.001). Myopic eyes with lower SEQ were associated with both safety (p = 0.002) and efficacy (p<0.001) indices above the cut-offs. The surgical procedure was found to significantly affect the outcome only using univariate analysis: Safety was higher in Photorefractive Keratectomy (PRK), while Efficacy was higher in Laser Assisted In Situ Keratomileusis (LASIK) (p<0.001, respectively) but no difference was found using multivariate analysis. Safety index above the cut-off level increased over the years (p<0.001). CONCLUSIONS:Efficacy in refractive surgery for myopia is correlated with younger age, male gender and low myopia. Safety is correlated with younger age, low myopia and increases over the years. Multivariate analysis found no differences between PRK and LASIK regarding safety and efficacy.
| S-EPMC6294382 | biostudies-literature
Project description:BackgroundNeonates undergoing open-heart surgery are particularly at risk of postoperative bleeding requiring blood transfusion. Aprotinin has attained high efficacy in reducing the requirement for a blood transfusion following a cardiopulmonary bypass, but is seldom studied in the neonatal age group. The aim of this study was to compare the efficacy and adverse effects of aprotinin and tranexamic acid in neonates undergoing open-heart surgery at a single centre.MethodsBetween October 2003 and March 2008, perioperative data of 552 consecutive neonatal patients undergoing open-heart surgery in Children's Hospital Boston were reviewed. Among them, 177 did not receive antifibrinolytic therapy (Group A); 100 were treated with tranexamic acid only (Group B); and 275 patients received aprotinin with or without tranexamic acid (Group C). Except for antifibrinolytic therapy, the anaesthesiological and surgical protocols remained identical. Postoperative complications and in-hospital mortality were the primary study endpoints.ResultsBody weight and Risk Adjustment for Congenital Heart Surgery (RACHS-1) scores were statistically comparable among the three groups. No statistically significant differences were observed between the duration of hospitalization, chest tube drainage, reexploration for bleeding, and kidney function impairment. In Group C, less blood was transfused within 24 hours than in GroupB. Operative mortality was similar among the three groups.ConclusionNo further risk and kidney injury were observed in the use of aprotinin in neonatal cardiac surgery, aprotinin demonstrated a reduced requirement for blood transfusion compared with tranexamic acid. Our data provide reasonable evidence that aprotinin and tranexamic acid are safe and efficacious as antifibrinolytic modalities in neonatal patients undergoing cardiac surgery.
| S-EPMC4425500 | biostudies-literature
Project description:17 patients with myelofibrosis contributed paired research samples; the time points were pre-study and 12 weeks after commencing study treatment with CYT387.Gene expression analysis was investigated to study the effects of drug treatment. Additional analysis invesitigated differences in expression patterns in groups of anemia responders and non-responders following drug treatment. 34 samples representing 17 patients. Each patient submitted 1 pre-treatment sample and 1 post 12 weeks of treatment.
2013-01-14 | E-GEOD-40841 | biostudies-arrayexpress
Project description: Not available
| S-EPMC7303182 | biostudies-literature
Project description:PurposeSpine surgery, particularly reconstructive surgery, can be associated with significant blood loss, and blood transfusion. Antifibrinolytic agents are used routinely to reduce bleeding in cardiac, orthopaedic, and hepatic surgery. The purpose of this study was to assess the efficacy and safety of using antifibrinolytic agents in reducing blood loss and blood transfusions in spine surgery.MethodsA systematic search of all related studies written in English published by October 2012 was conducted using the MEDLINE, EMBASE and the Cochrane Library databases. Randomized controlled trials that reported the drug dosage, total blood loss, blood transfusion and incidence of deep vein thrombosis as the primary outcome were included.ResultsNine studies involving 482 patients were identified. Patients receiving antifibrinolytic agents had reduced blood loss (WMD =-288.8, 95 % CI - 46.49, - 110.19; P = 0.002), reduced blood transfusion (WMD =-242.7, 95 % CI - 422.57, - 62.95; P = 0.008), reduced blood transfusion rate (RR 0.73, 95% CI 0.58, 0.93; p = 0.010) and no increase (RR 0.25, 95 % CI 0.03, 2.22; P = 0.21) in the risk of deep vein thrombosis.ConclusionsWe conclude that antifibrinolytic agents significantly decrease blood loss, blood transfusion, and there is no increase in the risk of deep vein thrombosisfor transfusion requirements in spine surgery.
| S-EPMC3838357 | biostudies-literature
Project description:ContextTranssphenoidal surgery is standard care in the treatment of hormone-secreting pituitary adenomas. Current clinician-reported surgical outcome measures are one-dimensional, typically focusing primarily on complete or partial resection, and secondarily on complication rates. However, outcomes are best reflected by the delicate balance of efficacy and complications at patient level.ObjectiveThis study proposes a novel way to classify and report outcomes, integrating efficacy and safety at the patient level.MethodsRetrospective chart review of all pure endoscopic transsphenoidal surgical procedures for acromegaly, Cushing's disease, and prolactinoma between 2010 and 2018 in a single tertiary referral center. We present our results in a classic (remission and complications separate) and in a novel outcome square integrating both outcomes, focusing on intended and adverse effects (long-term complications). This resulted in 4 outcome groups, ranging from good to poor. We use this approach to present these outcomes for several subgroups.ResultsA total of 198 surgical procedures were included (44 reoperations). Remission was achieved in 127 operations (64%). Good outcome was observed after 121 (61%), and poor outcome after 6 (3%) operations. When intended effect of surgery was applied (instead of remission), good outcome as intended was achieved after 148 of 198 surgeries (75%) and poor outcome after 4 (2%).ConclusionQuality of a surgical intervention can be presented in 4 simple categories, integrating both efficacy and safety with flexibility to adapt to the individualized situation at patient, disease, and surgical strategy and to the outcome of interest.
| S-EPMC8372644 | biostudies-literature
Project description:BackgroundSignificant blood loss is still one of the most frequent complications in spinal surgery, which often necessitates blood transfusion. Massive perioperative blood loss and blood transfusion can create additional risks. Aprotinin, tranexamic acid (TXA), and epsilon-aminocaproic acid (EACA) are antifibrinolytics currently offered as prophylactic agents to reduce surgery-associated blood loss. The aim of this study was to evaluate the efficacy and safety of aprotinin, EACA, and low/high doses of TXA in spinal surgery, and assess the use of which agent is the most optimal intervention using the network meta-analysis (NMA) method.MethodsFive electronic databases were searched, including PubMed, Cochrane Library, ScienceDirect, Embase, and Web of Science, from the inception to March 1, 2018. Trials that were randomized and compared results between TXA, EACA, and placebo were identified. The NMA was conducted with software R 3.3.2 and STATA 14.0.ResultsThirty randomized controlled trial (RCT) studies were analyzed. Aprotinin (standardized mean difference [SMD]=-0.65, 95% credibility intervals [CrI;-1.25, -0.06]), low-dose TXA (SMD = -0.58, 95% CrI [-0.92, -0.25]), and high-dose TXA (SMD = -0.70, 95% CrI [-1.04, -0.36]) were more effective than the respective placebos in reducing intraoperative blood loss. Low-dose TXA (SMD = -1.90, 95% CrI [-3.32, -0.48]) and high-dose TXA (SMD = -2.31, 95% CrI [-3.75, -0.87]) had less postoperative blood loss. Low-dose TXA (SMD = -1.07, 95% CrI [-1.82, -0.31]) and high-dose TXA (SMD = -1.07, 95% CrI [-1.82, -0.31]) significantly reduced total blood loss. However, only high-dose TXA (SMD = -2.07, 95% CrI [-3.26, -0.87]) was more effective in reducing the amount of transfusion, and was significantly superior to low-dose TXA in this regard (SMD = -1.67, 95% CrI [-3.20, -0.13]). Furthermore, aprotinin (odds ratio [OR] = 0.16, 95% CrI [0.05, 0.54]), EACA (OR = 0.46, 95% CrI [0.22, 0.97]) and high dose of TXA (OR = 0.34, 95% CrI [0.19, 0.58]) had a significant reduction in transfusion rates. Antifibrinolytics did not show a significantly increased risk of postoperative thrombosis. Results of ranking probabilities indicated that high-dose TXA had the greatest efficacy and a relatively high safety level.ConclusionsThe antifibrinolytic agents are able to reduce perioperative blood loss and transfusion requirement during spine surgery. And the high-dose TXA administration might be used as the optimal treatment to reduce blood loss and transfusion.
| S-EPMC6416000 | biostudies-literature
Project description:ImportancePostoperative packing in nasal surgery often results in nasal obstruction and discomfort. Commercially available silicone intranasal airways (IAs) serve as dual-nasal airway tubes aimed at alleviating this process, but the safety and efficacy of these devices are unknown.ObjectiveTo evaluate the safety and efficacy of an intraoperatively placed IA device in rhinoplasty and nasal surgery.Design, setting, and participantsIn this retrospective record review, the medical records of patients undergoing nasal surgery with insertion of the IA at a single institution from 2012 to 2017 were reviewed. After review of over 200 patients, a questionnaire was developed to assess device efficacy.ExposuresUse of the IA device. The IA is 12 cm long, anchored across the columella, extends distally along the nasal floor, and has a proximal external portion used for cleaning and maintaining patency. Placed intraoperatively, the device aims to support air flow postoperatively in the face of edema, hemorrhage, and packing.ResultsA total of 302 operations in 300 patients were analyzed, including primary and revision septorhinoplasty. A total of 24 (7.9%) patients self-removed or inadvertently dislodged the IA. Minor acute postoperative complications not unique to airway insertion included cellulitis in 4 (1.3%) participants and epistaxis in 6 (2%). Postoperatively, 1 (0.3%) patient developed dehiscence along transcolumellar incisions. A total of 59 patients (100% compliance) completed the efficacy questionnaire. The mean breathing score was between good and average (2.9 of 5), comfort scores between comfortable and average (2.9 of 5), and mean ease of irrigation score was between very easy and easy (1.96 of 5). The device was irrigated on average 3.57 times per day. A total of 43 (76%) particpiants had full patency or only partial obstruction, compared with 13 (24%) patients with total obstruction. In all patients, with or without obstruction, the effect lasted an average of 4 days.Conclusions and relevanceThe device is safe and well-tolerated for maintaining patency of the nasal airway in patients undergoing rhinoplasty and nasal reconstruction without increased risk of incisional dehiscence.Level of evidence4.
| S-EPMC6439732 | biostudies-literature