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Prospective Randomized Comparison (prospective + randomized_comparison)
Selected AbstractsMicrodebriders Used in Functional Endoscopic Sinus Surgery: Secondary Analysis and Validation of a New Tissue Model,THE LARYNGOSCOPE, Issue 9 2005Sandeep P. Dave MD Abstract Objectives/Hypothesis: To validate a previously reported in vitro tissue model for microdebrider comparison and determine which microdebrider, tissue type, blade type, and suction strength is most efficient. Specifically, the goal of the secondary analysis is to expand on the results of the preliminary analy-sis by increasing the sample size, and introduce an aspiration efficiency score (AES) to facilitate microdebrider comparison. Study Design: Prospective randomized comparison. Methods: A prospective randomized comparison of the Diego Powered Dissector and XPS 3000 Powered ENT System was conducted using a soft tissue and a firm tissue model. In addition to evaluating tissue aspiration with straight and angled blades, clogging rates and clearance times were measured. Both standard wall suction and liposuction were used. Basic statistical analysis, a one-way analysis of variance, and a post hoc Student's t test were performed to compare outcomes. Results: With standard wall suction, the microdebriders were equivalent for the overall microdebrider comparison. For the "head to head" comparison with standard wall suction, the devices were also equivalent when using the straight blades, but the XPS 3000 aspirated more tissue when using the angled blades. With liposuction, the XPS 3000 and liposuction independently aspirated more tissue but clogged more often compared with the Diego PD and regular suction. The aspiration efficiency of soft tissue (oysters) and straight blades was superior compared with firm tissue (scallops) and angled blades. For the "head to head" comparison with liposuction, the XPS 3000 aspirated more tissue regardless of tissue type, but the Diego PD clogged less with firm tissue (scallops). Overall, the AES favored the XPS 3000, soft tissue (oysters), straight blades, and liposuction. Conclusion: Our tissue model represents a reliable and reproducible means of microdebrider comparison. Statistically significant differences between the Diego PD and XPS 3000, as well as between tissue types, blade types, and suction strengths, are reported. Using these results, microdebrider manufacturers can adopt similar tissue models, expand on the current AES, and include other commercially available microdebrider devices to test and report product performance to the consumer. Perhaps an optimal open to closed ratio or liposuction pressure can be determined that yields the greatest tissue aspiration with the fewest number of clogs. [source] Prospective randomized comparison of endobutton versus cross-pin femoral fixation in hamstring anterior cruciate ligament reconstruction with 2-year follow-upANZ JOURNAL OF SURGERY, Issue 3 2010Rohan Price Abstract Background:, To determine if there is a different clinical outcome after TransFix versus endobutton femoral fixation in hamstring anterior cruciate ligament (ACL) reconstruction. Methods:, Twenty-nine patients were randomized into either Endobutton (Smith & Nephew, Andover, MA, USA) (n= 13) or TransFix (Arthrex, Naples, FL, USA) (n= 16) femoral fixation in hamstring ACL reconstruction. The distal fixation was with a bioabsorbable interference screw. The evaluation methods were clinical history and examination, KT1000 arthrometry for laxity as well as the International Knee Documentation Committee (IKDC) scores over a 2-year time frame. Results:, There were no significant differences between the study groups preoperatively. For the 2-year follow-up, 11 patients in the Endobutton group and 13 patients in the TransFix group were available (greater than 80%). No statistical differences between the two groups were found at the 1- or 2-year follow-up examinations. At the 2-year follow-up, 72.7% of the Endobutton and 84.6% of the TransFix group patients were in the IKDC A or B categories. Additional procedures postoperatively occurred more frequently in the TransFix group. Conclusions:, There were no significant differences in the results for either technique of femoral fixation. Level of Evidence:, Level I. [source] Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care , prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mgALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009A. EGGLESTON Summary Background, A trial of empirical PPI therapy is usual practice for most patients with symptoms of gastro-oesophageal reflux disease (GERD) in primary care. Aim, To determine if the 4-week efficacy of rabeprazole 20 mg for resolving heartburn and regurgitation symptoms is non-inferior to esomeprazole 40 mg or 20 mg. Methods, In all, 1392 patients were randomized to rabeprazole 20 mg, esomeprazole 20 mg or 40 mg once daily. Patients, doctors and assessors were blinded. Symptom resolution data were collected on days 0,7 and day-28 using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index with a shortened version used on days 8,27. Results, Rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete resolution of regurgitation and satisfactory resolution of heartburn and regurgitation. For complete heartburn resolution, the efficacy of rabeprazole 20 mg and esomeprazole 40 mg was statistically indistinguishable, although the non-inferiority test was inconclusive. Rabeprazole 20 mg was non-inferior to esomeprazole 20 mg for all outcomes. Conclusions, In uninvestigated GERD patients, rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete and satisfactory relief of regurgitation and satisfactory relief of heartburn, and not different for complete resolution of heartburn. [source] Microdebriders Used in Functional Endoscopic Sinus Surgery: Secondary Analysis and Validation of a New Tissue Model,THE LARYNGOSCOPE, Issue 9 2005Sandeep P. Dave MD Abstract Objectives/Hypothesis: To validate a previously reported in vitro tissue model for microdebrider comparison and determine which microdebrider, tissue type, blade type, and suction strength is most efficient. Specifically, the goal of the secondary analysis is to expand on the results of the preliminary analy-sis by increasing the sample size, and introduce an aspiration efficiency score (AES) to facilitate microdebrider comparison. Study Design: Prospective randomized comparison. Methods: A prospective randomized comparison of the Diego Powered Dissector and XPS 3000 Powered ENT System was conducted using a soft tissue and a firm tissue model. In addition to evaluating tissue aspiration with straight and angled blades, clogging rates and clearance times were measured. Both standard wall suction and liposuction were used. Basic statistical analysis, a one-way analysis of variance, and a post hoc Student's t test were performed to compare outcomes. Results: With standard wall suction, the microdebriders were equivalent for the overall microdebrider comparison. For the "head to head" comparison with standard wall suction, the devices were also equivalent when using the straight blades, but the XPS 3000 aspirated more tissue when using the angled blades. With liposuction, the XPS 3000 and liposuction independently aspirated more tissue but clogged more often compared with the Diego PD and regular suction. The aspiration efficiency of soft tissue (oysters) and straight blades was superior compared with firm tissue (scallops) and angled blades. For the "head to head" comparison with liposuction, the XPS 3000 aspirated more tissue regardless of tissue type, but the Diego PD clogged less with firm tissue (scallops). Overall, the AES favored the XPS 3000, soft tissue (oysters), straight blades, and liposuction. Conclusion: Our tissue model represents a reliable and reproducible means of microdebrider comparison. Statistically significant differences between the Diego PD and XPS 3000, as well as between tissue types, blade types, and suction strengths, are reported. Using these results, microdebrider manufacturers can adopt similar tissue models, expand on the current AES, and include other commercially available microdebrider devices to test and report product performance to the consumer. Perhaps an optimal open to closed ratio or liposuction pressure can be determined that yields the greatest tissue aspiration with the fewest number of clogs. [source] Radioimmunotherapy of small-volume disease of metastatic colorectal cancerCANCER, Issue S4 2002Results of a phase II trial with the iodine-13, carcinoembryonic antigen antibody hMN-1, labeled humanized anti Abstract BACKGROUND Whereas radioimmunotherapy (RIT) has shown disappointing results in bulky, solid tumors, preclinical results in small-volume disease and in an adjuvant setting are promising. In a previous Phase I study, the authors had encouraging results with the iodine-131 (131I),labeled humanized anti,carcinoembryonic antigen (anti-CEA) antibody (MAb) hMN-14 in small-volume disease of colorectal cancer. The aim of this study was to evaluate, in a subsequent Phase II trial, the therapeutic efficacy of this 131I-labeled humanized anti-CEA antibody in colorectal cancer patients with small-volume disease or in an adjuvant setting. METHODS Thirty colorectal cancer patients, with small-volume metastatic disease (n = 21; all lesions , 3.0 cm, and chemorefractory to 5-fluorouracil and folinic acid) or in an adjuvant setting (n = 9), 4,6 weeks after surgical resection of liver metastases with curative intention, were studied. The patients were given a single injection of 131I-hMN-14 immunoglobulin G at a 60 mCi/m2 dose level, which was shown to be the maximum tolerated dose in the previous Phase I study. Follow-up was obtained at 3-month intervals for as long as 36 months. RESULTS At a mean blood-based red marrow dose of 1.8 ± 0.8 Gy, myelotoxicity was the only toxicity observed, but only 1 of 28 assessable patients developed transient Grade 4 thrombocytopenia. Of the 21 patients with radiologically documented lesions, 19 were assessable. Three experienced partial remission and eight showed minor responses up to 15 months in duration (corresponding to an objective response rate of 16% and an overall response rate of 58%; the mean duration of response was 9 months). At the time this article was written, seven of nine patients in the adjuvant setting had remained free of disease for up to 36 months (one patient relapsed after 6 months and another after 30 months), whereas the relapse rate in a historical control group receiving chemotherapy was 67% over the same time period. Five patients with radiologically documented lesions, having experienced at least disease stabilization as a consequence of RIT, were retreated at the same 60-mCi/m2 dose level at 8,16 months after the first therapy. No evidence of increased toxicity was observed (no hematologic toxicity was higher than Grade 3). Two of four assessable retreated patients experienced partial remissions; one of these four again experienced disease stabilization as a consequence of the second radioantibody therapy injection. CONCLUSIONS These data suggest that RIT is a safe and effective form of therapy for small-volume colorectal cancer and has potential as treatment for colorectal cancer in an adjuvant setting. Toxicity is restricted to mild and transient leuko- and thrombocytopenia. Retreatment seems to be a feasible option. A prospective randomized comparison with standard chemotherapy is indicated. Cancer 2002;94:1373,81. © 2002 American Cancer Society. DOI 10.1002/cncr.10308 [source] Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents: The TAXi-LATE trialCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2007Alexandre Berger MD Abstract Goal: Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation. History: The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial. Method: During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months. Results: No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P = 0.98) or in major adverse cardiac event free survival (89% vs. 83%, P = 0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days). Conclusion: The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis. © 2007 Wiley-Liss, Inc. [source] | ||||||||||