Home  About us  Contact
 

Randomized Comparison (randomized + comparison)

Distribution by Scientific Domains
Medical Sciences96%
Distribution within Medical Sciences
Cardiovascular Disease45%
Surgery & Surgical Specialties8%
11 Other Subdomains47%

Kinds of Randomized Comparison

  • prospective randomized comparison
    		•

    Selected Abstracts

    Survey Conditioning in Self-Reported Mental Health Service Use: Randomized Comparison of Alternative Instrument Formats

    HEALTH SERVICES RESEARCH, Issue 2 2007
    Naihua Duan
    Objective. To test the effect of survey conditioning (whether observed survey responses are affected by previous experience in the same survey or similar surveys) in a survey instrument used to assess mental health service use. Data Sources. Primary data collected in the National Latino and Asian American Study, a cross-sectional household survey of Latinos and Asian Americans residing in the United States. Study Design. Study participants are randomly assigned to a Traditional Instrument with an interleafed format placing service use questions after detailed questions on disorders, or a Modified Instrument with an ensemble format screening for service use near the beginning of the survey. We hypothesize the ensemble format to be less susceptible to survey conditioning than the interleafed format. We compare self-reported mental health services use measures (overall, aggregate categories, and specific categories) between recipients of the two instruments, using 2 × 2 ,2 tests and logistic regressions that control for key covariates. Data Collection. In-person computer-assisted interviews, conducted in respondent's preferred language (English, Spanish, Mandarin Chinese, Tagalog, or Vietnamese). Principal Findings. Higher service use rates are reported with the Modified Instrument than with the Traditional Instrument for all service use measures; odds ratios range from 1.41 to 3.10, all p -values <.001. Results are similar across ethnic groups and insensitive to model specification. Conclusions. Survey conditioning biases downward reported mental health service use when the instrument follows an interleafed format. An ensemble format should be used when it is feasible for measures that are susceptible to survey conditioning. [source]

    Randomized Comparison Between Open Irrigation Technology and Intracardiac-Echo-Guided Energy Delivery for Pulmonary Vein Antrum Isolation: Procedural Parameters, Outcomes, and the Effect on Esophageal Injury

    JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 6 2007
    NASSIR F. MARROUCHE M.D.
    Introduction: We performed a prospective study to compare efficacy and safety of both open irrigation tip (OIT) technology with intracardiac echo (ICE)-guided energy delivery in patients presenting for PVAI. Methods and Results: Fifty-three patients presenting for PVAI were randomized to ablation using an OIT catheter (Group 1, 26 patients; temperature and power were set at 50° and 50 W, respectively, with a saline pump flow rate of 30 mL/min) or radiofrequency (RF) energy delivery under ICE guidance (Group 2, 27 patients; energy was titrated based on microbubbles formation). The mean procedure time and fluoroscopy exposure were lower in Group 1 (164 ± 42 min and 7,560 ± 2,298 ,Graym2 vs 204 ± 47 min and 12,240 ± 4,356 ,Graym2; P = 0.005 and 0.008, respectively). Moreover, the durations of RF lesions applied per PV antrum was lower in Group 1 compared with Group 2 (5.1 ± 2.2 min vs 9.2 ± 3.2 min, P = 0.03, respectively). Within 24 hours after PVAI in 35.7% (all erythema) of Group 1 and 57.1% (21.4% erythema and 35.7% necrosis) of Group 2, patients' esophageal wall changes were documented. After 14 ± 2 months of follow up, recurrences were documented in 19.2% of Group 1 and 22.2% of Group 2 patients. Conclusion: Although both OIT and ICE-guided energy delivery possess a similar effect in treating AF, OIT seems to be superior in terms of achieving isolation and shortening fluoroscopy exposure. Moreover, a lower incidence of esophageal wall injury was observed utilizing OIT for PVAI. [source]

    Achievement of Pulmonary Vein Isolation in Patients Undergoing Circumferential Pulmonary Vein Ablation: A Randomized Comparison Between Two Different Isolation Approaches

    JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 12 2006
    XINGPENG LIU M.D.
    Introduction: Circumferential pulmonary vein ablation (CPVA) with the endpoint of pulmonary vein (PV) isolation has been developed as an effective therapy for atrial fibrillation (AF). This endpoint can be achieved either by closing gaps along circular lines or by segmental PV isolation inside the circular lines after creation of initial CPVA lesions. We investigated whether the clinical outcome depends on the PV isolation approach used during the first-time CPVA procedure. Methods and Results: One hundred consecutive patients (69 male; age, 56.7 ± 11.6 years) who underwent first-time CPVA for treatment of symptomatic AF were enrolled. PV isolation was randomly achieved either by CPVA alone (aggressive CPVA [A-CPVA] group, n = 50) or by a combination of CPVA with segmental PV ostia ablation (modified CPVA [M-CPVA] group, n = 50). Recurrence of atrial tachyarrhythmias (ATa) within 3 months after the initial procedure occurred in 30 patients (60%) in the M-CPVA group and in only 15 patients (30%) in the A-CPVA group (P < 0.01). ATa relapse after the first 3 months was detected in 21 patients (42%) in the M-CPVA group, compared with 9 patients (18%) in the A-CPVA group (P = 0.01). At 13 ± 4 months, patients treated by the A-CPVA approach had greater freedom from ATa recurrence than patients who underwent M-CPVA (P = 0.01). The M-CPVA approach was the only independent predictor associated with procedural failure (RR 0.318; 95% CI 0.123,0.821; P = 0.02). Conclusions: When PV isolation is the endpoint of CPVA, the efficacy of the A-CPVA approach is better than that of M-CPVA. [source]

    Randomized Comparison of Bipolar versus Unipolar Plus Bipolar Recordings During Segmental Ostial Ablation of Pulmonary Veins

    JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 9 2002
    HIROSHI TADA M.D.
    Unipolar vs Bipolar Electrograms.Introduction: Segmental ostial ablation to isolate pulmonary veins is guided by pulmonary vein potentials. The aim of this prospective randomized study was to compare the utility of unipolar plus bipolar electrograms versus only bipolar electrograms as a guide for segmental ablation to isolate the pulmonary veins in patients with atrial fibrillation. Methods and Results: Isolation of the left superior, right superior, and left inferior pulmonary veins was attempted in 44 patients (35 men and 9 women; mean age 54 ± 10 years) with paroxysmal atrial fibrillation. A decapolar Lasso catheter was positioned in the pulmonary veins, near the ostium, and a conventional ablation catheter was used for segmental ablation aimed at elimination of all pulmonary vein potentials. One hundred fourteen pulmonary veins were randomly assigned for ostial ablation guided by either bipolar or unipolar plus bipolar recordings. Electrical isolation was achieved in 51 (96%) of 53 pulmonary veins randomized to the bipolar approach, and 57 (93%) of 61 pulmonary veins randomized to the unipolar plus bipolar approach (P = 0.7). In the unipolar plus bipolar group, the total duration of radiofrequency energy needed to achieve isolation, 5.5 ± 2.8 minutes/vein, was significant shorter than in the bipolar group, 7.6 ± 4.1 minutes/vein (P < 0.01). Mean procedure and fluoroscopy durations per vein were 19% to 28% shorter in the unipolar plus bipolar group. Conclusion: Segmental ostial ablation to isolate the pulmonary veins can be achieved more efficiently and with less radiofrequency energy when guided by both unipolar and bipolar recordings than by bipolar recordings alone. [source]

    Catheter Ablation for Paroxysmal Atrial Fibrillation: A Randomized Comparison between Multielectrode Catheter and Point-by-Point Ablation

    PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 9 2010
    ALAN BULAVA M.D., Ph.D.
    Introduction:,Catheter ablation for paroxysmal atrial fibrillation is widely used for patients with drug-refractory paroxysms of arrhythmia. Recently, novel technologies have been introduced to the market that aim to simplify and shorten the procedure. Aim:,To compare the clinical outcome of pulmonary vein (PV) isolation using a multipolar circular ablation catheter (PVAC group), with point-by-point PV isolation using an irrigated-tip ablation catheter and the CARTO mapping system (CARTO group; CARTO, Biosense Webster, Diamond Bar, CA, USA). Methods:,Patients with documented PAF were randomized to undergo PV isolation using PVAC or CARTO. Atrial fibrillation (AF) recurrences were documented by serial 7-day Holter monitoring. Results:,One hundred and two patients (mean age 58 ± 11 years, 68 men) were included in the study. The patients had comparable baseline clinical characteristics, including left atrial dimensions and left ventricular ejection fraction, in both study arms (PVAC: n = 51 and CARTO: n = 51). Total procedural and fluoroscopic times were significantly shorter in the PVAC group (107 ± 31 minutes vs 208 ± 46 minutes, P < 0.0001 and 16 ± 5 minutes vs 28 ± 8 minutes, P < 0.0001, respectively). The AF recurrence was documented in 23% and 29% of patients in the PVAC and CARTO groups, respectively (P = 0.8), during the mean follow-up of 200 ± 13 days. No serious complications were noted in both study groups. Conclusions:,Clinical success rates of PV isolation are similar when using multipolar circular PV ablation catheter and point-by-point ablation with a three-dimensional (3D) navigation system in patients with PAF, and results in shorter procedural and fluoroscopic times with a comparable safety profile. (PACE 2010; 33:1039,1046) [source]

    Percutaneous Balloon Valvuloplasty Versus Surgery: Randomized Comparisons

    JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2000
    ZOLTAN G. TURI M.D.
    [source]

    Randomized comparison of the SLIPA (Streamlined Liner of the Pharynx Airway) and the SS-LM (Soft Seal Laryngeal Mask) by medical students

    EMERGENCY MEDICINE AUSTRALASIA, Issue 5-6 2006
    Cindy Hein
    Abstract Objective:, The aim of the study was to compare the Streamlined Liner of the Pharynx Airway (SLIPA; Hudson RCI), a new supraglottic airway device, with the Soft Seal Laryngeal Mask (SS-LM; Portex) when used by novices. Methods:, Thirty-six medical students with no previous airway experience, received manikin training in the use of the SLIPA and the SS-LM. Once proficient, the students inserted each device in randomized sequence, in two separate patients in the operating theatre. Only two insertion attempts per patient were allowed. Students were assessed in terms of: device preference; success or failure; success at first attempt and time to ventilation. Results:, Sixty-seven per cent of the students preferred to use the SLIPA (95% confidence interval 49,81%). The SLIPA was successfully inserted (one or two attempts) in 94% of patients (34/36) and the SS-LM in 89% (32/36) (P = 0.39). First attempt success rates were 83% (30/36) and 67% (24/36) in the SLIPA and SS-LM, respectively (P = 0.10). Median time to ventilation was shorter with the SLIPA (40.6 s) than with the SS-LM (66.9 s) when it was the first device used (P = 0.004), but times were similar when inserting the second device (43.8 s vs 42.9 s) (P = 0.75). Conclusions:, In the present study novice users demonstrated high success rates with both devices. The SLIPA group achieved shorter times to ventilation when it was the first device they inserted, which might prove to be of clinical significance, particularly in resuscitation attempts. Although the Laryngeal Mask has gained wide recognition for use by both novice users and as a rescue airway in failed intubation, the data presented here suggest that the SLIPA might also prove useful in these areas. [source]

    Randomized comparison of dry tablet insertion versus gel form of vaginal misoprostol for second trimester pregnancy termination

    JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 2 2008
    Saipin Pongsatha
    Abstract Aim:, To compare the effectiveness of vaginal misoprostol between dry tablet insertion and gel form for second trimester pregnancy termination. Methods:, A non-blinded block randomized controlled trial was conducted on 148 pregnant women with live fetuses in the second trimester undergoing pregnancy termination. They were randomly allocated to receive vaginal misoprostol (400 ,g) either dry tablet insertion (n = 72) or gel form (n = 76). The same dose was then repeated every 3 h if adequate uterine contraction was not achieved until 48 h after the initiation of misoprostol. If abortion did not occur within this period, the treatment was considered a failure and other technique of termination was then given based on the decision of the attending physicians and the cervical status. Results:, The mean induction,abortion interval in group 1 (20.9 ± 12.3 h) was not significantly different from that in group 2 (17.7 ± 10.2 h). The mean total dose of misoprostol was also not significantly different between the two groups (group 1, 1556.9 ,g; group 2, 1350.9 ,g), but the adverse effects of misoprostol (chill and diarrhoea) were more common in the gel group. Conclusion:, Tablet insertion or gel form of vaginal misoprostol have similar effectiveness but the gel form was associated with more common adverse effects. [source]

    Randomized comparison of vasoseal and angioseal closure devices in patients undergoing coronary angiography and angioplasty

    CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2002
    Nicolas W. Shammas MD
    Abstract AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t -test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 ± 4.36 vs. 18.59 ± 11.77; P = 0.30) and ambulation (145.71 ± 124 vs. 109.89 ± 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 ± 12.70 vs. 19.57 ± 2.27; P = 0.077) and ambulation (607.32 ± 344.22 vs. 486.48 ± 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty. Cathet Cardiovasc Intervent 2002;55:421,425. © 2002 Wiley-Liss, Inc. [source]

    Autologous Cultured Fibroblast Injection for Facial Contour Deformities: A Prospective, Placebo-Controlled, Phase III Clinical Trial

    DERMATOLOGIC SURGERY, Issue 3 2007
    ROBERT A. WEISS MD
    BACKGROUND Previous data indicate that injections of autologous fibroblasts increase collagen formation, accompanied by a concomitant increase in thickness and density of dermal collagen. OBJECTIVE The purpose of this study was to determine efficacy and side effects of autologous living fibroblast injections versus placebo in a randomized Phase III trial for the treatment of various facial contour defects. METHODS This was a double-blind, randomized comparison of injectable living autologous fibroblast cells and placebo for the treatment of facial contour defects (N=215). Live fibroblasts (20 million/mL) or placebo (the transport medium without living cells) were given as three doses administered at 1- to 2-week intervals. Efficacy evaluations were performed 1, 2, 4, 6, 9, and 12 months after the first injection. RESULTS Living fibroblasts produced statistically significantly greater improvements in dermal deformities and acne scars than did placebo. The difference between live fibroblast injections and placebo achieved statistical significance at 6 months (p<.0001). At 9- and 12-month follow-up, live fibroblast,treated patients continued to demonstrate benefit from treatment with response rates of 75.0 and 81.6%, respectively. No serious treatment-related adverse events were reported. CONCLUSIONS Our results indicate that autologous fibroblast injections can safely and effectively produce improvements in rhytids, acne scars, and other dermal defects continuing for at least 12 months after injection. [source]

    A randomized comparison of cognitive behavioral therapy and behavioral weight loss treatment for overweight individuals with binge eating disorder

    INTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 2 2007
    Simone Munsch PhD
    Abstract Objectives: The aim of this study was to determine the efficacy of cognitive-behavioral therapy (CBT) and behavioral weight loss treatment (BWLT) for overweight patients with binge eating disorder (BED). Method: Eighty obese patients meeting criteria of BED according to DSM-IV-TR were randomly assigned to either CBT or BWLT consisting of 16 weekly treatments and 6 monthly follow-up sessions. Binge eating, general psychopathology, and body mass index (BMI) were assessed before, during, and after treatment, and at 12-month follow-up. Results: At posttreatment results favored CBT as the more effective treatment. Analysis of the course of treatments pointed to a faster improvement of binge eating in CBT based on the number of self-reported weekly binges, but faster reduction of BMI in BWLT. At 12-month follow-up, no substantial differences between the two treatment conditions existed. Conclusion: CBT was somewhat more efficacious than BWLT in treating binge eating but this superior effect was barely maintained in the long term. Further research into cost effectiveness is needed to assess which treatment should be considered the treatment of choice. © 2006 by Wiley Periodicals, Inc. Int J Eat Disord 2006 [source]

    A randomized comparison of plateletpheresis with the same donors using four blood separators at a single blood center,

    JOURNAL OF CLINICAL APHERESIS, Issue 4 2002
    Grace C. Tenorio
    Abstract At one blood center, each of 20 donors underwent plateletpheresis on four blood cell separators in random order. We compared the CS3000+, Amicus V 2.41, MCS Plus, and Spectra LRS V 7 Turbo regarding platelet (PLT) yield, pre- and post-procedure PLT counts, percent fall in donor PLT count, process time, efficiency, PLT product and donor PLT volume (MPV). Using , 150 × 109 PLTs/L pre-donation counts, a goal was set of 4.5 × 1011 PLTs unit in up to 100 minutes processing time. Results were (mean values) PLT yields of Amicus, Spectra, CS3000+, and MCS Plus: 4.3, 4.6, 4.3, 4.0 × 1011 PLTS, respectively; percent donor PLT fall: 24, 32, 30, 29%, respectively; processing times: 50, 74, 87, 101 minutes, respectively; relative efficiency (RE): 2.2, 1.6, 1.2,1.0, respectively (based on the MCS Plus performance with RE of 1 = 4 × 109 PLTS/min); PLT product MPV: 6.7, 7.4, 6.8,7.1 fL, respectively; pre-procedure donor MPV: 7.7, 7.3, 7.6 and 7.6 fL, respectively; and percent donor MPV change: ,5.2, 0, ,6.6, and ,10%, respectively. Significant changes in the donor MPV were noted (P < 0.05) but could not be related to product MPV. Spectra seemed to collect larger PLTs (higher MPV); the significance remains unknown for both donors and recipients. Importantly, all four separators gave acceptable and comparable PLT yields (P < 0.05) with Spectra trending higher. The short process time and high RE together indicate highly efficient collections particularly by Amicus and Spectra. J. Clin. Apheresis 17:170,176, 2002. © 2002 Wiley-Liss, Inc. [source]

    Oral surgery in patients on oral anticoagulant therapy: a randomized comparison of different INR targets

    JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 3 2006
    R. SACCO
    [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 mg

    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009
    A. 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]

    A randomized comparison of post-operative pain, quality of life, and physical performance during the first 6 weeks after abdominal or vaginal surgical correction of descensus uteri

    NEUROUROLOGY AND URODYNAMICS, Issue 4 2005
    J.P.W.R. Roovers
    Abstract Aims With respect to urogenital function, vaginal hysterectomy combined with anterior and/or posterior colporraphy has been shown to be superior to abdominal sacrocolpopexy with preservation of the uterus. We performed a randomized trial to compare the effects of both procedures on pain, quality of life and physical performance during the first six weeks after surgery. Methods Eighty-two patients were randomized to have surgery either by vaginal or abdominal approach. All patients were asked to complete the RAND-36 before surgery and 6 weeks after surgery and to keep a diary for the first 6 weeks after surgery. This diary assessed the pain perception and use of pain medication, bother of limitations due to the surgery and performance of daily activities after surgery. These outcomes were compared. Results All patients completed the RAND-36 and 68 patients completed the diary. Patients who had undergone abdominal surgery had a statistically lower score on the health change domain (56 vs 68), bodily pain domain (63 vs 80) and mental health domain (74 vs 81) of the RAND-36, as compared to patients who had undergone vaginal prolapse surgery. During hospital stay, the abdominal group experienced on average more days of pain (4.5 vs 3.0) and impaired mobility (3.7 vs 2.9) as compared to the vaginal group. Patients received more pain medication following abdominal surgery as compared to vaginal surgery. Conclusions The vaginal operation to correct a descensus uteri is associated with less pain, better quality of life and better mobility during the first 6 weeks of the recovery period as compared to the abdominal approach. Neurourol. Urodynam. © 2005 Wiley-Liss, Inc. [source]

    Microdebriders Used in Functional Endoscopic Sinus Surgery: Secondary Analysis and Validation of a New Tissue Model,

    THE LARYNGOSCOPE, Issue 9 2005
    Sandeep 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-up

    ANZ JOURNAL OF SURGERY, Issue 3 2010
    Rohan 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]

    Prosthetic femoropopliteal bypass: randomized comparison of polytetrafluoroethylene and heparin-bonded Dacron

    BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 4 2000
    C. Devine
    Background: Dacron was largely abandoned for femoropopliteal bypass 30 years ago as saphenous vein achieved better patencies. As patency in prosthetic above-knee (AK) femoropopliteal bypass in patients on aspirin is equivalent to that with saphenous vein, heparin-bonded Dacron (HBD) and polytetrafluoroethylene (PTFE) have been compared in a randomized trial involving ten hospitals which also included below-knee (BK) popliteal or tibioperoneal trunk bypass where the long saphenous vein was absent or inadequate. Methods: Over a 28-month recruitment period, 209 patients undergoing femoropopliteal bypass (180 AK, 29 BK) were randomized by the method of minimization to HBD (n = 106) or PTFE (n = 103). Aspirin 300 mg day,1 was started before surgery and continued unless the patient was intolerant. Results: Mean follow-up was 34 (range 19,48) months. Fifteen patients (7 per cent) died with patent grafts and three (1 per cent) infected grafts were removed. Patency (measured by Kaplan,Meier survival analysis) was 70, 63 and 55 per cent at 1, 2 and 3 years for HBD, compared with 56, 46 and 42 per cent respectively for PTFE (P = 0·0444). Patency at 3 years for AK bypass was significantly better than that for BK bypass. A total of 70 interventions were performed on 47 patients, achieving long-term patency in only three. Amputations were performed in 23 patients, six with HBD and 17 with PTFE grafts (P = 0·015, Fisher's exact test). Conclusion: In femoropopliteal bypass, primary patency was better with HBD than PTFE, and HBD was associated with a lower amputation rate. © 2000 British Journal of Surgery Society Ltd [source]

    Radioimmunotherapy of small-volume disease of metastatic colorectal cancer

    CANCER, Issue S4 2002
    Results 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]

    A randomized comparison of the magnetic navigation system versus conventional percutaneous coronary intervention,

    CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2008
    DPHIL, Steve Ramcharitar BMBCH
    Abstract Objective: A randomized comparison of the magnetic navigation system (MNS) to conventional guidewire techniques in percutaneous coronary interventions. Background: The MNS precisely directs a magnetized guidewire in vivo through two permanent external magnets. Methods: A total of 111 consecutive patients were enrolled. Crossing success, crossing-/fluoroscopy times, and contrast usage were directly compared. Lesions were classified according to the AHA/ACC criteria. Three tertiles of vessel/lesion complexity [low (<5), medium (6,10) and high (>10)] were defined using 3D reconstructions and angiographic information. Results: The crossing success for magnetic and the conventional wires were 93.3and 95.6%, respectively. Crossing and fluoroscopy times were longer with the magnetic wires (72.9 ± 50.3 sec vs. 58.1 ± 47.2 sec, P < 0.001 and 66.2 ± 44.1 sec vs. 55.2 ± 44.4 sec, P = 0.03, respectively). In vessels with low and medium complexity the magnetic wires had significantly longer times (P < 0.001) but for those with high scores (>10) a trend towards shorter times was observed. The MNS resulted in a small but significant reduction in contrast usage (2.3 ± 3.5 ml vs. 4.5 ± 4.4 ml, P < 0.001). Moreover by superimposing a virtual roadmap of the vessel on the live fluoroscopy image 48% of the lesions were crossed without requiring contrast agents with the MNS. Conclusion: The MNS has comparable crossing success to conventional PCI. It is relatively slower but there is a trend to support a potential advantage in more complex vessels. By simultaneously employing a virtual roadmap there is a small but significant reduction in contrast usage. © 2008 Wiley-Liss, Inc. [source]

    A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: The DECODE study,

    CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2008
    Charles Chan MD
    Abstract Objective: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions. Background: In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few. Methods: This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months. Results: Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006). Conclusions: In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS. © 2008 Wiley-Liss, Inc. [source]

    Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents: The TAXi-LATE trial

    CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2007
    Alexandre 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]

    Quantifying the effect of intraocular pressure reduction on the occurrence of glaucoma

    ACTA OPHTHALMOLOGICA, Issue 1 2010
    Andrea Peeters
    Abstract. Purpose:, To estimate the effect of reducing intraocular pressure (IOP) on: (i) the incidence of primary open-angle glaucoma (POAG) in patients with ocular hypertension (OH), and (ii) the progression of glaucoma. Methods:, A meta-analysis of relevant randomized controlled trials was conducted. A literature search was performed to identify trials with: a randomized comparison of IOP-lowering intervention versus placebo or no treatment; visual field loss or optic disc changes as outcome; and follow-up >6 months. A pooled relative risk (RR) was calculated by a random effects model. Risk reduction of glaucoma conversion per mmHg of IOP reduction was quantified in a meta-regression model. Results:, We identified nine OH and one POAG trials. A meta-analysis of OH trials gives a pooled RR of 0.61 [95% confidence interval (CI) 0.45,0.83]. A meta-regression shows a decrease of the RR of glaucoma conversion by 14% with each mmHg extra IOP reduction (P = 0.045). No meta-analysis of POAG trials was performed because only one study has been identified. Conclusion:, There is sufficient evidence that OH therapy reduces the risk of conversion to glaucoma. This risk reduction increases with greater IOP reduction. [source]