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Sample records for prostatectomy a prospective randomized

  1. Anesthesiologic Effects of Transperitoneal Versus Extraperitoneal Approach During Robot-Assisted Radical Prostatectomy: Results of a Prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Fabrizio Dal Moro

    2015-06-01

    Full Text Available ABSTRACTObjectives:To compare the effects of CO2 insufflation on hemodynamics and oxygen levels and on acid-base level during Robot-Assisted Radical Prostatectomy (RARP with transperitoneal (TP versus extra-peritoneal (EP accesses.Materials and Methods:Sixty-two patients were randomly assigned to TP (32 and EP (30 to RARP. Pre-operation data were collected for all patients. Hemodynamic, respiratory and blood acid-base parameters were measured at the moment of induction of anesthesia (T0, after starting CO2 insuffation (T1, and at 60 (T2 and 120 minutes (T3 after insufflation. In all cases, the abdominal pressure was set at 15 mmHg. Complications were reported according to the Clavien-Dindo classification. Student's two–t-test, with a significance level set at pResults:The demographic characteristics of the patients in both groups were statistically comparable. Analysis of intra-operative anesthesiologic parameters showed that partial CO2 pressure during EP was significantly higher than during TP, with a consequent decrease in arterial pH. Other parameters analysed were similar in the two groups. Postoperative complications were comparable between groups. The most important limitations of this study were the small size of the patient groups and the impossibility of maintaining standard abdominal pressure throughout the operational phases, despite attempts to regulate it.Conclusions:This prospective randomized study demonstrates that, from the anesthesiologic viewpoint, during RARP the TP approach is preferable to EP, because of lower CO2 reabsorption and risk of acidosis.

  2. Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

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    Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

    2017-12-04

    Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

  3. Impact of tamsulosin on urinary retention following early catheter removal after robot-assisted laparoscopic radical prostatectomy: a prospective randomized controlled trial.

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    Jeong, In Gab; You, Dalsan; Yoon, Jong Hyun; Hong, Sungwoo; Lim, Ju Hyun; Hong, Jun Hyuk; Choo, Myung-Soo; Ahn, Hanjong; Kim, Choung-Soo

    2014-02-01

    To examine the impact of tamsulosin on the rate of acute urinary retention following early catheter removal after robot-assisted laparoscopic radical prostatectomy. A total of 236 patients who underwent robot-assisted laparoscopic radical prostatectomy for prostate cancer carried out by a single surgeon were enrolled in this randomized study. Patients were randomly divided into two groups: treatment with tamsulosin (0.4 mg) from 1 day before to 14 days after surgery (tamsulosin group), or no tamsulosin treatment (control group). The urethral catheter was removed on the fifth postoperative day. The primary end-point was the acute urinary retention rate. Changes in each domain of the International Continence Society male short-form questionnaire and uroflowmetry parameters were secondary end-points. The primary end-point was assessed in 218 patients (92.4%; n = 109 in each group). It was not assessed in 18 patients because of cystographic leak from the vesicourethral anastomosis. The acute urinary retention rate was lower in the tamsulosin group (7.3%) than in the control group (17.4%, P = 0.018). Multivariate logistic regression analysis identified tamsulosin treatment and the operative experience of the surgeon as independent risk factors for acute urinary retention. Tamsulosin-treated patients had a 0.30-fold lower risk of developing acute urinary retention compared with control patients (95% confidence interval 0.12-0.76; P = 0.011). None of the International Continence Society male questionnaire domain scores showed significant changes between the groups. Perioperative treatment with tamsulosin in patients undergoing robot-assisted laparoscopic radical prostatectomy reduces the rate of acute urinary retention after early catheter removal, without aggravating urinary incontinence. © 2013 The Japanese Urological Association.

  4. Robotic prostatectomy: the anesthetist's view for robotic urological surgeries, a prospective study,

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    Menekse Oksar

    2014-09-01

    Full Text Available Background and objectives: Although many features of robotic prostatectomy are similar to those of conventional laparoscopic urological procedures (such as laparoscopic prostatectomy, the procedure is associated with some drawbacks, which include limited intravenous access, relatively long operating time, deep Trendelenburg position, and high intra-abdominal pressure. The primary aim was to describe respiratory and hemodynamic challenges and the complications related to high intra-abdominal pressure and the deep Trendelenburg position in robotic prostatectomy patients. The secondary aim was to reveal safe discharge criteria from the operating room. Methods: Fifty-three patients who underwent robotic prostatectomy between December 2009 and January 2011 were prospectively enrolled. Main outcome measures were non-invasive monitoring, invasive monitoring and blood gas analysis performed at supine (T0, Trendelenburg (T1, Trendelenburg + pneumoperitoneum (T2, Trendelenburg-before desufflation (T3, Trendelenburg (after desufflation (T4, and supine (T5 positions. Results: Fifty-three robotic prostatectomy patients were included in the study. The main clinical challenge in our study group was the choice of ventilation strategy to manage respiratory acidosis, which is detected through end-tidal carbon dioxide pressure and blood gas analysis. Furthermore, the mean arterial pressure remained unchanged, the heart rate decreased significantly and required intervention. The central venous pressure values were also above the normal limits. Conclusion: Respiratory acidosis and "upper airway obstruction-like" clinical symptoms were the main challenges associated with robotic prostatectomy procedures during this study.

  5. Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

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    Vickers Andrew J

    2012-02-01

    Full Text Available Abstract Background Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. Although small differences would be worthwhile, an appropriately powered randomized trial would need to be very large, and thus of doubtful feasibility given the expense, complexity and regulatory burden of contemporary clinical trials. We have proposed a novel methodology, the clinically-integrated randomized trial, which dramatically streamlines trial procedures in order to reduce the marginal cost of an additional patient towards zero. We aimed to determine the feasibility of implementing such a trial for radical prostatectomy. Methods Patients undergoing radical prostatectomy as initial treatment for prostate cancer were randomized in a factorial design to involvement of the fascia during placement of the anastomotic sutures, urethral irrigation, both or neither. Endpoint data were obtained from routine clinical documentation. Accrual and compliance rates were monitored to determine the feasibility of the trial. Results From a total of 260 eligible patients, 154 (59% consented; 56 patients declined to participate, 20 were not approached on recommendation of the treating surgeon, and 30 were not approached for logistical reasons. Although recording by surgeons of the procedure used was incomplete (~80%, compliance with randomization was excellent when it was recorded, with only 6% of procedures inconsistent with allocation. Outcomes data was received from 71% of patients at one year. This improved to 83% as the trial progressed. Conclusions A clinically-integrated randomized trial was conducted at low cost, with excellent accrual, and acceptable compliance with treatment allocation and outcomes reporting. This demonstrates the feasibility of the methodology. Improved methods to ensure documentation of surgical procedures would be required before wider implementation

  6. Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes.

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    Ferro, Matteo; Bottero, Danilo; D'Elia, Carolina; Matei, Deliu Victor; Cioffi, Antonio; Cozzi, Gabriele; Serino, Alessandro; Cordima, Giovanni; Bianchi, Roberto; Incarbone, Piero Giacomo; Brescia, Antonio; Musi, Gennaro; Fusco, Ferdinando; Detti, Serena; Mirone, Vincenzo; de Cobelli, Ottavio

    2017-03-01

    To evaluate the efficacy and safety of the Virtue ® male sling (Coloplast, Humlebaek, Denmark) in a cohort of patients affected by post-prostatectomy stress urinary incontinence (SUI). All 29 consecutive patients treated with a Virtue male sling at our Institution between July 2012 and October 2013 were included in the present prospective, non-randomized study. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery using a 24-h pad weight test, the International Consultation on Incontinence short-form questionnaire (ICIQ-SF), Urinary Symptom Profile (USP) questionnaire, a bladder diary, uroflowmetry and the Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity questionnaires. The mean patient age was 65.5 years. A total of 72.4% of patients had preoperative mild incontinence (1-2 pads/day), while nine patients used 3-5 pads/day. There were a total of 17 complications, which occurred in 29 patients (58.6%); all were Clavien-Dindo grade I. At 12-month follow-up patients showed a significant improvement in 24-h pad test (128.6 vs 2.5 g), number of pads per day (2 vs 0), ICIQ-SF score (14.3 vs 0.9) and USP score for SUI (4 vs 0), and outcomes remained stable at 36 months. At last follow-up, the median score on the PGI-I questionnaire was 1 (very much better). The Virtue male sling is an effective treatment option for low to moderate post-prostatectomy incontinence. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  7. Return to work and sick leave after radical prostatectomy: a prospective clinical study.

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    Dahl, Sigrun; Steinsvik, Eivind A S; Dahl, Alv A; Loge, Jon Håvard; Cvancarova, Milada; Fosså, Sophie D

    2014-06-01

    To evaluate work status at three months after radical prostatectomy (RP) in patients with prostate cancer (PCa) in relation to socio-demographics, urinary incontinence and bother, medical complications health-related quality of life (HRQOL) and surgical methods. To identify pre-RP available factors that can predict the duration of immediate post-RP sick leave. This prospective questionnaire-based study included 264 men with PCaPatients' work status was defined as either "stable/improved" or "declined" at three months compared to work status at baseline. Duration of immediate post-RP sick leave was considered as prolonged when lasting >6 weeks. Associations were analyzed using logistic regression analyses. Almost 30% of the patients had declined work status three months after RP. Change of physical HRQOL was the only factor remaining significantly associated with declined work status in the multivariate analysis. Half of the patients had prolonged immediate sick leave. Having physically strenuous work was the strongest predictor for this outcome. Long periods of sick leave and reduced workforce participation after RP should be considered potential adverse effects of this treatment.

  8. A PROSPECTIVE, RANDOMIZED STUDY OF PERIPROSTATIC

    African Journals Online (AJOL)

    is not very sensitive to pain, and transrectal lignocaine gel will presumably provide anesthesia to the rectal mucosa only“. Periprostatic lignocaine injection has been used to provide anesthesia for a number of indications, including laser prostatectomy, brachytherapy and TRUS guided prostate biopsyg. All but one of the 17 ...

  9. Psychotherapy and phosphodiesterase-5 inhibitor in early rehabilitation after radical prostatectomy: a prospective randomised controlled trial.

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    Naccarato, A M E P; Reis, L O; Ferreira, U; Denardi, F

    2016-12-01

    The aim of this study was to evaluate the impact of group psychotherapy and the use of a phosphodiesterase-5 inhibitor (PDE-5i) in the early rehabilitation stage of patients with prostate cancer undergoing radical prostatectomy (RP). Fifty-six patients undergoing RP for prostate cancer were randomised into four groups, and 53 completed the protocol: Group 1 - control (n = 11), Group 2 - group psychotherapy (n = 16), Group 3 - lodenafil 80 mg/one tablet per week (n = 12) and Group 4 - group psychotherapy + lodenafil 80 mg/one tablet per week (n = 14). The groups were individually evaluated for erectile function (IIEF-5) and quality of life - QoL (SF-36) weekly, with two meetings held a week apart before the RP and 12 weekly meetings after surgery. The ages ranged from 39 to 76 years, average 61.84. There were no significant medication side effects. Only Group 4 showed improvement in intimacy with a partner and satisfaction with their sex life (P = 0.045 and P = 0.013 respectively), and with no significant worsening of the IIEF-5 (P = 0.250) reported. All groups showed worsening in the final result of the role limitations caused by physical problems (P = 0.009) and role limitations caused by emotional problems (P = 0.002) of the SF-36, but Group 4 had a significantly higher score for the role limitations caused by physical problems (P = 0.009) than the other groups. In conclusion, precocious integral treatment involving group psychotherapy and PDE-5i before and after RP led to less deterioration of erectile function and other domains related to physical aspects (SF-36), with improvement in intimacy with their partner and satisfaction in their sex life, being superior to single treatments. © 2016 Blackwell Verlag GmbH.

  10. Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial.

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    Nyarangi-Dix, Joanne N; Radtke, Jan Philipp; Hadaschik, Boris; Pahernik, Sascha; Hohenfellner, Markus

    2013-03-01

    We investigated the influence of bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy. A total of 208 men who presented for radical prostatectomy were randomized to complete bladder neck preservation with subsequent urethro-urethral anastomosis or to no preservation as controls. Patients with failed bladder neck preservation were not included in study. We documented objective continence by the 24-hour pad test, social continence by the number of pads per day and quality of life outcomes by the validated Incontinence Quality of Life questionnaire in a single blind setting. Cancer resection was assessed by surgical margin status. At 0, 3, 6 and 12 months mean urine loss in the control vs the bladder neck preservation group was 713.3 vs 237.0, 49.6 vs 15.6, 44.4 vs 5.5 and 25.4 vs 3.1 gm, respectively (each p <0.001). At 3, 6 and 12 months in the control vs the preservation group the social continence rate was 55.3% vs 84.2% (p <0.001), 74.8% vs 89.5% (p = 0.05) and 81.4% vs 94.7% (p = 0.027), and the quality of life score was 80.4 vs 90.3 (p <0.001), 85.4 vs 91.7 (p = 0.016) and 86.0 vs 93.8 (p = 0.001), respectively. We noted significantly less urine loss, higher objective and social continence rates, and higher quality of life scores after complete bladder neck preservation at all followup points. On multiple logistic regression analysis complete bladder neck preservation was an independent positive predictor of continence. No significant difference was found in surgical margin status between the control and bladder neck preservation groups (12.5% vs 14.7%, p = 0.65). In what is to our knowledge the first prospective, randomized, controlled, single blind trial complete bladder neck preservation during radical prostatectomy was associated with a significantly higher urinary continence rate and increased patient satisfaction without compromising resection margins. Copyright © 2013 American Urological

  11. Multimedia support for improving preoperative patient education: a randomized controlled trial using the example of radical prostatectomy.

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    Huber, Johannes; Ihrig, Andreas; Yass, Mohammed; Bruckner, Tom; Peters, Tim; Huber, Christian G; Konyango, Beryl; Lozankovski, Novica; Stredele, Regina J F; Moll, Peter; Schneider, Meike; Pahernik, Sascha; Hohenfellner, Markus

    2013-01-01

    Growing evidence supports the use of multimedia presentations for informing patients. Therefore, we supported preoperative education by adding a multimedia tool and examined the effects in a randomized controlled trial. We randomized German-speaking patients scheduled for radical prostatectomy at our center to receive either a multimedia-supported (MME) or a standard education (SE). Outcomes were measured in a structured interview. Primary outcome was patient satisfaction. In addition, we applied validated instruments to determine anxiety and measures of decision-making. Results were given by mean and standard deviation. For comparison of groups we used t test and chi-square test. For an explorative analysis we applied multivariate logistic regression. We randomized 203 patients to receive MME (n=102) or SE (n=101). Complete satisfaction with preoperative education was more frequent in the MME group (69 vs 52%, p=.016) and patients after MME reported more questions (5.7 vs 4.2, p=.018). There was no difference concerning the duration of talks and the number of recalled risks. However, perceived knowledge was higher after MME (1.3 vs 1.6, p=.037). Anxiety and measures of decision-making were comparable. Patients judged the multimedia tool very positive, and 74% of the MME group thought that their preoperative education had been superior to SE. Multimedia support should be considered worthwhile for improving the informed consent process before surgery (www.germanctr.de; DRKS00000096).

  12. Brachytherapy versus prostatectomy in localized prostate cancer: Results of a French multicenter prospective medico-economic study

    International Nuclear Information System (INIS)

    Buron, Catherine; Le Vu, Beatrice; Cosset, Jean-Marc; Pommier, Pascal; Peiffert, Didier; Delannes, Martine; Flam, Thierry; Guerif, Stephane; Salem, Naji; Chauveinc, Laurent; Livartowski, Alain

    2007-01-01

    Purpose: To prospectively compare health-related quality of life (HRQOL), patient-reported treatment-related symptoms, and costs of iodine-125 permanent implant interstitial brachytherapy (IB) with those of radical prostatectomy (RP) during the first 2 years after these treatments for localized prostate cancer. Methods and Materials: A total of 435 men with localized low-risk prostate cancer, from 11 French hospitals, treated with IB (308) or RP (127), were offered to complete the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire QLQ-C30 version 3 (EORTC QLQ-C30) and the prostate cancer specific EORTC QLQ-PR25 module before and at the end of treatment, 2, 6, 12, 18, and 24 months after treatment. Repeated measures analysis of variance and analysis of covariance were conducted on HRQOL changes. Comparative cost analysis covered initial treatment, hospital follow-up, outpatient and production loss costs. Results: Just after treatment, the decrease of global HRQOL was less pronounced in the IB than in the RP group, with a 13.5 points difference (p < 0.0001). A difference slightly in favor of RP was observed 6 months after treatment (-7.5 points, p = 0.0164) and was maintained at 24 months (-8.2 points, p = 0.0379). Impotence and urinary incontinence were more pronounced after RP, whereas urinary frequency, urgency, and urination pain were more frequent after IB. Mean societal costs did not differ between IB ( Euro 8,019 at T24) and RP ( Euro 8,715 at T24, p = 0.0843) regardless of the period. Conclusions: This study suggests a similar cost profile in France for IB and RP but with different HRQOL and side effect profiles. Those findings may be used to tailor localized prostate cancer treatments to suit individual patients' needs

  13. A prospective evaluation of conventional cystography for detection of urine leakage at the vesicourethral anastomosis site after radical prostatectomy based on computed tomography.

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    Han, K S; Choi, H J; Jung, D C; Park, S; Cho, K S; Joung, J Y; Seo, H K; Chung, J; Lee, K H

    2011-03-01

    To evaluate the diagnostic accuracy of conventional cystography for the detection of urine leakage at the vesicourethral anastomosis (VUA) site after radical prostatectomy based on computed tomography (CT) cystography. Patients who underwent radical prostatectomies at a single tertiary cancer centre were prospectively enrolled. Conventional cystography was routinely performed on postoperative day 7. Non-enhanced pelvic CT images were obtained after retrograde instillation of the same contrast material for a reference standard of urine leakage at the VUA site. Urine leakage was classified as follows: none; a plication abnormality; mild; moderate; and excessive. One hundred and twenty consecutive patients were enrolled. Conventional cystography detected 14 urine leakages, but CT cystography detected 40 urine leakages, which consisted of 28 mild and 12 moderate urine leakages. When using CT cystography as the standard measurement, conventional cystography showed a diagnostic accuracy of 17.8% (5/28) for mild urine leakage and 75% (9/12) for moderate leakage. Of nine patients diagnosed with mild leakage on conventional cystography, four (44.4%) had complicated moderate urine leakages based on CT cystography, requiring prolonged catheterization. The sensitivity, specificity, positive and negative predictive values, and accuracy of conventional cystography were 35, 100, 100, 75.4, and 78.3%, respectively. Conventional cystography is less accurate than CT cystography for diagnosing urine leakage at the VUA site after a radical prostatectomy. The present results suggest that CT cystography is a good choice for diagnostic imaging of urine leakage after radical prostatectomy. Copyright © 2010 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  14. The effects of Pilates method on pelvic floor muscle strength in patients with post-prostatectomy urinary incontinence: A randomized clinical trial.

    Science.gov (United States)

    Gomes, Cíntia S; Pedriali, Fabiana R; Urbano, Mariana R; Moreira, Eliane H; Averbeck, Marcio A; Almeida, Silvio Henrique M

    2018-01-01

    To assess the effects of a Pilates exercise program compared to conventional pelvic floor muscle training (PFMT) protocol on pelvic floor muscle strength (PFMS) in patients with post-prostatectomy urinary incontinence. Patients were randomized into three treatment groups (G1: Pilates, G2: electrical stimulation combined with PFMT, and G3: control group). Duration of therapy was 10 weeks. Baseline assessment included the 24 h pad-test and the ICI-Q questionnaire. PFMS was measured using a manometric perineometry device at baseline and 4 months after radical prostatectomy (RP). The level of significance was P  0.05). G1 and G2 achieved a higher number of fully continent patients than G3 (P Pilates method promoted similar outcomes in the proportion of fully continent patients when compared to conventional PFMT 4 months after RP. © 2017 Wiley Periodicals, Inc.

  15. Karolinska prostatectomy: a robot-assisted laparoscopic radical prostatectomy technique.

    Science.gov (United States)

    Nilsson, Andreas E; Carlsson, Stefan; Laven, Brett A; Wiklund, N Peter

    2006-01-01

    The last decade has witnessed an increasing trend towards minimally invasive management of prostate cancer, including laparoscopic and, more recently, robot-assisted laparoscopic prostatectomy. Several different laparoscopic approaches have been continuously developed during the last 5 years and it is still unclear which technique yields the best outcome. We present our current technique of robot-assisted laparoscopic radical prostatectomy. The technique described has evolved during the course of >400 robotic prostatectomies performed by the robotic team since the robot-assisted laparoscopic radical prostatectomy program was introduced at Karolinska University Hospital in January 2002. Our procedure comprises several modifications of previously reported ones, and we utilize fewer robotic instruments to reduce costs. An extended posterior dissection is performed to aid in the bladder neck-sparing dissection. In nerve-sparing procedures the vesicles are divided to avoid damage to the erectile nerves. In order to preserve the apical anatomy the dorsal venous complex is incised sharply and is first over-sewn after the apical dissection is completed. Our technique enables a more fluent dissection than previously described robotic techniques. Minimizing changes of instruments and the camera not only cuts costs but also reduces inefficient operating maneuvers, such as switching between 30 degrees and 0 degrees lenses during the procedure. We present a technique which in our hands has achieved excellent functional and oncological results.

  16. Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy

    International Nuclear Information System (INIS)

    Garcia-Sanchez, Cristina; Roman Martin, Ana A.; Conde-Sanchez, J. Manuel; Congregado-Ruiz, C. Belen; Osman-Garcia, Ignacio; Medina-Lopez, Rafael A.

    2017-01-01

    Introduction: There is a growing interest in achieving higher survival rates with the lowest morbidity in localized prostate cancer (PC) treatment. Consequently, minimally invasive techniques such as low-dose rate brachytherapy (BT) and robotic-assisted prostatectomy (RALP) have been developed and improved. Comparative analysis of functional outcomes and quality of life in a prospective series of 51BT and 42Da Vinci prostatectomies DV. Materials and Methods: Comparative analysis of functional outcomes and quality of life in a prospective series of 93 patients with low-risk localized PC diagnosed in 2011. 51 patients underwent low-dose rate BT and the other 42 patients RALP. IIEF to assess erectile function, ICIQ to evaluate continence and SF36 test to quality of life wee employed. Results: ICIQ at the first revision shows significant differences which favour the BT group, 79% present with continence or mild incontinence, whereas in the DV group 45% show these positive results. Differences disappear after 6 months, with 45 patients (89%) presenting with continence or mild incontinence in the BT group vs. 30 (71%) in the DV group. 65% of patients are potent in the first revision following BT and 39% following DV. Such differences are not significant and cannot be observed after 6 months. No significant differences were found in the comparative analysis of quality of life. Conclusions: ICIQ after surgery shows significant differences in favour of BT, which disappear after 6 months. Both procedures have a serious impact on erectile function, being even greater in the DV group. Differences between groups disappear after 6 months. (author)

  17. Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy

    Energy Technology Data Exchange (ETDEWEB)

    Garcia-Sanchez, Cristina; Roman Martin, Ana A.; Conde-Sanchez, J. Manuel; Congregado-Ruiz, C. Belen; Osman-Garcia, Ignacio; Medina-Lopez, Rafael A. [Virgen del Rocio Universitary Hospital, Seville (Spain)

    2017-03-15

    Introduction: There is a growing interest in achieving higher survival rates with the lowest morbidity in localized prostate cancer (PC) treatment. Consequently, minimally invasive techniques such as low-dose rate brachytherapy (BT) and robotic-assisted prostatectomy (RALP) have been developed and improved. Comparative analysis of functional outcomes and quality of life in a prospective series of 51BT and 42Da Vinci prostatectomies DV. Materials and Methods: Comparative analysis of functional outcomes and quality of life in a prospective series of 93 patients with low-risk localized PC diagnosed in 2011. 51 patients underwent low-dose rate BT and the other 42 patients RALP. IIEF to assess erectile function, ICIQ to evaluate continence and SF36 test to quality of life wee employed. Results: ICIQ at the first revision shows significant differences which favour the BT group, 79% present with continence or mild incontinence, whereas in the DV group 45% show these positive results. Differences disappear after 6 months, with 45 patients (89%) presenting with continence or mild incontinence in the BT group vs. 30 (71%) in the DV group. 65% of patients are potent in the first revision following BT and 39% following DV. Such differences are not significant and cannot be observed after 6 months. No significant differences were found in the comparative analysis of quality of life. Conclusions: ICIQ after surgery shows significant differences in favour of BT, which disappear after 6 months. Both procedures have a serious impact on erectile function, being even greater in the DV group. Differences between groups disappear after 6 months. (author)

  18. A randomized trial comparing radical prostatectomy plus endocrine therapy versus external beam radiotherapy plus endocrine therapy for locally advanced prostate cancer. Results at median follow-up of 102 months

    International Nuclear Information System (INIS)

    Akakura, Koichiro; Suzuki, Hiroyoshi; Ichikawa, Tomohiko

    2006-01-01

    The background of this study was to investigate the optimal treatment of locally advanced prostate cancer, a prospective randomized trial was conducted to compare radical prostatectomy plus endocrine therapy versus external beam radiotherapy plus endocrine therapy. One hundred patients with T2b-3N0M0 prostate cancer were enrolled and 95 were evaluated. Of 95 cases, 46 underwent radical prostatectomy with pelvic lymph node dissection and 49 were treated with external beam radiation by linear accelerator with 40-50 Gy to the whole pelvis and 20-Gy boost to the prostatic area. For all patients, endocrine therapy was initiated 8 weeks before surgery or radiotherapy and continued thereafter. The long-term outcome and morbidity were examined. Median follow-up period was 102 months. At 10 years overall survival rates in the surgery group were better than the radiation group (76.2% versus 71.1% for biochemical progression-free rates; P=0.25, 83.5% versus 66.1% for clinical progression-free rates; P=0.14, 85.7% versus 77.1% for cause-specific survival rates; P=0.06, and 67.9% versus 60.9% for overall survival rates; P=0.30), although none of them reached statistical significance. Erectile dysfunction was recognized in almost all patients as a result of continuous endocrine therapy. Incontinence requiring more than one pad per day was observed more frequently in the surgery group than the radiation group (P<0.01). For the treatment of patients with locally advanced prostate cancer, when combined with endocrine therapy, either radical prostatectomy or external beam radiotherapy demonstrated favorable long-term outcomes. The radiation dose of 60-70 Gy might not be enough for the local treatment of locally advanced prostate cancer. (author)

  19. Stricture prophylaxis in transurethral prostatectomy

    DEFF Research Database (Denmark)

    Hansen, R I; Jensen, A R; Stage, P

    1987-01-01

    In a prospective study 317 patients with prostatic hypertrophy, admitted for transurethral prostatectomy (TUR P), were randomized into three different groups: (1) urethral dilation and TUR P; (2) urethrotomy according to Otis and TUR P, and (3) TUR P alone. The number of postoperative urethral...

  20. Metabolic syndrome is associated with advanced prostate cancer in patients treated with radical retropubic prostatectomy: results from a multicentre prospective study

    International Nuclear Information System (INIS)

    De Nunzio, Cosimo; Simone, Giuseppe; Brassetti, Aldo; Mastroianni, Riccardo; Collura, Devis; Muto, Giovanni; Gallucci, Michele; Tubaro, Andrea

    2016-01-01

    Prostate cancer (PCa) is the most common non-skin cancer in USA and the second leading cause of cancer death in Western Countries. Despite the high mortality associated with PCa, the only established risk factors are age, race and family history. A possible association between metabolic syndrome (MetS) and PCa was firstly described in 2004 and several subsequent studies in biopsy cohorts have shown conflicting results. Aim of our multicentre prospective study was to investigate the association between MetS and PCa in men undergoing radical prostatectomy (RP). From January 2012 to June 2015, 349 consecutive men undergoing RP for PCa at three centres in Italy were enrolled into a prospective database. Body Mass Index (BMI) as well as waist circumference was measured before RP. Blood samples were also collected and tested for total PSA, fasting glucose, triglycerides and HDLs. Blood pressure was also recorded. We evaluated the association between MetS, defined according to Adult Treatment Panel III, PCa stage (advanced stage defined as pT ≥ 3 or N1) and grade (high grade defined as Gleason Score ≥ 4 + 3) using logistic regression analyses. Median age and preoperative PSA levels were 66 years (IQR: 61-69) and 7 ng/ml (IQR: 5-10), respectively. Median BMI was 26.12 kg/m 2 (IQR 24-29) with 56 (16 %) obese (BMI ≥ 30 kg/m 2 ) patients and 87 (25 %) patients with MetS. At pathological evaluation, advanced PCa and high-grade disease were present in 126 (36 %) and 145 (41.5 %) patients, respectively. MetS was significantly associated with advanced PCa (45/87, 51 % vs 81/262, 31 %; p = 0.008) and high-grade disease (47/87, 54 % vs 98/262, 37 %; p = 0.001). On multivariable analysis, MetS was an independent predictor of pathological stage ≥ pT3a or N1 (OR: 2.227; CI: 1.273-3.893; p = 0.005) and Gleason score ≥ 4 + 3 (OR: 2.007, CI: 1.175-3.428; p = 0.011). We firstly demonstrated in a European radical retropubic prostatectomy cohort study that MetS is associated with

  1. A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy

    International Nuclear Information System (INIS)

    Lee, W. Robert; Hall, M. Craig; McQuellon, Richard P.; Case, L. Douglas; McCullough, David L.

    2001-01-01

    Purpose: To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after 3 different treatments for clinically localized prostate cancer. Methods and Materials: Ninety men with T1-T2 adenocarcinoma of the prostate were treated with curative intent between May 1998 and June 1999 and completed a quality-of-life Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire before treatment (T0) and 1 month (T1), 3 months (T3), and 12 months (T12) after treatment. Forty-four men were treated with permanent source interstitial brachytherapy (IB), 23 received external beam radiotherapy (EBRT), and 23 men were treated with radical prostatectomy (RP). The mean age of the entire study population was 65.9 years (median 67, range 42-79). The mean pretreatment prostate-specific antigen level of the entire study population was 6.81 ng/mL (median 6.25, range 1.33-19.6). The Gleason score was ≤6 in 65 (72%) of 90. The repeated measures analysis of variance and analysis of covariance were conducted on all quality-of-life and urinary outcome measures. Results: A comparison of the demographic characteristics of the 3 treatment groups demonstrated significant differences. The men treated with RP were significantly younger than the men in either the IB or EBRT group (median age 61.0 RP, 67.1 IB, 68.8 EBRT; p=0.0006). The men in the IB group were more likely to have a Gleason score of ≤6 than the EBRT group (Gleason score ≤6, 86% IB and 48% EBRT; p=0.015). The mean score (standard deviation) at T0, T1, T3, and T12 for the FACT-P questionnaire for each group was as follows: IB 138.4 (17.0), 120.5 (21.7), 130.0 (18.4), and 138.5 (14.2); EBRT 137.1 (12.1), 129.5 (21.0), 134.4 (19.2), and 136.9 (15.6); and RP 138.3 (14.7), 117.7 (18.3), 134.4 (17.8), and 140.4 (14.9), respectively. Statistically significant differences over time were observed for the FACT-P in the IB and RP groups (p<0.0001), but not for the EBRT group (p

  2. Low Pressure Robot-assisted Radical Prostatectomy With the AirSeal System at OLV Hospital: Results From a Prospective Study.

    Science.gov (United States)

    La Falce, Sabrina; Novara, Giacomo; Gandaglia, Giorgio; Umari, Paolo; De Naeyer, Geert; D'Hondt, Frederiek; Beresian, Jean; Carette, Rik; Penicka, Martin; Mo, Yujiing; Vandenbroucke, Geert; Mottrie, Alexandre

    2017-12-01

    Limited studies examined effects of pneumoperiotneum during robot-assisted radical prostatectomy (RARP) and with AirSeal. The aim of this study was to assess the effect on hemodynamics of a lower pressure pneumoperitoneum (8 mmHg) with AirSeal, during RARP in steep Trendelenburg 45° (ST). This is an institutional review board-approved, prospective, interventional, single-center study including patients treated with RARP at OLV Hospital by one extremely experienced surgeon (July 2015-February 2016). Intraoperative monitoring included: arterial pressure, central venous pressure, cardiac output, heart rate, stroke volume, systemic vascular resistance, intrathoracic pressure, airways pressures, left ventricular end-diastolic and end-systolic areas/volumes and ejection fraction, by transesophageal echocardiography, an esophageal catheter, and FloTrac/Vigileo system. Measurements were performed after induction of anesthesia with patient in horizontal (T0), 5 minutes after 8 mmHg pneumoperitoneum (TP), 5 minutes after ST (TT1) and every 30 minutes thereafter until the end of surgery (TH). Parameters modification at the prespecified times was assessed by Wilcoxon and Friedman tests, as appropriate. All analyses were performed by SPSS v. 23.0. A total of 53 consecutive patients were enrolled. The mean patients age was 62.6 ± 6.9 years. Comorbidity was relatively limited (51% with Charlson Comorbidity Index as low as 0). Despite the ST, working always at 8 mmHg with AirSeal, only central venous pressure and mean airways pressure showed a statistically significant variation during the operative time. Although other significant hemodynamic/respiratory changes were observed adding pneumoperitoneum and then ST, all variables remained always within limits safely manageable by anesthesiologists. The combination of ST, lower pressure pneumoperitoneum and extreme surgeon's experience enables to safely perform RARP. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. A prospective randomized trial of Kotase ® (Bromelain + Trypsin) in ...

    African Journals Online (AJOL)

    International Journal of Medicine and Health Development. Journal Home · ABOUT THIS ... A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria. Emmanuel R Ezeome, Aloy E Aghaji ...

  4. Preservation of the smooth muscular internal (vesical) sphincter and of the proximal urethra for the early recovery of urinary continence after retropubic radical prostatectomy: a prospective case-control study.

    Science.gov (United States)

    Brunocilla, Eugenio; Schiavina, Riccardo; Pultrone, Cristian Vincenzo; Borghesi, Marco; Rossi, Martina; Cevenini, Matteo; Martorana, Giuseppe

    2014-02-01

    To evaluate the influence of preservation of the muscular internal sphincter and proximal urethra on continence recovery after radical prostatectomy. This was a prospective single-center, case-control study. A total of 40 consecutive patients with organ-confined prostate cancer were submitted to radical prostatectomy with the preservation of the muscular internal sphincter and the proximal urethra (group 1), and their outcomes were compared with those of 40 patients submitted to a standard procedure (group 2). Continence rates were assessed using a self-administrated questionnaire at 3, 7 and 30 days, and 3 and 12 months after removal of the catheter. Group 1 had a faster recovery of early continence than group 2 at day 3 (45% vs 22%; P = 0.029) and at day 7 (75% vs 50%; P = 0.018). Considering the number of pads, group 1 had a faster recovery of continence at 3, 7 and 30 days, and also had less incidence of severe incontinence. There was no statistically significant difference in terms of continence at 3 and 12 months among the two groups. Multivariate logistic regression analysis showed that surgical technique and young age were significantly associated with earlier time to continence at 3 and 7 days. The two groups had no significant differences in terms of surgical margins. Our modified technique of radical retropubic prostatectomy with preservation of the smooth muscular internal sphincter, as well as of the proximal urethra during bladder neck dissection, results in a significantly increased urinary continence at 3, 7 and 30 days after catheter removal, with a minor incidence of severe incontinence. The technique is also oncologically safe, and it does not increase the operative duration of the procedure. © 2013 The Japanese Urological Association.

  5. A Double Blind, Randomized, Neoadjuvant Study of the Tissue effects of POMx Pills in Men with Prostate Cancer Prior to Radical Prostatectomy

    Science.gov (United States)

    Freedland, Stephen J.; Carducci, Michael; Kroeger, Nils; Partin, Alan; Rao, Jian-yu; Jin, Yusheng; Kerkoutian, Susan; Wu, Hong; Li, Yunfeng; Creel, Patricia; Mundy, Kelly; Gurganus, Robin; Fedor, Helen; King, Serina A.; Zhang, Yanjun; Heber, David; Pantuck, Allan J.

    2013-01-01

    Pomegranates slow prostate cancer xenograft growth and prolong PSA doubling times in single-arm human studies. Pomegranates’ effects on human prostate tissue are understudied. We hypothesized orally administered pomegranate extract (POMx; PomWonderful, Los Angeles, CA) would lower tissue 8-hydroxy-2-deoxyguanosine (8-OHdG), an oxidative stress biomarker. 70 men were randomized to 2 tablets POMx or placebo daily up to 4 weeks prior to radical prostatectomy. Tissue was analyzed for intra-prostatic Urolithin A, a pomegranate metabolite, benign and malignant 8-OHdG, and cancer pS6 kinase, NFκB, and Ki67. Primary end-point was differences in 8-OHdG powered to detect 30% reduction. POMx was associated with 16% lower benign tissue 8-OHdG (p=0.095), which was not statistically significant. POMx was well-tolerated with no treatment-related withdrawals. There were no differences in baseline clinicopathological features between arms. Urolithin A was detected in 21/33 patient in the POMx group vs. 12/35 in the placebo group (p=0.031). Cancer pS6 kinase, NFκB, Ki67, and serum PSA changes were similar between arms. POMx prior to surgery results in pomegranate metabolite accumulation in prostate tissues. Our primary end-point in this modest-sized short-term trial was negative. Future larger longer studies are needed to more definitely test whether POMx reduces prostate oxidative stress as well as further animal testing to better understand the multiple mechanisms through which POMx may alter prostate cancer biology. PMID:23985577

  6. Incontinence and Erectile Dysfunction Following Radical Prostatectomy: A Review

    Directory of Open Access Journals (Sweden)

    Gerasimos Alivizatos

    2005-01-01

    Full Text Available Radical prostatectomy remains the treatment of choice for localized prostate cancer in age-appropriate and health-appropriate men. Although cancer control is the most important aspect of a radical prostatectomy, minimization of postoperative morbidity, especially urinary incontinence and erectile dysfunction, is becoming a greater concern. We reviewed recent data available on Medline regarding the incidence, pathophysiology, evaluation, and treatment of incontinence and sexual dysfunction after radical prostatectomy. Health-related quality of life issues have been specifically addressed. Although low incidences of incontinence and erectile dysfunction after radical prostatectomy have been reported in the hands of experienced surgeons, the literature review revealed a great variety, with incontinence rates ranging from 0.3–65.6% and potency rates ranging from 11–87%. Several factors contribute to this wide difference, the most important being the application of a meticulous surgical technique. General and cancer-specific health-related quality of life is not being affected after radical prostatectomy. The incidence of incontinence and erectile dysfunction is higher after radical prostatectomy when compared to the incidence observed when other therapies for localized prostate cancer are applied. However, the majority of the patients undergoing radical prostatectomy would vote for the operation again. Today, avoidance of major complications after radical prostatectomy depends mostly on a high-quality surgical technique. When incontinence or erectile dysfunction persists after radical prostatectomy, the majority of the treated patients can be managed effectively by various methods.

  7. Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

    Science.gov (United States)

    Persson-Kjerstadius, N; Forsgren, H; Westgren, M

    1999-02-01

    To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

  8. A natural language processing program effectively extracts key pathologic findings from radical prostatectomy reports.

    Science.gov (United States)

    Kim, Brian J; Merchant, Madhur; Zheng, Chengyi; Thomas, Anil A; Contreras, Richard; Jacobsen, Steven J; Chien, Gary W

    2014-12-01

    Natural language processing (NLP) software programs have been widely developed to transform complex free text into simplified organized data. Potential applications in the field of medicine include automated report summaries, physician alerts, patient repositories, electronic medical record (EMR) billing, and quality metric reports. Despite these prospects and the recent widespread adoption of EMR, NLP has been relatively underutilized. The objective of this study was to evaluate the performance of an internally developed NLP program in extracting select pathologic findings from radical prostatectomy specimen reports in the EMR. An NLP program was generated by a software engineer to extract key variables from prostatectomy reports in the EMR within our healthcare system, which included the TNM stage, Gleason grade, presence of a tertiary Gleason pattern, histologic subtype, size of dominant tumor nodule, seminal vesicle invasion (SVI), perineural invasion (PNI), angiolymphatic invasion (ALI), extracapsular extension (ECE), and surgical margin status (SMS). The program was validated by comparing NLP results to a gold standard compiled by two blinded manual reviewers for 100 random pathology reports. NLP demonstrated 100% accuracy for identifying the Gleason grade, presence of a tertiary Gleason pattern, SVI, ALI, and ECE. It also demonstrated near-perfect accuracy for extracting histologic subtype (99.0%), PNI (98.9%), TNM stage (98.0%), SMS (97.0%), and dominant tumor size (95.7%). The overall accuracy of NLP was 98.7%. NLP generated a result in report. This novel program demonstrated high accuracy and efficiency identifying key pathologic details from the prostatectomy report within an EMR system. NLP has the potential to assist urologists by summarizing and highlighting relevant information from verbose pathology reports. It may also facilitate future urologic research through the rapid and automated creation of large databases.

  9. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  10. Transrectal contrast-enhanced ultrasonography, transrectal ultrasonography and retrograde cystography for the detection of vesicourethral anastomosis leakage after radical retropubic prostatectomy: a prospective comparative evaluation.

    Science.gov (United States)

    Cantiello, Francesco; Cicione, Antonio; Autorino, Riccardo; De Nunzio, Cosimo; Tubaro, Andrea; Damiano, Rocco

    2013-01-01

    To evaluate the diagnostic accuracy of cystography (CG), transrectal ultrasonography (TRUS) and transrectal contrast-enhanced ultrasonography (CEUS) for the detection of vesicourethral extravasation (VE) after radical retropubic prostatectomy (RRP). In 80 consecutive patients who underwent RRP, the strength of the vesicourethral anastomosis (VUA) was assessed by CG, TRUS and transrectal CEUS. The investigation started with a conventional CG evaluated by an experienced uroradiologist. Following this, patients underwent TRUS which was performed by an experienced urologist who was blinded to the CG findings. The examination started with a conventional B-scan and, subsequently, a CEUS was performed by emptying and refilling the bladder with 90 ml of NaCl 0.9% + 10 ml suspension of 1:10 SonoVue and NaCl 0.9%. 26 patients (32.5%) presented urinary VE and 54 (67.5%) a watertight VUA. In 16 patients (61%) we observed a small leakage, 9 patients (35%) presented a moderate VE, and a large VE was detected in 1 patient (4%). No statistically significant difference in detection of VE was found among the three tests (p = 0.472). TRUS and CEUS are able to provide information about the integrity of the VUA that is comparable with that of CG. Copyright © 2013 S. Karger AG, Basel.

  11. Improvement of lower urinary tract symptoms and sexual activity after open simple prostatectomy: Prospective analysis of 50 cases

    Directory of Open Access Journals (Sweden)

    Lorenzo Montesi

    2014-12-01

    Full Text Available Objectives: To evaluate the improvement of Lower Urinary Tract Symptoms (LUTS and Erectile Function (EF evaluated before and after Open Simple Prostatectomy, focusing on which patients this procedure allows better outcomes in term of sexual activity. Material and methods: 50 men with large size benign prostatic hyperplasia (BHP greater than 80 gr were prospectively evaluated before and 6 months after Open Simple Prostatectomy (Freyer procedure between October 2012 to September 2013. Patients had a pre-operative transrectal ultrasound (TRUS for volume evaluation and filled pre and post operative questionnaires for International Prostate Symptom Score (IPSS and International Index of Erectile Function (IIEF-5 score. Results: Mean patients age was 71 years (D.S. 3,5, mean prostate volume results 103 ml (D.S. 23,7; regarding LUTS and EF, mean improvement of IPSS score was 15,3 (D.S. 4 and mean increase of IIEF-5 score was 3,4 (D.S.3. This study highlights a correlation between patients’ age and increase of IIEF-5 score; no correlation with prostate size was found. Conclusion: According to the EAU Guidelines 2014, large size BPH (over 80-100 mL with LUTS refractory to medical management continue to have open prostatectomy as the treatment of choice. In our experience we found not only an reduction of LUTS after the procedure but also an improvement of erectile function; this improvement was related with patient’s age.

  12. The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

    2005-01-01

    BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

  13. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  14. The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J; Brawer, Michael K; Barry, Michael J; Jones, Karen M; Kwon, Young; Gingrich, Jeffrey R; Aronson, William J; Nsouli, Imad; Iyer, Padmini; Cartagena, Ruben; Snider, Glenn; Roehrborn, Claus; Fox, Steven

    2009-01-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia. We screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason

  15. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  16. Pertinent issues related to laparoscopic radical prostatectomy

    Directory of Open Access Journals (Sweden)

    Sidney C. Abreu

    2003-12-01

    Full Text Available PURPOSE: We describe the critical steps of the laparoscopic radical prostatectomy (LRP technique and discuss how they impact upon the pertinent issues regarding prostate cancer surgery: blood loss, potency and continence. RESULTS: A major advantage of LRP is the reduced operative blood loss. The precise placement of the dorsal vein complex stitch associated with the tamponading effect of the CO2 pneumoperitoneum significantly decrease venous bleeding, which is the main source of blood loss during radical prostatectomy. At the Cleveland Clinic, the average blood loss of our first 100 patients was 322.5 ml, resulting in low transfusion rates. The continuous venous bleeding narrowed pelvic surgical field and poor visibility can adversely impact on nerve preservation during open radical prostatectomy. Laparoscopy, with its enhanced and magnified vision in a relatively bloodless field allows for excellent identification and handling of the neurovascular bundles. During open retropubic radical prostatectomy, the pubic bone may impair visibility and access to the urethral stump, and the surgeon must tie the knots relying on tactile sensation alone. Consequently, open prostatectomy is associated with a prolonged catheterization period of 2 - 3 weeks. Comparatively, during laparoscopic radical prostatectomy all sutures are meticulously placed and each is tied under complete visual control, resulting in a precise mucosa-to-mucosa approximation. CONCLUSION: The laparoscopic approach may represent a reliable less invasive alternative to the conventional open approach. Despite the encouraging preliminary anatomical and functional outcomes, prospective randomized comparative trials are required to critically evaluate the role of laparoscopy for this sophisticated and delicate operation.

  17. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  18. Effects of Tadalafil Once-Daily or On-Demand vs Placebo on Return to Baseline Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy - Results from a Randomized Controlled Trial (REACTT)

    DEFF Research Database (Denmark)

    Mulhall, John P; Brock, Gerald; Oelke, Matthias

    2016-01-01

    INTRODUCTION AND AIM: The multicenter, randomized, double-blind, double-dummy, placebo-controlled REACTT trial suggested that treatment with tadalafil once daily (OaD) started early after bilateral nerve-sparing radical prostatectomy (nsRP) for prostate cancer may contribute to erectile function......: REACTT included 422 men blind treatment (DBT) with tadalafil 5 mg OaD (n = 139), tadalafil 20 mg on...

  19. Robotic simple prostatectomy: A consideration for large prostate adenomas

    Directory of Open Access Journals (Sweden)

    Joshua B. Nething

    2014-12-01

    Full Text Available Background: The management of benign prostatic hyperplasia (BPH has changed considerably over the last several decades. First line treatment of BPH and lower urinary tract symptoms (LUTS with medical therapy has created a population of men with much larger prostate glands, many of whom require surgical intervention. Patients with prostate glands greater than 80 to 100 grams may be better managed surgically with a retropubic prostatectomy. We explore our experience with robotic assisted simple prostatectomy and review the relevant literature. Database: The database reviewed includes our experience with seven patients undergoing robotic simple prostatectomy, and a comprehensive review of the previously published series of this procedure. In addition, the literature pertaining to a pure laparoscopic approach to simple prostatectomy is reviewed. Conclusion: Robotic experience and training has become a standard in resident training programs; while classic transurethral resection is being performed less for large prostate glands. The robotic approach to simple prostatectomy provides an excellent option for surgical treatment of very large prostate glands, providing patients acceptable results in terms of operative time, estimated blood loss, hospital stay and duration of Foley catheter.

  20. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial.

    NARCIS (Netherlands)

    K.T. Tran; C.H.J. van Eijck (Casper); V. di Carlo (Valerio); W.C.J. Hop (Wim); A. Zerbi (Alessandro); G. Balzano (Gianpaolo); J. Jeekel (Hans)

    2002-01-01

    textabstractOBJECTIVE: Using a prospective randomized study to assess postoperative morbidity and pancreatic function after pancreaticoduodenectomy with pancreaticojejunostomy and duct occlusion without pancreaticojejunostomy. SUMMARY BACKGROUND DATA: Postoperative complications

  1. Laparoscopic radical prostatectomy: omitting a pelvic drain

    Directory of Open Access Journals (Sweden)

    David Canes

    2008-03-01

    Full Text Available PURPOSE: Our goal was to assess outcomes of a selective drain placement strategy during laparoscopic radical prostatectomy (LRP with a running urethrovesical anastomosis (RUVA using cystographic imaging in all patients. Materials and Methods: A retrospective chart review was performed for all patients undergoing LRP between January 2003 and December 2004. The anastomosis was performed using a modified van Velthoven technique. A drain was placed at the discretion of the senior surgeon when a urinary leak was demonstrated with bladder irrigation, clinical suspicion for a urinary leak was high, or a complex bladder neck reconstruction was performed. Routine postoperative cystograms were obtained. RESULTS: 208 patients underwent LRP with a RUVA. Data including cystogram was available for 206 patients. The overall rate of cystographic urine leak was 5.8%. A drain was placed in 51 patients. Of these, 8 (15.6% had a postoperative leak on cystogram. Of the 157 undrained patients, urine leak was radiographically visible in 4 (2.5%. The higher leak rate in the drained vs. undrained cohort was statistically significant (p = 0.002. Twenty-four patients underwent pelvic lymph node dissection (8 drained, 16 undrained. Three undrained patients developed lymphoceles, which presented clinically on average 3 weeks postoperatively. There were no urinomas or hematomas in either group. CONCLUSIONS: Routine placement of a pelvic drain after LRP with a RUVA is not necessary, unless the anastomotic integrity is suboptimal intraoperatively. Experienced clinical judgment is essential and accurate in identifying patients at risk for postoperative leakage. When suspicion is low, omitting a drain does not increase morbidity.

  2. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-11-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2–12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mg kg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mg kg−1 neostigmine, Group RS (n = 40 received 2 mg kg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients’ characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures. Resumo: Justificativa e objetivos: Os inibidores da acetilcolinesterase podem causar curarização residual no p

  3. Robotic assisted radical prostatectomy: a different treatment for prostate cancer?

    Directory of Open Access Journals (Sweden)

    Alexandre Den Julio

    2010-09-01

    Full Text Available Considering the Health Care System in Brazil, a developing country,and public healthcare policies, robotic surgery is a reality to veryfew citizens. Therefore, robotic assisted radical prostatectomy isfar removed from the daily practice of the vast majority of Brazilianurologists. Scientific evidence of the superiority of robotic assistedradical prostatectomy does not presently justify public investmentsfor widespread development of robotic centers. Maybe over timeand with reductions in costs, robotic technology will become amore established practice, as observed in other countries, and morefeasible for the Brazilian urological community.

  4. An appraisal of a technical modification for prevention of bladder neck stenosis in retropubic prostatectomy: An initial report

    Directory of Open Access Journals (Sweden)

    Abdulwahab Akanbi Ajape

    2016-01-01

    Conclusion: Bladder neck stenosis can be a distressing complication of prostatectomy. The result of our technical modification of managing the trigone-bladder-neck complex looks promising for prevention or delaying the onset of BNS. A long-term observation and a prospective randomised control trial to ascertain this initial experience is needed.

  5. Simple prostatectomy

    Science.gov (United States)

    ... Han M, Partin AW. Simple prostatectomy: open and robot-assisted laparoscopic approaches. In: Wein AJ, Kavoussi LR, ... M. is also a founding member of Hi-Ethics and subscribes to the principles of the Health ...

  6. Age as a prognostic variable in patients undergoing transurethral prostatectomy

    DEFF Research Database (Denmark)

    Krogh, J; Jensen, J S; Iversen, H G

    1993-01-01

    In a retrospective study the outcome of transurethral prostatectomy (TURP) for benign prostatic hyperplasia (BPH) in patients more than 80 years old was compared to a control group of patients with a mean age ten years younger. The elderly had significantly more tissue resected and presented...

  7. The challenges of a prostatectomy in rural Africa | Gaido | East ...

    African Journals Online (AJOL)

    prostatectomy can occur in rural settings, where different factors can influence the outcome, beyond appropriate indication for surgery and technical skills of surgeons. Here we present a case that was per se surgically unremarkable, however a number of delayed omplications appeared in the post operative period, ...

  8. Patients undergoing radical prostatectomy have a better survival than the background population

    DEFF Research Database (Denmark)

    Andreas Røder, Martin; Brasso, Klaus; Drimer Berg, Kasper

    2013-01-01

    underwent radical prostatectomy. Patients were followed prospectively per protocol. No patients were lost to follow-up. Overall and cause-specific survival were described using Kaplan-Meier plots. Standardized relative survival and mortality ratio were calculated based on expected survival in the age......INTRODUCTION: The objective of this study was to investigate standardised relative survival and mortality ratio for patients undergoing radical prostatectomy for localized prostate cancer at our institution. MATERIAL AND METHODS: Between 1995 and 2010, a total of 1,350 consecutive patients......-matched Danish population using the methods and macros described by Dickmann. The country-specific population mortality rates used for calculation of the expected survival were based on data from The Human Mortality Database. RESULTS: The median follow-up was 3.4 years (range: 0-14.3 years). A total of 59 (4...

  9. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  10. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  11. Conventional versus computer-navigated TKA: a prospective randomized study.

    Science.gov (United States)

    Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

    2017-06-01

    The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant

  12. Ultrasonic root-end preparation in apical surgery : a prospective randomized study

    NARCIS (Netherlands)

    de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

    2007-01-01

    Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

  13. Urinary incontinence and voiding dysfunction after radical retropubic prostatectomy (prospective urodynamic study).

    Science.gov (United States)

    Majoros, Attila; Bach, Dietmar; Keszthelyi, Attila; Hamvas, Antal; Romics, Imre

    2006-01-01

    During this prospective study we analyzed the effects of radical retropubic prostatectomy (RRP) on bladder and sphincter function by comparing preoperative and postoperative urodynamic data. The aim of the study was to determine the reason for urinary incontinence after RRP and explain why one group of patients will be immediately continent after catheter removal, while others need some time to reach complete continence. Urodynamic examination was performed in 63 patients 3-7 days before and 2 months after surgery. Forty-three (68.2%) and 53 (84.1%) patients regained continence at 2 and 9 months following RRP, respectively. Ten patients (15.9%) were immediately continent after catheter removal. Urodynamic stress incontinence was detected in 18 (28.6%), and detrusor overactivity incontinence in 2 (3.2%) patients 2 months after surgery. The amplitude of preoperative maximal voluntary sphincteric contractions was significantly higher in the postoperative continent group (125 vs. 96.5 cmH(2)O, P continent following catheter removal had no lower urinary tract symptoms (LUTS) and urodynamic abnormality preoperatively, and they had significantly higher preoperative and postoperative maximum urethral closure pressure (at rest and during voluntary sphincter contraction) than those who became continent later on. These data suggest that the main cause of incontinence after RRP is sphincteric weakness. In the continent group, those who became immediately continent had significantly higher maximum urethral closure pressure values at rest and at voluntary sphincteric contraction even before the surgery. Neurourol. Urodynam. (c) 2005 Wiley-Liss, Inc.

  14. Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

    NARCIS (Netherlands)

    Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

    2013-01-01

    Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

  15. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  16. One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery : a prospective randomized trial

    NARCIS (Netherlands)

    Van der Steen, Annemarie; Detollenaere, Renee; Den Boon, Jan; Van Eijndhoven, Hugo

    For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. We conducted a prospective randomized trial in which 179

  17. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  18. Nonspecific genitourinary pain improves after prostatectomy using holmium laser enucleation of prostate in patients with benign prostatic hyperplasia: a prospective study.

    Directory of Open Access Journals (Sweden)

    Sung Han Kim

    Full Text Available OBJECTIVE: To investigate changes in nonspecific genitourinary discomfort or pain (GUDP before and after holmium laser enucleation of prostate (HoLEP. GUDP associated with lower urinary tract symptoms (LUTS is a common complaint among benign prostatic hyperplasia (BPH patients, but very little is known about this clinical entity. METHODS: From February 2010 to August 2011, 100 HoLEP patients with complete clinical data at a single institution were enrolled in the study to analyze the degree of GUDP with a visual analog scale (VAS from 0 to 10 points at baseline and at 3 and 6 months postoperatively, and to investigate any relationships between GUDP and urodynamics, uroflowmetry, and scores from the International Prostate Symptom Score (IPSS questionnaire. RESULTS: Fifty-six patients had LUTS only, while the remaining 44 had both LUTS and GUDP. Pain was located in the suprapubic (42.0%, perineal/penile (33.0%, back (17.0%, and perianal (8.0% regions. During the post-operative period, at six months, the VAS, IPSS, peak flow rate and post-void residual volume had improved significantly in 44 GUDP patients (p<0.010. GUDP had completely resolved in 40 (90.9% patients and had decreased in four (9.1% patients, while seven (12.5% patients developed GUDP with voiding in the urethral and perineal areas by the third month postoperatively. When compared to patients with complete resolution, those with persistent GUDP were found to have a significantly higher preoperative presence of bladder outlet obstruction (BOO as an independent risk factor (OR 6.173, 95% CI 1.132-1.323. CONCLUSION: Both GUDP and LUTS improved significantly after HoLEP. Patients with significant preoperative BOO tended to have persistent GUDP after surgery.

  19. A Prospective Randomized Clinical Study of the Influence of Primary ...

    African Journals Online (AJOL)

    of closure of the socket after surgical extraction of impacted mandibular third molar. ... mandibular third molar surgery concluded that there was a reduction in .... round bur (carbide no: 8) in a high speed straight hand piece under constant ...

  20. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... and 14-day quadruple therapies as first-line treatments for Helicobacter pylori infection in ..... Furthermore, in a large-scale, multicenter, Japanese study ... Taylor DE, Ge Z, Purych D, Lo T, Hiratsuka K. Cloning and sequence ...

  1. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... the H. pylori eradication group showed a markedly lower rate of metachronous recurrence after 3 years when compared with the non-eradication group.[16] These findings show that H. pylori eradication can inhibit the development of gastric cancer. Thus, the consensus among international guidelines is ...

  2. Adjuvant and Salvage Radiotherapy After Prostatectomy for Prostate Cancer: A Literature Review

    International Nuclear Information System (INIS)

    Pasquier, David; Ballereau, Charles

    2008-01-01

    Purpose: Given that postprostatectomy recurrence of prostate cancer occurs in 10-40% of patients, the best use of immediate postoperative radiotherapy (RT) in high-risk patients and salvage RT for biochemical recurrence remains a topic of debate. We assessed the levels of evidence (in terms of efficacy, prognostic factors, and toxicity) for the following treatment strategies: immediate postoperative RT alone, salvage RT alone, and the addition of androgen deprivation therapy to the two RT strategies. Methods and Materials: A systematic literature search for controlled randomized trials, noncontrolled trials, and retrospective studies between 1990 and 2008 was performed on PubMed, CancerLit, and MEDLINE. Only relevant articles that had appeared in peer-reviewed journals were selected. We report on the levels of evidence (according to the National Cancer Institute guidelines) supporting the various treatment strategies. Results: Immediate postoperative RT improves biochemical and clinical progression-free survival (Level of evidence, 1.ii) but has no significant effect on metastasis-free survival or overall survival. A pathologic review is of particular importance for correctly analyzing the treatment strategies. Low-grade morbidity has been significantly greater in the postoperative groups, but no severe toxicity has been observed. The influence of immediate postoperative RT on postprostatectomy continence appears to be slight; therefore, immediate postoperative RT should be considered in patients with major risk factors for local relapse (Level of evidence, 1.ii). On the basis of extensive retrospective data, salvage RT is effective in biochemical relapse after prostatectomy; some patients with few adverse prognostic factors might also benefit from salvage RT (Level of evidence, 3.ii). The addition of androgen deprivation therapy to immediate postoperative or salvage RT has only been supported by weak, retrospective data (Level of evidence, 3.ii). Conclusion

  3. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  4. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  5. Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

    NARCIS (Netherlands)

    Fockens, P.; Cohen, L.; Edmundowicz, S.A.; Binmoeller, K.; Rothstein, R.I.; Smith, D.; Lin, E.; Nickl, N.; Overholt, B.; Kahrilas, P.J.; Vakil, N.; Abdel Aziz Hassan, A.M.; Lehman, G.A.

    2010-01-01

    This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). A prospective, randomized, sham-controlled, single-blinded,

  6. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2017-06-01

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

  7. Risk of complications and urinary incontinence following cytoreductive prostatectomy: a multi-institutional study

    Directory of Open Access Journals (Sweden)

    Dae Keun Kim

    2018-01-01

    Full Text Available Emerging evidence has suggested that cytoreductive prostatectomy (CRP allows superior oncologic control when compared to current standard of care androgen deprivation therapy alone. However, the safety and benefit of cytoreduction in metastatic prostate cancer (mPCa has not been proven. Therefore, we evaluated the incidence of complications following CRP in men newly diagnosed with mPCa. A total of 68 patients who underwent CRP from 2006 to 2014 at four tertiary surgical centers were compared to 598 men who underwent radical prostatectomy for clinically localized prostate cancer (PCa. Urinary incontinence was defined as the use of any pad. CRP had longer operative times (200 min vs 140 min, P < 0.0001 and higher estimated blood loss (250 ml vs 125 ml, P < 0.0001 compared to the control group. However, both overall (8.82% vs 5.85% and major complication rates (4.41% vs 2.17% were comparable between the two groups. Importantly, urinary incontinence rate at 1-year after surgery was significantly higher in the CRP group (57.4% vs 90.8%, P < 0.0001. Univariate logistic analysis showed that the estimated blood loss was the only independent predictor of perioperative complications both in the unadjusted model (OR: 1.18; 95% CI: 1.02-1.37; P = 0.025 and surgery type-adjusted model (OR: 1.17; 95% CI: 1.01-1.36; P = 0.034. In conclusion, CRP is more challenging than radical prostatectomy and associated with a notably higher incidence of urinary incontinence. Nevertheless, CRP is a technically feasible and safe surgery for selecting PCa patients who present with node-positive or bony metastasis when performed by experienced surgeons. A prospective, multi-institutional clinical trial is currently underway to verify this concept.

  8. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors

    NARCIS (Netherlands)

    K.T. Tran; H.G. Smeenk; C.H.J. van Eijck (Casper); G. Kazemier (Geert); W.C.J. Hop (Wim); J.W. Greve (Jan Willem); O.T. Terpstra (Onno); J.A. Zijlstra (Jan); P. Klinkert; J. Jeekel (Hans)

    2004-01-01

    textabstractOBJECTIVE: A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss,

  9. Laser prostatectomy using a right angle delivery system

    Science.gov (United States)

    Trigo-Rocha, Flavio; Mitre, Anuar I.; Chavantes, Maria C.; Arap, Sami

    1995-05-01

    Benign prostate hyperplasia (BPH) represents a major health problem in old men. In the present transurethral resection of the prostate (TURP) is the gold standard treatment for BPH. Although TURP is related to low mortality rates its mobidity is quite high. To evaluate the efficacy and safety of a new surgical treatment for BPH we undertook 30 patients with symptomatic BPH. All of them were submitted to a laser prostatectomy using a lateral delivery system (non contact) connected to a Nd-YAG laser font. The preoperative evaluation showed a prostate weight ranging from 30,5 to 86 grams (mean equals 42,5). The preoperative prostatic specific antigen (PSA) ranged from 0,9 to 10,2 ng/dl (mean equals 4.3). The International prostate symptom score (I-PSS) ranged from 16 to 35 points (means equals 23,58). The flow rate ranged from 0 to m 12.8 ml/sec (mean equals 4,65) and the postvoid residual urine from 20 to 400 ml (mean equals 100). We obtained follow-up in 20 patients. After three months after the procedure the parameters were: I-PSS from 4 to 20 points (mean equals 7,0) p stenosis in one patient. We concluded that laser prostatectomy is a safe and effective treatment for BPH.

  10. Robot-assisted radical prostatectomy is a safe procedure

    DEFF Research Database (Denmark)

    Thomsen, Frederik Birkebæk; Berg, Kasper Drimer; Hvarness, Helle

    2013-01-01

    We present our departmental experience with robot-assisted radical prostatectomy and describe complications and early results for the first 239 consecutive patients.......We present our departmental experience with robot-assisted radical prostatectomy and describe complications and early results for the first 239 consecutive patients....

  11. Robots drive the German radical prostatectomy market: a total population analysis from 2006 to 2013.

    Science.gov (United States)

    Groeben, C; Koch, R; Baunacke, M; Wirth, M P; Huber, J

    2016-12-01

    To assess trends in the distribution of patients for radical prostatectomy in Germany from 2006 to 2013 and the impact of robotic surgery on annual caseloads. We hypothesized that the advent of robotics and the establishment of certified prostate cancer centers caused centralization in the German radical prostatectomy market. Using remote data processing we analyzed the nationwide German billing data from 2006 to 2013. We supplemented this database with additional hospital characteristics like the prostate cancer center certification status. Inclusion criteria were a prostate cancer diagnosis combined with radical prostatectomy. Hospitals with certification or a surgical robot in 2009 were defined as 'early' group. Linear covariant-analytic models were applied to describe trends over time. Annual radical prostatectomy numbers declined from 28 374 (2006) to 21 850 (2013). High-volume hospitals (⩾100 cases) decreased from 87 (22.0%) in 2006 to 43 (10.4%) in 2013. Low-volume hospitals (200 cases per year contrary to the overall trend (Pdecentralization of radical prostatectomy in Germany. The driving force for this development might consist in the overall decline of radical prostatectomy numbers. The most important factor for achieving higher caseloads was the presence of a robotic system. In order to optimize outcomes of radical prostatectomy additional health policy measures might be necessary.

  12. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared......, respectively, 15 and 12 minutes (pcancer of the esophagus or cardia. The choice of echoendoscope for TNM staging in patients with these malignancies is, therefore, a question...

  13. Is a wider angle of the membranous urethra associated with incontinence after radical prostatectomy?

    Science.gov (United States)

    Soljanik, Irina; Bauer, Ricarda M; Becker, Armin J; Stief, Christian G; Gozzi, Christian; Solyanik, Olga; Brocker, Kerstin A; Kirchhoff, Sonja M

    2014-12-01

    To investigate whether differences in the anatomy and dynamics of the pelvic floor (PF) in patients after radical prostatectomy (RP) depicted on magnetic resonance imaging (MRI) are associated with continence status. In the prospective designed study, 24 patients with post-prostatectomy stress urinary incontinence were enrolled. Additionally, 10 continent patients after RP were matched for age, body mass index and perioperative parameters. All patients underwent continence assessment and MRI (TrueFISP sequence; TR 4.57 ms; TE 2.29 ms; slice thickness 7 mm; FOV 270 mm) 12 months after RP. Images were analyzed for membranous urethra length (MUL), angle of the membranous urethra (AMU), severity of periurethral/urethral fibrosis, lifting of the levator ani muscle, lowering of the posterior bladder wall (BPW), bladder neck (BN) and external urinary sphincter (EUS), and symphyseal rotation of these structures during the Valsalva maneuver and voiding. Compared to continent controls, incontinent patients showed a significant wider AMU during voiding (p = 0.002) and more pronounced lowering of the BN and EUS (p urethra as a result of anchoring of the BN and EUS in the PF appears to be an important functional factor with an essential impact on continence after RP. Functional MRI seems to be a helpful imaging tool for morphologic and dynamic evaluation of the PF.

  14. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  15. The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

    NARCIS (Netherlands)

    de Jong, Leo A. M. S.

    2009-01-01

    The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

  16. Learning curve of robot-assisted laparoscopic radical prostatectomy for a single experienced surgeon: comparison with simultaneous laparoscopic radical prostatectomy.

    Science.gov (United States)

    Ku, Ja Yoon; Ha, Hong Koo

    2015-04-01

    Despite the large number of analytical reports regarding the learning curve in the transition from open to robot-assisted radical prostatectomy (RARP), few comparative results with laparoscopic radical prostatectomy (LRP) have been reported. Thus, we evaluated operative and postoperative outcomes in RARP versus 100 simultaneously performed LRPs. A single surgeon had performed more than 1,000 laparoscopic operations, including 415 cases of radical nephrectomy, 85 radical cystectomies, 369 radical prostatectomies, and treatment of 212 other urological tumors, since 2009. We evaluated operative (operation time, intraoperative transfusion, complications, hospital stay, margin status, pathological stage, Gleason score) and postoperative (continence and erectile function) parameters in initial cases of RARP without tutoring compared with 100 recently performed LRPs. Mean operation time and length of hospital stay for RARP and LRP were 145.5±43.6 minutes and 118.1±39.1 minutes, and 6.4±0.9 days and 6.6±1.1 days, respectively (p=0.003 and p=0.721). After 17 cases, the mean operation time for RARP was similar to LRP (less than 2 hours). Positive surgical margins in localized cancer were seen in 11.1% and 8.9% of cases in RARP and LRP, respectively (p=0.733). At postoperative 3 months, sexual intercourse was reported in 14.0% and 12.0%, and pad-free continence in 96.0% and 81.0% in patients with RARP and LRP, respectively (p=0.796 and p=0.012). Previous large-volume experience of LRPs may shorten the learning curve for RARP in terms of oncological outcome. Additionally, previous experience with laparoscopy may improve the functional outcomes of RARP.

  17. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  18. A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

    Science.gov (United States)

    McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

    2001-05-01

    Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

  19. ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY: OUR EXPERIENCE

    Directory of Open Access Journals (Sweden)

    S. N. Nesterov

    2014-08-01

    Full Text Available Background. Retropubic radical prostatectomy (RPE is now the gold standard of treatment for locally advanced prostate cancer (PC. However, robot-assisted RPE procedures using the da Vinci system are finding increasing acceptance.Materials and methods. The authors conducted a prospective study of 60 robot-assisted prostatectomies made at the Clinic of Urology, N.I. Pirogov National Medical Surgical Center, in the period January 2009 to December 2010.Results. The duration of an operation averaged 230 min; the average amount of blood loss was 200 ml. The mean duration of postoperative analgesia was 2,7 days. That of urinary catheterization was 8.5 days. A normal postoperative course was noted in most cases (88,4 %. Seven patients were found to have 8 (13,3 % mild and moderate complications. A pathohistological study revealed a positive surgical margin of resection in 21,7 % of the patients, extracapsular tumor growth in 21,7 %, and seminal vesicle invasion in 23,3 %. Tumor-affected regional lymph nodes were detected in 1 (1,7 % patient. In our observed series, 82 and 93 % of the subjects completely retained urine after 6 and 12 moths, respectively. Throughout the follow-up, erectile function recovered in 7 of the 15 patients undergoing a nerve-sparing surgical procedure.Conclusion. Postoperative results in our series of interventions are comparable to those obtained in the studies by Russian and foreign colleagues at the early stage of mastering this procedure. By considering a few observations, it is today difficult to say that our study is valid in the context of evidence-based medicine. Estimation of the benefits of robot-assisted laparoscopic prostatectomy calls for long-term multicenter randomized trials.

  20. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

    Directory of Open Access Journals (Sweden)

    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  1. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  2. Age as a prognostic variable in patients undergoing transurethral prostatectomy

    DEFF Research Database (Denmark)

    Krogh, J; Jensen, J S; Iversen, H G

    1993-01-01

    In a retrospective study the outcome of transurethral prostatectomy (TURP) for benign prostatic hyperplasia (BPH) in patients more than 80 years old was compared to a control group of patients with a mean age ten years younger. The elderly had significantly more tissue resected and presented...... with a higher rate of preoperative urinary tract infection. More urological complications were seen among the elderly but these were generally short lived and had no influence on the morbidity, mortality and symptomatic outcome. The perioperative mortality was 3.2% among elderly and 0% in the younger age group....... A cardiorespiratory risk score could not predict patients at risk. In conclusion the age per se had no major influence on the outcome of TURP....

  3. Orgasm after radical prostatectomy

    NARCIS (Netherlands)

    Koeman, M; VanDriel, MF; Schultz, WCMW; Mensink, HJA

    Objective To evaluate the ability to obtain and the quality of orgasm after radical prostatectomy, Patients and methods The orgasms experienced after undergoing radical prostatectomy were evaluated in 20 men (median age 65 years, range 56-76) using a semi-structured interview and a self-administered

  4. A prospective, randomized study addressing the need for physical simulation following virtual simulation

    International Nuclear Information System (INIS)

    Valicenti, Richard K.; Waterman, Frank M.; Corn, Benjamin W.; Curran, Walter J.

    1997-01-01

    Purpose: To accurately implement a treatment plan obtained by virtual or CT simulation, conventional or physical simulation is still widely used. To evaluate the need for physical simulation, we prospectively randomized patients to undergo physical simulation or no additional simulation after virtual simulation. Methods and Materials: From July 1995 to September 1996, 75 patients underwent conformal four-field radiation therapy planning for prostate cancer with a commercial grade CT simulator. The patients were randomized to undergo either port filming immediately following physical simulation or port filming alone. The precision of implementing the devised plan was evaluated by comparing simulator radiographs and/or port films against the digitally reconstructed radiographs (DRRs) for x, y, and z displacements of the isocenter. Changes in beam aperture were also prospectively evaluated. Results: Thirty-seven patients were randomized to undergo physical simulation and first day port filming, and 38 had first day treatment verification films only without a physical simulation. Seventy-eight simulator radiographs and 195 first day treatment port films were reviewed. There was no statistically significant reduction in treatment setup error (>5 mm) if patients underwent physical simulation following virtual simulation. No patient required a resimulation, and there was no significant difference in changes of beam aperture. Conclusions: Following virtual simulation, physical simulation may not be necessary to accurately implement the conformal four-field technique. Because port filming appears to be sufficient to assure precise and reliable execution of a devised treatment plan, physical simulation may be eliminated from the process of CT based planning when virtual simulation is available

  5. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

    Science.gov (United States)

    Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

    2016-01-01

    Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

  6. Critical appraisal of outcomes following open radical prostatectomy.

    Science.gov (United States)

    Galvin, David J; Eastham, James A

    2009-05-01

    Radical prostatectomy has evolved enormously over the last 25 years. Improvements include the use of smaller incisions, reduced blood loss, shorter hospital stays, and surgical refinement to improve the recovery of continence and potency. In addition, new technologies and minimally invasive techniques with the potential to further improve patient outcomes have been introduced. This article focuses on outcomes with open radical prostatectomy and is not meant to compare open radical prostatectomy and minimally invasive approaches. Despite a lack of randomized controlled trials, strong observational cohort studies demonstrate lower rates of positive surgical margins, high 10-year and 15-year biochemical recurrence-free rates, excellent prostate cancer-specific mortality rates, and improved recovery of urinary incontinence and erectile function after open radical prostatectomy. We review publications from the past 24 months regarding oncologic outcome, continence, and erectile function, as well as some earlier manuscripts that emphasize key aspects of open radical prostatectomy. Today open radical prostatectomy is a less-invasive procedure with low morbidity providing excellent control of clinically localized prostate cancer. Although open radical prostatectomy now accounts for a minority of radical prostatectomies in the United States, the concepts that have improved oncologic and quality-of-life outcomes are equally applicable to minimally invasive procedures.

  7. Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

    Science.gov (United States)

    Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

    2002-05-01

    Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

  8. A new nomogram to predict pathologic outcome following radical prostatectomy

    Directory of Open Access Journals (Sweden)

    Alexandre Crippa

    2006-04-01

    Full Text Available OBJECTIVE: To develop a preoperative nomogram to predict pathologic outcome in patients submitted to radical prostatectomy for clinical localized prostate cancer. MATERIALS AND METHODS: Nine hundred and sixty patients with clinical stage T1 and T2 prostate cancer were evaluated following radical prostatectomy, and 898 were included in the study. Following a multivariate analysis, nomograms were developed incorporating serum PSA, biopsy Gleason score, and percentage of positive biopsy cores in order to predict the risks of extraprostatic tumor extension, and seminal vesicle involvement. RESULTS: In univariate analysis there was a significant association between percentage of positive biopsy cores (p < 0.001, serum PSA (p = 0.001 and biopsy Gleason score (p < 0.001 with extraprostatic tumor extension. A similar pathologic outcome was seen among tumors with Gleason score 7, and Gleason score 8 to 10. In multivariate analysis, the 3 preoperative variables showed independent significance to predict tumor extension. This allowed the development of nomogram-1 (using Gleason scores in 3 categories - 2 to 6, 7 and 8 to 10 and nomogram-2 (using Gleason scores in 2 categories - 2 to 6 and 7 to 10 to predict disease extension based on these 3 parameters. In the validation analysis, 87% and 91.1% of the time the nomograms-1 and 2, correctly predicted the probability of a pathological stage to within 10% respectively. CONCLUSION: Incorporating percent of positive biopsy cores to a nomogram that includes preoperative serum PSA and biopsy Gleason score, can accurately predict the presence of extraprostatic disease extension in patients with clinical localized prostate cancer.

  9. Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

    Science.gov (United States)

    Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

    2001-01-01

    The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

  10. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  11. Robotic-assisted transperitoneal radical prostatectomy in a patient with pelvic kidney

    International Nuclear Information System (INIS)

    Rabah, Danny M.; Alyami, Fahad A.

    2008-01-01

    Robots are increasingly utilized in urology, due to their favorable performance characteristics especially in prostatectomy and pyeloplasty. However, preoperative diagnosis of urogenital congenital anomalies and preoperative planning are important aspects to be considered. The presence of ectopic pelvic kidney is a challenge for the surgeon to perform robotic-assisted radical prostatectomy (RARP) without injury to the pelvic kidney (PC) or its blood supply. We report our experience of performing RARP in a patient with a PK. (author)

  12. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  13. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

  14. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

  15. Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

    NARCIS (Netherlands)

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

    Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

  16. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

  17. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study.

    Science.gov (United States)

    Kc, Hari Bahadur; Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-09-01

    This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5-10 mm. Both drugs are safe, effective, and well tolerated with minor side effects.

  18. Prospective longitudinal comparative study of health-related quality of life in patients treated with radical prostatectomy or permanent brachytherapy for prostate cancer

    International Nuclear Information System (INIS)

    Kobuke, Makoto; Saika, Takashi; Nakanishi, Yoshiko

    2009-01-01

    To determine health-related quality of life (HRQOL) after radical retropubic prostatectomy (RRP) or permanent prostate brachytherapy (BT), third party-conducted QOL surveys were prospectively compared. Between 2004 and 2005, 37 patients underwent RRP and 36 were treated with BT. A QOL survey consisting of the Medical Outcomes Study 36-Item Short Form (SF-36), the University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) and the International Prostate Symptoms Score (IPSS) was completed prospectively by a research coordinator at baseline, and at 1, 3, 6 and 12 months after treatment. The RRP patients scored well in general QOL except at 1 month after surgery, with their mental health better than at baseline by 6 months after surgery. Disease-specific QOL in RRP patients received a low score at 1 month for both urinary and sexual function, though urinary function rapidly recovered to baseline levels. BT patient QOL was not affected by the therapy except in the IPSS score. However, general and mental health scores in BT patients were inferior to those in RRP patients. This prospective study revealed differences in QOL after RRP and BT. These results will be helpful in making treatment decisions. (author)

  19. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  20. Long-Term Follow-Up of a Prospective Trial of Trimodality Therapy of Weekly Paclitaxel, Radiation, and Androgen Deprivation in High-Risk Prostate Cancer With or Without Prior Prostatectomy

    Energy Technology Data Exchange (ETDEWEB)

    Hussain, Arif, E-mail: ahussain@som.umaryland.edu [University of Maryland Greenebaum Cancer Center, Baltimore, MD (United States); Department of Medicine, University of Maryland School of Medicine, Baltimore, MD (United States); Baltimore VA Medical Center, Baltimore, MD (United States); Wu, Yin [Department of Medicine, University of Maryland School of Medicine, Baltimore, MD (United States); Mirmiran, Alireza [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD (United States); DiBiase, Steven [Cooper University Hospital, Camden, NJ (United States); Goloubeva, Olga [University of Maryland Greenebaum Cancer Center, Baltimore, MD (United States); Bridges, Benjamin [University of Maryland Greenebaum Cancer Center, Baltimore, MD (United States); Department of Medicine, University of Maryland School of Medicine, Baltimore, MD (United States); Mannuel, Heather [University of Maryland Greenebaum Cancer Center, Baltimore, MD (United States); Department of Medicine, University of Maryland School of Medicine, Baltimore, MD (United States); Baltimore VA Medical Center, Baltimore, MD (United States); Engstrom, Christine [Baltimore VA Medical Center, Baltimore, MD (United States); Dawson, Nancy [Lombardi Cancer Center, Georgetown University, Washington, D.C (United States); Amin, Pradip; Kwok, Young [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD (United States)

    2012-01-01

    Purpose: Weekly paclitaxel, concurrent radiation, and androgen deprivation (ADT) were evaluated in patients with high-risk prostate cancer (PC) with or without prior prostatectomy (RP). Methods and Materials: Eligible post-RP patients included: pathological T3 disease, or rising prostate-specific antigen (PSA) {>=}0.5 ng/mL post-RP. Eligible locally advanced PC (LAPC) patients included: 1) cT2b-4N0N+, M0; 2) Gleason score (GS) 8-10; 3) GS 7 + PSA 10-20 ng/mL; or 4) PSA 20-150 ng/mL. Treatment included ADT (4 or 24 months), weekly paclitaxel (40, 50, or 60 mg/m{sup 2}/wk), and pelvic radiation therapy (total dose: RP = 64.8 Gy; LAPC = 70.2 Gy). Results: Fifty-nine patients were enrolled (LAPC, n = 29; RP, n = 30; ADT 4 months, n = 29; 24 months, n = 30; whites n = 29, African Americans [AA], n = 28). Baseline characteristics (median [range]) were: age 67 (45-86 years), PSA 5.9 (0.1-92.1 ng/mL), GS 8 (6-9). At escalating doses of paclitaxel, 99%, 98%, and 95% of doses were given with radiation and ADT, respectively, with dose modifications required primarily in RP patients. No acute Grade 4 toxicities occurred. Grade 3 toxicities were diarrhea 15%, urinary urgency/incontinence 10%, tenesmus 5%, and leukopenia 3%. Median follow-up was 75.3 months (95% CI: 66.8-82.3). Biochemical progression occurred in 24 (41%) patients and clinical progression in 11 (19%) patients. The 5- and 7-year OS rates were 83% and 67%. There were no differences in OS between RP and LAPC, 4- and 24-month ADT, white and AA patient categories. Conclusions: In addition to LAPC, to our knowledge, this is the first study to evaluate concurrent chemoradiation with ADT in high-risk RP patients. With a median follow-up of 75.3 months, this trial also represents the longest follow-up of patients treated with taxane-based chemotherapy with EBRT in high-risk prostate cancer. Concurrent ADT, radiation, and weekly paclitaxel at 40 mg/m{sup 2}/week in RP patients and 60 mg/m{sup 2}/week in LAPC patients is

  1. Long-Term Follow-Up of a Prospective Trial of Trimodality Therapy of Weekly Paclitaxel, Radiation, and Androgen Deprivation in High-Risk Prostate Cancer With or Without Prior Prostatectomy

    International Nuclear Information System (INIS)

    Hussain, Arif; Wu, Yin; Mirmiran, Alireza; DiBiase, Steven; Goloubeva, Olga; Bridges, Benjamin; Mannuel, Heather; Engstrom, Christine; Dawson, Nancy; Amin, Pradip; Kwok, Young

    2012-01-01

    Purpose: Weekly paclitaxel, concurrent radiation, and androgen deprivation (ADT) were evaluated in patients with high-risk prostate cancer (PC) with or without prior prostatectomy (RP). Methods and Materials: Eligible post-RP patients included: pathological T3 disease, or rising prostate-specific antigen (PSA) ≥0.5 ng/mL post-RP. Eligible locally advanced PC (LAPC) patients included: 1) cT2b-4N0N+, M0; 2) Gleason score (GS) 8–10; 3) GS 7 + PSA 10–20 ng/mL; or 4) PSA 20–150 ng/mL. Treatment included ADT (4 or 24 months), weekly paclitaxel (40, 50, or 60 mg/m 2 /wk), and pelvic radiation therapy (total dose: RP = 64.8 Gy; LAPC = 70.2 Gy). Results: Fifty-nine patients were enrolled (LAPC, n = 29; RP, n = 30; ADT 4 months, n = 29; 24 months, n = 30; whites n = 29, African Americans [AA], n = 28). Baseline characteristics (median [range]) were: age 67 (45–86 years), PSA 5.9 (0.1–92.1 ng/mL), GS 8 (6–9). At escalating doses of paclitaxel, 99%, 98%, and 95% of doses were given with radiation and ADT, respectively, with dose modifications required primarily in RP patients. No acute Grade 4 toxicities occurred. Grade 3 toxicities were diarrhea 15%, urinary urgency/incontinence 10%, tenesmus 5%, and leukopenia 3%. Median follow-up was 75.3 months (95% CI: 66.8–82.3). Biochemical progression occurred in 24 (41%) patients and clinical progression in 11 (19%) patients. The 5- and 7-year OS rates were 83% and 67%. There were no differences in OS between RP and LAPC, 4- and 24-month ADT, white and AA patient categories. Conclusions: In addition to LAPC, to our knowledge, this is the first study to evaluate concurrent chemoradiation with ADT in high-risk RP patients. With a median follow-up of 75.3 months, this trial also represents the longest follow-up of patients treated with taxane-based chemotherapy with EBRT in high-risk prostate cancer. Concurrent ADT, radiation, and weekly paclitaxel at 40 mg/m 2 /week in RP patients and 60 mg/m 2 /week in LAPC patients is

  2. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    International Nuclear Information System (INIS)

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-01-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m 2 ) six weekly and hydroxyurea (HU, 3.5 gm/m 2 over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease

  3. Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

    Science.gov (United States)

    Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

    2012-02-01

    The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

  4. Improving Prospective Memory in Persons With Parkinson Disease: A Randomized Controlled Trial.

    Science.gov (United States)

    Foster, Erin R; McDaniel, Mark A; Rendell, Peter G

    2017-05-01

    Prospective memory (PM) is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause PM deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions (IIs) is an encoding strategy that may improve PM in this population. To determine the effect of IIs on PM performance in PD. This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (n = 62) performed a computerized PM test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either IIs or a rehearsal (RR) encoding strategy. PM performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared with time-based cues. In addition, IIs resulted in a larger effect than RR for the nonrepeated tasks. Strategies that support full encoding of PM cues and actions can improve PM performance among people with PD, particularly for tasks with cues that are readily available in the environment. IIs may be more effective than RR for nonrepeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage PM impairment could improve function and quality of life and significantly affect clinical care for people with PD.

  5. Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

    Science.gov (United States)

    Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

    2016-11-03

    The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  6. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    Science.gov (United States)

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  7. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

    Directory of Open Access Journals (Sweden)

    Kallol K Roy

    2017-01-01

    Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

  8. Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

    Science.gov (United States)

    Parilla, B V; McDermott, T M

    1998-01-01

    The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

  9. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

  10. Penile vibratory stimulation in the treatment of post-prostatectomy incontinence

    DEFF Research Database (Denmark)

    Fode, Mikkel; Sønksen, Jens

    2015-01-01

    AIMS: To examine penile vibratory stimulation (PVS) in the treatment of post-prostatectomy urinary incontinence (UI). METHODS: Patients with post-prostatectomy UI were included in a 12-week trial. A 24-hr pad test and a 72-hr voiding diary were collected at baseline. Participants were randomized ...

  11. Salvage robotic radical prostatectomy

    Directory of Open Access Journals (Sweden)

    Samuel D Kaffenberger

    2014-01-01

    Full Text Available Failure of non-surgical primary treatment for localized prostate cancer is a common occurrence, with rates of disease recurrence ranging from 20% to 60%. In a large proportion of patients, disease recurrence is clinically localized and therefore potentially curable. Unfortunately, due to the complex and potentially morbid nature of salvage treatment, radical salvage surgery is uncommonly performed. In an attempt to decrease the morbidity of salvage therapy without sacrificing oncologic efficacy, a number of experienced centers have utilized robotic assistance to perform minimally invasive salvage radical prostatectomy. Herein, we critically evaluate the existing literature on salvage robotic radical prostatectomy with a focus on patient selection, perioperative complications and functional and early oncologic outcomes. These results are compared with contemporary and historical open salvage radical prostatectomy series and supplemented with insights we have gained from our experience with salvage robotic radical prostatectomy. The body of evidence by which conclusions regarding the efficacy and safety of robotic salvage radical prostatectomy can be drawn comprises fewer than 200 patients with limited follow-up. Preliminary results are promising and some outcomes have been favorable when compared with contemporary open salvage prostatectomy series. Advantages of the robotic platform in the performance of salvage radical prostatectomy include decreased blood loss, short length of stay and improved visualization. Greater experience is required to confirm the long-term oncologic efficacy and functional outcomes as well as the generalizability of results achieved at experienced centers.

  12. Comparative randomized study on the efficaciousness of treatment of BOO due to BPH in patients with prostate up to 100 gr by endoscopic gyrus prostate resection versus open prostatectomy. Preliminary data.

    Science.gov (United States)

    Giulianelli, Roberto; Brunori, Stefano; Gentile, Barbara Cristina; Vincenti, Giorgio; Nardoni, Stefano; Pisanti, Francesco; Shestani, Teuta; Mavilla, Luca; Albanesi, Luca; Attisani, Francesco; Mirabile, Gabriella; Schettini, Manlio

    2011-06-01

    With the advent of medical management and minimally techniques for benign prostate hypeplasia (BPH), invasive surgical procedures such open prostatectomy (OPSU) have become less common, although selected patients may still benefit from open prostatectomy. Aim of this study was to evaluate efficacy and safety of Bipolar TURP (Gyrus electro surgical system) versus standard open prostatectomy in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) with markedly enlarged glands refractory to medical therapy. From January 2003 to January 2004, 140 patients affected by mild-severe LUTS, secondary to BOO from BPH, refractory to medical therapy, with markedly enlarged glands, were randomized in two groups (1:1), and subjected to open prostatectomy (OPSU) carried out with traditional method (Bracci Thechnique) versus transurethral resection of the prostate (TURP) utilizing the bipolar methodology. Preoperative work-up included IPSS, IIEF-5 and Qol questionnaires. All patients were submitted to uroflowmetry, transrectal ultrasound (TRUS), measurament of postvoidal residual urine and PSA determination. IPSS, IIEF-5 and Qol, uroflowmetry, TRUS, measurement of post-voidal residual urine, PSA determination and number of reoperations were evaluated at 1, 3, 6, 12, 18, 24, 30 and 36 months. Operative time, resected tissue weight and perioperative complications were also registered. Total post-operative catheter time, total postoperative hospital stay, haemoglobin loss were recorded in the 2 groups. Comparative data on IPSS symptom score, IIEF-5 and Qol, PSA, peak urinary flow rates and post-void residual urine volume in the 2 groups were similar but showed a significative improvement with respect to baseline value. Postoperative haemoglobin levels, postoperative catheterization, hospital stay and 3-yr overall surgical re-treatment-free rate were significantly better in the Bipolar group. In the treatment of LUTS due to bladder outlet

  13. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  14. Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

    NARCIS (Netherlands)

    Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

    Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

  15. Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

    International Nuclear Information System (INIS)

    EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

    2010-01-01

    Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

  16. Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial.

    Science.gov (United States)

    Zeiderman, Matthew R; Kelishadi, Shahrooz Sean; Tutela, John Paul; Rao, Arun; Chowdhry, Saeed; Brooks, Ronald M; Wilhelmi, Bradon J

    2018-01-01

    Background: Minimally invasive cosmetic procedures are the most commonly performed aesthetic techniques by plastic surgeons. Patients are interested in a pain-free experience. Surgeons desire patient satisfaction and time-efficient utilization of office staff and resources. Clinical evidence exists for use of vapocoolant technology to reduce pain associated with intravenous cannulation in the pediatric population and in hemodialysis patients. Applying vapocoolant technology to facial rejuvenation is a novel approach to decrease pain associated with neurotoxin or filler injection. Methods: A randomized, prospective study was conducted, testing 15 subjects receiving filler injections and another 15 patients receiving neurotoxin injections using a split-face model. The vapocoolant spray used was composed of a 95:5 ratio of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane. Within each group, individual patients randomly received injection (filler or neurotoxin) alone versus injection (filler or neurotoxin) plus vapocoolant on an equivalent half of his or her face. An independent examiner recorded from each patient on a scale of 1 to 10 perceived pain for injection alone versus injection plus vapocoolant spray. Results were calculated as a percentage change of pain scores experienced after injection for each person between the control (nonvapocoolant) and treatment (vapocoolant) sides of the face. Results: Vapocoolant spray at the time of cosmetic facial injections leads to a 59% decrease in perceived pain score with neurotoxin injections (range, 0%-100% change) and 64% decrease in perceived pain score with filler injections (range, 0%-100% change). These results were statistically significant with P reduces pain associated with facial rejuvenation procedures.

  17. Determinants of peri-operative blood transfusion in a contemporary series of open prostatectomy for benign prostate hyperplasia.

    Science.gov (United States)

    Kyei, Mathew Y; Klufio, George O; Mensah, James E; Gepi-Attee, Samuel; Ampadu, Kwabena; Toboh, Bernard; Yeboah, Edward D

    2016-03-28

    The objective of this study was to determine the factors responsible for peri-operative blood transfusion in a contemporary series of open prostatectomy for benign prostate hyperplasia and thus offer a guide for blood product management for the procedure. This was a prospective study of 200 consecutive patients who underwent open prostatectomy for BPH from January 2010 to September 2013 at the Korle Bu Teaching Hospital, Accra. The data analyzed included the pre-operative blood haemoglobin level (Hb), presence of co-morbidities, the case type, indication for the surgery, ASA score, anaesthetic method used, systolic blood pressure, status of the operating surgeon, duration of surgery and the operative prostate weight. The transfusion of blood peri-operatively was also documented. The mean age of the patients was 69.1 years. Elective cases formed 83.5 % with refractory retention of urine being the commonest indication for surgery (68.0 %). The mean pre-operative Hb was 12.1 g/dl. Consultants performed 56.0 % of the prostatectomies. Transvesical approach was used in 90.0 % of the cases. The mean operative time was 101.3mins (range 35.0-240.0) with a mean operative prostate weight of 110.8 g (range 15-550 g). Most of the patients (82.0 %) had spinal anaesthesia. The blood transfusion rate was 23.5 %. The transfusion rate was significantly higher in patients with anaemia (p = .000), emergency cases (p = .000), the use of general anaesthesia (p = .002), a resident as the operating surgeons (p = .034), prostate weight >100 g (p = .000) and duration of surgery (p = .011). In a multivariable logistic regression analysis however only the pre-operative Hb (p = .000. OR 0.95, 95 % CI [0.035-0.257]) and the duration of surgery (p = .025, OR 1.021, 95 % CI [1.003-1.039]) could predict blood transfusion in open prostatectomy for BPH in this series. A 'group and save' policy should be the preferred blood ordering procedure for patients

  18. EFFICACY OF SPINAL-CORD STIMULATION AS ADJUVANT THERAPY FOR INTRACTABLE ANGINA-PECTORIS - A PROSPECTIVE, RANDOMIZED CLINICAL-STUDY

    NARCIS (Netherlands)

    DEJONGSTE, MJL; HAUTVAST, RWM; HILLEGE, HL; LIE, KI

    Objectives. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation an exercise capacity and quality of life in patients with intractable angina. Background. Despite important achievements in therapy for ischemic heart disease, there

  19. YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

    Science.gov (United States)

    Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

    2011-03-01

    To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

  20. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

    Science.gov (United States)

    Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

    2011-12-01

    This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

  1. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  2. Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial.

    Science.gov (United States)

    Hamlin, Katharine; Munro, Christopher; Barker, Scott L; McKenna, Sean; Kumar, Kapil

    2018-01-01

    Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

  3. Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial

    Directory of Open Access Journals (Sweden)

    Wahner-Roedler Dietlind

    2008-10-01

    Full Text Available Abstract Background Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception. Methods We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group or bar graph plus a frequency format diagram (BG+FF group, which was assessed by previsit and postvisit questionnaires. Results Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67% was not significantly different between the 2 groups (P = .10. Among women who inaccurately perceived very high risk (≥ 50% risk, inaccurate risk perception decreased significantly in the BG+FF group (22% to 3% compared with the BG group (28% to 19% (P = .004. Conclusion Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.

  4. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

    Science.gov (United States)

    Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

    2012-03-01

    A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

  5. Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

    Science.gov (United States)

    Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

    2014-05-01

    To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  6. [Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej

    2014-01-01

    Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

  7. The efficiency of sucralfate in corrosive esophagitis: a randomized, prospective study.

    Science.gov (United States)

    Gümürdülü, Yüksel; Karakoç, Emre; Kara, Banu; Taşdoğan, Burçak Evren; Parsak, Cem Kaan; Sakman, Gürhan

    2010-03-01

    Ingestion of a chemical agent is a serious problem, and several treatment protocols to prevent stricture formation have been proposed. We conducted a randomized prospective study to evaluate the effectiveness of oral intensive sucralfate plus conventional therapy compared to conventional therapy alone. Fifteen patients with stage 2b and 3 corrosive esophagitis admitted to our gastroenterology, general surgery and intensive care units between 2004 and 2007 were included. Patients were divided into two groups. The patients in the first group (n=8) received intensive sucralfate therapy plus conventional therapy, while the other group (n=7) received only conventional therapy. We performed upper endoscopic procedures on days: 0, 21, 45, 90 and 180 to identify the emergent complications. In the first group, only one patient had stricture formation, allowing passage of a 9.2 mm endoscope and causing no dysphagia, on day 45. There was no progression in the stricture on follow-ups at the 3rd and 6th months. In the second group, 6 patients had stricture formation causing narrowing and dysphagia. Intensive sucralfate therapy may decrease the frequency of stricture formation in patients with advanced corrosive esophagitis. Further studies with large groups of patients are required to confirm our findings.

  8. Behavioral measures to reduce non-adherence in renal transplant recipients: a prospective randomized controlled trial.

    Science.gov (United States)

    Garcia, Márcia Fátima Faraldo Martinez; Bravin, Ariane Moyses; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; Nga, Hong Si; Takase, Henrique Mochida; de Andrade, Luis Gustavo Modelli

    2015-11-01

    Solid-organ transplant recipients present a high rate of non-adherence to drug treatment. Few interventional studies have included approaches aimed at increasing adherence. The objective of this study was to evaluate the impact of an educational and behavioral strategy on treatment adherence of kidney transplant recipients. In a randomized prospective study, incident renal transplant patients (n = 111) were divided into two groups: control group (received usual transplant patient education) and treatment group (usual transplant patient education plus ten additional weekly 30-min education/counseling sessions about immunosuppressive drugs and behavioral changes). Treatment adherence was assessed using ITAS adherence questionnaire after 3 months. Renal function at 3, 6, and 12 months, and the incidence of transplant rejection were evaluated. The non-adherence rates were 46.4 and 14.5 % in the control and treatment groups (p = 0.001), respectively. The relative risk for non-adherence was 2.59 times (CI 1.38-4.88) higher in the control group. Multivariate analysis demonstrated a 5.84 times (CI 1.8-18.8, p = 0.003) higher risk of non-adherence in the control group. There were no differences in renal function and rejection rates between groups. A behavioral and educational strategy addressing the patient's perceptions and knowledge about the anti-rejection drugs significantly improved the short-term adherence to immunosuppressive therapy.

  9. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

    Science.gov (United States)

    Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

    2016-01-01

    To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal

  10. Percutaneous CT-guided lung biopsy: sequential versus spiral scanning. A randomized prospective study

    International Nuclear Information System (INIS)

    Ghaye, B.; Dondelinger, R.F.; Dewe, W.

    1999-01-01

    The aim of this study was to evaluate in a prospective and randomized study spiral versus sequential scanning in the guidance of percutaneous lung biopsy. Fifty thoracic lesions occurring in 48 patients were biopsied by a senior and a junior operator. Six different time segments of the procedure were measured. Scanning mode versus length of procedure, pathological results, irradiation and complications were evaluated. Total duration of the procedure and of the first sampling was significantly longer with spiral CT for the senior operator (p < 0.004). No significant time difference was observed for the junior operator. Diameter of the lesion, depth of location, position of the patient and needle entry site did not influence the results. The sensitivity was 90.9, specificity 100, positive predictive value 100 and negative predictive value 60 % for spiral CT, and 94.7, 100, 100 and 85.7 % for sequential CT, respectively. Eleven pneumothoraces and ten perinodular hemorrhages were seen with spiral CT and six and ten, respectively, with sequential CT. The mean dose of irradiation was 4027 mAs for spiral CT and 2358 mAs for conventional CT. Spiral CT does neither reduce procedure time nor the rate of complications. Pathological results do not differ compared with sequential CT, and total dose of irradiation is higher with spiral scanning. (orig.)

  11. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial.

    Science.gov (United States)

    Bickel, Amitai; Gurevits, Michael; Vamos, Ronny; Ivry, Simon; Eitan, Arieh

    2011-04-01

    To assess the influence of hyperoxygenation on surgical site infection by using the most homogeneous study population. A randomized, prospective, controlled trial. Department of surgery in a government hospital. A total of 210 patients who underwent open surgery for acute appendicitis. In the study group, patients received 80% oxygen during anesthesia, followed by high-flow oxygen for 2 hours in the recovery room. The control group received 30% oxygen, as usual. Open appendectomy via incision in the right lower quadrant of the abdomen. Surgical site infection, mainly assessed by the ASEPSIS (additional treatment, serous discharge, erythema, purulent discharge, separation of deep tissues, isolation of bacteria, and stay in hospital prolonged >14 days) system score. Surgical site infections were recorded in 6 of 107 patients (5.6%) in the study group vs 14 of 103 patients (13.6%) in the control group (P = .04). Significant differences in the ASEPSIS score were also found. The mean hospital stay was longer in the control group (2.92 days) compared with the study group (2.51 days) (P = .01). The use of supplemental oxygen is advantageous in operations for acute appendicitis by reducing surgical site infection rate and hospital stay. clinicaltrials.gov Identifier: NCT01002365.

  12. Topical sucralfate for pain after oral CO2 laser surgery: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Guo, Chau-Shiang; Chuang, Hui-Ching; Chien, Chih-Yen

    2012-01-01

    The aim of this study was to assess the effect of topical sucralfate on postoperative pain scores and other secondary outcomes including the frequency and duration of analgesic use and postoperative bleeding episodes after CO(2) laser treatment of oral leukoplakia. In this prospective trial, a total of 80 patients were randomized into the sucralfate group (n = 40) or the control group (n = 40). Postoperative pain scores, the frequency and duration of analgesic requirements, and postoperative wound bleeding episodes were compared between the 2 groups from the operative day to postoperative day 6. Patients in the sucralfate group experienced significantly less postoperative pain on postoperative days 1 and 2. Although there was no significant difference in frequency and duration of analgesic use between the 2 groups, a trend toward lower frequency and fewer days of analgesic use in the sucralfate group was observed. This study demonstrated the efficacy of topical sucralfate application in diminishing postoperative pain after CO(2) laser therapy for oral leukoplakia. Topical sucralfate can be considered a feasible adjuvant medication for the control of pain after CO(2) laser treatment of oral leukoplakia. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

    Science.gov (United States)

    Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

    2018-01-01

    Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

  14. Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial.

    Science.gov (United States)

    Chen, Hong-bin; Huang, Yue; Chen, Su-yu; Song, Hui-wen; Li, Xiao-lin; Dai, Dong-lin; Xie, Jia-tia; He, Song; Zhao, Yuan-yuan; Huang, Chun; Zhang, Sheng-jun; Yang, Lin-na

    2011-04-01

    There is no consensus concerning small bowel preparation before capsule endoscopy (CE). This study evaluated the effects of 4 regimens on small bowel cleansing and diagnostic yield. Patients were randomly divided into 4 groups. Group A consumed a clear liquid diet after lunch on the day before CE, followed by overnight fasting. Group B took 250 mL 20% mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of the procedure. In group C, the same regimen was taken at 20:00 hours on the day before and at 05:00 hours on the day of CE. In group D, in addition to the group C regimen, 20 mL oral simethicone was taken 30 minutes before CE. Two hundred patients were prospectively enrolled, and 7 were excluded from the final analysis because of incomplete small bowel transit. No significant difference was noted among the 4 groups for small bowel transit time. Bowel preparation in group D was significantly better than for the other regimens for overall cleansing of the proximal small bowel, and showed improved overall cleansing of the distal small bowel when compared with 10-hours overnight fasting. Pathological lesions of the proximal and distal small bowel were, respectively, achieved in 82 and 74 patients, mostly distributed in group D. Small bowel preparation that involves split-dose oral mannitol plus single-dose simethicone for CE can improve mucosal visualization and subsequent diagnostic yield when compared with 10-hours overnight fasting.

  15. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Introduction Succinylcholine and rocuronium are widely used to facilitate rapid sequence induction (RSI) intubation in intensive care. Concerns relate to the side effects of succinylcholine and to slower onset and inferior intubation conditions associated with rocuronium. So far, succinylcholine and rocuronium have not been compared in an adequately powered randomized trial in intensive care. Accordingly, the aim of the present study was to compare the incidence of hypoxemia after rocuronium or succinylcholine in critically ill patients requiring an emergent RSI. Methods This was a prospective randomized controlled single-blind trial conducted from 2006 to 2010 at the University Hospital of Basel. Participants were 401 critically ill patients requiring emergent RSI. Patients were randomized to receive 1 mg/kg succinylcholine or 0.6 mg/kg rocuronium for neuromuscular blockade. The primary outcome was the incidence of oxygen desaturations defined as a decrease in oxygen saturation ≥ 5%, assessed by continuous pulse oxymetry, at any time between the start of the induction sequence and two minutes after the completion of the intubation. A severe oxygen desaturation was defined as a decrease in oxygen saturation ≥ 5% leading to a saturation value of ≤ 80%. Results There was no difference between succinylcholine and rocuronium regarding oxygen desaturations (succinylcholine 73/196; rocuronium 66/195; P = 0.67); severe oxygen desaturations (succinylcholine 20/196; rocuronium 20/195; P = 1.0); and extent of oxygen desaturations (succinylcholine -14 ± 12%; rocuronium -16 ± 13%; P = 0.77). The duration of the intubation sequence was shorter after succinycholine than after rocuronium (81 ± 38 sec versus 95 ± 48 sec; P = 0.002). Intubation conditions (succinylcholine 8.3 ± 0.8; rocuronium 8.2 ± 0.9; P = 0.7) and failed first intubation attempts (succinylcholine 32/200; rocuronium 36/201; P = 1.0) did not differ between the groups. Conclusions In critically ill

  16. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

    Science.gov (United States)

    Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

    2014-08-01

    The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Dipyridamole reduces penile apoptosis in a rat model of post-prostatectomy erectile dysfunction

    Directory of Open Access Journals (Sweden)

    Omer Kutlu

    Full Text Available ABSTRACT Purpose: Despite the nerve-sparing technique, many patients suffer from erectile dysfunction after radical prostatectomy (RP due to cavernous nerve injury. The aim of this study was to evaluate dipyridamole as a potential treatment agent of post-radical prostatectomy erectile dysfunction. Material and methods: A total of 18 male Sprague-Dawley rats were randomized into three experimental Groups (SHAM+DMSO, BCNI+DMSO and BCNI+DIP. An animal model of bilateral cavernous nerve crush injury (BCNI was established to mimic the partial nerve damage during nerve-sparing RP. After creating of BCNI, dimethyl sulphoxide (DMSO was administered transperitoneally as a vehicle to SHAM+DMSO and BCNI+DMSO Groups. BCNI+DIP Group received dipyiridamole (10mg/kg/day as a solution in DMSO for 15 days. Afterwards, rats were evaluated for in vivo erectile response to cavernous nerve stimulation. Penile tissues were also analyzed biochemically for transforming growth factor-β1 (TGF-β1 level. Penile corporal apoptosis was determined by TUNEL method. Results: Erectile response was decreased in rats with BCNI and there was no significant improvement with dipyridamole treatment. TGF-β1 levels were increased in rats with BCNI and decreased with dipyridamole treatment. Dipyridamole led to reduced penile apoptosis in rats with BCNI and there was no significant difference when compared to sham operated rats. Conclusions: Although fifteen-day dipyridamole treatment has failed to improve erectile function in rats with BCNI, the decline in both TGF-β1 levels and apoptotic indices with treatment may be helpful in protecting penile morphology after cavernous nerve injury.

  18. Treatment of lateral epicondilitis using three different local injection modalities: a randomized prospective clinical trial.

    Science.gov (United States)

    Dogramaci, Yunus; Kalaci, Aydiner; Savaş, Nazan; Duman, I Gokhan; Yanat, A Nedim

    2009-10-01

    To determine the effectiveness of three different local injection modalities in the treatment of lateral epicondilitis. In a prospective randomized study on lateral epicondilitis, 75 patients were divided into three equal groups A, B and C (n = 25) and were treated using three different method of local injection. The patients in group A were treated with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine), those in group B were treated with injection of local anaesthetic (1 mL lidocaine) combined with peppering technique and those in group C with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine) and peppering technique. The outcome was defined by measuring the elbow pain during the activity using a 10-cm visual analogue scale (VAS) and satisfaction with the treatment using a scoring system based on the criteria of the Verhaar et al. at 3 weeks and 6 months after the injection and compared with the pre-treatment condition. There were significant (P = 0.006) differences in the successful outcomes between the three groups at 6 months. In group C in which local steroid + peppering injection technique were used; excellent results were obtained in 84% of patients comparing to 36% and 48% for patients in groups A and B, respectively. The successful outcomes were statistically higher in group C comparing to group A (P = 0.002) and group B (P = 0.011). In all groups, there was a significantly lower pain (VAS) at the 3-week and 6-month follow-ups comparing to the pre-treatment condition. VAS measured at 6-month follow-up were significantly lower in group C comparing to other groups (P = 0.002). In the treatment of lateral epicondilitis, combination of corticosteroid injections with peppering is more effective than corticosteroid injections or peppering injections alone and produces better clinical results.

  19. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

    Directory of Open Access Journals (Sweden)

    Cinnamon S. Bloss

    2016-01-01

    Full Text Available Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large

  20. A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

    Science.gov (United States)

    Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

    2017-11-01

    Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  1. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  2. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  3. Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

    Science.gov (United States)

    Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

    2011-06-01

    To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

  4. Influence of Gender on the Performance of Cardiopulmonary Rescue Teams: A Randomized, Prospective Simulator Study.

    Science.gov (United States)

    Amacher, Simon Adrian; Schumacher, Cleo; Legeret, Corinne; Tschan, Franziska; Semmer, Norbert Karl; Marsch, Stephan; Hunziker, Sabina

    2017-07-01

    Little is known about the influence of gender on resuscitation performance which may improve future education in resuscitation. The aim of this study was to compare female and male rescuers in regard to cardiopulmonary resuscitation and leadership performance. Prospective, randomized simulator study. High-fidelity patient simulator center of the medical ICU, University Hospitals Basel (Switzerland). Two hundred sixteen volunteer medical students (108 females and 108 males) of two Swiss universities in teams of three. None. We analyzed data on the group and the individual level separately. The primary outcome on the group level was the hands-on time within the first 180 seconds after the onset of the cardiac arrest. Compared with male-only teams, female-only teams showed less hands-on time (mean ± SD) (87 ± 41 vs 109 ± 33 s; p = 0.037) and a longer delay before the start of chest compressions (109 ± 77 vs 70 ± 56 s; p = 0.038). Additionally, female-only teams showed a lower leadership performance in different domains and fewer unsolicited cardiopulmonary resuscitation measures compared with male-only teams. On the individual level, which was assessed in mixed teams only, female gender was associated with a lower number of secure leadership statements (3 ± 2 vs 5 ± 3; p = 0.027). Results were confirmed in regression analysis adjusted for team composition. We found important gender differences, with female rescuers showing inferior cardiopulmonary resuscitation performance, which can partially be explained by fewer unsolicited cardiopulmonary resuscitation measures and inferior female leadership. Future education of rescuers should take gender differences into account.

  5. Next-generation narrow band imaging system for colonic polyp detection: a prospective multicenter randomized trial.

    Science.gov (United States)

    Horimatsu, Takahiro; Sano, Yasushi; Tanaka, Shinji; Kawamura, Takuji; Saito, Shoichi; Iwatate, Mineo; Oka, Shiro; Uno, Koji; Yoshimura, Kenichi; Ishikawa, Hideki; Muto, Manabu; Tajiri, Hisao

    2015-07-01

    Previous studies have yielded conflicting results on the colonic polyp detection rate with narrow-band imaging (NBI) compared with white-light imaging (WLI). We compared the mean number of colonic polyps detected per patient for NBI versus WLI using a next-generation NBI system (EVIS LUCERA ELITE; Olympus Medical Systems) used with standard-definition (SD) colonoscopy and wide-angle (WA) colonoscopy. this study is a 2 × 2 factorial, prospective, multicenter randomized controlled trial. this study was conducted at five academic centers in Japan. patients were allocated to one of four groups: (1) WLI with SD colonoscopy (H260AZI), (2) NBI with SD colonoscopy (H260AZI), (3) WLI with WA colonoscopy (CF-HQ290), and (4) NBI with WA colonoscopy (CF-HQ290). the mean numbers of polyps detected per patient were compared between the four groups: WLI with/without WA colonoscopy and NBI with/without WA colonoscopy. Of the 454 patients recruited, 431 patients were enrolled. The total numbers of polyps detected by WLI with SD, NBI with SD, WLI with WA, and NBI with WA were 164, 176, 188, and 241, respectively. The mean number of polyps detected per patient was significantly higher in the NBI group than in the WLI group (2.01 vs 1.56; P = 0.032). The rate was not higher in the WA group than in the SD group (1.97 vs 1.61; P = 0.089). Although WA colonoscopy did not improve the polyp detection, next-generation NBI colonoscopy represents a significant improvement in the detection of colonic polyps.

  6. Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: a prospective randomized study

    International Nuclear Information System (INIS)

    Shukla, P.N.; Gairola, M.; Mohanti, B.K.; Rath, G.K.

    2006-01-01

    Background and aims: Radiation induced wet desquamation of skin in carcinoma breast patients is a painful condition. In this study topical beclomethasone dipropionate spray was used as prophylaxis with the purpose of reducing risk of the wet desquamation of skin in irradiated field. Materials and methods: sixty patients of carcinoma breast were planned for postoperative loco regional radiotherapy (50 Gy in 25 fraction over five weeks) were prospectively randomized into two groups (1) steroid group-patients were advised to use beclomethasone dipropionate spray in irradiated axilla from day one of radiotherapy, (2) control group-patients were not allowed to use any topical agent in irradiated area. Radiation induced skin reaction was noted in terms of erythema, dry desquamation and wet desquamation weekly till end of prescribed 50Gy dose of the radiation therapy. Statistical method: Chi-square test was used to see the statistical significance of the difference in wet desquamation between two arms of the study. Chi-square value and P-value was calculated for the difference of wet desquamation in two study arms. Result: In steroid group 4/30 (13.33%) patients developed wet desquamation of the axillary skin at the end of the radiotherapy. For the control group, this figure was 11/30 (36.66%). The difference in wet desquamation of the axillary skin in the two groups was statistically significant (P-value=0.0369). Conclusion: Topical steroid (beclomethasone dipropionate spray) for skin during radiotherapy significantly reduces the risk of wet desquamation of the skin. (author)

  7. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Christos Asteriou

    2016-01-01

    Full Text Available Background: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. Patients and Methods: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60 or mini-muscle-sparing thoracotomy (n = 60. The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. Results: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006. Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042. Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560. Conclusion: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected.

  8. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study.

    Science.gov (United States)

    Hersh, P S; Brint, S F; Maloney, R K; Durrie, D S; Gordon, M; Michelson, M A; Thompson, V M; Berkeley, R B; Schein, O D; Steinert, R F

    1998-08-01

    This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). A randomized, prospective multicenter clinical trial. A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more

  9. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    OpenAIRE

    Stefan Landgraeber; Henning Quitmann; Sebastian Güth; Marcel Haversath; Wojciech Kowalczyk; Andrés Kecskeméthy; Hansjörg Heep; Marcus Jäger

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and ...

  10. Influence of the pneumatic tourniquet on patella tracking in total knee arthroplasty: a prospective randomized study in 100 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Toftgaard Jensen, T

    2005-01-01

    One hundred consecutive patients with osteoarthritis of the knee joint and scheduled for primary total knee arthroplasty performed in a bloodless field were prospectively randomized to have the tourniquet inflated on either straight leg or maximally flexed knee. There was no difference in the num...... deflation led to better patella tracking and saved 5 (31%) of 16 releases with no difference between groups. We recommend tourniquet deflation and reevaluation of patella tracking before performing lateral release in patellar maltracking....

  11. Ketamine as an Adjunct to Postoperative Pain Management in Opioid Tolerant Patients After Spinal Fusions: A Prospective Randomized Trial

    OpenAIRE

    Urban, Michael K.; Ya Deau, Jacques T.; Wukovits, Barbara; Lipnitsky, Jane Y.

    2007-01-01

    Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl d-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1–2 level poster...

  12. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

    Directory of Open Access Journals (Sweden)

    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  13. Does penile rehabilitation have a role in the treatment of erectile dysfunction following radical prostatectomy?

    Science.gov (United States)

    Blecher, Gideon; Almekaty, Khaled; Kalejaiye, Odunayo; Minhas, Suks

    2017-01-01

    In men undergoing radical treatment for prostate cancer, erectile function is one of the most important health-related quality-of-life outcomes influencing patient choice in treatment. Penile rehabilitation has emerged as a therapeutic measure to prevent erectile dysfunction and expedite return of erectile function after radical prostatectomy. Penile rehabilitation involves a program designed to increase the likelihood of return to baseline-level erectile function, as opposed to treatment, which implies the therapeutic treatment of symptoms, a key component of post-radical prostatectomy management. Several pathological theories form the basis for rehabilitation, and a plethora of treatments are currently in widespread use. However, whilst there is some evidence supporting the concept of penile rehabilitation from animal studies, randomised controlled trials are contradictory in outcomes. Similarly, urological guidelines are conflicted in terms of recommendations. Furthermore, it is clear that in spite of the lack of evidence for the role of penile rehabilitation, many urologists continue to employ some form of rehabilitation in their patients after radical prostatectomy. This is a significant burden to health resources in public-funded health economies, and no effective cost-benefit analysis has been undertaken to support this practice. Thus, further research is warranted to provide both scientific and clinical evidence for this contemporary practice and the development of preventative strategies in treating erectile dysfunction after radical prostatectomy.

  14. Tandem-robot assisted laparoscopic radical prostatectomy to improve the neurovascular bundle visualization: a feasibility study.

    Science.gov (United States)

    Han, Misop; Kim, Chunwoo; Mozer, Pierre; Schäfer, Felix; Badaan, Shadie; Vigaru, Bogdan; Tseng, Kenneth; Petrisor, Doru; Trock, Bruce; Stoianovici, Dan

    2011-02-01

    To examine the feasibility of image-guided navigation using transrectal ultrasound (TRUS) to visualize the neurovascular bundle (NVB) during robot-assisted laparoscopic radical prostatectomy (RALP). The preservation of the NVB during radical prostatectomy improves the postoperative recovery of sexual potency. The accompanying blood vessels in the NVB can serve as a macroscopic landmark to localize the microscopic cavernous nerves in the NVB. A novel, robotic transrectal ultrasound probe manipulator (TRUS Robot) and three-dimensional (3-D) reconstruction software were developed and used concurrently with the daVinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA) in a tandem-robot assisted laparoscopic radical prostatectomy (T-RALP). After appropriate approval and informed consent were obtained, 3 subjects underwent T-RALP without associated complications. The TRUS Robot allowed a steady handling and remote manipulation of the TRUS probe during T-RALP. It also tracked the TRUS probe position accurately and allowed 3-D image reconstruction of the prostate and surrounding structures. Image navigation was performed by observing the tips of the daVinci surgical instruments in the live TRUS image. Blood vessels in the NVB were visualized using Doppler ultrasound. Intraoperative 3-D image-guided navigation in T-RALP is feasible. The use of TRUS during radical prostatectomy can potentially improve the visualization and preservation of the NVB. Further studies are needed to assess the clinical benefit of T-RALP. Copyright © 2011 Elsevier Inc. All rights reserved.

  15. Use of Play Therapy in Nursing Process: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Sezici, Emel; Ocakci, Ayse Ferda; Kadioglu, Hasibe

    2017-03-01

    Play therapy is a nursing intervention employed in multidisciplinary approaches to develop the social, emotional, and behavioral skills of children. In this study, we aim to determine the effects of play therapy on the social, emotional, and behavioral skills of pre-school children through the nursing process. A single-blind, prospective, randomized controlled study was undertaken. The design, conduct, and reporting of this study adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The participants included 4- to 5-year-old kindergarten children with no oral or aural disabilities and parents who agreed to participate in the study. The Pre-school Child and Family Identification Form and Social Competence and the Behavior Evaluation Scale were used to gather data. Games in the play therapy literature about nursing diagnoses (fear, social disturbance, impaired social interactions, ineffective coping, anxiety), which were determined after the preliminary test, constituted the application of the study. There was no difference in the average scores of the children in the experimental and control groups in their Anger-Aggression (AA), Social Competence (SC), and Anxiety-Withdrawal (AW) scores beforehand (t = 0.015, p = .988; t = 0.084, p = .933; t = 0.214, p = .831, respectively). The difference between the average AA and SC scores in the post-test (t = 2.041, p = .045; t = 2.692, p = .009, respectively), and the retests were statistically significant in AA and SC average scores in the experimental and control groups (t = 4.538, p = .000; t = 4.693; p = .000, respectively). In AW average scores, no statistical difference was found in the post-test (t = 0.700, p = .486), whereas in the retest, a significant difference was identified (t = 5.839, p = .000). Play therapy helped pre-school children to improve their social, emotional, and behavioral skills. It also provided benefits for the children to decrease their fear and anxiety levels, to improve

  16. Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

    Science.gov (United States)

    Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

    2012-02-01

    To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (PPRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

  17. Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

    Science.gov (United States)

    Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

    2010-01-01

    To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

  18. A comparison of bladder neck preservation and bladder neck reconstruction for urinary incontinence after radical retro pubic prostatectomy

    Directory of Open Access Journals (Sweden)

    Mohammad Hossein Izadpanahi

    2014-01-01

    Full Text Available Background: Prostate cancer is the sixth most common cancer worldwide and will include about 30% of all malignancies in men. Since the initial report of the anatomic radical prostatectomy, refinements in the surgical technique have been made. Several studies show that bladder neck preservation (BNP during radical prostatectomy makes improve early return of urinary continence, erectile function or both. However, some clinical trials have suggested little difference between the return of continence while using modifications. In this study, we compared outcomes of BNP and bladder neck reconstruction (BNR during radical retropubic prostatectomy (RRP. Materials and Methods: This prospective study was performed on 60 patients at a referral university hospital from March 2010 to March 2012. Study population was all patients candidate for RRP (RRP in this period. All patients divided into two groups, A and B (30 patients in each group. Group A (n = 30 who preserved bladder neck (BNP and Group B (n = 30 who had BNR. Prostate specific antigen (PSA before and at 2, 6, 9, 12 and18 months after surgery, anastomotic stricture symptoms, positive bladder neck margin, Gleason score and urine incontinence were compared between two groups. Also, we compared bladder neck contracture, urinary continence and positive surgical margin rates after BNP and BNR while retropubic prostatectomy in 24 months period follow-up. Results: The mean age of the patients was 61.81 ± 7.15 years (range, 50-74 years. After a follow-up period of 24 months, the PSA rising was not different between the two groups. After 2 months, 19 (63.33% of patients in A group and the same number in B group were continent (P = 0.78. Stricture of the bladder neck at the anastomosis site requiring transurethral dilation occurred in 7 (23.33% and 3 (10.0% patients in groups A and B, respectively (P = 0.04. Conclusion: Although there was no difference in prevalence and duration of return of urinary

  19. Validation study of a web-based assessment of functional recovery after radical prostatectomy

    Directory of Open Access Journals (Sweden)

    Vickers Andrew J

    2010-08-01

    Full Text Available Abstract Background Good clinical care of prostate cancer patients after radical prostatectomy depends on careful assessment of post-operative morbidities, yet physicians do not always judge patient symptoms accurately. Logistical problems associated with using paper questionnaire limit their use in the clinic. We have implemented a web-interface ("STAR" for patient-reported outcomes after radical prostatectomy. Methods We analyzed data on the first 9 months of clinical implementation to evaluate the validity of the STAR questionnaire to assess functional outcomes following radical prostatectomy. We assessed response rate, internal consistency within domains, and the association between survey responses and known predictors of sexual and urinary function, including age, time from surgery, nerve sparing status and co-morbidities. Results Of 1581 men sent an invitation to complete the instrument online, 1235 responded for a response rate of 78%. Cronbach's alpha was 0.84, 0.86 and 0.97 for bowel, urinary and sexual function respectively. All known predictors of sexual and urinary function were significantly associated with survey responses in the hypothesized direction. Conclusions We have found that web-based assessment of functional recovery after radical prostatectomy is practical and feasible. The instrument demonstrated excellent psychometric properties, suggested that validity is maintained when questions are transferred from paper to electronic format and when patients give responses that they know will be seen by their doctor and added to their clinic record. As such, our system allows ready implementation of patient-reported outcomes into routine clinical practice.

  20. Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial.

    Science.gov (United States)

    Kwon, Brian K; Curt, Armin; Belanger, Lise M; Bernardo, Arlene; Chan, Donna; Markez, John A; Gorelik, Stephen; Slobogean, Gerard P; Umedaly, Hamed; Giffin, Mitch; Nikolakis, Michael A; Street, John; Boyd, Michael C; Paquette, Scott; Fisher, Charles G; Dvorak, Marcel F

    2009-03-01

    Ischemia is an important factor in the pathophysiology of secondary damage after traumatic spinal cord injury (SCI) and, in the setting of thoracoabdominal aortic aneurysm repair, can be the primary cause of paralysis. Lowering the intrathecal pressure (ITP) by draining CSF is routinely done in thoracoabdominal aortic aneurysm surgery but has not been evaluated in the setting of acute traumatic SCI. Additionally, while much attention is directed toward maintaining an adequate mean arterial blood pressure (MABP) in the acute postinjury phase, little is known about what is happening to the ITP during this period when spinal cord perfusion pressure (MABP - ITP) is important. The objectives of this study were to: 1) evaluate the safety and feasibility of draining CSF to lower ITP after acute traumatic SCI; 2) evaluate changes in ITP before and after surgical decompression; and 3) measure neurological recovery in relation to the drainage of CSF. Twenty-two patients seen within 48 hours of injury were prospectively randomized to a drainage or no-drainage treatment group. In all cases a lumbar intrathecal catheter was inserted for 72 hours. Acute complications of headache/nausea/vomiting, meningitis, or neurological deterioration were carefully monitored. Acute Spinal Cord Injury motor scores were documented at baseline and at 6 months postinjury. On insertion of the catheter, mean ITP was 13.8 +/- 1.3 mm Hg (+/- SD), and it increased to a mean peak of 21.7 +/- 1.5 mm Hg intraoperatively. The difference between the starting ITP on catheter insertion and the observed peak intrathecal pressure after decompression was, on average, an increase of 7.9 +/- 1.6 mm Hg (p drainage group was 30.6 +/- 2.3 mm Hg, which was significantly higher than the peak intraoperative ITP (p = 0.0098). During the same period, the peak recorded ITP in patients randomized to receive drainage was 28.1 +/- 2.8 mm Hg, which was not statistically higher than the peak intraoperative ITP (p = 0.15). The

  1. Surgical complications of radical retropubic prostatectomy: A single institutional experience of seven years

    Directory of Open Access Journals (Sweden)

    Neeraj K Goyal

    2007-01-01

    Full Text Available Aim: To determine the surgical complications of open retropubic radical prostatectomy. Materials and Methods: Fifty-nine cases of localized prostate cancer underwent retropubic radical prostatectomy in our department in the last seven years. Standard technique of open retropubic radical prostatectomy as described by Walsh was used. During follow-up cancer control and quality of life indices (potency and urinary continence were noted. Result: Postoperative recovery of all patients except one was excellent. This patient required cardio-respiratory support and nine units of blood transfusion. Forty-nine out of 52 patients were continent, two had stress incontinence and one was totally incontinent at one year. Bladder neck contracture was present in eight out of 52 patients at one year. Forty-five patients were impotent at one year with or without oral tablet sildenafil. Cancer control was present in 45 out of 52 cases. Seven cases had biochemical failure at one year. Conclusion: Though retropubic radical prostatectomy is the standard treatment for early prostate cancer it is not without complications. It has a steep learning curve. More number of cases and refinement in technique is required to achieve world-class results.

  2. Collagen content in the bladder of men with LUTS undergoing open prostatectomy: A pilot study.

    Science.gov (United States)

    Averbeck, Marcio A; De Lima, Nelson G; Motta, Gabriela A; Beltrao, Lauro F; Abboud Filho, Nury J; Rigotti, Clarice P; Dos Santos, William N; Dos Santos, Steven K J; Da Silva, Luis F B; Rhoden, Ernani L

    2018-03-01

    To evaluate the collagen content in the bladder wall of men undergoing open prostate surgery. From July 2014 to August 2016, men aged ≥ 50 years, presenting LUTS and undergoing open prostate surgery due to benign prostatic enlargement (BPE) or prostate cancer were prospectively enrolled. Preoperative assessment included validated questionnaires (IPSS and OAB-V8), lower urinary tract ultrasound, and urodynamics. Bladder biopsies were obtained during open prostatectomy for determination of collagen content (sirius red-picric acid stain; polarized light analysis). Collagen to smooth muscle ratio (C/M) in the detrusor was measured and its relationship with preoperative parameters was investigated. The level of significance was P non-diabetic patients (17.71 ± 6.82% vs 12.46 ± 5.2%, respectively; P = 0.024). Reduced bladder compliance was also marker for higher collagen content (P = 0.042). Bladder outlet obstruction (BOO) was not a predictor of increased collagen deposition in the bladder wall (P = 0.75). Patients with PVR ≥ 200 mL showed a higher collagen to smooth muscle ratio in the bladder wall (P = 0.036). DM2 and urodynamic parameters, such as increased PVR and reduced bladder compliance, were associated with higher collagen content in the bladder wall of men with LUTS. © 2017 Wiley Periodicals, Inc.

  3. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study

    OpenAIRE

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-01-01

    PURPOSE: Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. METHODS: Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and ...

  4. Frequency of malignancy in clinically benign open transvesical prostatectomy-a study of 100 cases

    International Nuclear Information System (INIS)

    Shah, A.A.; Sohu, M.; Balouch, I.; Rind, G.H.

    2012-01-01

    Background: Enlargement of prostate can be benign and malignant. Though differentiation between the two can be made on clinical grounds and surgery but still some cases can be missed if not subjected to histopathology. Objectives: To find out the frequency of malignancy in patients operated for clinically benign open transvesical prostatectomy. Study type settings and duration: It was a prospective observational study conducted in the Department of surgery (Surgical Unit-I), Ghulam Muhammad Mahar Medical College and Hospital, Sukkur from January 2011 to December 2011. Patients and Methods: Patients presented with the history of prostatic symptoms were evaluated in surgical out-patient's department using digital rectal examination and ultrasound. The findings were recorded in a proforma and those having enlarged prostate weighing above 40gm underwent prostate specific antigen testing. Patients having no malignant findings on history, digital rectal examination and whose prostate specific antigen levels were below 10 ng/dl underwent open transvesical prostatectomy and all specimens were sent for histopathology. Those with suspicion of malignancy either on history or digital rectal examination or high prostate specific antigen were excluded from the study, also the glands below 40 gm in volume were excluded and referred for transurethral resection.All specimens were sent for histopathology. Results: Out of 100 cases, 41 were between 56 to 65 years of age. The mean age was 58 years. Acute urinary retention requiring catheterization was seen in 36 cases while 18 patients had symptoms suggestive of inguinal hernia but on examination had enlarged prostate. Prostate specific antigen was done in 07 patients with suspicion of malignancy but its value was below 10 ng/dl therefore they were included in the study. On ultrasound the gland volume ranged from 40 to 85 gm and residual post-voidal urinary volume ranged from 100 to 450ml. On histology 06 patients were found to have

  5. Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

    Science.gov (United States)

    Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

    2012-04-01

    The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

  6. Salvage radiotherapy for macroscopic local recurrences after radical prostatectomy. A national survey on patterns of practice

    Energy Technology Data Exchange (ETDEWEB)

    Dal Pra, Alan [Bern University Hospital, Inselspital Bern, Department of Radiation Oncology, Bern (Switzerland); Panje, Cedric; Glatzer, Markus; Putora, Paul Martin [Kantonsspital St. Gallen, Department of Radiation Oncology, St. Gallen (Switzerland); Zilli, Thomas [Hospitaux Universitaires de Geneve, Department of Radiation Oncology, Geneve (Switzerland); Arnold, Winfried [Luzerner Kantonsspital, Department of Radiation Oncology, Luzerner (Switzerland); Brouwer, Kathrin [Stadtspital Triemli, Department of Radiation Oncology, Zuerich (Switzerland); Garcia, Helena [Universitaetsspital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Gomez, Silvia [Kantonsspital Aarau, Department of Radiation Oncology, Aarau (Switzerland); Herrera, Fernanda [Centre Hospitalier Universitaire Vaudois, Department of Radiation Oncology, Lausanne (Switzerland); Kaouthar, Khanfir [Hopital du Valais, Department of Radiation Oncology, Sion (Switzerland); Papachristofilou, Alexandros [Universitaetsspital Basel, Department of Radiation Oncology, Basel (Switzerland); Pesce, Gianfranco [EOC Bellinzona, Department of Radiation Oncology, Bellinzona (Switzerland); Reuter, Christiane [Kantonsspital Muensterlingen, Department of Radiation Oncology, Muensterlingen (Switzerland); Vees, Hansjoerg [Klinik Hirslanden, Department of Radiation Oncology, Zuerich (Switzerland); Zwahlen, Daniel Rudolf [Kantonsspital Graubuenden, Department of Radiation Oncology, Chur (Switzerland); Engeler, Daniel [Kantonsspital St. Gallen, Department of Urology, St. Gallen (Switzerland)

    2018-01-15

    Although salvage radiotherapy (SRT) for PSA recurrence after radical prostatectomy provides better oncological outcomes when delivered early, in the absence of detectable disease many patients are treated for macroscopic locally recurrent tumors. Due to limited data from prospective studies, we hypothesized an important variability in the SRT management of these patients. Our aim was to investigate current practice patterns of SRT for local macroscopic recurrence after radical prostatectomy. A total of 14 Swiss radiation oncology centers were asked to complete a survey on treatment specifications for macroscopic locally recurrent disease including information on pretherapeutic diagnostic procedures, dose prescription, radiation delivery techniques and androgen deprivation therapy (ADT). Treatment recommendations on ADT were analyzed using the objective consensus methodology. The majority of centers recommended pretreatment magnetic resonance imaging (MRI) of the pelvis and choline positron emission tomography (PET). The median prescribed dose to the prostate bed was 66 Gy (range 65-72 Gy) with a boost to the macroscopic lesion used by 79% of the centers with a median total dose of 72 Gy (range 70-80 Gy). Intensity-modulated rotational techniques were used by all centers and daily cone beam computed tomography (CT) was recommended by 43%. The use of concomitant ADT for any macroscopic recurrence was recommended by 43% of the centers while the remaining centers recommended it only for high-risk disease, which was not consistently defined. We observed a high variability of treatment paradigms when SRT is indicated for macroscopic local recurrences after prostatectomy. These data reflect the need for more standardized approaches and ultimately further research in this field. (orig.) [German] Obwohl die Evidenz fuer eine fruehzeitige Salvage-Radiotherapie (SRT) bei einem PSA-Rezidiv nach radikaler Prostatektomie spricht, werden viele Patienten erst bei einem

  7. BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Pavel Skok

    2002-06-01

    Full Text Available Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98.Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80 in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80 with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks, and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week. The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05. In 6 patients (7.5%, 6/ 80 from the study group and in 7 (8.8%, 7/80 from the control group we introduced a replacement treatment

  8. Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

    Science.gov (United States)

    Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

    2012-05-01

    Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

  9. Adjuvant Versus Salvage Radiotherapy for Patients With Adverse Pathological Findings Following Radical Prostatectomy: A Decision Analysis

    Directory of Open Access Journals (Sweden)

    Christopher J. D. Wallis MD

    2017-05-01

    Full Text Available Background: Patients undergoing surgery for prostate cancer who have adverse pathological findings experience high rates of recurrence. While there are data supporting adjuvant radiotherapy compared to a wait-and-watch strategy to reduce recurrence rates, there are no randomized controlled trials comparing adjuvant radiotherapy with the other standard of care, salvage radiotherapy (radiotherapy administered at the time of recurrence. Methods: We constructed a health state transition (Markov model employing two-dimensional Monte Carlo simulation using a lifetime horizon to compare the quality-adjusted survival associated with postoperative strategies using adjuvant or salvage radiotherapy. Prior to analysis, we calibrated and validated our model using the results of previous randomized controlled trials. We considered clinically important oncological health states from immediately postoperative to prostate cancer–specific death, commonly described complications from prostate cancer treatment, and other causes of mortality. Transition probabilities and utilities for disease states were derived from a literature search of MEDLINE and expert consensus. Results: Salvage radiotherapy was associated with an increased quality-adjusted life expectancy (QALE (58.3 months as compared with adjuvant radiotherapy (53.7 months, a difference of 4.6 months (standard deviation 8.8. Salvage radiotherapy had higher QALE in 53% of hypothetical cohorts. There was a minimal difference in overall life expectancy (-0.1 months. Examining recurrence rates, our model showed validity when compared with available randomized controlled data. Conclusions: A salvage radiotherapy strategy appears to provide improved QALE for patients with adverse pathological findings following radical prostatectomy, compared with adjuvant radiotherapy. As these findings reflect, population averages, specific patient and tumor factors, and patient preferences remain central for individualized

  10. Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

    Science.gov (United States)

    Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

    2014-05-01

    To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

  11. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  12. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy.

    Science.gov (United States)

    Mulhall, John P; Burnett, Arthur L; Wang, Run; McVary, Kevin T; Moul, Judd W; Bowden, Charles H; DiDonato, Karen; Shih, Winnie; Day, Wesley W

    2013-06-01

    We evaluated the safety and efficacy of 100 and 200 mg avanafil for the treatment of adult males with erectile dysfunction after bilateral nerve sparing radical prostatectomy. This was a double-blind, placebo controlled, parallel group, phase 3 study in males age 18 to 70 years with a history of erectile dysfunction of 6 months or more after bilateral nerve sparing radical prostatectomy. Patients were randomized to 100 or 200 mg avanafil or placebo (taken 30 minutes before sexual activity) for 12 weeks. Primary end points included successful vaginal insertion (Sexual Encounter Profile [SEP] question 2), successful intercourse (SEP3) and change in score on the erectile function domain of the International Index of Erectile Function (IIEF-EF) questionnaire. A total of 298 patients were randomized and 84.6% completed the study. At baseline 16.1% were age 65 years or older and 71.5% had severe erectile dysfunction (mean overall IIEF-EF domain score 9.2). After 12 weeks there were significantly greater increases in SEP2 and SEP3 and change in mean IIEF-EF domain score with 100 and 200 mg avanafil vs placebo (p erectile function after prostatectomy. Results suggest a rapid onset of action and sustained duration of effect, with all 3 primary end points being achieved at both dose levels. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  13. Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

    Science.gov (United States)

    Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

    2012-06-01

    The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

    Science.gov (United States)

    Raunest, J; Löhnert, J

    1990-01-01

    A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

  15. Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

    Science.gov (United States)

    Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

    1992-03-01

    To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

  16. A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

    Science.gov (United States)

    Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

    2003-12-01

    The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

  17. Comparative evaluation of left ventricular mass regression after aortic valve replacement: a prospective randomized analysis

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    Kiessling Arndt H

    2011-10-01

    Full Text Available Abstract Background We assessed the hemodynamic performance of various prostheses and the clinical outcomes after aortic valve replacement, in different age groups. Methods One-hundred-and-twenty patients with isolated aortic valve stenosis were included in this prospective randomized randomised trial and allocated in three age-groups to receive either pulmonary autograft (PA, n = 20 or mechanical prosthesis (MP, Edwards Mira n = 20 in group 1 (age 75. Clinical outcomes and hemodynamic performance were evaluated at discharge, six months and one year. Results In group 1, patients with PA had significantly lower mean gradients than the MP (2.6 vs. 10.9 mmHg, p = 0.0005 with comparable left ventricular mass regression (LVMR. Morbidity included 1 stroke in the PA population and 1 gastrointestinal bleeding in the MP subgroup. In group 2, mean gradients did not differ significantly between both populations (7.0 vs. 8.9 mmHg, p = 0.81. The rate of LVMR and EF were comparable at 12 months; each group with one mortality. Morbidity included 1 stroke and 1 gastrointestinal bleeding in the stentless and 3 bleeding complications in the MP group. In group 3, mean gradients did not differ significantly (7.8 vs 6.5 mmHg, p = 0.06. Postoperative EF and LVMR were comparable. There were 3 deaths in the stented group and no mortality in the stentless group. Morbidity included 1 endocarditis and 1 stroke in the stentless compared to 1 endocarditis, 1 stroke and one pulmonary embolism in the stented group. Conclusions Clinical outcomes justify valve replacement with either valve substitute in the respective age groups. The PA hemodynamically outperformed the MPs. Stentless valves however, did not demonstrate significantly superior hemodynamics or outcomes in comparison to stented bioprosthesis or MPs.

  18. Partial splenic embolization using polyvinyl alcohol particles for hypersplenism in cirrhosis: A prospective randomized study

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    Zhu Kangshun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: zhksh010@163.com; Meng Xiaochun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: mengxiaochun1972@163.com; Li Zhengran [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: andyreede@21cn.com; Huang Mingsheng [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: laom502@tom.com; Guan Shouhai [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: guanshouhai@163.com; Jiang Zaibo [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: jiangzaibo@yahoo.com.cn; Shan Hong [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: gzshsums@public.guangzhou.gd.cn

    2008-04-15

    Purpose: To prospectively evaluate the efficacy and safety of partial splenic embolization (PSE) using polyvinyl alcohol (PVA) particles for hypersplenism in cirrhosis, as compared to PSE using gelfoam particles. Materials and methods: PSE was performed in 60 consecutive patients with hypersplenism caused by cirrhosis. The patients were randomly assigned into 2 groups: gelfoam group, 32 patients received PSE using gelfoam particles as the embolic material; PVA group, 28 patients received PSE using PVA particles. The follow-up contents included peripheral blood cell counts (leukocyte, platelet and red blood cell) and complications associated with PSE. Results: Prior to PSE, there was no significant difference between the two groups in sex, age, Child-Pugh grade, the extent of embolization and peripheral blood cell counts. After PSE, no matter in which group, leukocyte and platelet counts kept significantly higher than pre-PSE during the 3-year follow-up period (P < .0001), but the post-PSE improvement of leukocyte and platelet counts was significantly better in PVA group than in gelfoam group (P < .05). Red blood cell counts showed no remarkable changes after PSE (P > .05). Severe complications occurred in 8 patients (25.0%) in gelfoam group and 6 patients (21.4%) in PVA group (P > .05), but the degree of abdominal pain was higher in the latter than in the former (P < .05). Among 17 patients who received more than 70% embolization of spleen, 10 (58.8%) developed severe complications, while among 43 patients who received 70% or less embolization of spleen, only four (9.3%) had severe complications. This difference was statistically significant (P < .05). Conclusion: PVA particles could be used as the embolic material in PSE; in comparison with PSE using gelfoam particles, PSE using PVA particles can achieve even better efficacy in alleviating hypersplenism, but the extent of embolization should be strictly limited to not more than 70% of splenic volume.

  19. Intrafascial versus interfascial nerve sparing in radical prostatectomy for localized prostate cancer: a systematic review and meta-analysis.

    Science.gov (United States)

    Weng, Hong; Zeng, Xian-Tao; Li, Sheng; Meng, Xiang-Yu; Shi, Ming-Jun; He, Da-Lin; Wang, Xing-Huan

    2017-09-13

    The present study aimed to systematically evaluate the effectiveness and safety of the intrafascial and interfascial nerve sparing (ITR-NS and ITE-NS) radical prostatectomy. PubMed, Embase, and Cochrane Library databases were searched for eligible studies. Meta-analysis with random-effects model was performed. Six comparative trials were selected and embraced in this research, including one randomized controlled trial, three prospective comparative trials, and two retrospective comparative trials. With regard to perioperative parameters, no significant association of operative time, blood loss, transfusion rates, duration of catheterization, and hospital stay existed between ITR-NS and ITE-NS. With respect to the functional results, ITR-NS had advantages in terms of both continence and potency recovery compared with ITE-NS. In reference to the oncologic results, the ITR-NS showed lower overall positive surgical margin (PSM) compared with ITE-NS but pT2 PSM and biochemical recurrence free rates were similar to the two surgical types. This study demonstrates that ITR-NS has better continence at 6 mo and 36 mo and better potency recovery at 6 mo and 12 mo postoperatively, regardless of the surgical technique. The cancer control of ITR-NS was also better than that of ITE-NS. This may be explained by the fact that patients in ITE-NS group present higher risk cancer than patients in ITR-NS group.

  20. Optimal chest compression rate in cardiopulmonary resuscitation: a prospective, randomized crossover study using a manikin model.

    Science.gov (United States)

    Lee, Seong Hwa; Ryu, Ji Ho; Min, Mun Ki; Kim, Yong In; Park, Maeng Real; Yeom, Seok Ran; Han, Sang Kyoon; Park, Seong Wook

    2016-08-01

    When performing cardiopulmonary resuscitation (CPR), the 2010 American Heart Association guidelines recommend a chest compression rate of at least 100 min, whereas the 2010 European Resuscitation Council guidelines recommend a rate of between 100 and 120 min. The aim of this study was to examine the rate of chest compression that fulfilled various quality indicators, thereby determining the optimal rate of compression. Thirty-two trainee emergency medical technicians and six paramedics were enrolled in this study. All participants had been trained in basic life support. Each participant performed 2 min of continuous compressions on a skill reporter manikin, while listening to a metronome sound at rates of 100, 120, 140, and 160 beats/min, in a random order. Mean compression depth, incomplete chest recoil, and the proportion of correctly performed chest compressions during the 2 min were measured and recorded. The rate of incomplete chest recoil was lower at compression rates of 100 and 120 min compared with that at 160 min (P=0.001). The numbers of compressions that fulfilled the criteria for high-quality CPR at a rate of 120 min were significantly higher than those at 100 min (P=0.016). The number of high-quality CPR compressions was the highest at a compression rate of 120 min, and increased incomplete recoil occurred with increasing compression rate. However, further studies are needed to confirm the results.

  1. A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

    Science.gov (United States)

    Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

    2011-01-01

    A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

  2. The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study.

    Science.gov (United States)

    Yurtlu, S; Hanci, V; Kargi, E; Erdoğan, G; Köksal, B G; Gül, Ş; Okyay, R D; Ayoğlu, H; Turan, I Ö

    2011-01-01

    This prospective, randomized, placebo-controlled study evaluated the effects of dexketoprofen as an adjunct to lidocaine in intravenous regional anaesthesia (IVRA) or as a supplemental intravenous (i.v.) analgesic. Patients scheduled for elective hand or forearm soft-tissue surgery were randomly divided into three groups. All 45 patients received 0.5% lidocaine as IVRA. Dexketoprofen was given either i.v. or added into the IVRA solution and the control group received an equal volume of saline both i.v. and as part of the IVRA. The times of sensory and motor block onset, recovery time and postoperative analgesic consumption were recorded. Compared with controls, the addition of dexketoprofen to the IVRA solution resulted in more rapid onset of sensory and motor block, longer recovery time, decreased intra- and postoperative pain scores and decreased paracetamol use. It is concluded that coadministration of dexketoprofen with lidocaine in IVRA improves anaesthetic block and decreases postoperative analgesic requirements.

  3. Effects of daikenchuto, a Japanese herb, on intestinal motility after total gastrectomy: a prospective randomized trial.

    Science.gov (United States)

    Akamaru, Yusuke; Takahashi, Tsuyoshi; Nishida, Toshirou; Omori, Takeshi; Nishikawa, Kazuhiro; Mikata, Shoki; Yamamura, Noriyuki; Miyazaki, Satoru; Noro, Hiroshi; Takiguchi, Shuji; Mori, Masaki; Doki, Yuichiro

    2015-03-01

    This study aimed to assess the efficacy of daikenchuto (DKT), a commonly prescribed, traditional Japanese herbal medicine, on postoperative intestinal dysfunction after gastric cancer surgery. Patients with gastric cancer scheduled for a total gastrectomy were randomly assigned before surgery to receive either no treatment (n = 40; control group) or DKT (7.5 g/day, t.i.d.) for 3 months (n = 41) postoperatively. We examined gastrointestinal motility, stool attributes, the quantity of bowel gas, the quality of life, and the incidence of postoperative ileus. During the hospital stay, significant differences were observed between the DKT group and controls in the number of stools per day (1.1 ± 0.6 vs 0.8 ± 0.4, respectively; P = 0.037) and stool consistencies (Bristol scale ratings were 3.7 ± 0.8 vs 3.1 ± 0.8, respectively; P = 0.041). The DKT group showed significant reductions in gas volume scores, calculated from abdominal radiographs, at 7 days, 1 month, and 3 months after surgery. The groups did not show significant differences in quality of life scores (based on the Gastrointestinal Symptom Rating Scale) or in the incidence of postoperative ileus. DKT improved bowel movements, stool properties, and bowel gas. These results suggested that DKT promoted early postoperative bowel functions after total gastrectomy.

  4. A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

    Science.gov (United States)

    Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

    2014-01-01

    Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

  5. Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

    Science.gov (United States)

    Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

    2015-12-01

    To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  6. Perioperative analgesia with a buprenorphine transdermal patch for hallux valgus surgery: a prospective, randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Xu C

    2018-04-01

    Full Text Available Can Xu, Mingqing Li, Chenggong Wang, Hui Li, Hua Liu Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, Hunan Province, People’s Republic of China Purpose: Hallux valgus surgery often results in significant postoperative pain. Adequate control of pain is essential for patient satisfaction and improves the outcome of the procedure. This study aimed to investigate the perioperative analgesic effect of a buprenorphine transdermal patch in patients who underwent hallux valgus surgery.Patients and methods: A total of 90 patients were randomly divided into the following three groups based on the perioperative analgesic method: flurbiprofen axetil intravenous injection (Group F, oral celecoxib (Group C, and buprenorphine transdermal delivery system (BTDS (Group BTDS. The pain status, degree of satisfaction, adverse effects, and administration of tramadol hydrochloride for uncontrolled pain were recorded on the night before surgery, postoperative day 1, postoperative day 2, and postoperative day 3.Results: The BTDS could effectively control perioperative pain for patients undergoing ­hallux valgus surgery. The analgesic effect of the BTDS was better than that of oral celecoxib. In addition, statistically significant differences were not observed in the visual analog scale (VAS scores, adverse effects, and rescue analgesia between the patients who received the BTDS and the patients who received the flurbiprofen axetil intravenous injection. However, the degree of patient satisfaction of the BTDS group was significantly higher (P<0.05 than that of the other two groups.Conclusion: The BTDS (a preemptive analgesia regimen could exert an analgesic effect during the perioperative period for patients who had received hallux valgus surgery, and this effect is beneficial for sustaining postoperative physiological and psychological states and promoting functional rehabilitation. Keywords: hallux valgus, buprenorphine transdermal

  7. Advantages of Arthroscopic Rotator Cuff Repair With a Transosseous Suture Technique: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Randelli, Pietro; Stoppani, Carlo Alberto; Zaolino, Carlo; Menon, Alessandra; Randelli, Filippo; Cabitza, Paolo

    2017-07-01

    Rotator cuff tear is a common finding in patients with painful, poorly functioning shoulders. The surgical management of this disorder has improved greatly and can now be fully arthroscopic. To evaluate clinical and radiological results of arthroscopic rotator cuff repair using 2 different techniques: single-row anchor fixation versus transosseous hardware-free suture repair. Randomized controlled trial; Level of evidence, 1. Sixty-nine patients with rotator cuff tears were enrolled: 35 patients were operated with metal anchors and 34 with standardized transosseous repair. The patients were clinically evaluated before surgery, during the 28 days after surgery, and at least 1 year after the operation by the use of validated rating scores (Constant score, QuickDASH, and numerical rating scale [NRS]). Final follow-up was obtained at more than 3 years by a QuickDASH evaluation to detect any difference from the previous follow-up. During the follow-up, rotator cuff integrity was determined through magnetic resonance imaging and was classified according to the 5 Sugaya categories. Patients operated with the transosseous technique had significantly less pain, especially from the 15th postoperative day: In the third week, the mean NRS value for the anchor group was 3.00 while that for transosseous group was 2.46 ( P = .02); in the fourth week, the values were 2.44 and 1.76, respectively ( P rotator cuff repair integrity, based on Sugaya magnetic resonance imaging classification, no significant difference was found between the 2 techniques in terms of retear rate ( P = .81). No significant differences were found between the 2 arthroscopic repair techniques in terms of functional and radiological results. However, postoperative pain decreased more quickly after the transosseous procedure, which therefore emerges as a possible improvement in the surgical repair of the rotator cuff. Registration: NCT01815177 ( ClinicalTrials.gov identifier).

  8. Use of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized study.

    Science.gov (United States)

    Lequaglie, Cosimo; Giudice, Gabriella; Marasco, Rita; Morte, Aniello Della; Gallo, Massimiliano

    2012-10-08

    Pulmonary air leaks are common complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this study was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal®) could reduce air leaks detected by means of a digital chest drain system (DigiVent™), in patients undergoing lung resection (sutures and/or staples alone). Patients who intraoperatively showed moderate or severe air leaks (evaluated by water submersion tests) were intraoperatively randomized to receive just sutures/staples (control group) or sutures/staples plus CoSeal® (sealant group). Differences among the groups in terms of air leaks, prolonged air leaks, time to chest tube removal, length of hospital stay and related costs were assessed. In total, 216 lung resection patients completed the study. Nineteen patients (18.1%) in the control group and 12 (10.8%) patients in the sealant group experienced postoperative air leaks, while a prolonged air leak was recorded in 11.4% (n=12) of patients in the control group and 2.7% (n=3) of patients in the sealant group. The difference in the incidence of air leaks and prolonged air leaks between the two groups was statistically significant (p=0.0002 and p=0.0013). The mean length of hospital stay was significantly shorter in the sealant group (4 days) than the control group (8 days) (p=0.0001). We also observed lower costs in the sealant group than the control group. The use of CoSeal® may decrease the occurrence and severity of postoperative air leaks after lung resection and is associated with shorter hospital stay. Not registered. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy.

  9. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

    Science.gov (United States)

    Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

    2014-01-01

    It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

  10. Adjuvant radiotherapy after radical prostatectomy: A failure of marketing-based medicine?

    International Nuclear Information System (INIS)

    Shakespeare, Thomas P.

    2016-01-01

    Adjuvant radiotherapy for high-risk patients after radical prostatectomy has been shown to reduce local and metastatic failure, improve overall survival and improve quality of life (QOL). The evidence, based on three randomised studies and a meta-analysis, is so compelling that the national and internatioanl professional bodies, representing urologists and radiation oncologist alike, recommend that high-risk patients be offered immediate adjuvant radiotherapy. Despite this being the standard of care, few patients fo on to recive it. This paper looks at the possibilities of why this is so, highlighting that it could possibly be related to poor marketing, communication and delivery of health information to patients and professional alike. It concludes that we need a more coordinated way to increase utilisation of the gold standard adjuvant radiotherapy post-radical prostatectomy, perhaps learning some valuable lessons from the business community.

  11. VERIFICATION OF A TUMOR LESION OF INTRAPELVIC LYMPH NODES AFTER RADICAL PROSTATECTOMY. THE FIRST EXPERIENCE

    Directory of Open Access Journals (Sweden)

    V. V. Kapustin

    2014-08-01

    Full Text Available Objective: to study the possibilities of transrectal ultrasound scan (TRUS and magnetic resonance imaging (MRI in identifying and verifying a tumor lesion of intrapelvic lymph nodes (LN in patients with biochemical recurrence after radical prostatectomy.Subjects and methods. Metastatic tumor lesion of intrapelvic LNs was verified in 4 patients by transrectal ultrasound (US-guided needle biopsies. All the patients underwent multi-parametric MRI studies and TRUS.Results. The application of current MRI technologies (for qualitative and quantitative analysis of diffusion-weighted images and for postcontrast sequences could detect and judge with confidence the metastatic lesion of intrapelvic LNs. TRUS permits clearly visualizing pathologically altered LNs, by taking into account their MRI pattern and verifying their tumor lesion by US-guided core needle biopsy.Conclusion. The combined use of multi-parametric MRI and TRUS provides a means for diagnosing and verifying the tumor lesion of pelvic LNs in patients after prostatectomy.

  12. VERIFICATION OF A TUMOR LESION OF INTRAPELVIC LYMPH NODES AFTER RADICAL PROSTATECTOMY. THE FIRST EXPERIENCE

    Directory of Open Access Journals (Sweden)

    V. V. Kapustin

    2012-01-01

    Full Text Available Objective: to study the possibilities of transrectal ultrasound scan (TRUS and magnetic resonance imaging (MRI in identifying and verifying a tumor lesion of intrapelvic lymph nodes (LN in patients with biochemical recurrence after radical prostatectomy.Subjects and methods. Metastatic tumor lesion of intrapelvic LNs was verified in 4 patients by transrectal ultrasound (US-guided needle biopsies. All the patients underwent multi-parametric MRI studies and TRUS.Results. The application of current MRI technologies (for qualitative and quantitative analysis of diffusion-weighted images and for postcontrast sequences could detect and judge with confidence the metastatic lesion of intrapelvic LNs. TRUS permits clearly visualizing pathologically altered LNs, by taking into account their MRI pattern and verifying their tumor lesion by US-guided core needle biopsy.Conclusion. The combined use of multi-parametric MRI and TRUS provides a means for diagnosing and verifying the tumor lesion of pelvic LNs in patients after prostatectomy.

  13. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

    Science.gov (United States)

    Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

    2012-01-01

    The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

  14. A simple method to take urethral sutures for neobladder reconstruction and radical prostatectomy

    Directory of Open Access Journals (Sweden)

    B Satheesan

    2007-01-01

    Full Text Available For the reconstruction of urethra-vesical anastamosis after radical prostatectomy and for neobladder reconstruction, taking adequate sutures to include the urethral mucosa is vital. Due to the retraction of the urethra and unfriendly pelvis, the process of taking satisfactory urethral sutures may be laborious. Here, we describe a simple method by which we could overcome similar technical problems during surgery using Foley catheter as the guide for the suture.

  15. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  16. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  17. Use of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Lequaglie Cosimo

    2012-10-01

    Full Text Available Abstract Background Pulmonary air leaks are common complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this study was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal® could reduce air leaks detected by means of a digital chest drain system (DigiVent™, in patients undergoing lung resection (sutures and/or staples alone. Methods Patients who intraoperatively showed moderate or severe air leaks (evaluated by water submersion tests were intraoperatively randomized to receive just sutures/staples (control group or sutures/staples plus CoSeal® (sealant group. Differences among the groups in terms of air leaks, prolonged air leaks, time to chest tube removal, length of hospital stay and related costs were assessed. Results In total, 216 lung resection patients completed the study. Nineteen patients (18.1% in the control group and 12 (10.8% patients in the sealant group experienced postoperative air leaks, while a prolonged air leak was recorded in 11.4% (n = 12 of patients in the control group and 2.7% (n = 3 of patients in the sealant group. The difference in the incidence of air leaks and prolonged air leaks between the two groups was statistically significant (p = 0.0002 and p = 0.0013. The mean length of hospital stay was significantly shorter in the sealant group (4 days than the control group (8 days (p = 0.0001. We also observed lower costs in the sealant group than the control group. Conclusion The use of CoSeal® may decrease the occurrence and severity of postoperative air leaks after lung resection and is associated with shorter hospital stay. Trial registration Not registered. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy.

  18. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  19. A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

    Science.gov (United States)

    Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

    2017-07-01

    A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

  20. Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

    Directory of Open Access Journals (Sweden)

    Nafisi Shahram

    2006-12-01

    Full Text Available Abstract Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate.

  1. rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

    Science.gov (United States)

    Hurlbert, R John; Alexander, David; Bailey, Stewart; Mahood, James; Abraham, Ed; McBroom, Robert; Jodoin, Alain; Fisher, Charles

    2013-12-01

    Multicenter randomized controlled trial. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

  2. Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

    NARCIS (Netherlands)

    Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

    Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

  3. A six-year prospective randomized study of a nano-hybrid and a conventional hybrid resin composite in Class II restorations

    DEFF Research Database (Denmark)

    van Dijken, Jan W V; Pallesen, Ulla

    2013-01-01

    The objective of this 6 year prospective randomized equivalence trial was to evaluate the long-term clinical performance of a new nano-hybrid resin composite (RC) in Class II restorations in an intraindividual comparison with its well-established conventional hybrid RC predecessor....

  4. Late-onset incontinence in a cohort of radical prostatectomy patients

    International Nuclear Information System (INIS)

    Naselli, A.; Introini, C.; Andreatta, R.; Puppo, P.; Simone, G.; Papalia, R.; Gallucci, M.

    2011-01-01

    A cohort of 235 subjects, who underwent radical prostatectomy from 1994 to 2002, completely continent at the 2-year follow up and with the last follow-up visit in 2009, was examined to assess incidence and risk factors of late-onset incontinence. Median follow up was 100 months, range 84-176. At the last follow-up visit, 209 (89%) maintained continence, and 26 (11%) became incontinent. Specifically 14 out of 26 (6%) used one pad and 12 (5%) used two or more pads daily. Incidence of age ≥65 years at radical prostatectomy was greater in the subgroup who developed late incontinence, 109/209 (52%) vs 19/26 (73%). Incidence of adjuvant or salvage radiotherapy, of hormonal manipulation and of extraprostatic disease was similar in the two subgroups. Univariate and multivariate analysis did not disclose any difference. Late-onset incontinence is to be expected in about 10% of subjects who became completely continent after radical prostatectomy. The cause is likely to be related to ageing. Patients should be informed about the long-term risk of becoming incontinent. (author)

  5. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study.

    Science.gov (United States)

    Vagnoli, Laura; Caprilli, Simona; Robiglio, Arianna; Messeri, Andrea

    2005-10-01

    The induction of anesthesia is one of the most stressful moments for a child who must undergo surgery: it is estimated that 60% of children suffer anxiety in the preoperative period. Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness, and worry. These reactions reflect the child's fear of separation from parents and home environment, as well as of loss of control, unfamiliar routines, surgical instruments, and hospital procedures. High levels of anxiety have been identified as predictors of postoperative troubles that can persist for 6 months after the procedure. Both behavioral and pharmacologic interventions are available to treat preoperative anxiety in children. The aim of this study was to investigate the effects of the presence of clowns on a child's preoperative anxiety during the induction of anesthesia and on the parent who accompanies him/her until he/she is asleep. The sample was composed of 40 subjects (5-12 years of age) who had to undergo minor day surgery and were assigned randomly to the clown group (N = 20), in which the children were accompanied in the preoperative room by the clowns and a parent, or the control group (N = 20), in which the children were accompanied by only 1 of his/her parents. The anxiety of the children in the preoperative period was measured through the Modified Yale Preoperative Anxiety Scale instrument (observational behavioral checklist to measure the state anxiety of young children), and the anxiety of the parents was measured with the State-Trait Anxiety Inventory (Y-1/Y-2) instrument (self-report anxiety behavioral instrument that measures trait/baseline and state/situational anxiety in adults). In addition, a questionnaire for health professionals was developed to obtain their opinion about the presence of clowns during the induction of anesthesia, and a self-evaluation form was developed to be filled out by the clowns themselves about their interactions with the child

  7. Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

    2017-10-01

    This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

  8. A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

    Science.gov (United States)

    Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

    2014-02-01

    Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P aromatherapy was significantly higher in the treatment group (P Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

  9. High-definition resolution three-dimensional imaging systems in laparoscopic radical prostatectomy: randomized comparative study with high-definition resolution two-dimensional systems.

    Science.gov (United States)

    Kinoshita, Hidefumi; Nakagawa, Ken; Usui, Yukio; Iwamura, Masatsugu; Ito, Akihiro; Miyajima, Akira; Hoshi, Akio; Arai, Yoichi; Baba, Shiro; Matsuda, Tadashi

    2015-08-01

    Three-dimensional (3D) imaging systems have been introduced worldwide for surgical instrumentation. A difficulty of laparoscopic surgery involves converting two-dimensional (2D) images into 3D images and depth perception rearrangement. 3D imaging may remove the need for depth perception rearrangement and therefore have clinical benefits. We conducted a multicenter, open-label, randomized trial to compare the surgical outcome of 3D-high-definition (HD) resolution and 2D-HD imaging in laparoscopic radical prostatectomy (LRP), in order to determine whether an LRP under HD resolution 3D imaging is superior to that under HD resolution 2D imaging in perioperative outcome, feasibility, and fatigue. One-hundred twenty-two patients were randomly assigned to a 2D or 3D group. The primary outcome was time to perform vesicourethral anastomosis (VUA), which is technically demanding and may include a number of technical difficulties considered in laparoscopic surgeries. VUA time was not significantly shorter in the 3D group (26.7 min, mean) compared with the 2D group (30.1 min, mean) (p = 0.11, Student's t test). However, experienced surgeons and 3D-HD imaging were independent predictors for shorter VUA times (p = 0.000, p = 0.014, multivariate logistic regression analysis). Total pneumoperitoneum time was not different. No conversion case from 3D to 2D or LRP to open RP was observed. Fatigue was evaluated by a simulation sickness questionnaire and critical flicker frequency. Results were not different between the two groups. Subjective feasibility and satisfaction scores were significantly higher in the 3D group. Using a 3D imaging system in LRP may have only limited advantages in decreasing operation times over 2D imaging systems. However, the 3D system increased surgical feasibility and decreased surgeons' effort levels without inducing significant fatigue.

  10. Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

    Science.gov (United States)

    Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

    2016-01-01

    Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects.

  11. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial.

    Directory of Open Access Journals (Sweden)

    Janine Krüger

    Full Text Available Patients with biliopancreatic tumors frequently suffer from weight loss and cachexia. The in-hospital work-up to differentiate between benign and malignant biliopancreatic lesions requires repeated pre-interventional fasting periods that can aggravate this problem. We conducted a randomized intervention study to test whether routine in-hospital peripheral intravenous nutrition on fasting days (1000 ml/24 h, 700 kcal has a beneficial effect on body weight and body composition.168 patients were screened and 100 enrolled in the trial, all undergoing in-hospital work-up for biliopancreatic mass lesions and randomized to either intravenous nutrition or control. Primary endpoint was weight loss at time of hospital discharge; secondary endpoints were parameters determined by bioelectric impedance analysis and quality of life recorded by the EORTC questionnaire.Within three months prior to hospital admission patients had a median self-reported loss of 4.0 kg (25*th: -10.0 kg and 75*th* percentile: 0.0kg of body weight. On a multivariate analysis nutritional intervention increased body weight by 1.7 kg (95% CI: 0.204; 3.210, p = 0.027, particularly in patients with malignant lesions (2.7 kg (95% CI: 0.71; 4.76, p < 0.01.In a hospital setting, patients with suspected biliopancreatic mass lesions stabilized their body weight when receiving parenteral nutrition in fasting periods even when no total parenteral nutrition was required. Analysis showed that this effect was greatest in patients with malignant tumors. Further studies will be necessary to see whether patient outcome is affected as well.ClinicalTrials.gov NCT02670265.

  12. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study.

    Science.gov (United States)

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-12-01

    Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and 64% were assessed again after 4 years. Measures included anthropometry, fasting blood samples, and a health assessment questionnaire. Participants scored one point for each negative lifestyle factor at baseline: overweight; physical inactivity; high media consumption; little outdoor time; skipping breakfast; and having a parent who has ever smoked, is inactive, or overweight. A CVR score at follow-up was constructed by averaging sex- and age-related z-scores of waist circumference, blood pressure, glucose, inverted high-density lipoprotein, and triglycerides. The age-, sex-, pubertal stage-, and social class-adjusted probabilities (95% confidence interval) for being in the highest CVR score tertile at follow-up for children who had at most one (n = 48), two (n = 64), three (n = 56), four (n = 41), or five or more (n = 14) risky lifestyle factors were 15.4% (8.9-25.3), 24.3% (17.4-32.8), 36.0% (28.6-44.2), 49.8% (38.6-61.0), and 63.5% (47.2-77.2), respectively. Even in childhood, an accumulation of negative lifestyle factors is associated with higher CVR scores after 4 years. These negative lifestyle factors are easy to assess in clinical practice and allow early detection and prevention of CVR in childhood. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  13. High dose Senna or Poly Ethylene Glycol (PEG for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Ahmad Shavakhi

    2011-01-01

    Full Text Available Background: The aim of this study was to determine the efficacy of two methods of colon preparation for colon cleansing in a randomized controlled trial. Methods: In this prospective randomized investigator-blinded trial, consecutive outpatients indicated for elective colonoscopy were randomized into two groups. Patients in Senna group took 24 tablets of 11 mg Senna in two divided doses 24 hour before colonoscopy. In Poly Ethylene Glycol (PEG group they solved 4 sachets in 4 liters of water the day before the procedure and were asked to drink 250 ml every 15 minutes. The overall quality of colon cleansing was evaluated using the Aronchick scoring scale. Difficulty of the procedure, patients′ tolerance and compliance and adverse events were also evaluated. Results: 322 patients were enrolled in the study. There was no significant difference in the quality of colon cleansing, patients′ tolerance, compliance and the difficulty of the procedure between two groups (p > 0.05. The incidence of adverse effects was similar between two groups except for abdominal pain that was more severe in Senna group (p < 0.05 and nausea and vomiting that was more common in PEG group (p < 0.05 Conclusions: In conclusion we deduce that Senna has the same efficacy and patient′s acceptance as Polyethylene glycol-electrolyte solution (PEG-ES and it could be prescribed as an alternative method for bowel preparation.

  14. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

    Directory of Open Access Journals (Sweden)

    Sudha Prathikanti

    Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

  15. A prospective randomized trial of content expertise versus process expertise in small group teaching.

    Science.gov (United States)

    Peets, Adam D; Cooke, Lara; Wright, Bruce; Coderre, Sylvain; McLaughlin, Kevin

    2010-10-14

    Effective teaching requires an understanding of both what (content knowledge) and how (process knowledge) to teach. While previous studies involving medical students have compared preceptors with greater or lesser content knowledge, it is unclear whether process expertise can compensate for deficient content expertise. Therefore, the objective of our study was to compare the effect of preceptors with process expertise to those with content expertise on medical students' learning outcomes in a structured small group environment. One hundred and fifty-one first year medical students were randomized to 11 groups for the small group component of the Cardiovascular-Respiratory course at the University of Calgary. Each group was then block randomized to one of three streams for the entire course: tutoring exclusively by physicians with content expertise (n = 5), tutoring exclusively by physicians with process expertise (n = 3), and tutoring by content experts for 11 sessions and process experts for 10 sessions (n = 3). After each of the 21 small group sessions, students evaluated their preceptors' teaching with a standardized instrument. Students' knowledge acquisition was assessed by an end-of-course multiple choice (EOC-MCQ) examination. Students rated the process experts significantly higher on each of the instrument's 15 items, including the overall rating. Students' mean score (±SD) on the EOC-MCQ exam was 76.1% (8.1) for groups taught by content experts, 78.2% (7.8) for the combination group and 79.5% (9.2) for process expert groups (p = 0.11). By linear regression student performance was higher if they had been taught by process experts (regression coefficient 2.7 [0.1, 5.4], p teach first year medical students within a structured small group environment; preceptors with process expertise result in at least equivalent, if not superior, student outcomes in this setting.

  16. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2002-01-01

    cholecystectomy using two 10-mm and two 5-mm trocars (LC). Incisional pain at each port incision and overall pain were recorded for 1 week after the operation. Fatigue, nausea and vomiting, pulmonary function, and cosmetic results were also measured. RESULTS: Data from 52 patients were analyzed; eight patients......BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic.......01). In both groups, pain scores at the supraumbilical 10-mm port were significantly higher compared with other port sites (p

  17. Comparison of two picosecond lasers to a nanosecond laser for treating tattoos: a prospective randomized study on 49 patients.

    Science.gov (United States)

    Lorgeou, A; Perrillat, Y; Gral, N; Lagrange, S; Lacour, J-P; Passeron, T

    2018-02-01

    Q-switched nanosecond lasers demonstrated their efficacy in treating most types of tattoos, but complete disappearance is not always achieved even after performing numerous laser sessions. Picosecond lasers are supposed to be more efficient in clearing tattoos than nanosecond lasers, but prospective comparative data remain limited. To compare on different types of tattoos the efficacy of a nanosecond laser with two types of picosecond lasers. We conducted a prospective randomized study performed from December 2014 to June 2016 on adult patients with all types of tattoos. The tattoos were divided into two halves of equal size. After randomization, half of the tattoo was treated with a picosecond laser and the other half with a nanosecond laser. The evaluation was performed on standardized pictures performed before treatment and 2 months after the last session, by two physicians, not involved in the treatment, blinded on the type of treatments received. The main end point was a clearance above 75% of the tattoos. A total of 49 patients were included. Professional tattoos represented 85.7%, permanent make-up 8.2% and non-professional tattoo 6.1%. The majority were black or blue and 10.2% were polychromatic. No patient was lost during follow-up. A reduction of 75% or more of the colour intensity was obtained for 33% of the tattoos treated with the picosecond lasers compared to 14% with the nanosecond laser (P = 0.008). An improvement superior to 75% was obtained in 34% monochromic black or blue tattoos with the picosecond lasers compared to 9% for the nanosecond laser. Only one of the five polychromic tattoos achieved more than 75% of improvement with the two types of laser. Our results show a statistically significant superiority of the picosecond lasers compared to the nanosecond laser for tattoo clearance. However, they do not show better efficacy for polychromic tattoos and the difference in terms of side-effects was also minimal with a tendency of picosecond

  18. Evaluation of the Achieve Mapping Catheter in cryoablation for atrial fibrillation: a prospective randomized trial.

    Science.gov (United States)

    Gang, Yi; Gonna, Hanney; Domenichini, Giulia; Sampson, Michael; Aryan, Niloufar; Norman, Mark; Behr, Elijah R; Zuberi, Zia; Dhillon, Paramdeep; Gallagher, Mark M

    2016-03-01

    The purpose of this study is to establish the role of Achieve Mapping Catheter in cryoablation for paroxysmal atrial fibrillation (PAF) in a randomized trial. A total of 102 patients undergoing their first ablation for PAF were randomized at 2:1 to an Achieve- or Lasso-guided procedure. Study patients were systematically followed up for 12 months with Holter monitoring. Primary study endpoint was acute procedure success. Secondary endpoint was clinical outcomes assessed by AF free at 6 and 12 months after the procedure. Of 102 participants, 99 % of acute procedure success was achieved. Significantly shorter procedure duration with the Achieve-guided group than with the Lasso-guided group (118 ± 18 vs. 129 ± 21 min, p < 0.05) was observed as was the duration of fluoroscopy (17 ± 5 vs. 20 ± 7 min, p < 0.05) by subgroup analysis focused on procedures performed by experienced operators. In the whole study patients, procedure and fluoroscopic durations were similar in the Achieve- (n = 68) and Lasso-guided groups (n = 34). Transient phrenic nerve weakening was equally prevalent with the Achieve and Lasso. No association was found between clinical outcomes and the mapping catheter used. The use of second-generation cryoballoon (n = 68) reduced procedure time significantly compared to the first-generation balloon (n = 34); more patients were free of AF in the former than the latter group during follow-up. The use of the Achieve Mapping Catheter can reduce procedure and fluoroscopic durations compared with Lasso catheters in cryoablation for PAF after operators gained sufficient experience. The type of mapping catheter used does not affect procedure efficiency and safety by models of cryoballoon.

  19. Transcriptome modulation by hydrocortisone in severe burn shock: ancillary analysis of a prospective randomized trial.

    Science.gov (United States)

    Plassais, Jonathan; Venet, Fabienne; Cazalis, Marie-Angélique; Le Quang, Diane; Pachot, Alexandre; Monneret, Guillaume; Tissot, Sylvie; Textoris, Julien

    2017-06-16

    Despite shortening vasopressor use in shock, hydrocortisone administration remains controversial, with potential harm to the immune system. Few studies have assessed the impact of hydrocortisone on the transcriptional response in shock, and we are lacking data on burn shock. Our objective was to assess the hydrocortisone-induced transcriptional modulation in severe burn shock, particularly modulation of the immune response. We collected whole blood samples during a randomized controlled trial assessing the efficacy of hydrocortisone administration in burn shock. Using whole genome microarrays, we first compared burn patients (n = 32) from the placebo group to healthy volunteers to describe the transcriptional modulation induced by burn shock over the first week. Then we compared burn patients randomized for either hydrocortisone administration or placebo, to assess hydrocortisone-induced modulation. Study groups were similar in terms of severity and major outcomes, but shock duration was significantly reduced in the hydrocortisone group. Many genes (n = 1687) were differentially expressed between burn patients and healthy volunteers, with 85% of them exhibiting a profound and persistent modulation over seven days. Interestingly, we showed that hydrocortisone enhanced the shock-associated repression of adaptive, but also innate immunity. We found that the initial host response to burn shock encompasses wide and persistent modulation of gene expression, with profound modulation of pathways associated with metabolism and immunity. Importantly, hydrocortisone administration may worsen the immunosuppression associated with severe injury. These data should be taken into account in the risk ratio of hydrocortisone administration in patients with inflammatory shock. ClinicalTrials.gov, NCT00149123 . Registered on 6 September 2005.

  20. Immediate loading versus immediate provisionalization of maxillary single-tooth replacements: a prospective randomized study with BioComp implants

    NARCIS (Netherlands)

    Lindeboom, Jerome A.; Frenken, Joost W.; Dubois, Leander; Frank, Michael; Abbink, Ingmar; Kroon, Frans H.

    2006-01-01

    PURPOSE: The aim of this prospective randomized study was to evaluate the clinical outcome of immediately loaded solid plasma sprayed (TPS) BioComp (BioComp Industries BV, Vught, The Netherlands) implants versus immediate provisionalized but non-loaded BioComp implants in the anterior and premolar

  1. Duration of antimicrobial prophylaxis in patients undergoing hepatectomy: a prospective randomized controlled trial using flomoxef.

    Science.gov (United States)

    Togo, Shinji; Tanaka, Kuniya; Matsuo, Kenichi; Nagano, Yasuhiko; Ueda, Michio; Morioka, Daisuke; Endo, Itaru; Shimada, Hiroshi

    2007-05-01

    Although the usefulness of antimicrobial prophylaxis for clean-contaminated surgery has been recognized, only a few randomized controlled studies on the duration of administration after hepatectomy have been performed. We investigated the duration of antimicrobial prophylaxis after hepatectomy. The subjects were 180 patients who underwent hepatectomy without reconstruction of the biliary or intestinal tract between April 2003 and March 2006 at our department. The patients were randomly allocated to groups to be treated with flomoxef sodium as antimicrobial prophylaxis for 2 days (89 patients) or 5 days (91 patients), including the operation day. The presence or absence of systemic inflammatory response syndrome (SIRS) and infections was investigated. No significant differences were noted in patient background between the two groups. Infections occurred in seven and six patients in the 2 day and 5 day treatment groups (7.9% and 6.6%), respectively, showing no significant difference between the two groups. No significant difference was noted when the cases were divided into surgical site infections and remote infections. The positive rate of SIRS was significantly higher in the 2 day treatment group than in the 5 day treatment group on days 2 and 3 after surgery. The risk factors in patients who developed infections were blood loss, operation time and the complication of biliary fistula. Two day administration of flomoxef sodium may be sufficient for antimicrobial prophylaxis after hepatectomy. However, when SIRS is positive on post-operative day 2, and induction of liver failure is of concern, it may be safer to continue antimicrobial drug administration until SIRS is eliminated.

  2. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial.

    Science.gov (United States)

    Cherian, Jeffrey J; Bhave, Anil; Kapadia, Bhaveen H; Starr, Roland; McElroy, Mark J; Mont, Michael A

    2015-05-01

    Pneumatic unloader bracing with extension assists have been proposed as a non-operative modality that may delay the need for knee surgery by reducing pain and improving function. This prospective, randomized trial evaluated 52 patients who had knee osteoarthritis for changes in: (1) muscle strength; (2) objective functional improvements; (3); subjective functional improvements; (4) pain; (5) quality of life; and (6) conversion to total knee arthroplasty (TKA) compared to standard of care. Patient outcomes were evaluated at a minimum 3 months. Braced patient's demonstrated significant improvements in muscle strength, several functional tests, and patient reported outcomes when compared to the matched cohort. These results are encouraging and suggest that this device may represent a promising alternative to standard treatment methods for knee osteoarthritis. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

    2010-01-01

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  4. Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

    Science.gov (United States)

    Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

    2014-12-01

    To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p Physiotherapy may be more effective when provided regularly rather than in blocks.

  5. Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

    2015-12-01

    There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

    Science.gov (United States)

    Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

    2018-02-01

    There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial.

    Science.gov (United States)

    Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören

    2014-03-01

    A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.

  8. Hypofractionated radiation therapy in the treatment of epidemic Kaposi sarcoma - A prospective randomized trial

    International Nuclear Information System (INIS)

    Singh, Niveditha B.; Lakier, Roy H.; Donde, Bernard

    2008-01-01

    Purpose: To compare a conventional fractionation regimen with a hypofractionated regimen in the treatment of Epidemic Kaposi sarcoma with radiation therapy. Materials and methods: Sixty patients were randomized to receive a standard regimen of 24 Gy in 12 fractions (ARM A) or the study regimen of 20 Gy in five fractions (ARM B). Radiation technique was individualized. Treatment response, local control and toxicity were recorded. Results: Thirty five sites were treated in ARM A and 30 sites in ARM B. Treatment arms were similar for gender, ECOG performance score, treated site, antiretroviral therapy usage, T stage, I stage and S stage. The overall survival using the Kaplan Meier method was 37% at 1 year. Complete responses were recorded at 28 sites (13 Arm A, 15 Arm B), partial responses at 19 sites (8 Arm A, 11 Arm B) and stable disease at three sites (2 Arm A, 1 Arm B). The mean time to maximum objective response was 3 months (range: 1-14 months). Response rates and local control were equal in the two arms (p = 0.73 and 0.77, respectively, log rank test). Acute skin toxicity (p = 0.77) and late skin toxicity (p = 0.24) were equal in the two arms. Conclusion: The two treatment regimens produced equivalent results for treatment response, local recurrence-free survival and toxicity

  9. Defining Dogma: Quantifying Crystalloid Hemodilution in a Prospective Randomized Control Trial with Blood Donation as a Model for Hemorrhage.

    Science.gov (United States)

    Ross, Samuel Wade; Christmas, A Britton; Fischer, Peter E; Holway, Haley; Seymour, Rachel; Huntington, Ciara R; Heniford, B Todd; Sing, Ronald F

    2018-06-04

    The concept of hemodilution after blood loss and crystalloid infusion is a surgical maxim that remains unproven in humans. We sought to quantify the effect of hemodilution after crystalloid administration in voluntary blood donors as a model for acute hemorrhage. A prospective, randomized control trial was conducted in conjunction with community blood drives. Donors were randomized to receive no IV fluid(noIVF), two liters normal saline(NS), or two liters lactated ringers(LR) after blood donation. Blood samples were taken before donation of 500 mL of blood, immediately after donation, and following IV fluid administration. Hemoglobin(Hgb) was measured at each time point. Hgb between time points were compared between groups using standard statistical tests and the Bonferroni correction for multiple comparisons. Statistical significance was set at p≤0.0167. Of 165 patients consented, 157 patients completed the study. Average pre-donation Hgb was 14.3 g/dL. There was no difference in the mean Hgb levels after blood donation between the three groups(p>0.05). Compared to the control group, there was a significant drop in Hgb in the crystalloid infused groups from the post-donation level to post-resuscitation(13.2 vs 12.1 vs 12.2 g/dL, pdonation Hgb - hemorrhage Hgb drop - equilibration hemoglobin drop - resuscitation Hgb drop)=MeanPre-donation Hgb - [(EBL/TBV)*l] - [(EBL/TBV)*h] - [(VR/TBV)*r], l = 5.111g/dL = blood loss coefficient, h=6.722 g/dL=equilibration coefficient, r= 2.617g/dL= resuscitation coefficient. This study proves the concept of hemodilution and derived a mathematical relationship between blood loss and resuscitation. This data may help to estimate response of hemoglobin levels to blood loss and fluid resuscitation in clinical practice. Copyright © 2018. Published by Elsevier Inc.

  10. A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

    Science.gov (United States)

    Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

    2018-05-01

    Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  11. Effect of Sugammadex on Postoperative Bleeding and Coagulation Parameters After Septoplasty: A Randomized Prospective Study

    Science.gov (United States)

    Taş, Nilay; Korkmaz, Hakan; Yağan, Özgür; Korkmaz, Mukadder

    2015-01-01

    Backround Sugammadex is a reversal agent with well known advantages but it’s effects on haemostasis and bleeding have been a topic of interest. Septoplasty is a common surgical procedure with postoperative respiratory complications and bleeding. The aim of this study is to investigate the effects of sugammadex on postoperative coagulation parameters and bleeding after septoplasty procedure. Material/Methods In this randomized controlled study, fifty patients were grouped into two groups; neostigmine (Group N) vs. sugammadex (Group S). For the evaluation of PT, aPTT and INR, blood samples were taken for at the postoperative 120th minutes and alteration of these values with respect to preoperative values were documented. Postoperative bleeding was measured by evaluating the amount of blood absorbed on the nasal tip dressing during 3 hours postoperatively. Results Postoperative bleeding amount was significantly higher in the Group S compared to Group N (p=0.013). No significant difference was observed between two groups according to coagulation parameters (PT; p=0.953, aPTT; p=0.734, INR; p=0.612). Conclusions Sugammadex was associated with higher amount of postoperative bleeding than neostigmine in septoplasty patients. In surgical procedures having high risk of bleeding the safety of sugammadex need to be verified. PMID:26271275

  12. ABC versus CAB for cardiopulmonary resuscitation: a prospective, randomized simulator-based trial.

    Science.gov (United States)

    Marsch, Stephan; Tschan, Franziska; Semmer, Norbert K; Zobrist, Roger; Hunziker, Patrick R; Hunziker, Sabina

    2013-09-06

    After years of advocating ABC (Airway-Breathing-Circulation), current guidelines of cardiopulmonary resuscitation (CPR) recommend CAB (Circulation-Airway-Breathing). This trial compared ABC with CAB as initial approach to CPR from the arrival of rescuers until the completion of the first resuscitation cycle. 108 teams, consisting of two physicians each, were randomized to receive a graphical display of either the ABC algorithm or the CAB algorithm. Subsequently teams had to treat a simulated cardiac arrest. Data analysis was performed using video recordings obtained during simulations. The primary endpoint was the time to completion of the first resuscitation cycle of 30 compressions and two ventilations. The time to execution of the first resuscitation measure was 32 ± 12 seconds in ABC teams and 25 ± 10 seconds in CAB teams (P = 0.002). 18/53 ABC teams (34%) and none of the 55 CAB teams (P = 0.006) applied more than the recommended two initial rescue breaths which caused a longer duration of the first cycle of 30 compressions and two ventilations in ABC teams (31 ± 13 vs.23 ± 6 sec; P = 0.001). Overall, the time to completion of the first resuscitation cycle was longer in ABC teams (63 ± 17 vs. 48 ± 10 sec; P ABC with an earlier start of CPR and a shorter time to completion of the first 30:2 resuscitation cycle. These findings endorse the change from ABC to CAB in international resuscitation guidelines.

  13. Regenerative Endodontics Versus Apexification in Immature Permanent Teeth with Apical Periodontitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lin, Jiacheng; Zeng, Qian; Wei, Xi; Zhao, Wei; Cui, Minyi; Gu, Jing; Lu, Jiaxuan; Yang, Maobin; Ling, Junqi

    2017-11-01

    The aim of the study was to compare the outcomes of regenerative endodontic treatment (RET) and apexification on immature permanent teeth with pulp necrosis and apical periodontitis. A total of 118 patients (118 teeth) were recruited and randomly assigned to either RET or apexification treatment. Each treatment group was divided into 2 subgroups according to the etiology: dens evaginatus or trauma. Clinical symptoms and complications were recorded, and cone-beam computed tomographic imaging with a limited field of view was used to measure the change of root length, root thickness, and apical foramen size at the 12-month follow-up. The t test/rank sum test and Fisher exact test were applied to compare the change of root morphology between RET and apexification. One hundred three of 118 cases were completed at the 12-month follow-up. The survival rate was 100% for both treatment groups. All cases were asymptomatic with apical healing. The RET group showed a significant increase in root length and root thickness compared with the apexification group (P apical healing. RET showed a better outcome than apexification regarding increased root thickness and root length. The etiology had an impact on the outcome of RET. Dens evaginatus cases showed better prognoses than trauma cases after RET. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

    Science.gov (United States)

    Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

    2016-09-01

    Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon

  15. Standard versus Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Daniel Serban

    2017-01-01

    Full Text Available Symptomatic spondylolisthesis patients may benefit from surgical decompression and stabilization. The standard (S technique is a transforaminal lumbar interbody fusion (TLIF. Newer, minimally invasive (MI techniques seem to provide similar results with less morbidity. We enrolled patients with at least 6 months of symptoms and image-confirmed low-grade spondylolisthesis, at a single academic institution, between 2011 and 2015. The patients were randomized to either S or MI TLIF. The primary outcome measure was the Oswestry Disability Index (ODI improvement at 1 year. Secondary outcome measures included length of operation, estimated blood loss, length of hospitalization, and fusion rates at 1 year. Forty patients were enrolled in each group. The differences in mean operative time and estimated blood loss were not statistically significant between the two groups. The patients were discharged after surgery at 4.12 days for the S TLIF group and 1.92 days for the MI TLIF group. The ODI improvement was similar and statistically significant in both groups. The fusion was considered solid in 36 (90% of patients at 1 year in both groups. In conclusion, the two techniques provided similar clinical and radiological outcomes at 1 year. The patients undergoing MI TLIF had a shorter hospital stay. This trial is registered with NCT03155789.

  16. A prospective, randomized, controlled study of a suspension positioning system used with elderly bedridden patients with neurogenic fecal incontinence.

    Science.gov (United States)

    Su, Mei-Yin; Lin, Shi-Quan; zhou, Ye-Wen; Zhou, Ye-Wen; Liu, Si-Ya; Lin, Ai; Lin, Xi-Rong

    2015-01-01

    Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition. To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P <0.05). Length of hospitalization and costs of care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients.

  17. A prospective randomized study assessing optimal method for teaching vascular anastomoses.

    Science.gov (United States)

    Schwartz, Samuel; de Virgilio, Michael; Chisum, Patrick; Heslin, Andrew; Zein, Alyssar; McDermott, Meilu; Kaji, Amy; Yaghoubian, Arezou; de Virgilio, Christian

    2014-07-01

    Laboratory skills training is now required for general surgery residents. The optimal method of teaching vascular anastomosis (VA) is not well defined. Teaching VA skills one-on-one with a faculty instructor will result in a more rapid accumulation of skills than teaching in a large group setting. Residents were shown an instructional video on how to perform a VA using a standardized model (cadaver saphenous vein and porcine aorta). Each resident then performed a baseline VA. Sixteen first- and second-year surgical residents were then randomized to 2 VA teaching sessions that consisted of either 1) group teaching (GT, 8 residents in a room with 1 faculty instructor circulating) or 2) one-on-one teaching (1-on-1, faculty member focused on individual resident). After each of these sessions, residents performed a standardized VA. The anastomoses were video recorded. Performance was evaluated using a standardized scoring system by a separate expert who viewed the video recordings in a blinded fashion. Outcome measures included total errors, total time, global rating scale, and an anastomosis-specific end-product evaluation (leak and passage of coronary dilator). Overall, significant decreases in total errors (21 to 15, P=0.001) and time to complete anastomoses (42 to 38 min, P=0.02) and an increase in global rating scales (7 to 11, P=0.003) were noted in both groups from baseline after 2 VA teaching session. The 1-on-1 group demonstrated significantly greater improvement in terms of reduced anastomotic time (30 vs. 42 min, P=0.007) and in reduction of errors (13 vs. 19 errors, P=0.09) than the GT group. The high-fidelity VA model is a useful tool for junior general surgery residents. Both GT and 1-on-1 groups demonstrated significant improvement in total errors and time after only 2 sessions. Greater improvement was noted using the 1-on-1 model. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Is There a Concordance Between the Gleason Scores of Needle Biopsy and Radical Prostatectomy Specimens in Prostatic Carsinoma?

    Directory of Open Access Journals (Sweden)

    Faruk Özgör

    2016-03-01

    Full Text Available Aim: To evaluate the concordance between the Gleason Scores (GS of prostate biopsy and radical prostatectomy specimens. Methods: Prostate biopsy was performed in 1135 patients with the suspicion of prostate cancer in our clinic between 2008 and 2012. A total of 366 patients were diagnosed with prostate cancer. Radical prostatectomy was performed in 73 of these patients and GS of pathology specimens were included in this study for comparison. The patients were divided into three groups (low intermediate- and high-risk patients according to the D’amico risk classification for prostate cancer. Results: The median age of the patients was 64.2±6.1 years (54- 73. The mean prostate specific antigen level was 20.34 ng/mL and the mean biopsy core number was 12±0.58. A statistically significant concordance was detected between the GS of biopsy specimens and radical prostatectomy materials in 65.7% of patients (p<0.01. There were 40 patients in the low-risk group, however, 8 (20% of them were identified to be intermediate-risk patients and one (2.5% was found to be a high-risk patient after radical prostatectomy. Conclusion: Concordance between the GS of prostate biopsy and radical prostatectomy materials are important for selection of the appropriate treatment

  19. Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

    Science.gov (United States)

    Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

    2013-09-01

    We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

  20. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    Science.gov (United States)

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  1. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    Directory of Open Access Journals (Sweden)

    I. L. Toscano Jr.

    Full Text Available ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week. Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5 score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019 and 50.4° and 42.08° before and after verapamil, respectively (p=0.012. The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23 in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58. In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine.

  2. The effect of posture and repetition on urodynamic parameters: A prospective randomized study

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    Ho Joon Jeon

    2017-01-01

    Full Text Available Purpose: To evaluate the effect of posture and repetition of filling cystometry on urodynamic parameters. Materials and Methods: Seventy-one men with benign prostatic hyperplasia participated in a urodynamic study between September 2015 and August 2016 and were randomly assigned to a supine to supine (group SS, n=16, erect to erect (group EE, n=16, supine to erect (group SE, n=19 or erect to supine (group ES, n=20 group. The patients underwent filling cystometry twice. We evaluated the effect of posture and the effect of repetition on filling cystometric parameters. We also evaluated the correlation between overactive bladder (OAB and detrusor overactivity (DO and between maximum voided volume (MVV and maximum cystometric capacity (MCC for each posture and filling cystometry time. Results: There was a decrease in bladder sensation and occurrence of DO, and an increase in bladder compliance and MCC in the supine posture group compared to that in the erect posture group. A more significant decrease in bladder sensation and occurrence of DO as well as an increase in MCC was seen during the second filling cystometry than the first one. The supine posture during first filling cystometry showed a better correlation between OAB and DO and between MVV and MCC than erect posture. Conclusions: There were clear effects of posture and filling cystometry repetition on urodynamic parameters. The supine posture and repeated filling cystometry caused the bladder to be less sensitive and less overactive. The supine posture showed a better correlation to OAB symptoms than erect posture during first filling cystometry.

  3. Comparison of 3 different methods of anesthesia before transrectal prostate biopsy: a prospective randomized trial

    International Nuclear Information System (INIS)

    Oebek, C.; Oezkan, B.; Tunc, B.; Can, G.; Yalcin, V.; Solok, V.

    2004-01-01

    Purpose: Periprostatic nerve block (PNB) is the most common anesthesia technique used before prostate biopsy. However, needle punctures for anesthetic infiltration may be painful and cause higher infectious complications. We assessed whether addition of rectal lidocaine gel would improve its efficacy. We also investigated the efficacy and safety of tramadol, a codeine derivative, as a noninvasive method. Materials and Methods: A total of 300 patients who underwent prostate biopsies were randomized into 4 groups of controls, PNB, perianal/intrarectal lidocaine gel plus PNB and tramadol. Pain was assessed with a numeric analog scale. Results: Each group consisted of 75 patients, and there was a statistically significant difference among pain scores (p = 0.001). Mean pain scores were 4.63 for controls, 2.57 for PNB, 2.03 for infiltration plus gel group and 3.11 for tramadol. Pain and discomfort were least in PNB plus gel arm. The difference of pain score between PNB alone and tramadol group did not reach statistical significance. Infectious complications were higher in the combination group, whereas there were no complications with tramadol. Conclusions: Any form of analgesia/anesthesia was superior to none. The combination of PNB plus gel provided significantly better analgesia compared to PNB alone or tramadol. If this can be duplicated in other trials, the combination may be accepted as the new gold standard of anesthesia for prostate biopsy. The efficacy of tramadol was similar to that of PNB, and was free of complications. Therefore, tramadol may have a role before prostate biopsy, which needs to be explored. (author)

  4. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

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    Henzen Christoph

    2007-07-01

    Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

  5. Effect of a clown's presence at botulinum toxin injections in children: a randomized, prospective study

    DEFF Research Database (Denmark)

    Hansen, Lars Kjaersgaard; Kibæk, Maria; Martinussen, Torben

    2011-01-01

    The effect of the presence of a hospital clown during pediatric procedures has rarely been evaluated. In a pediatric ward, botulinum toxin injection is a painful procedure and a stressful experience for the child. We undertook a study of the effect of the presence of a hospital clown on children...... treated with botulinum toxin in an outpatient setting....

  6. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

    Science.gov (United States)

    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  7. Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

    Science.gov (United States)

    Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

    2012-06-01

    To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

  8. A Prospective, Randomized Trial in the Emergency Department of Suggestive Audio-Therapy under Deep Sedation for Smoking Cessation.

    Science.gov (United States)

    Rodriguez, Robert M; Taylor, Opal; Shah, Sushma; Urstein, Susan

    2007-08-01

    In a sample of patients undergoing procedural deep sedation in the emergency department (ED), we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. We asked subjects about their smoking, including desire to quit (0-10 numerical scale) and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone) or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 +/- 2.6 and mean cigarettes per day was 17.5 +/- 12.1. We successfully contacted 69 (62%) patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: -22.0% to 18.8%). Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: -8.7% to 35.6%). Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  9. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  10. Outpatient parenteral antimicrobial therapy in children with febrile urinary tract infection: a prospective randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Nasiri Kalmarzi R

    2009-01-01

    Full Text Available "nBackground: Acute pyelonephritis may lead to permanent renal scarring. The standard recommendation for treatment of febrile children with urinary tract infection (UTI is hospitalization for intravenous antibiotics. The purpose of this study was to compare the efficacy of outpatient intravenous ceftriaxone and cefixime versus inpatient of the same regimen for children with febrile UTI.   "nMethods: In a randomized clinical trial, we compared the efficacy of administration two days intravenous ceftriaxone followed by an oral cefixime for eight days (as outpatient group versus four days intravenous ceftriaxone followed by an oral cefixime for six days (as inpatient group, in 203 children (99 cases in outpatient group and 104 cases in inpatient group 3 months to 15 years of age with febrile UTI, in terms of short-term clinical outcomes (sterilization of the urine and defeverescence and long-term morbidity (incidence of reinfection and renal scarring documented by DMSA scintigraphy. "nResults: Repeat urine cultures were sterile within 48 hours in all children, mean time to defeverescence was 27.58 (SD=±12.62 and 31.44 (SD=±17.06 hours for children in outpatient and inpatient groups, respectively (P=0.067. Reinfection occurred in 9.1% of outpatient and 13.4% of inpatient group (P=0.326. Renal scarring developed in 11% of children of outpatient and 7.6% of children of inpatient group (P=0.884. There was no significant difference between the two groups in respect of renal scarring. "nConclusions: Outpatient ceftriaxone for two days followed by cefixime to complete a 10 days course can be recommended as a safe and effective treatment for children with febrile UTI.

  11. One- vs 2-Stage Bursectomy for Septic Olecranon and Prepatellar Bursitis: A Prospective Randomized Trial.

    Science.gov (United States)

    Uçkay, Ilker; von Dach, Elodie; Perez, Cédric; Agostinho, Americo; Garnerin, Philippe; Lipsky, Benjamin A; Hoffmeyer, Pierre; Pittet, Didier

    2017-07-01

    To assess the optimal surgical approach and costs for patients hospitalized with septic bursitis. From May 1, 2011, through December 24, 2014, hospitalized patients with septic bursitis at University of Geneva Hospitals were randomized (1:1) to receive 1- vs 2-stage bursectomy. All the patients received postsurgical oral antibiotic drug therapy for 7 days. Of 164 enrolled patients, 130 had bursitis of the elbow and 34 of the patella. The surgical approach used was 1-stage in 79 patients and 2-stage in 85. Overall, there were 22 treatment failures: 8 of 79 patients (10%) in the 1-stage arm and 14 of 85 (16%) in the 2-stage arm (Pearson χ 2 test; P=.23). Recurrent infection was caused by the same pathogen in 7 patients (4%) and by a different pathogen in 5 (3%). Outcomes were better in the 1- vs 2-stage arm for wound dehiscence for elbow bursitis (1 of 66 vs 9 of 64; Fisher exact test P=.03), median length of hospital stay (4.5 vs 6.0 days), nurses' workload (605 vs 1055 points), and total costs (Sw₣6881 vs Sw₣11,178; all Pbursitis requiring hospital admission, bursectomy with primary closure, together with antibiotic drug therapy for 7 days, was safe, effective, and resource saving. Using a 2-stage approach may be associated with a higher rate of wound dehiscence for olecranon bursitis than the 1-stage approach. Clinicaltrials.gov Identifier: NCT01406652. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  12. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds.

    Science.gov (United States)

    Eginton, Mark T; Brown, Kellie R; Seabrook, Gary R; Towne, Jonathan B; Cambria, Robert A

    2003-11-01

    Optimal treatment for large diabetic foot wounds is ill defined. The purpose of this study was to compare the rate of wound healing with the Vacuum Assisted Closure device trade mark (VAC) to conventional moist dressings in the treatment of large diabetic foot wounds. Diabetics with significant soft tissue defects of the foot were considered for enrollment. Patients were randomized to receive either moist gauze dressings or VAC treatments for 2 weeks, after which they were treated with the alternative dressing for an additional 2 weeks. Wounds were photographed weekly and wound dimensions calculated in a blinded fashion with spatial analysis software. Percent change in wound dimensions were calculated and compared for each weekly assessment and over 2 weeks of therapy with each dressing type. Ten patients were enrolled in the trial, but two were lost to follow-up and two were withdrawn. Complete data were available for analysis on seven wounds in six patients. Average length, width, and depth of the wounds at initiation of the trial was 7.7, 3.5, and 3.1 cm, respectively. Only the wound depth was significantly decreased over the weeks of the trial to 1.2 cm ( p VAC dressings decreased the wound volume and depth significantly more than moist gauze dressings (59% vs. 0% and 49% vs. 8%, respectively). VAC dressings were associated with a decrease in all wound dimensions while wound length and width increased with moist dressings. In summary, over the first several weeks of therapy, VAC dressings decreased wound depth and volume more effectively than moist gauze dressings. Negative-pressure wound treatment may accelerate closure of large foot wounds in the diabetic patient.

  13. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study.

    Science.gov (United States)

    Bogachev-Prokophiev, Alexander; Afanasyev, Alexander; Zheleznev, Sergey; Fomenko, Michael; Sharifulin, Ravil; Kretov, Eugenie; Karaskov, Alexander

    2017-09-01

    The optimal surgical strategy for concomitant mitral valve intervention during myectomy remains controversial. The purpose of this study was to compare the results of mitral valve replacement versus repair in patients with hypertrophic obstructive cardiomyopathy and severe mitral regurgitation. Between 2010 and 2013, a total of 88 patients with hypertrophic obstructive cardiomyopathy and severe mitral regurgitation were randomly assigned to undergo either mitral valve replacement or repair in addition to extended myectomy. Three patients from the repair group were switched to mitral valve replacement after repair failure. There was 1 early death (2.4%) in the replacement group. The resting left ventricular outflow tract gradient was reduced from 89.1 ± 20.4 to 18.3 ± 5.7 mmHg (P replacement and repair groups, respectively; there was no significant difference between the groups (P = 0.458). At 2-year follow-up, overall survival was 87.2 ± 4.9% and 96.7 ± 3.3% (P = 0.034); freedom from sudden cardiac death was 95.6 ± 3.1% and 96.7 ± 3.3% (P = 0.615); and freedom from thromboembolic events was 91.2 ± 4.2% and 100%, respectively (P = 0.026). Both mitral valve repair and valve replacement in addition to extended myectomy are effective methods of surgical treatment in patients with hypertrophic obstructive cardiomyopathy who have severe mitral regurgitation. The benefits of mitral valve repair are better overall survival and a lower rate of thromboembolic events. ClinicalTrials.gov: NCT02054221. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  14. Pharmacological strategies to reduce pruritus during postoperative epidural analgesia after lumbar fusion surgery - a prospective randomized trial in 150 patients

    Directory of Open Access Journals (Sweden)

    Robinson Yohan

    2011-05-01

    Full Text Available Abstract Background Epidural analgesia with bupivacain, epinephrine and fentanyl provides excellent pain control after lumbar fusion surgery, but pruritus and motor block are frequent side effects. Theoretically epidural ropivacain combined with oral oxycodone could decrease the incidence of these side effects. The two regimens were compared in a prospective randomized trial. Patients and methods 150 patients (87 women treated with posterior instrumented lumbar fusion were included. The mean age was 51 +/- 11 years. 76 were randomized to bupivacain, epinephrine and fentanyl (group B and 74 to ropivacain and oxycodone (group R. Pruritus, motor block and pain were measured 6 hours after surgery, thereafter 6 times per day for 5 days. Any pain breakthrough episode was registered whenever it occurred. Results The epidural treatment could be performed in 143 patients (72 in group B and 71 in group R. Disturbing pruritus occurred in 53 patients in group B compared to 12 in group R (p Conclusions Pruritus could be reduced with a combination of epidural ropivacain and oral oxycodone, at the price of a slightly higher pain level. Ropivacaine was not found to be superior to bupivacaine with regard to motor blocks.

  15. Peyton’s four-step approach for teaching complex spinal manipulation techniques – a prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Gertraud Gradl-Dietsch

    2016-11-01

    Full Text Available Abstract Background The objectives of this prospective randomized trial were to assess the impact of Peyton’s four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. Methods We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG or a control group, which received conventional teaching (CG. Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC exam and practical skills (Objective Structured Practical Examination (OSPE with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. Results There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Conclusions Peyton’s approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  16. A Prospective Randomized Trial of Functional Outcomes Following Rotator Cuff Repair With and Without Acromioplasty

    Science.gov (United States)

    Tetteh, Elizabeth; Hussey, Kristen Elizabeth; Abrams, Geoffrey D.; Gupta, Anil K.; Dhawan, Aman; Karas, Vasili; Cole, Brian J.; Romeo, Anthony A.; Verma, Nikhil N.

    2013-01-01

    Objectives: The purpose of this study is to report the clinical outcomes of patients undergoing an arthroscopic rotator cuff repair with and without acromioplasty at a minumul of two year follow-up. Methods: Patients undergoing arthroscopic repair of full thickness rotator cuff tears were randomized into acromioplasty or non-acromioplasty groups. Pre-operatively, validated outcome scores including the Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons score (ASES), UCLA score, and SF-12 health assessment were collected along with physical examination including range of motion and dynamometer strength testing. Pre-operative imaging was also reviewed to classify the acromial morphology, acromial angle, and lateral acromial angulation. Intra-operative data including tear size, repair configuration, and concomitant procedures were recorded. Postoperatively, data was collected at 6 weeks, 6 months, one year and at two years. Results are reported as mean ± standard deviation. Student’s t-test was utilized for statistical analysis with an alpha value of 0.05 set as significant. Results: Sixty-one patients completed surveys pre- and post-operatively at a mean 2.6 years. All patients had at least two year follow-up. Thirty-five patients with an average age of 58.4 years (range 44.4 - 74.7) were randomized to the acromioplasty group (22 male, 13 female) and 26 patients with a mean age of 58.2 years (range 42.9-77.0) to the non-acromioplasty group (17 male, 9 female). All outcome scores improved significantly (p < 0.05) in both groups from pre- to post-operatively at two year follow-up. In the acromioplasty group, improvements were observed for SST (5.6 ± 2.7 to 10.7 ± 1.7), ASES (53.5 ± 16.8 to 91.0 ± 13.5) and UCLA (10.7 ± 3.1 to 17.9 ± 30.0) scores. In the non-acromioplasty group, SST increased from 5.6 ± 3.1 to 10.5 ± 2.2; ASES from 58.9 ± 19.1 to 93.5 ± 10.8, and UCLA from 12.0 ± 2.8 to 17.4 ± 3.7. There was no statistical difference in

  17. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent

    DEFF Research Database (Denmark)

    Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T

    2011-01-01

    We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).......We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)....

  18. Predictors and rate of adjuvant radiation therapy following radical prostatectomy: A report from the Prostate Cancer Registry

    International Nuclear Information System (INIS)

    Daniels, Christopher P.; Millar, Jeremy L.; Spelman, Tim; Sengupta, Shomik; Evans, Sue M.

    2016-01-01

    Long-term data from three randomized trials have demonstrated that adjuvant radiation therapy (ART) reduces the rate of biochemical failure in high-risk men following radical prostatectomy (RP). One of these trials has shown a survival advantage. We investigated the rate of ART in Victoria and the predictors for this treatment. We analysed data from eligible patients who were notified to the Victorian Prostate Cancer Registry (PCR) by 37 Victorian hospitals between 1 August 2008 and 31 October 2011. We defined ART as radiation therapy (RT) delivered within 6 months of RP. Predictors of ART receipt were modelled using adjusted and unadjusted logistic regression. There were 4626 eligible cases from which 2018 underwent RP with recorded date of surgery. Of these eligible prostatectomy cases, a total of 89 received ART. A subgroup of 833 men had an adverse pathologic feature, of whom 78 received ART. In a multivariate model, pathologic tumour stage pT3a (odds ratio (OR) 2.64; 95% confidence interval (CI) 1.4–5.00; P = 0.003), pT3b (OR 4.58; 95% CI 2.12–9.89; P = 0.000), a positive surgical margin (OR 8.91; 95% CI 4.61–17.2; P = 0.000) and pathologic Gleason grade >7 (OR 7.18; 95% CI 1.54–33.6; P = 0.012) predicted receipt of ART. Adverse pathologic features and high pathologic Gleason score predict for receiving ART in Victorian men after RP, but overall, ART is not commonly prescribed. This finding is consistent with other published series and may reflect clinician scepticism regarding the benefit of ART over salvage RT and concern about toxicity and the risk of over treatment.

  19. Prophylactic antibiotics in transurethral prostatectomy

    DEFF Research Database (Denmark)

    Qvist, N; Christiansen, H.M.; Ehlers, D

    1984-01-01

    The study included 88 patients with sterile urine prior to transurethral prostatectomy. Forty-five received a preoperative dose of 2 g of cefotaxime (Claforan) and the remaining 43 were given 10 ml of 0.9% NaCl. The two groups did not differ in frequency of postoperative urinary infection (greate...... of infection and the few side effects of the infections that did occur, prophylactic treatment with an antibiotic is not indicated for transurethral prostatectomy in patients with sterile urine....

  20. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  1. Postoperative pain after foraminal enlargement in anterior teeth with necrosis and apical periodontitis: a prospective and randomized clinical trial.

    Science.gov (United States)

    Silva, Emmanuel João Nogueira Leal; Menaged, Karyne; Ajuz, Natasha; Monteiro, Maria Rachel Figueiredo Penalva; Coutinho-Filho, Tauby de Souza

    2013-02-01

    The aim of this randomized, controlled, prospective clinical study was to determine if foraminal enlargement instrumentation during endodontic treatment is associated with more postoperative pain compared with standard nonenlargement instrumentation. Forty volunteers with a single root canal were diagnosed with asymptomatic necrosis with apical periodontitis and randomized into 2 experimental groups (ie, the control group and the foraminal enlargement group). Endodontic treatment was performed in a single visit, and volunteers were instructed to record pain intensity (ie, none, slight, moderate, and severe). Scores from 1 to 4 were attributed to each kind of pain after 12, 24, and 48 hours. The Kolmogorov-Smirnov and Student's t tests were used to determine significant differences at P .05, Student's t test). Postoperative pain showed no statistically significant difference between the groups at any observation period (P > .05). Also, no significant difference was observed in the mean number of analgesic tablets used between the groups (P > .05). The foraminal enlargement and nonenlargement techniques resulted in the same postoperative pain and necessity for analgesic medication. This may suggest that the use of foraminal enlargement should be performed for endodontic treatment previsibility without increasing postoperative pain. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  2. One-site versus two-site phacotrabeculectomy: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Moschos MM

    2015-08-01

    Full Text Available Marilita M Moschos,1 Irini P Chatziralli,2 Michael Tsatsos3 1First Department of Ophthalmology, University of Athens, 2Second Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece; 3Department of Ophthalmology, Cambridge University Hospital NHS, Cambridge, UK Purpose: The purpose of this study is to compare the efficacy and safety of one-site and two-site combined phacotrabeculectomy with foldable posterior chamber intraocular lens implantation.Methods: Thirty-four patients (41 eyes with glaucoma and cataract were randomly assigned to undergo either a one-site (22 eyes or a two-site (19 eyes combined procedure. One-site approach consisted of a standard superior phacotrabeculectomy with a limbus-based conjunctival flap, while two-site approach consisted of a clear cornea phacoemulsification and a separate superior trabeculectomy with a limbus-based conjunctival flap.Results: Mean follow-up period was 54 months (standard deviation [SD] 2.3. Mean preoperative intraocular pressure (IOP in the one-site group was 21.3 mmHg (SD 2.8 and in the two-site group was 21.8 mmHg (SD 3.0 (P>0.1. Mean postoperative IOP significantly decreased in both groups compared to the preoperative level and was 15.6 mmHg (SD 3.5 in the one-site group and 14.9 mmHg (SD 2.7 in the two-site group. Three months later, the difference between the two groups was not statistically significant (P=0.058. The one-site group required significantly more medications than the two-site group (P=0.03. Best-corrected visual acuity (BCVA improved similarly in both groups, but there was less postoperative (induced astigmatism in the two-site group in a marginal statistical level (P=0.058. Intra- and postoperative complications were comparable in the two groups.Conclusion: Both techniques yielded similar results concerning final BCVA and IOP reduction. However, the two-site group had less induced astigmatism and a better postoperative IOP control with less required

  3. Use of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized study

    OpenAIRE

    Lequaglie Cosimo; Giudice Gabriella; Marasco Rita; Morte Aniello; Gallo Massimiliano

    2012-01-01

    Abstract Background Pulmonary air leaks are common complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this study was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal®) could reduce air leaks detected by means of a digital chest drain system (DigiVent™), in patients undergoing lung resection (sutures and/or staples alone). Methods Patients who intraoperatively showed moderate o...

  4. Laparoscopic distal pancreatectomy: results of a prospective non-randomized study from a tertiary center.

    Science.gov (United States)

    Palanivelu, C; Shetty, R; Jani, K; Sendhilkumar, K; Rajan, P S; Maheshkumar, G S

    2007-03-01

    Though laparoscopic distal pancreatectomy for benign conditions was first described in the early 1990s, it has not become as popular as other laparoscopic surgeries. Published literature on this topic consists of several case reports and a handful of small series. We present our experience, which, to the best of our knowledge, is the largest series reported to date. Since 1998, 22 patients have undergone distal pancreatectomy at our institute. The technique of distal pancreatosplenectomy, as well as spleen-preserving distal pancreatectomy, is described. Four males and 18 females in the age range of 12-69 years underwent operation. Splenic preservation was possible in 7 patients. The tumor diameter ranged from 2.1 cm to 7.4 cm. The mean operating time was 215 min. The mean length of incision required for specimen retrieval was 3.4 cm. All patients were started on a liquid diet on the first postoperative day. The median hospital stay was 4 days. One patient developed a pancreatic fistula that was managed conservatively. At the end of an average follow-up of 4.6 years, no recurrence has been reported. Laparoscopic distal pancreatectomy is a safe procedure, with minimal morbidity, rapid recovery, and short hospital stay. In appropriate cases, splenic preservation is feasible.

  5. Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial

    Directory of Open Access Journals (Sweden)

    Fotouhi M

    2007-07-01

    Full Text Available Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30, and the other received the new treatment, 0.1% calendula ointment (30. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7%; I, 73.3%; II, 16

  6. Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

    Science.gov (United States)

    He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

    2009-05-20

    To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (pVitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

  7. Effectiveness of Topical Sucralfate in the Management of Pressure Ulcer in Hospitalized Patients: A Prospective, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Gholipour, Afshin; Ahmadi, Motahareh; Asoodeh, Ali; Shiva, Afshin

    2018-04-10

    The aim of this study was to evaluate the effectiveness of topical sucralfate in the management of pressure ulcer (PU) in hospitalized patients. Forty hospitalized patients with stage II PU were included in this prospective, double-blind, randomized, placebo-controlled trial and were randomly divided into 2 groups receiving either sucralfate gel or placebo, on a daily basis. The patients were visited every day for 14 days, the ulcer was evaluated using the Pressure Ulcer Scale for Healing (PUSH) and changes to the measured scores over time were used as an indicator of wound healing. There were no statistically significant differences in any of the demographic characteristics between both groups. Both of the interventions reduced the average PUSH score, and at the end of the trial, all but 2 patients were healed. One in each group discontinued the trial because of exacerbation of the ulcer. No significant between-group difference in the average PUSH score reduction was observed (6.36 ± 2.11 vs. 5.89 ± 1.41, P = 0.42). Although the average healing time was less in the sucralfate group (6.05 ± 2.17 vs. 7.78 ± 3.42), the difference was not statistically significant (P = 0.07). Sucralfate gel does not improve healing of PU compared with placebo.

  8. Hypospadias repair using laser tissue soldering (LTS): preliminary results of a prospective randomized study

    Science.gov (United States)

    Kirsch, Andrew J.; Cooper, Christopher S.; Canning, Douglas A.; Snyder, Howard M., III; Zderic, Stephen A.

    1998-07-01

    Purpose: The purpose of this study was to evaluate laser tissue soldering using an 808 nm diode laser and wavelength- matched human albumin solder for urethral surgery in children. Methods: Currently, 30 boys, ages 3 months to 8 years were randomized to standard suturing (n equals 22) or 'sutureless' laser hypospadias repair (n equals 18). Laser soldering was performed with a human albumin solder doped with indocyanine green dye (2.5 mg/ml) using a laser power output of 0.5 W, pulse duration of 0.5 sec, and interval of 0.1 sec. Power density was approximately 16 W/cm2. In the laser group, sutures were used for tissue alignment only. At the time of surgery, neourethral and penile lengths, operative time for urethral repair, and number of sutures/throws were measured. Postoperatively, patients were examined for complications of wound healing, stricture, or fistula formation. Results: Mean age, severity of urethral defect, type of repair, and neourethra length were equivalent between the two groups. Operative time was significantly faster for laser soldering in both simple (1.6 plus or minus 0.21 min, p less than 0.001) and complex (5.4 plus or minus 0.28 min, p less than 0.0001) hypospadias repairs compared to controls (10.6 plus or minus 1.4 min and 27.8 plus or minus 2.9 min, respectively). The mean number of sutures used in the laser group for simple and complex repairs (3.3 plus or minus 0.3 and 8.1 plus or minus 0.64, respectively) were significantly (p less than 0.0001) less than for controls (8.2 plus or minus 0.84 and 20 plus or minus 2.3, respectively). Followup was between 3 months and 14 months. The overall complication rate in the laser group (11%) was lower than the controls (23%). However, statistical significance (p less than 0.05) was achieved only for the subgroup of patients undergoing simple repairs (LTS, 100% success versus suturing, 69% success). Conclusions: These preliminary results indicate that laser tissue soldering for hypospadias repair

  9. Influence of low ambient temperature on epitympanic temperature measurement: a prospective randomized clinical study.

    Science.gov (United States)

    Strapazzon, Giacomo; Procter, Emily; Putzer, Gabriel; Avancini, Giovanni; Dal Cappello, Tomas; Überbacher, Norbert; Hofer, Georg; Rainer, Bernhard; Rammlmair, Georg; Brugger, Hermann

    2015-11-05

    Epitympanic temperature (Tty) measured with thermistor probes correlates with core body temperature (Tcore), but the reliability of measurements at low ambient temperature is unknown. The aim of this study was to determine if commercially-available thermistor-based Tty reflects Tcore in low ambient temperature and if Tty is influenced by insulation of the ear. Thirty-one participants (two females) were exposed to room (23.2 ± 0.4 °C) and low (-18.7 ± 1.0 °C) ambient temperature for 10 min using a randomized cross-over design. Tty was measured using an epitympanic probe (M1024233, GE Healthcare Finland Oy) and oesophageal temperature (Tes) with an oesophageal probe (M1024229, GE Healthcare Finland Oy) inserted into the lower third of the oesophagus. Ten participants wore ear protectors (Arton 2200, Emil Lux GmbH & Co. KG, Wermelskirchen, Switzerland) to insulate the ear from ambient air. During exposure to room temperature, mean Tty increased from 33.4 ± 1.5 to 34.2 ± 0.8 °C without insulation of the ear and from 35.0 ± 0.8 to 35.5 ± 0.7 °C with insulation. During exposure to low ambient temperature, mean Tty decreased from 32.4 ± 1.6 to 28.5 ± 2.0 °C without insulation and from 35.6 ± 0.6 to 35.2 ± 0.9 °C with insulation. The difference between Tty and Tes at low ambient temperature was reduced by 82% (from 7.2 to 1.3 °C) with insulation of the ear. Epitympanic temperature measurements are influenced by ambient temperature and deviate from Tes at room and low ambient temperature. Insulating the ear with ear protectors markedly reduced the difference between Tty and Tes and improved the stability of measurements. The use of models to correct Tty may be possible, but results should be validated in larger studies.

  10. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

    2017-02-01

    Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

    Science.gov (United States)

    Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

    2010-03-01

    This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P suppositories.

  12. Salvage radiotherapy for prostate-specific antigen relapse after radical prostatectomy for prostate cancer. A single-center experience

    International Nuclear Information System (INIS)

    Yoshida, Takahiro; Nakayama, Masashi; Suzuki, Osamu

    2011-01-01

    The aim of this study was to investigate the efficacy and prognostic factors of salvage radiotherapy for prostate-specific antigen relapse after radical prostatectomy for prostate cancer at a single center in Japan. A retrospective review of the medical records of 51 patients who underwent salvage radiotherapy for prostate-specific antigen relapse after radical prostatectomy was carried out. Salvage radiotherapy was undergone for the single indication of at least two consecutive prostate-specific antigen elevations >0.1 ng/ml. Salvage radiotherapy was delivered to the prostatic bed at a total dose of 60 or 64 Gy. Late toxicity was scored according to the Common Terminology Criteria for Adverse Events 3.0. A total dose of 60 and 64 Gy were administered to 26 and 25 patients, respectively. The median prostate-specific antigen level at the initiation of radiotherapy was 0.29 ng/ml (range, 0.11-1.10 ng/ml). With a median follow-up of 57.3 months (range, 9.9-134.0 months), the prostate-specific antigen relapse-free rate at 5 years was 50.7%. Multivariate analysis using Cox's proportional hazards regression model revealed that the Gleason score at radical prostatectomy ≥8 significantly predicted prostate-specific antigen relapse after salvage radiotherapy (hazard ratio 4.531; 95% confidence interval 1.413-14.535; P=0.011). The prostate-specific antigen relapse-free rate at 5 years in the Gleason score at radical prostatectomy ≤7 and at radical prostatectomy ≥8 was 62.7 and 15.4%, respectively. Salvage radiotherapy was effective for prostate-specific antigen relapse after radical prostatectomy with tolerable toxicities in Japanese patients. A high Gleason score seemed to be a poor prognostic factor. (author)

  13. Artificial urinary sphincter for urinary incontinence after radical prostatectomy: a historical cohort from 2004 to 2015

    Directory of Open Access Journals (Sweden)

    Augusto Cesar Soares dos Santos Junior

    Full Text Available ABSTRACT This study aimed to retrospectively evaluate a cohort of patients with prostate cancer and persistent urinary incontinence after radical prostatectomy. From January 2004 to December 2015, eighty-six individuals were identified to have received an AUS implant, provided by a private nonprofit HMO operating in Belo Horizonte, Brazil. On total, there were 91 AUS implants, with a median interval between radical prostatectomy and AUS implant of 3.6 years (IQR 1.9 to 5.5. The rate of AUS cumulative survival, after a median follow-up of 4.1 years (IQR 1.7-7.2 years, was 44% (n=40. The median survival of AUS implants was 2.9 years (IQR 0.5-7.9 years. Thirty-seven AUS implants (40.7% resulted in grade III surgical complications. There were 5 deaths at 2.1, 4.7, 5.7, 5.7 and 6.5 years of follow-up, but none due to causes directly associated to the AUS implant. Persistent severe incontinence was documented in 14 (15.3% additional patients. From the 51 AUS implants which resulted in grade III surgical complications or persistent severe incontinence, 24 (47.1% underwent surgical revisions. Explantation of the sphincter or its components was observed in 6 cases (25.0%. Mechanical failure, described as fluid loss and/or inability to recycle the AUS device, was observed in 4 devices (16.7%. In conclusion, although AUS implants are recommended as the gold-standard treatment of severe urinary incontinence after prostatectomy, the observed high rates of malfunction and grade III adverse events are a matter of concern warranting further assessment on the safety and efficacy of these devices.

  14. The role of topical vitamin A in promoting healing in surface refractive procedures: a prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Chelala E

    2013-09-01

    Full Text Available Elias Chelala,1 Ali Dirani,1 Ali Fadlallah,1 Sharbel Fahd21Saint Joseph University, Faculty of Medicine, Beirut, Lebanon; 2Ophthalmic Consultant of Beirut, Chairman Ophthalmology, Lebanese American University, Beirut, LebanonAim: To evaluate the effect of topical vitamin A supplementation on corneal re-epithelialization time, postoperative pain, visual acuity, and haze following photorefractive keratectomy (PRK.Patients and methods: This prospective study included 32 patients. For each patient, one eye was randomized to the vitamin A group and the fellow eye to the non-vitamin A group (control group. Eyes in the vitamin A group received perioperative topical vitamin A (retinol palmitate, 250 IU/g VitAPOS eye ointment [AFT Pharmaceuticals Pty, Ltd, Sydney, NSW, Australia] in addition to the classic treatment for PRK. Clinical outcomes were evaluated up to 3 months after PRK.Results: There was no difference in the mean time to complete healing between the vitamin A group and the control group (3.36 ± 0.6 days in the control group; 3.42 ± 0.7 days in the vitamin A group; P = 0.854. Mean postoperative pain at the 48-hour visit was 4.35 ± 1.42 over 10 in the control group, and 4.42 ± 1.37 over 10 in the vitamin A group, with no difference between the two groups (P = 0.589. Subepithelial haze evaluated at 3 months postoperatively did not differ between the two groups (P = 0.960. Also, visual and refractive outcomes were not different between the two groups 3 months postoperatively.Conclusion: Topical vitamin A supplementation did not affect re-epithelialization time, postoperative pain, corneal haze formation, or visual outcomes after PRK.Keywords: photorefractive keratectomy, topical vitamin A, corneal re-epithelialization

  15. Outcome of postoperative radiotherapy following radical prostatectomy: a single institutional experience

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sea Won; Chung, Mi Joo; Jeong, Song Mi; Kim, Sung Hwan; Lee, Jong Hoon [Dept.of Radiation Oncology, St. Vincent' s Hospital, The Catholic University of Korea College of Medicine, Suwon (Korea, Republic of); Hwang, Tae Kon; Hong, Sung Hoo; Lee, Ji Youl; Jang, Hong Seok [Seoul St. Mary' s Hospital, The Catholic University of Korea College of Medicine, Seoul (Korea, Republic of); Yoon, Sei Chul [Dept.of Radiation Oncology, Bucheon St. Mary' s Hospital, The Catholic University of Korea College of Medicine, Bucheon (Korea, Republic of)

    2014-09-15

    This single institutional study is aimed to observe the outcome of patients who received postoperative radiotherapy after radical prostatectomy. A total of 59 men with histologically identified prostate adenocarcinoma who had received postoperative radiation after radical prostatectomy from August 2005 to July 2011 in Seoul St. Mary's Hospital of the Catholic University of Korea, was included. They received 45-50 Gy to the pelvis and boost on the prostate bed was given up to total dose of 63-72 Gy (median, 64.8 Gy) in conventional fractionation. The proportion of patients given hormonal therapy and the pattern in which it was given were analyzed. Primary endpoint was biochemical relapse-free survival (bRFS) after radiotherapy completion. Secondary endpoint was overall survival (OS). Biochemical relapse was defined as a prostate-specific antigen level above 0.2 ng/mL. After median follow-up of 53 months (range, 0 to 104 months), the 5-year bRFS of all patients was estimated 80.4%. The 5-year OS was estimated 96.6%. Patients who were given androgen deprivation therapy had a 5-year bRFS of 95.1% while the ones who were not given any had that of 40.0% (p < 0.01). However, the statistical significance in survival difference did not persist in multivariate analysis. The 3-year actuarial grade 3 chronic toxicity was 1.7% and no grade 3 acute toxicity was observed. The biochemical and toxicity outcome of post-radical prostatectomy radiotherapy in our institution is favorable and comparable to those of other studies.

  16. A short-term cost-effectiveness study comparing robot-assisted laparoscopic and open retropubic radical prostatectomy

    DEFF Research Database (Denmark)

    Hohwü, Lena; Borre, Michael; Ehlers, Lars

    2011-01-01

    OBJECTIVE: To evaluate cost effectiveness and cost utility comparing robot-assisted laparoscopic prostatectomy (RALP) versus retropubic radical prostatectomy (RRP). METHODS: In a retrospective cohort study a total of 231 men between the age of 50 and 69 years and with clinically localised prostate....... An economic evaluation was made to estimate direct costs of the first postoperative year and an incremental cost-effectiveness ratio (ICER) per successful surgical treatment and per quality-adjusted life-year (QALY). A successful RP was defined as: no residual cancer (PSA ... high volume urology centres and utilise the full potential of each robot....

  17. Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.

    Science.gov (United States)

    Chugh, A Jessey; Pace, Jonathan R; Singer, Justin; Tatsuoka, Curtis; Hoffer, Alan; Selman, Warren R; Bambakidis, Nicholas C

    2017-03-01

    OBJECTIVE The field of neurosurgery is constantly undergoing improvements and advances, both in technique and technology. Cerebrovascular neurosurgery is no exception, with endovascular treatments changing the treatment paradigm. Clipping of aneurysms is still necessary, however, and advances are still being made to improve patient outcomes within the microsurgical treatment of aneurysms. Surgical rehearsal platforms are surgical simulators that offer the opportunity to rehearse a procedure prior to entering the operative suite. This study is designed to determine whether use of a surgical rehearsal platform in aneurysm surgery is helpful in decreasing aneurysm dissection time and clip manipulation of the aneurysm. METHODS The authors conducted a blinded, prospective, randomized study comparing key effort and time variables in aneurysm clip ligation surgery with and without preoperative use of the SuRgical Planner (SRP) surgical rehearsal platform. Initially, 40 patients were randomly assigned to either of two groups: one in which surgery was performed after use of the SRP (SRP group) and one in which surgery was performed without use of the SRP (control group). All operations were videotaped. After exclusion of 6 patients from the SRP group and 9 from the control group, a total of 25 surgical cases were analyzed by a reviewer blinded to group assignment. The videos were analyzed for total microsurgical time, number of clips used, and number of clip placement attempts. Means and standard deviations (SDs) were calculated and compared between groups. RESULTS The mean (± SD) amount of operative time per clip used was 920 ± 770 seconds in the SRP group and 1294 ± 678 seconds in the control group (p = 0.05). In addition, the mean values for the number of clip attempts, total operative time, ratio of clip attempts to clips used, and time per clip attempt were all lower in the SRP group, although the between-group differences were not statistically significant

  18. Treatment of varicocele: a prospective randomized comparison of laparoscopy versus antegrade sclerotherapy.

    Science.gov (United States)

    Sautter, T; Sulser, T; Suter, St; Gretener, H; Hauri, D

    2002-04-01

    To compare the therapeutic success, the morbidity and the costs of antegrade sclerotherapy versus laparoscopic varicocelectomy. Seventy-six consecutive varicocele patients were randomly assigned to two treatment arms. Preoperative and 3 month postoperative sperm density, motility and morphology were analysed. The diagnosis of the varicocele was established clinically and with Doppler ultrasonography. Fifty-eight patients treated by either of the two methods were followed up. The recurrence rate increased progressively with the size of the varicocele in both groups. The postoperative incidence of complications particularly hydrocele formation was significantly higher in the laparoscopic group. The costs of the disposable material for laparoscopic varicocelectomy was twice as high as for sclerotherapy. Antegrade sclerotherapy is the less invasive treatment method of male varicocele with lower costs and better outcome and should therefore be the preferred treatment method for male varicocele.

  19. Effect of branched chain amino acid enrichment of total parenteral nutrition on nitrogen sparing and clinical outcome of sepsis and trauma: a prospective randomized double blind trial

    NARCIS (Netherlands)

    von Meyenfeldt, M. F.; Soeters, P. B.; Vente, J. P.; van Berlo, C. L.; Rouflart, M. M.; de Jong, K. P.; van der Linden, C. J.; Gouma, D. J.

    1990-01-01

    Administration of extra branched chain amino acids (BCAA) has been associated with a nitrogen sparing effect in septic and traumatized patients. Whether nitrogen sparing is associated with decreased morbidity and mortality rates is unknown. We therefore undertook a prospective, randomized, double

  20. Change in functional bowel symptoms after prostatectomy: A case-control study

    Directory of Open Access Journals (Sweden)

    Peyman Adibi

    2011-01-01

    Conclusions: This is the first forward study regarding bowel symptom changes following prostatectomy. The main positive finding of this study is that open prostatectomy was followed by significant increase in diarrhea and bowel habit alternation associated with onset of abdominal pain. Specifically the change was found after open operation but not after TURP. Prostatectomy whether in form of open or transurethral may cause onset of abdominal discomfort and bowel habit change.

  1. Dexmedetomidine in a surgically inserted catheter for transversus abdominis plane block in donor hepatectomy: A prospective randomized controlled study.

    Science.gov (United States)

    Aboelela, Mohamed Adel; Kandeel, Al-Refaey; Elsayed, Usama; Elmorshedi, Mohamed; Elsarraf, Waleed; Elsayed, Eman; Elgawalby, Ahmed; Sultan, Ahmed Mohamed; Wahab, Mohamed Abdel; Yassen, Amr

    2018-01-01

    Transversus abdominis plane (TAP) block is a promising technique for analgesia after abdominal surgery. This prospective, randomized controlled trial assessed the effect of adding dexmedetomidine to bupivacaine in TAP block for donor hepatectomy. We hypothesized that this would improve postoperative morphine consumption and reduce analgesia related complication and inflammation. A total of 50 donor hepatectomy were enrolled in this study. Patients divided into two equal groups according to drugs used for TAP block. Group (B) received 20 ml of bupivacaine hydrochloride 0.25%, Group (BD) received 20 ml of bupivacaine hydrochloride 0.25% and 0.3 μg/kg dexmedetomidine, on both sides at the end of surgery and every 8 h for 48 h at right side only through inserted catheter. Primary outcome objective was morphine consumption at first 72 h. Secondary outcome objectives were morphine requirement, numbers of intake, time to first intake, pain score numerical analog scale (NAS), postoperative analgesia related complications, recovery of intestinal motility, and inflammatory markers. Data were analyzed, rescue morphine analgesia was significantly lower in (BD) group compared with (B) groups as considering total morphine consumption (B 4 ± 1.9, BD 1.5 ± 0.5, P = 0.03), numbers of morphine intake ( P = 0.04), morphine requirement ( P = 0.03), and first time of analgesia intake ( P = 0.04). NAS was significantly lower in group (BD) compared with group (B) group in the first 12 h (NAS 0 - P = 0.001, NAS 1 - P = 0.03). Adding dexmedetomidine improved gut motility, first oral intake without detectable anti-inflammatory effect. Adding dexmedetomidine to bupivacine in a surgically inserted catheter for TAP block in donor hepatectomy reduced morphine consumption without detectable anti-inflammatory effect.

  2. Concomitant boost radiation therapy for inoperable non-small-cell lung cancer: preliminary report of a prospective randomized study

    International Nuclear Information System (INIS)

    Sun, L.-M.; Leung, Stephen Wan; Wang, C.-J.; Chen, H.-C.; Fang, F.-M.; Huang, E.-Y.; Hsu, H.-C.; Yeh, S.-A.; Hsiung, C.-Y.; Huang, David T.

    2000-01-01

    Purpose: The radiation therapy results for patients with inoperable non-small-cell lung cancer (NSCLC) have been disappointing. Tumor dose escalation using concomitant boost technique (CBT) has been shown to improve local control in a few prospective studies. This trial was carried out to prospectively assess the radiation response and acute toxicity of CBT in comparison to the conventional treatment technique (CTT). Methods and Materials: Ninety-seven consecutive eligible patients were entered in this prospective clinical trial between November 1994 and February 1998. Patients were randomized to receive either CBT (43 patients) or CTT (54 patients) radiation therapy. These patients either refused chemotherapy or were judged as unsuitable for chemotherapy. Patients in the CBT group received 46.8 Gy in 26 fractions using large fields that encompassed the gross and occult disease. A concomitant boost of 18.2 Gy (0.7 Gy per fraction) was delivered to the gross disease using small fields with 1.5-cm margins. The small fields were treated concurrently with the large fields and the total dose to the tumor area was 65 Gy in 26 fractions. Patients in the CTT group received 70.8 Gy in 38 fractions. The acute toxicity between each group was compared. The response rate was analyzed and compared by treatment group, gender, age, stage, histology, initial Karnofsky performance score (KPS), severity of acute toxicity, and maximum body weight loss (MBWL) during treatment course. Results: The demographic parameters such as sex, age, and stage were evenly distributed in each treatment group. The majority of these patients had Stage IIIA and IIIB disease. Overall median treatment times were 39 days for the CBT group of patients and 62 days for the CTT group. No treatment-related mortality was found. There were 2 patients in the CTT group with acute RTOG Grade 3 lung toxicity, and no Grade 3 lung or esophageal toxicity was observed in CBT group. The response rates, assessed by

  3. A Prospective Randomized Study of the Radiotherapy Volume for Limited-stage Small Cell Lung Cancer: A Preliminary Report

    Directory of Open Access Journals (Sweden)

    Xiao HU

    2010-07-01

    Full Text Available Background and objective Controversies exists with regard to target volumes as far as thoracic radiotherapy (TRT is concerned in the multimodality treatment for limited-stage small cell lung cancer (LSCLC. The aim of this study is to prospectively compare the local control rate, toxicity profiles, and overall survival (OS between patients received different target volumes irradiation after induction chemotherapy. Methods LSCLC patients received 2 cycles of etoposide and cisplatin (EP induction chemotherapy and were randomly assigned to receive TRT to either the post- or pre-chemotherapy tumor extent (GTV-T as study arm and control arm, CTV-N included the positive nodal drainage area for both arms. One to 2 weeks after induction chemotherapy, 45 Gy/30 Fx/19 d TRT was administered concurrently with the third cycle of EP regimen. After that, additional 3 cycles of EP consolidation were administered. Prophylactic cranial irradiation (PCI was administered to patients with a complete response. Results Thirty-seven and 40 patients were randomly assigned to study arm and control arm. The local recurrence rates were 32.4% and 28.2% respectively (P=0.80; the isolated nodal failure (INF rate were 3.0% and 2.6% respectively (P=0.91; all INF sites were in the ipsilateral supraclavicular fossa. Medastinal N3 disease was the risk factor for INF (P=0.02, OR=14.13, 95%CI: 1.47-136.13. During radiotherapy, grade I, II weight loss was observed in 29.4%, 5.9% and 56.4%, 7.7% patients respectively (P=0.04. Grade 0-I and II-III late pulmonary injury was developed in 97.1%, 2.9% and 86.4%, 15.4% patients respectively (P=0.07. Median survival time was 22.1 months and 26.9 months respectively. The 1 to 3-year OS were 77.9%, 44.4%, 37.3% and 75.8%, 56.3%, 41.7% respectively (P=0.79. Conclusion The preliminary results of this study indicate that irradiant the post-chemotherapy tumor extent (GTV-T and positive nodal drainage area did not decrease local control and overall

  4. Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

    Science.gov (United States)

    Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

    2006-01-01

    To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

  5. Role of modified ultrfiltration in adult cardic surgery: a prospective randomized control trial

    International Nuclear Information System (INIS)

    Naveed, D.; Khan, R.A.; Malik, A.; Shah, S.Z.A.; Ullah, I.; Hussain, A.

    2016-01-01

    Background: Cardiopulmonary bypass (CPB) is associated with morbidity and mortality. To reduce its adverse effect modified ultrafiltration is being increasingly employed. This study is planned to evaluate the benefits of modified ultrafiltration (MUF) in adult cardiac surgery. Methods: Eighty consecutive patients presenting to adult cardiac surgery as elective case were enrolled. These patients were randomly divided in to two groups. MUF group which received modified ultrafiltration after separation from CPB and control group which did not receive modified ultrafiltration. Postoperative mediastinal and chest drainage in 24 hrs, blood products requirement, reopening, ICU stay, and mortality in 30 days were recorded. These variables were compared between MUF group and control group. Results: Forty patients were randomized to control group and 40 in MUF group. Mean age was 51.15±8.90 in control group as compared to 46.95±13.24 MUF group (p=0.1). Out of 40 patients in control group 7 (17.5 percentage) were female while 11 (27.5 percentage) out of total 40 were female in MUF group. (p=.284). Mean CBP time was 120.62±20.97 in control group versus 117.37±38.78 in MUF group (p=0.64). Post-operative drain output ranged from 330 ml to 1300 ml in control group and 300 ml to 780 ml in MUF group. Mean postoperative drain output 554.25±192.57 in control group versus 439.22±89.59 in MUF group (p=.001). Three (7.5 percentage) out of 40 patients required re-exploration in control group versus 1 (2.5 percentage) in MUF group. (p=.305). Mean ICU stay was 52.80±22.37 hours in control group versus 45.30±21.82 hours in MUF group (p=0.133). Three (7.5 percentage) out of 40 patients died in control group versus 1 (2.5 percentage) in MUF group. (p=0.305). Conclusion: Use of modified ultrafiltration is associated with low postoperative bleeding less requirements of blood and blood products. (author)

  6. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial

    NARCIS (Netherlands)

    Stevens, Markus F.; Werdehausen, Robert; Golla, Elisabeth; Braun, Sebastian; Hermanns, Henning; Ilg, Ansgar; Willers, Reinhardt; Lipfert, Peter

    2007-01-01

    BACKGROUND: In this prospective, randomized, double-blind trial we investigated the use of stimulating catheters in patients during and after shoulder surgery; functional improvement being the primary outcome measurement. METHODS: After eliciting an adequate muscular twitch at A nerve

  7. A prospective randomized evaluation of the prophylactic use of low-dose dopamine in cancer patients receiving interleukin-2.

    Science.gov (United States)

    Cormier, J N; Hurst, R; Vasselli, J; Lee, D; Kim, C J; McKee, M; Venzon, D; White, D; Marincola, F M; Rosenberg, S A

    1997-07-01

    The administration of high-dose interleukin-2 (IL-2) causes tumor regression in 17-25% of patients with metastatic melanoma or renal cell carcinoma. Renal dysfunction is a common dose-limiting toxicity of IL-2 administration, limiting 26% of treatment cycles. We have conducted a prospective randomized trial to evaluate whether the prophylactic administration of low-dose dopamine (2 mg/kg/min) can minimize renal toxicity and thus affect the amount of IL-2 administered. Forty-two patients were randomly assigned to receive systemic high-dose IL-2 with standard supportive measures (group A = 21 patients) or with the addition of prophylactic dopamine (group B = 21 patients) at 2 mg/kg/min. For patients in group B, dopamine was instituted 1 h before the initiation of IL-2 administration and was discontinued 6-12 h after the maximum number of doses of IL-2 were given. There was no difference in the amount of IL-2 administered for each course of therapy for groups A and B. Despite differences in urine flow (milliliters per kilogram per day), fluid balance (liters per day), and overall weight gain, prophylactic low-dose dopamine did not significantly alter maximum plasma urea or creatinine levels in group B when compared with the control group (group A). The overall toxicity profile considering all grade 3 and 4 toxicities for patients in groups A and B was comparable. Thus, there is no evidence to support the routine use of prophylactic low-dose dopamine in patients receiving high-dose IL-2.

  8. A prospective randomized study of operative treatment for noncomminuted humeral shaft fractures: conventional open plating versus minimal invasive plate osteosynthesis.

    Science.gov (United States)

    Kim, Ji Wan; Oh, Chang-Wug; Byun, Young-Soo; Kim, Jung Jae; Park, Ki Chul

    2015-04-01

    To compare the clinical and radiologic results of conventional open plating (COP) and minimally invasive plate osteosynthesis (MIPO) in the treatment of noncomminuted humeral shaft fractures. Randomized prospective study. Five level 1 trauma centers. Sixty-eight consecutive patients were randomized into 2 study groups: those treated by COP (COP group; n = 32) and those treated by MIPO (MIPO group; n = 36). Simple humeral shaft fractures (AO/OTA classification types A and B) were reduced by open reduction or closed reduction and fixed with a narrow 4.5/5.0 locking compression plate, metaphyseal locking compression plate, or proximal humeral internal locking system plate to the anterior lateral aspect of the humerus. Fracture healing time, operative time, radiation exposure time, and intraoperative nerve injury. To assess shoulder and elbow function, we used the University of California, Los Angeles (UCLA) scoring system and the Mayo elbow performance index, including the range of motion and pain. Radiographic measurements included fracture alignment, delayed union, and nonunion. Thirty-one fractures (97%) healed in the COP group within 16 weeks, whereas 36 fractures (100%) were healed in the MIPO group by 15 weeks. No significant difference was observed in the operative time or complication rates. In both groups, all fractures achieved union without malunion and with excellent functional outcomes by definition of the Mayo elbow performance index and UCLA scoring system. This study confirmed a high overall rate of union and excellent functional outcomes in both MIPO and COP groups. MIPO is equivalent to COP as a safe and effective method for simple types of humeral shaft fractures when surgery is indicated, and the surgeon is experienced in the technique. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  9. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation.

    Science.gov (United States)

    Clavieras, Noémie; Wysocki, Marc; Coisel, Yannael; Galia, Fabrice; Conseil, Matthieu; Chanques, Gerald; Jung, Boris; Arnal, Jean-Michel; Matecki, Stefan; Molinari, Nicolas; Jaber, Samir

    2013-09-01

    Intellivent is a new full closed-loop controlled ventilation that automatically adjusts both ventilation and oxygenation parameters. The authors compared gas exchange and breathing pattern variability of Intellivent and pressure support ventilation (PSV). In a prospective, randomized, single-blind design crossover study, 14 patients were ventilated during the weaning phase, with Intellivent or PSV, for two periods of 24 h in a randomized order. Arterial blood gases were obtained after 1, 8, 16, and 24 h with each mode. Ventilatory parameters were recorded continuously in a breath-by-breath basis during the two study periods. The primary endpoint was oxygenation, estimated by the calculation of the difference between the PaO2/FIO2 ratio obtained after 24 h of ventilation and the PaO2/FIO2 ratio obtained at baseline in each mode. The variability in the ventilatory parameters was also evaluated by the coefficient of variation (SD to mean ratio). There were no adverse events or safety issues requiring premature interruption of both modes. The PaO2/FIO2 (mean ± SD) ratio improved significantly from 245 ± 75 at baseline to 294 ± 123 (P = 0.03) after 24 h of Intellivent. The coefficient of variation of inspiratory pressure and positive end-expiratory pressure (median [interquartile range]) were significantly higher with Intellivent, 16 [11-21] and 15 [7-23]%, compared with 6 [5-7] and 7 [5-10]% in PSV. Inspiratory pressure, positive end-expiratory pressure, and FIO2 changes were adjusted significantly more often with Intellivent compared with PSV. Compared with PSV, Intellivent during a 24-h period improved the PaO2/FIO2 ratio in parallel with more variability in the ventilatory support and more changes in ventilation settings.

  10. Metoclopramide improves the quality of tramadol PCA indistinguishable to morphine PCA: a prospective, randomized, double blind clinical comparison.

    Science.gov (United States)

    Pang, Weiwu; Liu, Yu-Cheng; Maboudou, Edgard; Chen, Tom Xianxiu; Chois, John M; Liao, Cheng-Chun; Wu, Rick Sai-Chuen

    2013-09-01

    Multimodal analgesia has been effectively used in postoperative pain control. Tramadol can be considered "multimodal" because it has two main mechanisms of action, an opioid agonist and a reuptake inhibitor of norepinephrine and serotonin. Tramadol is not as commonly used as morphine due to the increased incidence of postoperative nausea and vomiting (PONV). As metoclopramide is an antiemetic and an analgesic, it was hypothesized that when added to reduce PONV, metoclopromide may enhance the multimodal feature of tramadol by the analgesic property of metoclopramide. Therefore, the effectiveness of postoperative patient-controlled analgesia (PCA) with morphine was compared against PCA with combination of tramadol and metoclopramide. A prospective, randomized, double blind clinical trial. Academic pain service of a university hospital. Sixty patients undergoing elective total knee arthroplasty with general anesthesia. Sixty patients were randomly divided into Group M and Group T. In a double-blinded fashion, Group M received intraoperative 0.2 mg/kg morphine and postoperative PCA with 1 mg morphine per bolus, whereas Group T received intraoperative tramadol 2.5 mg/kg and postoperative PCA with 20 mg tramadol plus 1 mg metoclopramide per bolus. Lockout interval was 5 minutes in both groups. Pain scale, satisfaction rate, analgesic consumption, PCA demand, and side effects were recorded by a blind investigator. These two groups displayed no statistically significant difference between the items and variables evaluated. This combination provides analgesia equivalent to that of morphine and can be used as an alternative to morphine PCA. Wiley Periodicals, Inc.

  11. A Prospective, Randomized Trial in The Emergency Department Of Suggestive Audio-Therapy Under Deep Sedation for Smoking Cessation

    Directory of Open Access Journals (Sweden)

    Shah, Sushma

    2007-08-01

    Full Text Available Objectives: In a sample of patients undergoing procedural deep sedation in the emergency department (ED, we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. Methods: We asked subjects about their smoking, including desire to quit (0-10 numerical scale and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. Results: One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 ± 2.6 and mean cigarettes per day was 17.5 ± 12.1. We successfully contacted 69 (62% patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: –22.0% to 18.8%. Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: –8.7% to 35.6%. Conclusion: Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  12. Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial.

    Science.gov (United States)

    Walther, Claudia; Gaede, Luise; Adams, Volker; Gelbrich, Götz; Leichtle, Alexander; Erbs, Sandra; Sonnabend, Melanie; Fikenzer, Kati; Körner, Antje; Kiess, Wieland; Bruegel, Mathias; Thiery, Joachim; Schuler, Gerhard

    2009-12-01

    The aim of this prospective, randomized study was to examine whether additional school exercise lessons would result in improved peak oxygen uptake (primary end point) and body mass index-standard deviation score, motor and coordinative abilities, circulating progenitor cells, and high-density lipoprotein cholesterol (major secondary end points). Seven sixth-grade classes (182 children, aged 11.1+/-0.7 years) were randomized to an intervention group (4 classes with 109 students) with daily school exercise lessons for 1 year and a control group (3 classes with 73 students) with regular school sports twice weekly. The significant effects of intervention estimated from ANCOVA adjusted for intraclass correlation were the following: increase of peak o(2) (3.7 mL/kg per minute; 95% confidence interval, 0.3 to 7.2) and increase of circulating progenitor cells evaluated by flow cytometry (97 cells per 1 x 10(6) leukocytes; 95% confidence interval, 13 to 181). No significant difference was seen for body mass index-standard deviation score (-0.08; 95% confidence interval, -0.28 to 0.13); however, there was a trend to reduction of the prevalence of overweight and obese children in the intervention group (from 12.8% to 7.3%). No treatment effect was seen for motor and coordinative abilities (4; 95% confidence interval, -1 to 8) and high-density lipoprotein cholesterol (0.03 mmol/L; 95% confidence interval, -0.08 to 0.14). Regular physical activity by means of daily school exercise lessons has a significant positive effect on physical fitness (o(2)max). Furthermore, the number of circulating progenitor cells can be increased, and there is a positive trend in body mass index-standard deviation score reduction and motor ability improvement. Therefore, we conclude that primary prevention by means of increasing physical activity should start in childhood. URL: http://www.clinicaltrials.gov. Identifier: NCT00176371.

  13. The effect of raloxifene on left ventricular hypertrophy in postmenopausal women: A prospective, randomized, and controlled study

    Science.gov (United States)

    Bal, Uğur Abbas; Atar, İlyas; Öktem, Mesut; B. Zeyneloğlu, Hulusi; Yıldırır, Aylin; Kuşcu, Esra; Müderrisoğlu, Haldun

    2015-01-01

    Objective: In healthy women, there is a progressive age-related increase in myocardial mass that is not seen in their male counterparts and occurs primarily in postmenopausal women. Raloxifene is a selective estrogen receptor modulator that has estrogenic actions on bone and the cardiovascular system. The aim of this study was to investigate the effect of raloxifene on myocardial hypertrophy in postmenopausal patients. Methods: A total of 22 postmenopausal osteoporotic women were included in this open-label, randomized, prospective, controlled study. Patients were randomized into two groups: 11 of the patients (group 1) were treated with raloxifene 60 mg/day, and the other 11 patients (group 2) were defined as the control group. Quantitative 2-dimensional and M-mode echocardiographic examination was performed in all patients at the beginning and repeated at the end of the 6-month follow-up period. Left ventricle mass (LVM) and left ventricle mass index (LVMI) were calculated for all patients. Results: The mean age of the patients was 57.2±3.9 years, and baseline clinical characteristics and echocardiographic parameters were similar between the two groups. After 6 months of raloxifene treatment, there was no difference in echocardiographic parameters of LVM and LVMI compared with the control group (201.2±25.9 gr vs. 169.7±46.2 gr, p=0.14 and 120.4±25.9 gr/m2 vs. 105.5±26.3 gr/m2, p=0.195, respectively). There was also no significant difference in LVM and LVMI in the within-group analysis of both groups. Conclusion: Raloxifene therapy does not affect myocardial hypertrophy in postmenopausal women after 6 months of treatment. PMID:25430415

  14. Air charged and microtip catheters cannot be used interchangeably for urethral pressure measurement: a prospective, single-blind, randomized trial.

    Science.gov (United States)

    Zehnder, Pascal; Roth, Beat; Burkhard, Fiona C; Kessler, Thomas M

    2008-09-01

    We determined and compared urethral pressure measurements using air charged and microtip catheters in a prospective, single-blind, randomized trial. A consecutive series of 64 women referred for urodynamic investigation underwent sequential urethral pressure measurements using an air charged and a microtip catheter in randomized order. Patients were blinded to the type and sequence of catheter used. Agreement between the 2 catheter systems was assessed using the Bland and Altman 95% limits of agreement method. Intraclass correlation coefficients of air charged and microtip catheters for maximum urethral closure pressure at rest were 0.97 and 0.93, and for functional profile length they were 0.9 and 0.78, respectively. Pearson's correlation coefficients and Lin's concordance coefficients of air charged and microtip catheters were r = 0.82 and rho = 0.79 for maximum urethral closure pressure at rest, and r = 0.73 and rho = 0.7 for functional profile length, respectively. When applying the Bland and Altman method, air charged catheters gave higher readings than microtip catheters for maximum urethral closure pressure at rest (mean difference 7.5 cm H(2)O) and functional profile length (mean difference 1.8 mm). There were wide 95% limits of agreement for differences in maximum urethral closure pressure at rest (-24.1 to 39 cm H(2)O) and functional profile length (-7.7 to 11.3 mm). For urethral pressure measurement the air charged catheter is at least as reliable as the microtip catheter and it generally gives higher readings. However, air charged and microtip catheters cannot be used interchangeably for clinical purposes because of insufficient agreement. Hence, clinicians should be aware that air charged and microtip catheters may yield completely different results, and these differences should be acknowledged during clinical decision making.

  15. Comparison of del Nido and St Thomas Cardioplegia Solutions in Pediatric Patients: A Prospective Randomized Clinical Trial.

    Science.gov (United States)

    Talwar, Sachin; Bhoje, Amolkumar; Sreenivas, Vishnubhatla; Makhija, Neeti; Aarav, Sudheer; Choudhary, Shiv Kumar; Airan, Balram

    2017-01-01

    We conducted a prospective randomized trial to compare del Nido (DN) cardioplegia with conventional cold blood cardioplegia (St Thomas [STH]) in pediatric patients. We randomized 100 pediatric patients aged ≤12 years undergoing elective repair of ventricular septal defects and tetralogy of Fallot to the DN and the STH groups. In the DN group, a 20 mL/kg single dose was administered. In the STH group, a 30 mL/kg dose was administered, followed by repeated doses at 25- to 30-minute intervals. The primary outcome was cardiac index that was measured 4 times intra- and postoperatively. Troponin-I, interleukin-6, and tissue necrosis factor-alpha were measured. Myocardial biopsy was obtained to assess electron-microscopic ultrastructural changes. Cardiac indices were significantly higher in the DN group than in the STH group 2 hours after termination of cardiopulmonary bypass (P = 0.0006), after 6 hours (P = 0.0006), and after 24 hours (P ≤ 0.0001). On repeated measure regression analysis, the cardiac index was on an average 0.50 L/min/m 2 higher in the DN group than in the STH group at any time point (P = 0.002). Duration of mechanical ventilation (P = 0.01), intensive care unit stay (P = 0.01), and hospital stay (P = 0.0007) was significantly lower in the DN group. Patients in the DN group exhibited lower troponin-I release 24 hours following cardiopulmonary bypass (P = 0.021). Electron microscopic studies showed more myofibrillar disarray in the STH group (P = 0.02). Use of long-acting DN cardioplegia solution was associated with better preservation of cardiac index, lesser troponin-I release, and decreased morbidity. Ultrastructural changes showed better preservation of myofibrillar architecture. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

  17. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    Science.gov (United States)

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  18. Ketamine as an adjunct to postoperative pain management in opioid tolerant patients after spinal fusions: a prospective randomized trial.

    Science.gov (United States)

    Urban, Michael K; Ya Deau, Jacques T; Wukovits, Barbara; Lipnitsky, Jane Y

    2008-02-01

    Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl D-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1-2 level posterior lumbar fusions with segmental instrumentation were randomly assigned to receive ketamine or act as a control. Patients in the ketamine group received 0.2 mg/kg on induction of general anesthesia and then 2 mcg kg(-1) hour(-1) for the next 24 hours. Patients were extubated in the operating room and within 15 minutes of arriving in the Post Anesthesia Care Unit (PACU) were started on intravenous patient-controlled analgesia (PCA) hydromorphone without a basal infusion. Patients were assessed for pain (numerical rating scale [NRS]), narcotic use, level of sedation, delirium, and physical therapy milestones until discharge. The ketamine group had significantly less pain during their first postoperative hour in the PACU (NRS 4.8 vs 8.7) and continued to have less pain during the first postoperative day at rest (3.6 vs 5.5) and with physical therapy (5.6 vs 8.0). Three patients in the control group failed PCA pain management and were converted to intravenous ketamine infusions when their pain scores improved. Patients in the ketamine group required less hydromorphone than the control group, but the differences were not significant. Subanesthetic doses of ketamine reduced postoperative pain in narcotic tolerant patients undergoing posterior spine fusions.

  19. Combination therapy with milrinone and esmolol for heart protection in patients with severe sepsis: a prospective, randomized trial.

    Science.gov (United States)

    Wang, Zenggeng; Wu, Qinghua; Nie, Xiangbi; Guo, Jinghua; Yang, Chunli

    2015-11-01

    As a β-adrenoceptor antagonist (β-blocker), esmolol can reduce cardiac output and the phosphodiesterase III inhibitor milrinone has been shown to improve heart contractility in patients with septic shock. This study was performed to assess the effects of esmolol combined with milrinone in patients with severe sepsis. This prospective randomized study was conducted in patients with severe sepsis in the intensive care unit of the Jiangxi Provincial People's Hospital (Nanchang, Jiangsu, China) between June 2013 and June 2014. Patients were randomly divided into control (C), milrinone (M), and milrinone-esmolol (ME) groups. The primary outcome was the rate of controlling the heart rate (HR) to achieve target levels. Secondary outcomes included the 28-day survival rate and changes in hemodynamic variables, organ function variables, myocardial injury markers, and the serum levels of proinflammatory factors. A total of 90 patients with severe sepsis were included in this study (30 per group). The HR in the ME group was lower than in the M and C groups after 12 h. The rate of successful HR control during the first 96 h was significantly higher in the ME group (60.0 vs. 33.3 % in the M group, vs. 26.7 % in the C group). Also, patients in the ME group had higher 28-day overall survival compared with the M (Log rank statistic = 5.452; P = 0.020) and C groups (Log rank statistic = 10.206; P = 0.001). Additionally, several variables showed significant improvement in the ME group 96 h after treatment compared with the M and C groups (P milrinone and esmolol could improve cardiac function and the 28-day survival rate in patients with severe sepsis.

  20. Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

    Science.gov (United States)

    Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

    2014-07-01

    The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  1. Exploring gay couples' experience with sexual dysfunction after radical prostatectomy: a qualitative study.

    Science.gov (United States)

    Hartman, Mary-Ellen; Irvine, Jane; Currie, Kristen L; Ritvo, Paul; Trachtenberg, Lianne; Louis, Alyssa; Trachtenberg, John; Jamnicky, Leah; Matthew, Andrew G

    2014-01-01

    This exploratory study examines the experience of three gay couples managing sexual dysfunction as a result of undergoing a radical prostatectomy. Semi-structured interviews were conducted as part of a larger study at an urban hospital in Toronto, Ontario, Canada. Interview transcripts were transcribed verbatim, and analyzed using interpretative phenomenological analysis. The authors clustered 18 subordinate themes under 3 superordinate themes: (a) acknowledging change in sexual experience (libido, erectile function, sexual activity, orgasmic function); (b) accommodating change in sexual experience (strategies: emphasizing intimacy, embracing plan B, focus on the other; barriers: side-effect concerns, loss of naturalness, communication breakdown, failure to initiate, trial and failure, partner confounds); and (c) accepting change in sexual experience (indicators: emphasizing health, age attributions, finding a new normal; barriers: uncertain outcomes, treatment regrets). Although gay couples and heterosexual couples share many similar challenges, we discovered that gay men have particular sexual roles and can engage in novel accommodation practices, such as open relationships, that have not been noted in heterosexual couples. All couples, regardless of their level of sexual functioning, highlighted the need for more extensive programming related to sexual rehabilitation. Equitable rehabilitative support is critical to assist homosexual couples manage distress associated with prostatectomy-related sexual dysfunction.

  2. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  3. Hemodiafiltration Improves Plasma 25-Hepcidin Levels: A Prospective, Randomized, Blinded, Cross-Over Study Comparing Hemodialysis and Hemodiafiltration

    Directory of Open Access Journals (Sweden)

    Bergur V. Stefánsson

    2012-03-01

    Full Text Available Background/Aims: Data from studies comparing the effect of hemodiafiltration (HDF and conventional hemodialysis (HD on clinically important outcomes are insufficient to support superiority of HDF. None of these studies has been participant-blinded. Methods: We performed a prospective, randomized, and patient-blinded cross-over study. Twenty patients on chronic HD received either HD for 2 months followed by post-dilution HDF for 2 months or in opposite order. A range of clinical parameters, as well as markers of inflammation, oxidative stress and iron metabolism was measured. Results: The two treatments were similar with respect to dialysis-related complications, quality of life, and the biomarkers of oxidative stress and inflammation. Compared to HD, 25-hepcidin and β2-microglobulin were 38 and 32%, respectively, lower after 60 days of HDF (p Conclusion: In short term, HDF is not superior to HD regarding dialysis-related complications. The higher ESA consumption observed with HDF can be explained by blood clotting in tubing and dialyzers, as more anticoagulation was needed with post-dilution HDF. In a longer perspective, lowering serum hepcidin levels may improve pathological iron homeostasis.

  4. Transfer of training in the development of intracorporeal suturing skill in medical student novices: a prospective randomized trial.

    Science.gov (United States)

    Muresan, Claude; Lee, Tommy H; Seagull, Jacob; Park, Adrian E

    2010-10-01

    To help optimize the use of limited resources in trainee education, we developed a prospective randomized trial to determine the most effective means of teaching laparoscopic suturing to novices. Forty-one medical students received rudimentary instruction in intracorporeal suturing, then were pretested on a pig enterotomy model. They then were posttested after completion of 1 of 4 training arms: laparoscopic suturing, laparoscopic drills, open suturing, and virtual reality (VR) drills. Tests were scored for speed, accuracy, knot quality, and mental workload (National Aeronautics and Space Administration [NASA] Task Load Index). Paired t tests were used. Task time was improved in all groups except the VR group. Knot quality improved only in the open or laparoscopic suturing groups. Mental workload improved only for those practicing on a physical laparoscopic trainer. For novice trainees, the efficacy of VR training is questionable. In contrast, the other training methods had benefits in terms of time, quality, and perceived workload. Copyright © 2010 Elsevier Inc. All rights reserved.

  5. Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy.

    Science.gov (United States)

    Hwang, Chang Ho; Seong, Jin Wan; Son, Dae-Sik

    2012-08-01

    To evaluate individual finger synchronized robot-assisted hand rehabilitation in stroke patients. Prospective parallel group randomized controlled clinical trial. The study recruited patients who were ≥18 years old, more than three months post stroke, showed limited index finger movement and had weakened and impaired hand function. Patients with severe sensory loss, spasticity, apraxia, aphasia, disabling hand disease, impaired consciousness or depression were excluded. Patients received either four weeks (20 sessions) of active robot-assisted intervention (the FTI (full-term intervention) group, 9 patients) or two weeks (10 sessions) of early passive therapy followed by two weeks (10 sessions) of active robot-assisted intervention (the HTI (half-term intervention) group, 8 patients). Patients underwent arm function assessments prior to therapy (baseline), and at 2, 4 and 8 weeks after starting therapy. Compared to baseline, both the FTI and HTI groups showed improved results for the Jebsen Taylor test, the wrist and hand subportion of the Fugl-Meyer arm motor scale, active movement of the 2nd metacarpophalangeal joint, grasping, and pinching power (P vs. 46.4 ± 37.4) and wrist and hand subportion of the Fugl-Meyer arm motor scale (4.3 ± 1.9 vs. 3.4 ± 2.5) after eight weeks. A four-week rehabilitation using a novel robot that provides individual finger synchronization resulted in a dose-dependent improvement in hand function in subacute to chronic stroke patients.

  6. Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

    Science.gov (United States)

    Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

    2014-07-01

    A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  7. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

    Science.gov (United States)

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

  8. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  9. A randomized prospective study of oral levofloxacin vs intravenous flomoxef prophylaxis in postoperative infection after endoscopic sinus surgery.

    Science.gov (United States)

    Inoshita, Ayako; Yokoi, Hidenori; Matsumoto, Fumihiko; Yao, Toru; Kawano, Kenji; Furukawa, Masayuki; Ikeda, Katsuhisa

    2010-01-01

    The clinical efficacy and cost effectiveness of oral antimicrobial prophylaxis with levofloxacin (LVFX) on endoscopic sinus surgery (ESS) was evaluated. Ninety-three patients undergoing ESS were prospectively enrolled in the present study. The patients were randomly divided into 2 groups, LVFX and flomoxef (FMOX). Two hundred milligrams of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days. There were no statistically significant differences between 2 groups in terms of age, sex, systemic complications, surgical procedures, the duration of the operation, the length of hospitalization, the amount of blood loss, body temperature, or the number of white blood cells or C-reactive protein. Although no statistical significance was observed in the bacterial resistance between the two antibiotics, LVFX seems to show a low rate of resistance pattern change as compared to FMOX. The present study demonstrated that no patients treated with LVFX or FMOX were afflicted with postsurgical infection. Oral administration of LVFX is a simple, cost-effective and safe alternative to intravenous prophylaxis in ESS based on clinical efficacy and bacteriological study. Copyright 2010 Elsevier Inc. All rights reserved.

  10. Gut barrier function and systemic endotoxemia after laparotomy or laparoscopic resection for colon cancer: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Mario Schietroma

    2016-01-01

    Full Text Available Purpose: The gut barrier is altered in certain pathologic conditions (shock, trauma, or surgical stress, resulting in bacterial and/or endotoxin translocation from the gut lumen into the systemic circulation. In this prospective randomized study, we investigated the effect of surgery on intestinal permeability (IP and endotoxemia in patients undergoing elective colectomy for colon cancer by comparing the laparoscopic with the open approach. Patients and Methods: A hundred twenty-three consecutive patients underwent colectomy for colon cancer: 61 cases were open resection (OR and 62 cases were laparoscopic resection (LR. IP was measured preoperatively and at days 1 and 3 after surgery. Serial venous blood sample were taken at 0, 30, 60, 90, 120, and 180 min, and at 12, 24, and 48 h after surgery for endotoxin measurement. Results: IP was significantly increased in the open and closed group at day 1 compared with the preoperative level (P < 0.05, but no difference was found between laparoscopic and open surgery group. The concentration endotoxin systemic increased significantly in the both groups during the course of surgery and returned to baseline levels at the second day. No difference was found between laparoscopic and open surgery. A significant correlation was observed between the maximum systemic endotoxin concentration and IP measured at day 1 in the open group and in the laparoscopic group. Conclusion: An increase in IP, and systemic endotoxemia were observed during the open and laparoscopic resection for colon cancer, without significant statistically difference between the two groups.

  11. Use of ready-made insoles in the treatment of lesser metatarsalgia: a prospective randomized controlled trial.

    Science.gov (United States)

    Kelly, A; Winson, I

    1998-04-01

    Two insoles designed to treat primary lesser metatarsalgia were compared in terms of their effect on plantar pressures and the subjective symptom relief. A prospective single blind randomized trial of 8 weeks' treatment in 46 feet in 33 patients was performed. Subjective outcome measures were visual analogue pain scores and estimated compliance. Objective outcome measures were dynamic plantar pressures using the Musgrave Footprint System. In group 1 (Viscoped), 6 of 18 patients rated themselves much improved or somewhat improved, and in group 2 (Langer) the proportion was 12 of 15 (P = 0.02). Reported mean compliance was 16% higher in the Langer group. Plantar forefoot pressure was lowered by the insoles in all cases. The reduction was significantly greater (P < 0.001) in group 2, both in absolute pressure and as a percentage of initial pressure. Group 2 (Langer) was significantly better in terms of reduction of peak metatarsal pressure. All the subjective outcome measures were better for the group 2 (Langer).

  12. Efficacy of Clopidogrel and Clinical Outcome When Clopidogrel Is Coadministered With Atorvastatin and Lansoprazole: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang

    2015-12-01

    This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10  mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30  mg daily, Group B: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30  mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 ligand (sCD40L)) were assessed before randomization and at 15- and 30-day follow-up visits. All patients were maintained on treatment for 6 months and observed for bleeding and ischemic events. A total of 104 patients were enrolled, 27 patients in group A, 26 patients in Group B/C, 25 patients in Group D separately, and all the patients were analyzed. There were no differences in platelet function and the levels of platelet activation markers (P-selectin, TXB2, and sCD40L) among or within the 4 groups at the 3 time points of interest (P > 0.05). In the subsequent 6 months, no significant bleeding events occurred, and 12 patients experienced ischemic events, these results were also not significantly different among the groups (P > 0.05). In patients diagnosed with NSTE-ACS who have had drug-eluting stent implantation

  13. Pharmacodynamic and pharmacokinetic neoadjuvant study of hedgehog pathway inhibitor Sonidegib (LDE-225) in men with high-risk localized prostate cancer undergoing prostatectomy.

    Science.gov (United States)

    Ross, Ashley E; Hughes, Robert M; Glavaris, Stephanie; Ghabili, Kamyar; He, Ping; Anders, Nicole M; Harb, Rana; Tosoian, Jeffrey J; Marchionni, Luigi; Schaeffer, Edward M; Partin, Alan W; Allaf, Mohamad E; Bivalacqua, Trinity J; Chapman, Carolyn; O'Neal, Tanya; DeMarzo, Angelo M; Hurley, Paula J; Rudek, Michelle A; Antonarakis, Emmanuel S

    2017-11-28

    To determine the pharmacodynamic effects of Sonidegib (LDE-225) in prostate tumor tissue from men with high-risk localized prostate cancer, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested post-treatment at prostatectomy. We conducted a prospective randomized (Sonidegib vs. observation) open-label translational clinical trial in men with high-risk localized prostate cancer undergoing radical prostatectomy. The primary endpoint was the proportion of patients in each arm who achieved at least a two-fold reduction in GLI1 mRNA expression in post-treatment versus pre-treatment tumor tissue. Secondary endpoints included the effect of pre-surgical treatment with Sonidegib on disease progression following radical prostatectomy, and safety. Fourteen men were equally randomized (7 per arm) to either neoadjuvant Sonidegib or observation for 4 weeks prior to prostatectomy. Six of seven men (86%) in the Sonidegib arm (and none in the control group) achieved a GLI1 suppression of at least two-fold. In the Sonidegib arm, drug was detectable in plasma and in prostatic tissue; and median intra-patient GLI1 expression decreased by 63-fold, indicating potent suppression of Hedgehog signaling. Sonidegib was well tolerated, without any Grade 3-4 adverse events observed. Disease-free survival was comparable among the two arms (HR = 1.50, 95% CI 0.26-8.69, P = 0.65). Hedgehog pathway activity (as measured by GLI1 expression) was detectable at baseline in men with localized high-risk prostate cancer. Sonidegib penetrated into prostatic tissue and induced a >60-fold suppression of the Hedgehog pathway. The oncological benefit of Hedgehog pathway inhibition in prostate cancer remains unclear.

  14. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Sabeti-Aschraf, M., E-mail: manuel.sabeti-aschraf@meduniwien.ac.a [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Ochsner, A. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schueller-Weidekamm, C. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Schmidt, M. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Funovics, Ph.T. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Skrbensky, G. von [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Goll, A. [Vienna Medical School, Core Unit for Medical Statistics and Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schatz, K.D. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria)

    2010-07-15

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  15. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

    International Nuclear Information System (INIS)

    Sabeti-Aschraf, M.; Ochsner, A.; Schueller-Weidekamm, C.; Schmidt, M.; Funovics, Ph.T.; Skrbensky, G. von; Goll, A.; Schatz, K.D.

    2010-01-01

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  16. A prospective randomized comparison of continuous hemihepatic with intermittent total hepatic inflow occlusion in hepatectomy for liver tumors.

    Science.gov (United States)

    Liang, Guanlin; Wen, Tianfu; Yan, Lunan; Li, B O; Wu, Guochang; Yang, Jian; Lu, Bo; Chen, Zheyu; Liao, Zhixue; Ran, Shun; Yu, Zhang

    2009-01-01

    To evaluate whether continuous hemihepatic inflow occlusion (HHO) during hepatectomy can be safer than and be as effective as intermittent total hepatic inflow occlusion (THO) in reducing blood loss. Eighty patients undergoing liver resections were included in a prospective randomized study comparing the intra- and postoperative course under THO (n=40) or HHO (n=40). THO was performed with periods of 20 minutes of occlusion and 5 minutes of releasing, while HHO was performed with continuous occlusion. The surface area of liver transection, amount of blood loss, measurements of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and postoperative evolution were recorded. The two groups were similar at entry in terms of preoperative liver function and in the proportion of patients experiencing major hepatectomy. The total ischemic time of the two groups was similar (p=0.37), but the operative time in the THO group was longer than in the HHO group (p=0.02). No significant difference was found between the HHO and THO group in blood loss during liver parenchyma transection (p=0.14), the elevations of ALT and AST on the first postoperative day (ALT: p=0.12; AST: p=0.66) and postoperative morbidity (p=0.35). On the basis of our findings, if it is feasible, continuous HHO is recommended for complex liver resection.

  17. The impact of bladder neck sparing on urinary continence during laparoscopic radical prostatectomy; Results from a high volume centre

    Directory of Open Access Journals (Sweden)

    Ali Serdar Gozen

    2017-10-01

    Full Text Available Objective: To evaluate the effects of bladder neck reconstruction techniques on early continence after laparoscopic radical prostatectomy (LRP. Materials and methods: This non-randomized retrospective study analyzed prospectively collected data concerning LRP. In total, 3107 patients underwent LRP between March 1999 and December 2016. Exclusion criteria were preoperative urinary incontinence, previous history of external beam radiotherapy, co-morbities which may affect urinary continence such as diabetes mellitus and/or neurogenic disorders, irregular followup, and follow-up shorter than 24 months. All patients were divided into one of three groups, posterior reconstruction being performed in Group 1 (n = 112, anterior reconstruction in Group 2 (n = 762, and bladder neck sparing (BNS in Group 3 (n = 987. Demographic and pre-, peri-, and postoperative data were collected. Multivariate analyses were performed to determine factors affecting early continence after LRP. Results: 1861 patients were enrolled in the study. The mean follow-up period was 48.12 ± 29.8 months, and subjects’ mean age was 63.6 ± 6.2 years. There was no significant difference among the groups in terms of demographic or preoperative data. Postoperative data, including oncological outcomes, were similar among the groups. The level of early continence was higher in Group 3 than in the other groups (p < 0.001. Multivariate analyses identified BNS and age as parameters significantly affecting early continence levels after LRP (p < 0.001 and p < 0.001, respectively. Bladder neck reconstruction provided less earlier continence than BNS.

  18. Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial

    NARCIS (Netherlands)

    Brandsma, H.T.; Hansson, B.M.; Aufenacker, T.J.; Geldere, D. van; Lammeren, F.M. van; Mahabier, C.; Steenvoorde, P.; Reilingh, T.S. de Vries; Wiezer, R.J.; Wilt, J.H.W. de; Bleichrodt, R.P.; Rosman, C.

    2016-01-01

    PURPOSE: Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure

  19. Does penile rehabilitation have a role in the treatment of erectile dysfunction following radical prostatectomy? [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Gideon Blecher

    2017-10-01

    Full Text Available In men undergoing radical treatment for prostate cancer, erectile function is one of the most important health-related quality-of-life outcomes influencing patient choice in treatment. Penile rehabilitation has emerged as a therapeutic measure to prevent erectile dysfunction and expedite return of erectile function after radical prostatectomy. Penile rehabilitation involves a program designed to increase the likelihood of return to baseline-level erectile function, as opposed to treatment, which implies the therapeutic treatment of symptoms, a key component of post–radical prostatectomy management. Several pathological theories form the basis for rehabilitation, and a plethora of treatments are currently in widespread use. However, whilst there is some evidence supporting the concept of penile rehabilitation from animal studies, randomised controlled trials are contradictory in outcomes. Similarly, urological guidelines are conflicted in terms of recommendations. Furthermore, it is clear that in spite of the lack of evidence for the role of penile rehabilitation, many urologists continue to employ some form of rehabilitation in their patients after radical prostatectomy. This is a significant burden to health resources in public-funded health economies, and no effective cost-benefit analysis has been undertaken to support this practice. Thus, further research is warranted to provide both scientific and clinical evidence for this contemporary practice and the development of preventative strategies in treating erectile dysfunction after radical prostatectomy.

  20. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy.

    Science.gov (United States)

    Montorsi, Francesco; Oelke, Matthias; Henneges, Carsten; Brock, Gerald; Salonia, Andrea; d'Anzeo, Gianluca; Rossi, Andrea; Mulhall, John P; Büttner, Hartwig

    2016-09-01

    Understanding predictors for the recovery of erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) might help clinicians and patients in preoperative counseling and expectation management of EF rehabilitation strategies. To describe the effect of potential predictors on EF recovery after nsRP by post hoc decision-tree modeling of data from A Study of Tadalafil After Radical Prostatectomy (REACTT). Randomized double-blind double-dummy placebo-controlled trial in 423 men aged decision-tree models, using the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score at the end of double-blind treatment, washout, and open-label treatment as response variable. Each model evaluated the association between potential predictors: presurgery IIEF domain and IIEF single-item scores, surgical approach, nerve-sparing score (NSS), and postsurgery randomized treatment group. The first decision-tree model (n=422, intention-to-treat population) identified high presurgery sexual desire (IIEF item 12: ≥3.5 and decision-tree analyses identified high presurgery sexual desire, confidence, and intercourse satisfaction as key predictors for EF recovery. Patients meeting these criteria might benefit the most from conserving surgery and early postsurgery EF rehabilitation. Strategies for improving EF after surgery should be discussed preoperatively with all patients; this information may support expectation management for functional recovery on an individual patient level. Understanding how patient characteristics and different treatment options affect the recovery of erectile function (EF) after radical surgery for prostate cancer might help physicians select the optimal treatment for their patients. This analysis of data from a clinical trial suggested that high presurgery sexual desire, sexual confidence, and intercourse satisfaction are key factors predicting EF recovery. Patients meeting these criteria might benefit the most from conserving

  1. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction

    NARCIS (Netherlands)

    van Berkel, A. M.; Boland, C.; Redekop, W. K.; Bergman, J. J.; Groen, A. K.; Tytgat, G. N.; Huibregtse, K.

    1998-01-01

    Clogging of biliary stents continues to be a major clinical problem. Different polymer materials may have different effects on clogging. In vitro studies have shown a direct relation between the frictional coefficient of a polymer and the amount of encrusted material. Teflon appeared to be the best

  2. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

    Science.gov (United States)

    Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

    2015-01-01

    Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

  3. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy

    DEFF Research Database (Denmark)

    Haahr, Martha Kirstine; Jensen, Charlotte Harken; Toyserkani, Navid Mohamadpour

    2016-01-01

    BACKGROUND: Prostate cancer is the most common cancer in men, and radical prostatectomy (RP) often results in erectile dysfunction (ED) and a substantially reduced quality of life. The efficacy of current interventions, principal treatment with PDE-5 inhibitors, is not satisfactory and this condi......BACKGROUND: Prostate cancer is the most common cancer in men, and radical prostatectomy (RP) often results in erectile dysfunction (ED) and a substantially reduced quality of life. The efficacy of current interventions, principal treatment with PDE-5 inhibitors, is not satisfactory...... and this condition presents an unmet medical need. Preclinical studies using adipose-derived stem cells to treat ED have shown promising results. Herein, we report the results of a human phase 1 trial with autologous adipose-derived regenerative cells (ADRCs) freshly isolated after a liposuction. METHODS: Seventeen...... men suffering from post RP ED, with no recovery using conventional therapy, were enrolled in a prospective phase 1 open-label and single-arm study. All subjects had RP performed 5-18 months before enrolment, and were followed for 6 months after intracavernosal transplantation. ADRCs were analyzed...

  4. A prospective randomized study comparing transnasal and peroral 5-mm ultrathin endoscopy

    Directory of Open Access Journals (Sweden)

    Lian-Feng Lin

    2014-06-01

    Conclusion: PO intubation seems an excellent alternative method when using a 5-mm ultrathin endoscopy because it achieves comparable patient tolerance, acceptance, and satisfaction as TN intubation, takes less time and causes lower intubation failure and epistaxis.

  5. Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

    Science.gov (United States)

    2017-08-01

    Virtual Reality Simulation Curriculum GEARS - Global Evaluative Assessment of Robotic Skills Surgical Education 6 of 41 3. ACCOMPLISHMENTS: What... especially at UW and UMN. A formal budget modification request will be forthcoming in Year 3 to detail these 13 of 41 expenditure changes once we

  6. Instructional authenticity and clinical reasoning in undergraduate medical education: a 2-year, prospective, randomized trial

    NARCIS (Netherlands)

    Durning, S.J.; Dong, T.; Artino, A.R.; LaRochelle, J.; Pangaro, L.N.; Vleuten, C.P.M. van der; Schuwirth, L.

    2012-01-01

    OBJECTIVE: The purpose of the study was to investigate the relationship between authenticity (how close to actual practice) of preclerkship instructional formats and preclerkship and clerkship outcome measures. A secondary purpose was to investigate the effect of student's small-group assignment

  7. A Prospective Randomized Study Comparing Manual and Wall Suction in the Performance of Bronchoalveolar Lavage.

    Science.gov (United States)

    Seijo, Luis M; Flandes, Javier; Somiedo, Maria V; Naya, Alba; Manjón, Josefina; Álvarez, Susana; Fernández-Navamuel, Iker

    2016-01-01

    Bronchoalveolar lavage (BAL) may be performed using a hand-held syringe or wall suction. The aim was to study BAL volume and diagnostic yields based on BAL technique. A total of 220 consecutive patients undergoing BAL at our center were included. Manual aspiration was performed in 115 patients (group 1), and wall suction (<50 mm Hg of negative pressure) was used in 105 patients (group 2). All bronchoscopies were performed under conscious sedation applying topical anesthesia with lidocaine. Three 50-ml sterile saline aliquots were instilled in all patients. The mean total amount of fluid recovered was 67 ± 20 ml in group 1 and 55 ± 22 ml in group 2 (p < 0.001). More patients in the manual aspiration group met American Thoracic Society criteria (recovery of ≥30% of instilled fluid) for an optimal BAL (81 vs. 59%; p < 0.001). The quantity of recovered fluid was also related to BAL location (p < 0.001) and radiologic findings (p = 0.002). Forty-eight (22%) BALs were diagnostic (23 in group 1 and 25 in group 2), including 37 positive bacterial cultures, 6 positive stains for Pneumocystis, and 5 cases of malignancy. No statistically significant difference in diagnostic yield was observed between the two groups. A BAL diagnosis was more likely in patients with certain radiologic (p = 0.033) and endoscopic findings (p = 0.001). When taking into account all bronchoscopic techniques performed during the procedure (e.g. biopsies, brushing, etc.), bronchoscopy was diagnostic in 37% of patients. Manual aspiration is superior to wall suction during BAL yielding a larger quantity of aspirate. Diagnostic yields are similar for both techniques. © 2016 S. Karger AG, Basel.

  8. Reduced Suprathreshold Odor Identification in Patients with Pseudotumor Cerebri: A Non-Randomized Prospective Study.

    Science.gov (United States)

    Dotan, Gad; Cohen, Eyal; Klein, Ainat; Kesler, Anat

    2018-01-01

    Recent evidence suggests that olfaction is impaired in patients with pseudotumor cerebri (PTC). To measure suprathreshold olfactory function by using the University of Pennsylvania Smell Identification Test (UPSIT), assessing its usefulness for routine clinical use. Forty PTC patients underwent USPIT olfactory testing. Twenty-nine out of 40 (73%) PTC patients (36 women, 4 men; mean age 34 years) had reduced suprathreshold smell sensation according to UPSIT scores: 19 (47%) had mild microsmia, 9 (23%) had moderate microsmia, and one (3%) was classified as having severe microsmia. The mean UPSIT score of all patients was 32.4 (95% confidence interval 31.4-33.4). Multivariate regression analysis found that UPSIT scores were not related to disease activity, disease duration, initial intracranial pressure (ICP), or visual function. Many PTC patients have reduced suprathreshold olfactory dysfunction that can be discovered by UPSIT, a rapidly administered smell test, which is suitable for clinical office use.

  9. Analysis of complications in a prospective randomized trial comparing two brachytherapy low dose rates in cervical carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-07-30

    The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented. The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic aresenal for this patient population, in terms of survival, local control, and complications. Overall survival, 85% at 2 years and local control, 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%), and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12) Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs 45% at 2 years (p = 0.03). The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. 33 refs., 3 figs., 5 tabs.

  10. Effects of smoking on venous cannulation pain: a randomized prospective trial

    Directory of Open Access Journals (Sweden)

    Volkan Hanci

    2015-02-01

    Full Text Available BACKGROUND AND OBJECTIVES: It has been demonstrated that smoking increases pain perception; however the effect of smoking on perception of pain during venous cannulation is not known. The purpose of this study is to determine whether or not smoking has an effect on pain perception due to peripheral venous cannulation. METHODS: 220 patients scheduled to have elective surgery were enrolled in the study and were divided into two groups (Group S and C, n = 110 for each according to their smoking habits. Numerical rating scale was introduced to the patients and then peripheral venous cannulation at the dorsum of the hand was made with a 20 G intracath. Pain perception of the patients was scored by subsequent numerical rating scale questioning. RESULTS: The demographic characteristics of the groups were identical. Numerical rating scale scores in Group S and C were 3.31 ± 1.56 and 1.65 ± 1.23, respectively (p < 0.001. CONCLUSION: Pain perception due to peripheral venous cannulation is higher in smokers. Future studies on pain treatment should consider the smoking habits of patients.

  11. Does Stepwise Voltage Ramping Protect the Kidney from Injury During Extracorporeal Shockwave Lithotripsy? Results of a Prospective Randomized Trial.

    Science.gov (United States)

    Skuginna, Veronika; Nguyen, Daniel P; Seiler, Roland; Kiss, Bernhard; Thalmann, George N; Roth, Beat

    2016-02-01

    Renal damage is more frequent with new-generation lithotripters. However, animal studies suggest that voltage ramping minimizes the risk of complications following extracorporeal shock wave lithotripsy (SWL). In the clinical setting, the optimal voltage strategy remains unclear. To evaluate whether stepwise voltage ramping can protect the kidney from damage during SWL. A total of 418 patients with solitary or multiple unilateral kidney stones were randomized to receive SWL using a Modulith SLX-F2 lithotripter with either stepwise voltage ramping (n=213) or a fixed maximal voltage (n=205). SWL. The primary outcome was sonographic evidence of renal hematomas. Secondary outcomes included levels of urinary markers of renal damage, stone disintegration, stone-free rate, and rates of secondary interventions within 3 mo of SWL. Descriptive statistics were used to compare clinical outcomes between the two groups. A logistic regression model was generated to assess predictors of hematomas. Significantly fewer hematomas occurred in the ramping group(12/213, 5.6%) than in the fixed group (27/205, 13%; p=0.008). There was some evidence that the fixed group had higher urinary β2-microglobulin levels after SWL compared to the ramping group (p=0.06). Urinary microalbumin levels, stone disintegration, stone-free rate, and rates of secondary interventions did not significantly differ between the groups. The logistic regression model showed a significantly higher risk of renal hematomas in older patients (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.00-1.05; p=0.04). Stepwise voltage ramping was associated with a lower risk of hematomas (OR 0.39, 95% CI 0.19-0.80; p=0.01). The study was limited by the use of ultrasound to detect hematomas. In this prospective randomized study, stepwise voltage ramping during SWL was associated with a lower risk of renal damage compared to a fixed maximal voltage without compromising treatment effectiveness. Lithotripsy is a noninvasive

  12. Beneficial role of green plantain [Musa paradisiaca] in the management of persistent diarrhea: a prospective randomized trial.

    Science.gov (United States)

    Alvarez-Acosta, Thais; León, Cira; Acosta-González, Salvador; Parra-Soto, Haydeé; Cluet-Rodriguez, Isabel; Rossell, Maria Rosario; Colina-Chourio, José A

    2009-04-01

    To evaluate the beneficial effects of green plantain-based diet on stool volume, frequency and weight gain as compared with a traditional yogurt-based diet in children with persistent diarrhea. In a prospective, in-hospital controlled trial, two different treatments were administered to a sample of 80 children of both sexes, with ages ranging from 1 to 28 months, who had experienced >or= 14 days of persistent diarrhea. The sample was divided into two groups of isocaloric (100 kcal/kg/d) diets: experimental and control, of 40 patients each. The experimental group was randomly given a-week treatment consisting of a 50 g/L of cooked green plantain-based diet. The control group was fed on a yogurt-based diet. Both groups were not statistically different at admission. Pathogens were isolated from stools in 21.2% and 25% of patients in the experimental and control groups respectively; Aeromonas hydrophilia and Shigela flexneri were the most frequently found bacteria. The experimental group fed on a green plantain diet had a significantly better response in: diminishing stool output and consistency (p < 0.002), stool weight, diarrhea duration (p < 0.001), and increasing daily body weight gain (p < 0.001) than the yogurt-based diet group. The average duration of diarrhea in the plantain-based diet group was 18 hours shorter (p < 0.005) and it also had lower cost (p < 0.005). Our results support the benefits of green plantain in the dietary management of persistent diarrhea in hospitalized children, in relation to diarrheal duration, weight gain and costs.

  13. Effect of Continuous Motion Parameter Feedback on Laparoscopic Simulation Training: A Prospective Randomized Controlled Trial on Skill Acquisition and Retention.

    Science.gov (United States)

    Buescher, Julian Frederik; Mehdorn, Anne-Sophie; Neumann, Philipp-Alexander; Becker, Felix; Eichelmann, Ann-Kathrin; Pankratius, Ulrich; Bahde, Ralf; Foell, Daniel; Senninger, Norbert; Rijcken, Emile

    To investigate the effect of motion parameter feedback on laparoscopic basic skill acquisition and retention during a standardized box training curriculum. A Lap-X Hybrid laparoscopic simulator was designed to provide individual and continuous motion parameter feedback in a dry box trainer setting. In a prospective controlled trial, surgical novices were randomized into 2 groups (regular box group, n = 18, and Hybrid group, n = 18) to undergo an identical 5-day training program. In each group, 7 standardized tasks on laparoscopic basic skills were completed twice a day on 4 consecutive days in fixed pairs. Additionally, each participant performed a simulated standard laparoscopic cholecystectomy before (day 1) and after training (day 5) on a LAP Mentor II virtual reality (VR) trainer, allowing an independent control of skill progress in both groups. A follow-up assessment of skill retention was performed after 6 weeks with repetition of both the box tasks and VR cholecystectomy. Muenster University Hospital Training Center, Muenster, Germany. Medical students without previous surgical experience. Laparoscopic skills in both groups improved significantly during the training period, measured by the overall task performance time. The 6 week follow-up showed comparable skill retention in both groups. Evaluation of the VR cholecystectomies demonstrated significant decrease of operation time (p Simulation training on both trainers enables reliable acquisition of laparoscopic basic skills. Furthermore, individual and continuous motion feedback improves laparoscopic skill enhancement significantly in several aspects. Thus, training systems with feedback of motion parameters should be considered to achieve long-term improvement of motion economy among surgical trainees. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  14. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

  15. Opening the Internal Hematoma Membrane Does Not Alter the Recurrence Rate of Chronic Subdural Hematomas: A Prospective Randomized Trial.

    Science.gov (United States)

    Unterhofer, Claudia; Freyschlag, Christian F; Thomé, Claudius; Ortler, Martin

    2016-08-01

    Factors determining the recurrence of chronic subdural hematomas (CSDHs) are not clear. Whether opening the so-called internal hematoma membrane is useful has not been investigated. To investigate whether splitting the inner hematoma membrane influences the recurrence rate in patients undergoing burr-hole craniotomy for CSDH. Fifty-two awake patients undergoing surgery for 57 CSDHs were prospectively randomized to either partial opening of the inner hematoma membrane (group A) or not (group B) after enlarged burr-hole craniotomy and hematoma evacuation. Drainage was left in situ for several days postoperatively. Groups were comparable with regard to demographic, clinical, and imaging variables. Outcome was assessed after 3-6 weeks for the combined outcome variable of reoperation or residual hematoma of one third or more of the original hematoma thickness. Fourteen patients underwent reoperation for clinical deterioration or residual hematoma during follow-up (n = 6 in group A, 21%; n = 8 in group B, 28 %) (P = 0.537). Residual hematoma of ≥ one third not requiring surgery was present in 7 patients in group A (25%) and 10 patients in group B (36%) (P = 0.383). The overall cumulative failure rate (reoperation or hematoma thickness ≥ one third) was 13/28 (46%) in group A and 18/28 in group B (P = 0.178; relative risk, 0.722 [95% confidence interval, 0.445-1.172]; absolute risk reduction -16% [95% confidence interval, -38% to 8%]). Opening the internal hematoma membrane does not alter the rate of patients requiring revision surgery and the number of patients showing a marked residual hematoma 6 weeks after evacuation of a CSDH. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Impact of outpatient clinic ultrasound imaging in the diagnosis and treatment for shoulder impingement: a randomized prospective study.

    LENUS (Irish Health Repository)

    Saeed, Aamir

    2013-11-05

    The use of musculoskeletal ultrasonography (MSUS) in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer-term outcome and larger sample size. This randomized prospective study assessed whether clinic-based MSUS can significantly improve diagnostic accuracy in shoulder pain and whether MSUS-guided shoulder injection results in improved long-term outcomes. One hundred consecutive patients with 125 painful shoulders were recruited. Patients were randomized to receive either sonographic assessment with consequent palpation-guided injection (Group 1, n = 66) or sonographic assessment with a MSUS-guided injection of 40 mg of methylprednisolone acetate (Group 2, n = 59). A blinded rheumatologist (ADF) performed clinical assessments at baseline, 6 and 12 weeks including shoulder function tests (SFTs) (Hawkins-Kennedy test, supraspinatus tendon tenderness), physician global assessment (PGA) and patient visual analogue scores (VAS) for pain (0-10). Eighty patients with 90 symptomatic shoulders completed 12-week follow-up. Twenty patients, 11 (20 shoulders) from the palpation-guided group and 9 (15 shoulders) from the MSUS-guided group, were excluded at 6 weeks either due to requirement for repeat injection or due to surgical referral. Mean age for patients was 57.7 years, and 65 % patients were female; mean shoulder pain duration was 18 weeks (range 14-22 weeks). SFTs, patient VAS and PGA scores for pain improved significantly from baseline in both groups with significantly greater improvements in the MSUS-guided group (44 shoulders) compared to the palpation-guided group (46 shoulders) in all parameters at 6 (p < 0.01) and 12 weeks (p < 0.05). The use of MSUS in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer

  17. Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Shimonovich, Shachar; Gigi, Roy; Shapira, Amir; Sarig-Meth, Tal; Nadav, Danielle; Rozenek, Mattan; West, Debra; Halpern, Pinchas

    2016-11-09

    Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.

  18. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2012-01-01

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  19. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis.

    Science.gov (United States)

    Disa, Joseph J; Polvora, Virginia P; Pusic, Andrea L; Singh, Bhuvinesh; Cordeiro, Peter G

    2003-11-01

    Increased experience with free-tissue transfer has minimized flap loss secondary to microvascular thrombosis, yet pharmacologic antithrombotic prophylaxis continues to be used routinely. Currently there is no consensus on the ideal pharmacologic agent, dosing, or efficacy. Low-molecular-weight dextran has been widely used for prophylaxis due to its properties of volume expansion and enhanced microrheology. Significant systemic morbidity (pulmonary morbidity, cardiac morbidity, anaphylaxis) is known to occur with use of low-molecular-weight dextran. The purpose of this study was to evaluate morbidity associated with postoperative low-molecular-weight dextran and aspirin prophylaxis in head and neck microsurgery patients. This study was a randomized prospective analysis of 100 consecutive patients undergoing microvascular reconstruction for head and neck malignancy during a 2-year period. Patients were randomized into one of three postoperative antithrombotic prophylaxis treatment groups: low-molecular-weight dextran 20 cc/hour for 48 hours (n = 35), low-molecular-weight dextran 20 cc/hour for 120 hours (n = 32), or aspirin 325 mg/day for 120 hours (n = 27). Six patients were excluded intraoperatively due to the need for systemic heparin therapy. Treatment groups were compared for age, sex, prior medical problems, duration of anesthesia, and intraoperative fluid intake. Flap outcome and the incidence of local and systemic complications were evaluated in the treatment groups. Patient ages ranged from 12 to 84 years (mean age, 58 years). No significant difference was found among the treatment groups with respect to age, sex, prior medical problems, duration of anesthesia, intraoperative fluid intake, and the distribution of donor and recipient sites. There were no total flap losses and two partial flap losses in this series. Three flaps were reexplored and all were salvaged. The incidence of systemic complications (congestive heart failure, myocardial infarction

  20. A Prospective Randomized Peri- and Post-Operative Comparison of the Minimally Invasive Anterolateral Approach Versus the Lateral Approach

    Science.gov (United States)

    Landgraeber, Stefan; Quitmann, Henning; Güth, Sebastian; Haversath, Marcel; Kowalczyk, Wojciech; Kecskeméthy, Andrés; Heep, Hansjörg; Jäger, Marcus

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and McMaster Universities Osteoarthritis Index and Harris Hip score (HHS) were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045). But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study. PMID:24191179

  1. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    Directory of Open Access Journals (Sweden)

    Stefan Landgraeber

    2013-07-01

    Full Text Available There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS or a conventional lateral approach (CON. We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36 or CON (n=39 approach. The Western Ontario\tand\tMcMaster\tUniversities Osteoarthritis Index and Harris Hip score (HHS were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045. But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study.

  2. [Alcohol versus bath and natural drying for term newborns' umbilical cord care: a prospective randomized clinical trial].

    Science.gov (United States)

    Covas, María del Carmen; Alda, Ernesto; Medina, María Sol; Ventura, Silvia; Pezutti, Ornella; Paris de Baeza, Ana; Sillero, Josefna; Esandi, María Eugenia

    2011-08-01

    Umbilical cord (UC) care is a cause of concern for parents right from birth until its separation. Standard practice in Argentina includes frequent cleansing of the UC with alcohol and body bath only two days after its separation. The effect of different methods of UC care on its separation time and on colonization with microorganisms has been insufficiently explored. Main: To compare the effect on time of UC separation when using body bath with neutral soap followed by natural drying of the UC vs. standard care. Secondary: a) colonization rates during hospitalization; b) incidence of skin infection and conjunctivitis and c) parental comfort with both types of care. Normal term newborns (≥37 weeks), born at the HPS, and whose parents provided informed consent. Open prospective controlled clinical trial, with random allocation to two groups: study group -natural drying of the UC and body bath with neutral soap- and control group -UC hygiene with alcohol 70% at each diaper change until its separation and bath two days later-. UC separation time; UC colonization during hospital stay and skin and conjunctive infections in the first 30 days of life were monitored. Analysis was by intention-to-treat. 362 newborns were included, 181 in each group. The groups were well balanced in baseline characteristics. Being in the study group was associated with a shorter time to UC separation (median [interquartile range]= 6.00 [3] vs. 7.00 [4] days; p natural drying of the UC reduced the time to cord separation. This practice increased the colonization rate, but the risk of skin and conjunctive infections was apparently not modified by it. However, the study has insufficient power for secondary outcomes. Health care providers should continue to develop evidence to support or eliminate historical practices.

  3. A Prospective Randomized Study Comparing Mini-surgical Percutaneous Dilatational Tracheostomy With Surgical and Classical Percutaneous Tracheostomy

    Science.gov (United States)

    Hashemian, Seyed Mohammad-Reza; Digaleh, Hadi

    2015-01-01

    Abstract Although percutaneous dilatational tracheostomy (PDT) is more accessible and less time-demanding compared with surgical tracheostomy (ST), it has its own limitations. We introduced a modified PDT technique and brought some surgical knowledge to the bedside to overcome some standard percutaneous dilatational tracheostomy relative contraindications. PDT uses a blind route of tracheal access that usually requires perioperational imaging guidance to protect accidental injuries. Moreover, there are contraindications in certain cases, limiting widespread PDT application. Different PDT modifications and devices have been represented to address the problem; however, these approaches are not generally popular among professionals due to limited accessibility and/or other reasons. We prospectively analyzed the double-blinded trial, patient and nurse head evaluating the complications, and collected data from 360 patients who underwent PDT, ST, or our modified mini-surgical PDT (msPDT, Hashemian method). These patients were divided into 2 groups—contraindicated to PDT—and randomization was done for msPDT or PDT in PDT-indicated group and msPDT or ST for PDT-contraindicated patients. The cases were compared in terms of pre and postoperational complications. Data analysis demonstrated that the mean value of procedural time was significantly lower in the msPDT group, either compared with the standard PDT or the ST group. Paratracheal insertion, intraprocedural hypoxemia, and bleeding were also significantly lower in the msPDT group compared with the standard PDT group. Other complications were not significantly different between msPDT and ST patients. The introduced msPDT represented a semiopen incision, other than blinded PDT route of tracheal access that allowed proceduralist to withdraw bronchoscopy and reduced the total time of procedure. Interestingly, the most important improvement was performing msPDT on PDT-contraindicated patients with the complication rate

  4. Adjuvant chemotherapy and radiotherapy in triple-negative breast carcinoma: A prospective randomized controlled multi-center trial

    International Nuclear Information System (INIS)

    Wang, Jianhua; Shi, Mei; Ling, Rui; Xia Yuesheng; Luo Shanquan; Fu Xuehai; Xiao Feng; Li Jianping; Long Xiaoli; Wang Jianguo; Hou Zengxia; Chen Yunxia; Zhou Bin; Xu, Man

    2011-01-01

    Background and purpose: Triple-negative breast cancer (TNBC) presents a high risk breast cancer that lacks the benefit from hormone treatment, chemotherapy is the main strategy even though it exists in poor prognosis. Use of adjuvant radiation therapy, which significantly decreases breast cancer mortality, has not been well described among poor TNBC women. The aim of this study was to evaluate whether the combination of chemotherapy and radiotherapy could significantly increase survival outcomes in TNBC women after mastectomy. Patients and methods: A prospective randomized controlled multi-center study was performed between February 2001 and February 2006 and comprised 681 women with triple-negative stage I-II breast cancer received mastectomy, of them, 315 cases received systemic chemotherapy alone, 366 patients received radiation after the course of chemotherapy. Recurrence-free survival (RFS) and overall survival (OS) were estimated. Simultaneously local and systemic toxicity were observed. Results: After a median follow-up of 86.5 months, five-year RFS rates were 88.3% and 74.6% for adjuvant chemotherapy plus radiation and adjuvant chemotherapy alone, respectively, with significant difference between the two groups (HR 0.77 [95% CI 0.72, 0.98]; P = 0.02). Five-year OS significantly improved in adjuvant chemotherapy plus radiation group compared with chemotherapy alone (90.4% and 78.7%) (HR 0.79 [95% CI 0.74, 0.97]; P = 0.03). No severe toxicity was reported. Conclusions: Patients received standard adjuvant chemotherapy plus radiation therapy was more effective than chemotherapy alone in women with triple-negative early-stage breast cancer after mastectomy.

  5. Shoulder Magnetic Resonance Arthrography: A Prospective Randomized Study of Anterior and Posterior Ultrasonography-Guided Contrast Injections

    Energy Technology Data Exchange (ETDEWEB)

    Koivikko, M.P.; Mustonen, A.O.T. (Dept. of Radiology, Helsinki Univ. Central Hospital, Helsinki (Finland))

    2008-10-15

    Background: Magnetic resonance (MR) arthrography is an accurate imaging method for internal shoulder derangements and rotator cuff pathologies. Both anterior and posterior contrast injection techniques, under palpatory, fluoroscopic, or ultrasonographic guidance have been described in the literature. However, clinical comparisons of the injection techniques remain few. Purpose: To compare the performance of anterior and posterior ultrasonography (US)-guided arthrography injections of the shoulder regarding patient discomfort and influence on diagnostic MR reading, and to illustrate the typical artifacts resulting from contrast leakage in the respective techniques. Material and Methods: 43 MR arthrographies were prospectively randomized into anterior and posterior US-guided contrast injections and performed by two radiologists, with the study of artifacts from contrast leakage. Pain from the injections was assessed by a survey utilizing a 100-mm visual analogue scale (VAS). Results: Of the 23 anterior injections, nine caused contrast artifacts in the subscapular tendon, and in three the leakage extended further anteriorly. Of the 20 posterior injections, 12 showed injection artifacts of the rotator cuff, extending outside the cuff in seven. Two of the anterior and none of the posterior artifacts compromised diagnostic quality. In posterior injections, the leakage regularly occurred at the caudal edge of the infraspinatus muscle and was easily distinguishable from rotator cuff tears. All patients completed the pain survey. Mean VAS scores were 25.0 (median 18, SD 22) for anterior, and 25.4 (median 16, SD 25) for posterior injections. The two radiologists achieved different mean VAS scores but closely agreed as to anterior and posterior VAS scores. Conclusion: Arthrography injections were fairly simple to perform under US guidance. Patient discomfort for anterior and posterior injections was equally minor. A tailored approach utilizing anterior or posterior injections

  6. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

    Science.gov (United States)

    Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

    2015-01-01

    To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

  7. Pars Plana-Modified versus Conventional Ahmed Glaucoma Valve in Patients Undergoing Penetrating Keratoplasty: A Prospective Comparative Randomized Study.

    Science.gov (United States)

    Parihar, Jitendra Kumar Singh; Jain, Vaibhav Kumar; Kaushik, Jaya; Mishra, Avinash

    2017-03-01

    To compare the outcome of pars-plana-modified Ahmed glaucoma valve (AGV) versus limbal-based conventional AGV into the anterior chamber, in patients undergoing penetrating keratoplasty (PK) for glaucoma with coexisting corneal diseases. In this prospective randomized clinical trial, 58 eyes of 58 patients with glaucoma and coexisting corneal disease were divided into two groups. Group 1 (29 eyes of 29 patients) included patients undergoing limbal-based conventional AGV into the anterior chamber (AC) along-with PK and group 2 (29 eyes of 29 patients) included those undergoing pars-plana-modified AGV along-with PK. Outcome measures included corneal graft clarity, intraocular pressure (IOP), number of antiglaucoma medications, and postoperative complications. Patients were followed up for a minimum period of 2 years. Out of 58 eyes (58 patients), 50 eyes (50 patients: 25 eyes of 25 patients each in group 1 and group 2) completed the study and were analyzed. Complete success rate for AGV (group 1: 76%; group 2: 72%; p = 0.842) and corneal graft clarity (group 1: 68%; group 2: 76%; p = 0.081) were comparable between the two groups at 2 years. Graft failure was more in conventional AGV (32%) as compared to pars plana-modified AGV (24%) but not statistically significant (p = 0.078) at 2 years. Though both procedures were comparable in various outcome measures, pars-plana-modified AGV is a viable option for patients undergoing PK, as it provides a relatively better corneal graft survival rate and lesser complications that were associated with conventional AGV.

  8. A prospective, randomized controlled trial of conscious sedation using propofol combined with inhaled nitrous oxide for dental treatment.

    Science.gov (United States)

    Yokoe, Chizuko; Hanamoto, Hiroshi; Sugimura, Mitsutaka; Morimoto, Yoshinari; Kudo, Chiho; Niwa, Hitoshi

    2015-03-01

    Adverse reactions during propofol sedation include a decrease in arterial blood pressure, propofol-induced pain on injection, and airway complications. The purpose of this study was to investigate whether combined use of intravenous propofol and inhaled nitrous oxide could decrease the hypotensive and other adverse effects of propofol. We designed and implemented a prospective, randomized controlled trial. Patients undergoing dental procedures requiring intravenous sedation were randomly allocated to 2 groups: group P comprised those receiving sedation with propofol alone, and group N+P comprised those receiving sedation with 40% nitrous oxide inhalation and propofol. During the dental procedures, the sedation level was maintained at an Observer's Assessment of Alertness/Sedation scale score of 4 by adjusting propofol's target plasma concentration. Nitrous oxide inhalation was the predictor variable, whereas the hemodynamic changes, amount and concentration of propofol, and adverse events were the outcome variables. Eighty-eight patients were successfully analyzed without any complications. The total amount of propofol was significantly less in group N+P (249.8 ± 121.7 mg) than in group P (310.3 ± 122.4 mg) (P = .022), and the mean concentration of propofol was significantly less in group N+P (1.81 ± 0.34 μg/mL) than in group P (2.05 ± 0.44 μg/mL) (P = .006). The mean blood pressure reduction in group N+P (11.0 ± 8.0 mm Hg) was significantly smaller than that in group P (15.8 ± 10.2 mm Hg) (P = .034). Pain associated with the propofol injection and memory of the procedure were less in group N+P (P = .011 and P = .048, respectively). Nitrous oxide did not affect respiratory conditions or recovery characteristics. The results of this study suggest that nitrous oxide inhalation combined with propofol sedation attenuates the hypotensive effect and pain associated with propofol injections, along with potentiating the amnesic effect. Copyright © 2015 American

  9. Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China.

    Science.gov (United States)

    Su, Yingying; Liu, Gang; Tian, Fei; Ren, Guoping; Jiang, Mengdi; Chun, Brian; Zhang, Yunzhou; Zhang, Yan; Ye, Hong; Gao, Daiquan; Chen, Weibi

    2016-12-01

    Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. We conducted this prospective, randomized, controlled trial to evaluate the relative efficacy and safety of intravenous phenobarbital and valproate in patients with GCSE. After the failure of first-line diazepam treatment, Chinese adult patients with GCSE were randomized to receive either intravenous phenobarbital (standard doses, low rate) or valproate (standard). Successful treatment was considered when clinical and electroencephalographic seizure activity ceased. Adverse events following treatment, as well as the neurological outcomes at discharge and 3 months later, were also evaluated. Overall, 73 cases were enrolled in the study. Intravenous phenobarbital was successful in 81.1% of patients, and intravenous valproate was successful in 44.4% of patients (p phenobarbital (6.7%) was significantly lower than that in patients receiving valproate (31.3%), and the total number of adverse events did not differ significantly between the two groups (p > 0.05). In the phenobarbital group, two patients (5.4%) required ventilation and two patients (5.4%) developed serious hypotension. The neurological outcomes of the phenobarbital group were generally better than those of the valproate group; however, no significant differences were observed between phenobarbital and valproate with respect to mortality (8.1 vs. 16.6%) at discharge, or mortality (16.2 vs. 30.5%) and post-symptomatic epilepsy (26.3 vs. 42.8%) at 3-month follow-up. Intravenous phenobarbital appears to be more effective than intravenous valproate for Chinese adult patients with GCSE. The occurrence of serious respiratory depression and hypotension caused by phenobarbital was reduced by decreasing the intravenous infusion rate; however, even at a lower infusion rate than typically used in other institutions, intravenous

  10. Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial.

    Science.gov (United States)

    Victor, Jan; Dujardin, Jan; Vandenneucker, Hilde; Arnout, Nele; Bellemans, Johan

    2014-01-01

    Recently, patient-specific guides (PSGs) have been introduced, claiming a significant improvement in accuracy and reproducibility of component positioning in TKA. Despite intensive marketing by the manufacturers, this claim has not yet been confirmed in a controlled prospective trial. We (1) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and (2) logged the need for applying changes in the suggested position of the PSG. In this randomized controlled trial, we enrolled 128 patients. In the PSG cohort, surgical navigation was used as an intraoperative control. When the suggested cut deviated more than 3° from target, the use of PSG was abandoned and marked as an outlier. When cranial-caudal position or size was adapted, the PSG was marked as modified. All patients underwent long-leg standing radiography and CT scan. Deviation of more than 3° from the target in any plane was defined as an outlier. The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment (25% versus 28%; p = 0.69), femoral coronal alignment (7% versus 14%) (p = 0.24), and femoral axial alignment (23% versus 17%; p = 0.50). There were more outliers in tibial coronal (15% versus 3%; p = 0.03) and sagittal 21% versus 3%; p = 0.002) alignment in the PSG group than in the conventional group. PSGs were abandoned in 14 patients (22%) and modified in 18 (28%). PSGs do not improve accuracy in TKA and, in our experience, were somewhat impractical in that the procedure needed to be either modified or abandoned with some frequency.

  11. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: a prospective, blinded, multicenter, randomized clinical trial.

    Science.gov (United States)

    Bush, Sean P; Ruha, Anne-Michelle; Seifert, Steven A; Morgan, David L; Lewis, Brandon J; Arnold, Thomas C; Clark, Richard F; Meggs, William J; Toschlog, Eric A; Borron, Stephen W; Figge, Gary R; Sollee, Dawn R; Shirazi, Farshad M; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D; Boyer, Leslie V

    2015-01-01

    Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation.

  12. A prospective randomized trial comparing the efficacy of Letrozole and Clomiphene citrate in induction of ovulation in polycystic ovarian syndrome

    Directory of Open Access Journals (Sweden)

    Kallol Kumar Roy

    2012-01-01

    Full Text Available Objectives: To compare the efficacy of letrozole and clomiphene citrate (CC in patients of anovulatory polycystic ovarian syndrome (PCOS with infertility. Materials and Methods: This prospective randomized clinical trial included 204 patients of PCOS. 98 patients (294 cycles received 2.5-5 mg of letrozole; 106 patients (318 cycles received 50-100 mg of CC (both orally from Days 3-7 of menstrual cycle. The treatment continued for three cycles in both the groups. Main outcome measures: ovulation rate, endometrial thickness, and pregnancy rate. Statistical analysis was done using SPSS 13 software. P value less than 0.05 was considered significant. Results: The mean number of dominant follicles in letrozole groups and CC groups was 1.86±0.26 and 1.92±0.17, respectively (P=0.126. Number of ovulatory cycle in letrozole group was 196 (66.6% versus 216 (67.9% in CC group (P=0.712. The mean mid-cycle endometrial thickness was 9.1±0.3 mm in letrozole group and 6.3±1.1 in CC group, which was statistically significant (P=0.014. The mean Estradiol [E2] level in clomiphene citrate group was significantly higher in CC group (364.2±71.4 pg/mL than letrozole group (248.2± 42.2 pg/mL. 43 patients from the letrozole group (43.8% and 28 patients from the CC group (26.4% became pregnant. Conclusion: Letrozole and CC have comparable ovulation rate. The effect of letrozole showed a better endometrial response and pregnancy rate compared with CC.

  13. Urethral stricture disease after bipolar prostatectomy: Is it a concern?

    African Journals Online (AJOL)

    A.A. Zamel

    2018-02-16

    Feb 16, 2018 ... and transrectal ultrasound (TRUS) for total gland and adenoma vol- ume assessment. ... Germany) bipolar high-frequency generator was used. .... incident power (even if in short bursts), and a long operation time in case of a ...

  14. Salvage radiation therapy following radical prostatectomy. A national Danish study

    DEFF Research Database (Denmark)

    Ervandian, Maria; Høyer, Morten; Petersen, Stine Elleberg

    2015-01-01

    BACKGROUND: The purpose of this observational cohort study was to evaluate the outcome and prognostic factors following salvage radiotherapy (SRT) in a consecutive national cohort. MATERIAL AND METHODS: Between 2006 and 2010, 259 patients received SRT in Denmark. Patient- and cancer-related chara...

  15. Active patient decision making regarding nerve sparing during radical prostatectomy: a novel approach.

    Science.gov (United States)

    Lavery, Hugh J; Prall, David N; Abaza, Ronney

    2011-08-01

    The motivation to preserve sexual function can vary widely among patients before prostatectomy. Increasing patient involvement may allow a more personalized experience and may improve satisfaction. We assessed a strategy of surgeon deference to patient choice in regard to nerve sparing to determine to what degree patients are rational actors and capable of active decision making. A total of 150 patients treated with prostatectomy participated in a standardized preoperative discussion regarding the concept of nerve sparing, extracapsular extension and the potential need for adjuvant radiation in the event of local recurrence. Each patient was given his nomogram predicted risk of extracapsular extension and then elected nerve sparing or nonnerve sparing. The corresponding procedure was performed unless grossly invasive disease was encountered. Of the 150 patients 109 chose nerve sparing (73%) and 41 chose nonnerve sparing (27%). In patients with a nomogram predicted risk of extracapsular extension less than 20%, 20% to 50% and greater than 50%, nerve sparing was elected by 88%, 41% and 25%, respectively. Patients with lower risks of extracapsular extension electing nonnerve sparing were older and had higher rates of erectile dysfunction. Empowering patients to decide on their nerve sparing status is a reasonable strategy that did not lead to a high rate of patients with a high risk of extracapsular extension electing nerve sparing. With proper counseling informed patients made reasonable decisions, and appeared to be conservative, prioritizing cancer control in the majority of instances where extracapsular extension risk was high. In addition, they may have been overly conservative in electing nonnerve sparing when the risk was low. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  16. Autologous platelet-rich plasma reduces transfusions during ascending aortic arch repair: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Zhou, Shao Feng; Estrera, Anthony L; Loubser, Paul; Ignacio, Craig; Panthayi, Sreelatha; Miller, Charles; Sheinbaum, Roy; Safi, Hazim J

    2015-04-01

    Blood conservation using autologous platelet-rich plasma (aPRP), a technique of whole blood harvest that separates red blood cells from plasma and platelets before cardiopulmonary bypass with retransfusion of the preserved platelets after completion of cardiopulmonary bypass, has not been studied extensively. We sought to prospectively determine whether aPRP reduces blood transfusions during ascending and transverse aortic arch repair. We randomly assigned 80 patients undergoing elective ascending and transverse aortic arch repair using deep hypothermic circulatory arrest to receive either aPRP (n = 38) or no aPRP (n = 42). Volume of aPRP retransfused was 726 ± 124 mL. The primary end point was transfusion amount. Secondary end points were death, stroke, renal failure, pulmonary failure, and transfusion costs. Perioperative transfusion rate was defined as blood transfusions given during surgery and up to 72 hours afterward. The surgeon and intensivist were blinded to the treatment arm. Because an anesthesiologist initiated the protocol, the surgeon was not aware of aPRP collection, as this occurred only after the sterile drape was in place. In addition, because cell salvage was performed on all cases, differentiation in perfusionist activities (during spinning of aPRP) was not evident. Platelet, fresh frozen plasma, and cryoprecipitate intraoperative transfusions were performed only after heparin was reversed and the patient was judged as coagulopathic on the basis of associated criteria: cryoprecipitate transfusion for fibrinogen level less than 150 μg/dL, platelet transfusion for platelet count less than 80,000, and fresh frozen plasma when thromboelastogram test was suggestive or a partial thromboplastin time was greater than 55 seconds, and prothrombin time was greater than 1.6 seconds. Early mortality, stroke, and respiratory complications were similar between groups. Only acute renal failure was reduced in the aPRP group, 7% versus 0% (p platelets by 56

  17. Unexpected difficulties in randomizing patients in a surgical trial: A prospective study comparing extracorporeal shock wave lithotripsy with open cholecystectomy

    NARCIS (Netherlands)

    P.W. Plaisier; M.Y. Berger (Marjolein); R.L. van der Hul (René); H.G. Nijs (Huub); R. den Toom (Rene); O.T. Terpstra (Onno); H.A. Bruining (Hajo); S.M. Strasberg (S.)

    1994-01-01

    textabstractShortly after extracorporeal shock wave lithotripsy (ESWL) was introduced as a promising new treatment modality for gallstone disease, a randomized controlled study was performed to assess the cost-effectiveness of ESWL compared to open cholecystectomy, the gold standard. During the

  18. A Literature-Based Analysis of the Learning Curves of Laparoscopic Radical Prostatectomy

    Directory of Open Access Journals (Sweden)

    Daniel W. Good

    2014-05-01

    Full Text Available There is a trend for the increased adoption of minimally invasive techniques of radical prostatectomy (RP – laparoscopic (LRP and robotic assisted (RARP – from the traditional open radical retropubic prostatectomy (ORP, popularised by Partin et al. Recently there has been a dramatic expansion in the rates of RARP being performed, and there have been many early reports postulating that the learning curve for RARP is shorter than for LRP. The aim of this study was to review the literature and analyse the length of the LRP learning curves for the various outcome measures: perioperative, oncologic, and functional outcomes. A broad search of the literature was performed in November 2013 using the PubMed database. Only studies of real patients and those from 2004 until 2013 were included; those on simulators were excluded. In total, 239 studies were identified after which 13 were included. The learning curve is a heterogeneous entity, depending entirely on the criteria used to define it. There is evidence of multiple learning curves; however the length of these is dependent on the definitions used by the authors. Few studies use the more rigorous definition of plateauing of the curve. Perioperative learning curve takes approximately 150-200 cases to plateau, oncologic curve approximately 200 cases, and the functional learning curve up to 700 cases to plateau (700 for potency, 200 cases for continence. In this review, we have analysed the literature with respect to the learning curve for LRP. It is clear that the learning curve is long. This necessitates centralising LRP to high volume centres such that surgeons, trainees, and patients are able to utilise the benefits of LRP.

  19. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

  20. A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lee, Jae-Hoo; Park, In; Hyun, Hwan-Sub; Shin, Sang-Jin

    2018-01-20

    To compare the clinical effects of radiofrequency (RF)-based microtenotomy and arthroscopic release of the extensor carpi radialis brevis (ECRB) tendon in patients with recalcitrant lateral epicondylitis through a prospective randomized controlled study. A total of 46 patients were randomly assigned to receive arthroscopic release (group A, 24 patients) or RF-based microtenotomy (group B, 22 patients). The visual analog scale (VAS) score for pain, flexion-extension arc, operation time, Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH), Mayo Elbow Performance Score (MEPS), and grip power of groups A and B were compared during the recovery phases for up to 2 postoperative years. Both groups showed statistically significant functional improvement compared with their preoperative grip strength and DASH, VAS, and MEPS scores at 2 years after surgery (P lateral epicondylitis provided clinical outcomes comparable with those from arthroscopic release of ECRB tendon during the recovery phase. RF-based microtenotomy is considered as one of the surgical procedures for treating recalcitrant lateral epicondylitis, with the advantages of reliable elbow functional restoration and significantly shorter operation time. Level I, prospective randomized trial. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  1. A new technique of bladder neck reconstruction during radical prostatectomy in patients with prostate cancer

    Directory of Open Access Journals (Sweden)

    Yuri Tolkach

    2015-06-01

    Full Text Available ABSTRACTPurpose:To evaluate continence after radical prostatectomy in prostate cancer patients, in whom a new method of the bladder neck reconstruction (BNR using deep dorsal stitch was implemented (deep single stitch through all bladder layers directly dorsal to the bladder opening after “tennis racket” reconstruction and to provide justification for its use by means of anatomical study in cadavers.Material and Methods:Open radical retropubic prostatectomy was performed in 84 patients: 39 patients with a new BNR method used to improve continence and control group of 45 patients with standard “tennis racket” BNR. Median follow-up was 14 months in control group and 12 months in study group. Continence recovery was accessed early postoperatively and every 3 months thereafter. Anatomical study was performed on 2 male fresh cadavers reproducing two different BNR techniques to clarify any underlying continence related mechanisms.Results:Patients with new BNR achieved full continence significantly faster (p=0.041, but the continence rates after 12 months were similar between groups. The severity of incontinence up to month 9 was significantly reduced in BNR group. The anastomotic stricture rate was not affected. Applying new BNR to the cadaver model revealed effects on early continence, namely presence of proximal passive closure mechanism in area of bladder neck.Conclusions:Continence in patients with the new BNR method using deep dorsal stitch recovered significantly faster. Moreover, a reduced grade of residual incontinence was documented. The effect was non-significant at month 12 of follow-up, meaning that only early effect was present.

  2. Training With Curved Laparoscopic Instruments in Single-Port Setting Improves Performance Using Straight Instruments: A Prospective Randomized Simulation Study.

    Science.gov (United States)

    Lukovich, Peter; Sionov, Valery Ben; Kakucs, Timea

    2016-01-01

    Lately single-port surgery is becoming a widespread procedure, but it is more difficult than conventional laparoscopy owing to the lack of triangulation. Although, these operations are also possible with standard laparoscopic instruments, curved instruments are being developed. The aims of the study were to identify the effect of training on a box trainer in single-port setting on the quality of acquired skills, and transferred with the straight and curved instruments for the basic laparoscopic tasks, and highlight the importance of a special laparoscopic training curriculum. A prospective study on a box trainer in single-port setting was conducted using 2 groups. Each group performed 2 tasks on the box trainer in single-port setting. Group-S used conventional straight laparoscopic instruments, and Group-C used curved laparoscopic instruments. Learning curves were obtained by daily measurements recorded in 7-day sessions. On the last day, the 2 groups changed instruments between each other. 1st Department of Surgery, Semmelweis University of Medicine from Budapest, Hungary, a university teaching hospital. In all, 20 fifth-year medical students were randomized into 2 groups. None of them had any laparoscopic or endoscopic experience. Participation was voluntary. Although Group-S performed all tasks significantly faster than Group-C on the first day, the difference proved to be nonsignificant on the last day. All participants achieved significantly shorter task completion time on the last day than on the first day, regardless of the instrument they used. Group-S showed improvement of 63.5%, and Group-C 69.0% improvement by the end of the session. After swapping the instruments, Group-S reached significantly higher task completion time with curved instruments, whereas Group-C showed further progression of 8.9% with straight instruments. Training with curved instruments in a single-port setting allows for a better acquisition of skills in a shorter period. For this

  3. Open vs Laparoscopic Simple Prostatectomy: A Comparison of Initial Outcomes and Cost.

    Science.gov (United States)

    Demir, Aslan; Günseren, Kadir Ömür; Kordan, Yakup; Yavaşçaoğlu, İsmet; Vuruşkan, Berna Aytaç; Vuruşkan, Hakan

    2016-08-01

    We compared the cost-effectiveness of laparoscopic simple prostatectomy (LSP) vs open prostatectomy (OP). A total of 73 men treated for benign prostatic hyperplasia were enrolled for OP and LSP in groups 1 and 2, respectively. The findings were recorded perioperative, including operation time (OT), blood lost, transfusion rate, conversion to the open surgery, and the complications according to the Clavien Classification. The postoperative findings, including catheterization and drainage time, the amount of analgesic used, hospitalization time, postoperative complications, international prostate symptom score (IPSS) and International Index of Erectile Function (IIEF) scores, the extracted prostate weight, the uroflowmeter, as well as postvoiding residual (PVR) and quality of life (QoL) score at the postoperative third month, were analyzed. The cost of both techniques was also compared statistically. No statistical differences were found in the preoperative parameters, including age, IPSS and QoL score, maximum flow rate (Qmax), PVR, IIEF score, and prostate volumes, as measured by transabdominal ultrasonography. No statistical differences were established in terms of the OT and the weight of the extracted prostate. No differences were established with regard to complications according to Clavien's classification in groups. However, the bleeding rate was significantly lower in group 2. The drainage, catheterization, and hospitalization times and the amount of analgesics were significantly lower in the second group. The postoperative third month findings were not different statistically. Only the Qmax values were significantly greater in group 2. While there was only a $52 difference between groups with regard to operation cost, this difference was significantly different. The use of LSP for the prostates over 80 g is more effective than the OP in terms of OT, bleeding amount, transfusion rates, catheterization time, drain removal time, hospitalization time

  4. Reverse Stage Shift at a Tertiary Care Center: Escalating Risk in Men Undergoing Radical Prostatectomy

    Science.gov (United States)

    Silberstein, Jonathan L.; Vickers, Andrew J.; Power, Nicholas E.; Fine, Samson W.; Scardino, Peter T.; Eastham, James A.; Laudone, Vincent P.

    2011-01-01

    Purpose To evaluate changes in clinical and pathological characteristics of prostate cancer in patients treated surgically at a large tertiary care center in the context of increased use of active surveillance (AS) and minimally invasive surgery (MIS). Materials We performed retrospective review of 6,624 patients with localized prostate cancer who underwent radical prostatectomy from 2000–2010 at Memorial Sloan-Kettering Cancer Center. Patients were stratified by surgical approach (open, laparoscopic or robotic) and risk categories (low, intermediate, or high). Patients with low-risk disease, without intervention and minimum followup of 6 months were considered to have elected AS. Results AS cases increased from <20 per year between 2000–2004 to ≥100 per year between 2007–2009. Over the same decade MIS cases (laparoscopic or robotic) increased from zero to 63% of all surgical cases. The percentage of patients in intermediate- and high-risk categories increased over time, while the percentage in the low-risk category decreased (OR per year 0.91, 95% CI 0.89, 0.92, p <0.0005). The proportion of surgery patients with Gleason 6 tumors decreased over time (OR per year 0.87, 95% CI 0.85, 0.88; p <0.0005) while pathologic stage and Gleason score increased (p <0.0005). The proportion of low-risk cases decreased across all types of surgery, with the largest decrease in robotic surgery (p <0.0005). Conclusions We observed a reverse stage shift in patients undergoing radical prostatectomy since 2000 despite the introduction and rapid proliferation of MIS. These findings may be due to increased use of AS and institutional focus on treatment of higher-risk disease. PMID:21484780

  5. Validation of orthopedic postoperative pain assessment methods for dogs: a prospective, blinded, randomized, placebo-controlled study.

    Directory of Open Access Journals (Sweden)

    Pascale Rialland

    Full Text Available In the context of translational research, there is growing interest in studying surgical orthopedic pain management approaches that are common to humans and dogs. The validity of postoperative pain assessment methods is uncertain with regards to responsiveness and the potential interference of analgesia. The hypothesis was that video analysis (as a reference, electrodermal activity, and two subjective pain scales (VAS and 4A-VET would detect different levels of pain intensity in dogs after a standardized trochleoplasty procedure. In this prospective, blinded, randomized study, postoperative pain was assessed in 25 healthy dogs during a 48-hour time frame (T. Pain was managed with placebo (Group 1, n = 10, preemptive and multimodal analgesia (Group 2, n = 5, or preemptive analgesia consisting in oral tramadol (Group 3, n = 10. Changes over time among groups were analyzed using generalized estimating equations. Multivariate regression tested the significance of relationships between pain scales and video analysis. Video analysis identified that one orthopedic behavior, namely 'Walking with full weight bearing' of the operated leg, decreased more in Group 1 at T24 (indicative of pain, whereas three behaviors indicative of sedation decreased in Group 2 at T24 (all p<0.004. Electrodermal activity was higher in Group 1 than in Groups 2 and 3 until T1 (p<0.0003. The VAS was not responsive. 4A-VET showed divergent results as its orthopedic component (4A-VETleg detected lower pain in Group 2 until T12 (p<0.0009, but its interactive component (4A-VETbeh was increased in Group 2 from T12 to T48 (p<0.001. Concurrent validity established that 4A-VETleg scores the painful orthopedic condition accurately and that pain assessment through 4A-VETbeh and VAS was severely biased by the sedative side-effect of the analgesics. Finally, the video analysis offered a concise template for assessment in dogs with acute orthopedic pain. However, subjective pain

  6. Systematic Review of Studies Reporting Positive Surgical Margins After Bladder Neck Sparing Radical Prostatectomy.

    Science.gov (United States)

    Bellangino, Mariangela; Verrill, Clare; Leslie, Tom; Bell, Richard W; Hamdy, Freddie C; Lamb, Alastair D

    2017-11-07

    Bladder neck preservation (BNP) during radical prostatectomy (RP) has been proposed as a method to improve early recovery of urinary continence after radical prostatectomy. However, there is concern over a possible increase in the risk of positive surgical margins and prostate cancer recurrence rate. A recent systematic review and meta-analysis reported improved early recovery and overall long-term urinary continence without compromising oncologic control. The aim of our study was to perform a critical review of the literature to assess the impact on bladder neck and base margins after bladder neck sparing radical prostatectomy. We carried out a systematic review of the literature using Pubmed, Scopus and Cochrane library databases in May 2017 using medical subject headings and free-text protocol according to PRISMA guidelines. We used the following search terms: bladder neck preservation, prostate cancer, radical prostatectomy and surgical margins. Studies focusing on positive surgical margins (PSM) in bladder neck sparing RP pertinent to the objective of this review were included. Overall, we found 15 relevant studies reporting overall and site-specific positive surgical margins rate after bladder neck sparing radical prostatectomy. This included two RCTs, seven prospective comparative studies, two retrospective comparative studies and four case series. All studies were published between 1993 and 2015 with sample sizes ranging between 50 and 1067. Surgical approaches included open, laparoscopic and robot-assisted radical prostatectomy. The overall and base-specific PSM rates ranged between 7-36% and 0-16.3%, respectively. Mean base PSM was 4.9% in those patients where bladder neck sparing was performed, but only 1.85% in those without sparing. Bladder neck preservation during radical prostatectomy may increase base-positive margins. Further studies are needed to better investigate the impact of this technique on oncological outcomes. A future paradigm could

  7. Questioning the wisdom of tubeless percutaneous nephrolithotomy (PCNL): a prospective randomized controlled study of early tube removal vs tubeless PCNL.

    Science.gov (United States)

    Mishra, Shashikant; Sabnis, Ravindra B; Kurien, Abraham; Ganpule, Arvind; Muthu, Veeramani; Desai, Mahesh

    2010-10-01

    To establish the efficacy of early removal of a nephrostomy tube after percutaneous nephrolithotomy (PCNL), to challenge the wisdom of tubeless PCNL, as we hypothesized that it would result in a shorter hospital stay, comparable benefit and safety, while maintaining the option of check nephroscopy ensuring far superior stone clearance. In all, 22 patients were prospectively randomized equally into two groups, group 1 (early nephrostomy removal) or group 2 (tubeless) during a 1-month study period. Inclusion criteria for the study were: a simple stone of Foley catheter were used, while in group 2 only a 6 F retrograde ureteric catheter and Foley catheter were placed at the end of the procedure. Computed tomography (CT) with no contrast medium was done on the first morning after surgery before removing all catheters/tubes, and patients discharged subsequently. The variables assessed were stone clearance, hospital stay, analgesic requirement, postoperative complications and auxiliary procedures. The mean (SD) stone bulk was similar between the groups, at 2737 (946.9) and 2934.2 (2090.7) µL, respectively. Despite an on-table complete clearance, clearance assessed by CT was nine of 11 vs eight of 11 in groups 1 and 2, respectively. CT showed a 6 mm stone in one patient in group 1, while the remaining patients had stones of haematuria in none vs three (P= 0.21), urinoma none vs one, and fever in two vs one, respectively; one patient in group 1 required a check nephroscopy for a residual fragment. Overall clearance including re-treatment was 10/11 vs eight of 11 (P= 0.009), respectively. Early tube removal after PCNL results in an equivalent analgesic requirement, decrease in haemoglobin and hospital stay as tubeless PCNL. It has a significantly lower incidence of early haematuria, better clearance rates and preserves the option of check nephroscopy. It can be considered as an accepted standard of care, with the preserved advantages of tubeless PCNL. © 2010 THE AUTHORS

  8. Robotic Prostatectomy on the Web: A Cross-Sectional Qualitative Assessment.

    Science.gov (United States)

    Borgmann, Hendrik; Mager, René; Salem, Johannes; Bründl, Johannes; Kunath, Frank; Thomas, Christian; Haferkamp, Axel; Tsaur, Igor

    2016-08-01

    Many patients diagnosed with prostate cancer search for information on robotic prostatectomy (RobP) on the Web. We aimed to evaluate the qualitative characteristics of the mostly frequented Web sites on RobP with a particular emphasis on provider-dependent issues. Google was searched for the term "robotic prostatectomy" in Europe and North America. The mostly frequented Web sites were selected and classified as physician-provided and publically-provided. Quality was measured using Journal of the American Medical Association (JAMA) benchmark criteria, DISCERN score, and addressing of Trifecta surgical outcomes. Popularity was analyzed using Google PageRank and Alexa tool. Accessibility, usability, and reliability were investigated using the LIDA tool and readability was assessed using readability indices. Twenty-eight Web sites were physician-provided and 15 publically-provided. For all Web sites, 88% of JAMA benchmark criteria were fulfilled, DISCERN quality score was high, and 81% of Trifecta outcome measurements were addressed. Popularity was average according to Google PageRank (mean 2.9 ± 1.5) and Alexa Traffic Rank (median, 49,109; minimum, 7; maximum, 8,582,295). Accessibility (85 ± 7%), usability (92 ± 3%), and reliability scores (88 ± 8%) were moderate to high. Automated Readability Index was 7.2 ± 2.1 and Flesch-Kincaid Grade Level was 9 ± 2, rating the Web sites as difficult to read. Physician-provided Web sites had higher quality scores and lower readability compared with publically-provided Web sites. Websites providing information on RobP obtained medium to high ratings in all domains of quality in the current assessment. In contrast, readability needs to be significantly improved so that this content can become available for the populace. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Prospective, Randomized Study on the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia of Permanent Colostomy.

    Science.gov (United States)

    Vierimaa, Mika; Klintrup, Kai; Biancari, Fausto; Victorzon, Mikael; Carpelan-Holmström, Monika; Kössi, Jyrki; Kellokumpu, Ilmo; Rauvala, Erkki; Ohtonen, Pasi; Mäkelä, Jyrki; Rautio, Tero

    2015-10-01

    Prophylactic placement of a mesh has been suggested to prevent parastomal hernia, but evidence to support this approach is scarce. The aim of this study was to evaluate whether laparoscopic placement of a prophylactic, dual-component, intraperitoneal onlay mesh around a colostomy is safe and prevents parastomal hernia formation after laparoscopic abdominoperineal resection. This is a prospective, multicenter, randomized controlled clinical trial. This study was conducted at 2 university and 3 central Finnish hospitals. From 2010 to 2013, 83 patients undergoing laparoscopic abdominoperineal resection for rectal cancer were recruited. After withdrawals and exclusions, the outcome of 70 patients, 35 patients in each study group, could be examined. In the intervention group, an end colostomy was created with placement of a intraperitoneal, dual-component onlay mesh and compared with a group with a traditional stoma. The main outcome measures were the incidence of clinically and radiologically detected parastomal hernias and their extent 12 months after surgery. Stoma-related morbidity and the need for surgical repair of parastomal hernia were secondary outcome measures. Parastomal hernia was observed by clinical inspection in 5 intervention patients (14.3%) and in 12 control patients (32.3%; p = 0.049). Surgical repair of parastomal hernia was performed in 1 control patient (3.2%) and in none of the patients in the intervention group. CT detected parastomal hernia in 18 intervention patients (51.4%) and in 17 control patients (53.1%; p = 1.00). The extent of hernias was similar according to European Hernia Society classification (p = 0.41). Colostomy-related morbidity (32.3% vs 14.3%; p = 0.140) did not differ between the study groups. The study was limited by its small size and short follow-up time. Prophylactic laparoscopic placement of intraperitoneal onlay mesh does not significantly reduce the overall risk of radiologically detected parastomal hernia after

  10. Advanced colorectal carcinoma. A prospective randomized trial of sequential methotrexate, 5-fluorouracil, and leucovorin versus 5-fluorouracil alone.

    Science.gov (United States)

    Machiavelli, M; Leone, B A; Romero, A; Rabinovich, M G; Vallejo, C T; Bianco, A; Pérez, J E; Rodríguez, R; Cuevas, M A; Alvarez, L A

    1991-06-01

    One hundred and twenty-five previously untreated patients bearing metastatic or advanced recurrent (inoperable) colorectal carcinoma and measurable disease were prospectively randomized. Those in arm A received 5-fluorouracil (5-FU), 1,200 mg/m2 i.v. infusion over 2 h, while those in arm B received methotrexate (MTX), 200 mg/m2 i.v. (push injection), followed 20 h later by 5-FU, 1,200 mg/m2 i.v. infusion over 2 h, plus calcium leucovorin (LV), 25 mg i.m. every 6 h for eight doses beginning 24 h after MTX administration. Cycles were repeated every 15 days. All patients receiving treatment were evaluable for toxicity and survival, and 118 patients were evaluable for response. The objective regression rate (complete plus partial response) was 12% (7 of 58) in arm A and 28% (17 of 60) in arm B (p = 0.049). No change was observed in 24% (14 of 58) in arm A and in 35% (21 of 60) in arm B (p = 0.28), while progressive disease was registered in 64% (37 of 58) and 37% (22 of 60) in arms A and B, respectively (p = 0.006). Median duration of response was 3 months in arm A and 5 months in arm B (p = 0.39). The median survival was 8.3 months in arm A and 11.2 months in arm B (p = 0.25). No statistically significant differences were found when objective regression and survival were related to site of primary tumor, performance status, and number of involved organs. There were two drug-related deaths in arm B due to severe myelosuppression followed by mucositis and sepsis. Of nonhematologic toxicities, diarrhea was more frequently observed in arm B, as were mucositis and infectious complications. Our results indicate that the sequential schedule MTX-5-FU-LV with 20-h intervals between MTX and 5-FU is superior in terms of objective regression to 5-FU alone given at the dose and schedule used in the present study. However, MTX-5-FU-LV did not have a significant impact on survival.

  11. Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

    2016-10-01

    Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the

  12. Outcomes After Radical Prostatectomy in Men Receiving Prior Pelvic Radiation for Non-Prostate Malignancies

    Science.gov (United States)

    Masterson, Timothy A.; Wedmid, Alexei; Sandhu, Jaspreet S.; Eastham, James A.

    2010-01-01

    Purpose Morbidity associated with salvage radical prostatectomy for locally recurrent prostate cancer after primary radiotherapy is well documented, but little is known about the impact on surgical difficulty and outcomes for radical prostatectomy in men who have had prior pelvic radiotherapy for non-prostate malignancies. We report functional outcomes of 9 patients treated at our institution. Materials and Methods From 1993 to 2007, 9 patients underwent radical prostatectomy following external beam radiotherapy for testicular seminoma (6), anorectal cancer (2), and colon cancer (1). Clinical information was obtained from a prospective prostate cancer database. Results Radical prostatectomy was completed without identifiable injury to adjacent structures in all 9 patients. Four patients had significant pelvic fibrosis, 3 required bilateral neurovascular bundle resection. Neurovascular bundle preservation was performed in the remaining 6 patients, 4 with good preoperative erectile function. However, no patient recovered erectile function postoperatively at a median follow-up time of 75 months (range 12 to 172). Of preoperatively continent men, 57% required ≤1 pad daily and 43% were completely dry, achieving complete urinary control at a median follow-up time of 7.5 months (range 2 to 20). Two patients developed anastomotic stricture, one being associated with concomitant ureteral stricture. Conclusions Radical prostatectomy after pelvic radiotherapy for non-prostate malignancies was not associated with increased intraoperative morbidity. However, rates of anastomotic stricture, erectile dysfunction, and urinary incontinence appear to be higher than those observed after radical prostatectomy in men with no prior radiotherapy and comparable to those seen in the salvage radical prostatectomy setting. PMID:19239447

  13. Can probiotics improve efficiency and safety profile of triple Helicobacter pylori eradication therapy? A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Grgov Saša

    2016-01-01

    Full Text Available Background/Aim. Some studies suggest the benefit of applying different probiotic strains in combination with antibiotics in the eradication of Helicobacter pylori (H. pylori infection. The aim of this study was to evaluate the effect of co-administration of multiple probiotic strains with triple H. pylori eradication therapy. Methods. This prospective study included 167 patients with dyspeptic symptoms and chronic gastritis who were diagnosed with H. pylori infection and randomized into two groups. The group I of 77 patients underwent triple eradication therapy, for 7 days, with lansoprazole, 2 × 30 mg half an hour before the meal, amoxicillin 2 × 1.000 mg per 12 hours and clarithromycin 2 × 500 mg per 12 hours. After the 7th day of the therapy, lansoprazole continued at a dose of 30 mg for half an hour before breakfast for 4 weeks. The group II of 90 patients received the same treatment as the patients of the group I, with the addition of the probiotic cultures in the form of a capsule comprising Lactobacillus Rosell-52, Lactobacillus Rosell-11, Bifidobacterium Rosell-1755 and Saccharomyces boulardii, since the beginning of eradication for 4 weeks. Eradication of H. pylori infection control was performed 8 weeks after the therapy by rapid urease test and histopathologic evaluation of endoscopic biopsies or by stool antigen test for H. pylori. Results. Eradication of H. pylori infection was achieved in 93.3% of the patients who received probiotics with eradication therapy and in 81.8% of patients who were only on eradication therapy without probiotics. The difference in eradication success was statistically significant, (p < 0.05. The incidence of adverse effects of eradication therapy was higher in the group of patients who were not on probiotic (28.6% than in the group that received probiotic (17.7%, but the difference was not statistically significant. Conclusion. Multiple probiotic strains addition to triple eradication therapy of H

  14. Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

    2018-06-01

    There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

  15. Corneal power, thickness, and stiffness: results of a prospective randomized controlled trial of PRK and LASIK for myopia.

    Science.gov (United States)

    Hjortdal, Jesper Ø; Møller-Pedersen, Torben; Ivarsen, Anders; Ehlers, Niels

    2005-01-01

    To compare the short-, medium-, and long-term changes in corneal optical power and corneal aberrations, central corneal thickness, and corneal "stiffness" assessed by pneumotonometry readings in patients having laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) for myopia. Department of Ophthalmology, Arhus University Hospital, Arhus, Denmark. One eye of each of 45 patients with myopia ranging from -6.00 to -8.00 diopters (D) (spherical equivalent spectacle refraction [SER]) was randomized to LASIK (n=25; mean SER -7.12 D +/- 0.57 [SD]) or PRK (n=20; mean SER -6.91 +/- 0.57 D). Data were collected prospectively before and 1, 3, 6, 12, and 36 months after surgery. Measurements included corneal topography (TMS-1, Tomey), corneal thickness (ultrasound pachymetry), and apparent intraocular pressure (IOP) (pneumotonometry). Retreatments were not performed during the first year, and retreated eyes were excluded from the 3-year follow-up. Changes in corneal power and aberrations, thickness, and apparent IOP were calculated in a pair-wise manner for 3 time periods: short term (preoperative to 1 month after surgery), medium term (1 to 12 months after surgery), and long term (1 to 3 years after surgery). In the short term, corneal power decreased equally in LASIK and PRK eyes. Spherical aberrations and coma-like aberrations increased equally, while corneal thickness decreased significantly less in LASIK eyes than in PRK eyes. The apparent IOP decreased more in LASIK eyes than in PRK eyes. In the medium term, corneal power increased significantly in both groups. Spherical aberrations decreased significantly in PRK eyes but not in LASIK eyes. From 1 to 12 months, corneal thickness increased more in PRK eyes than in LASIK eyes. During this period, the apparent IOP increased significantly in LASIK eyes. In the long term, corneal power and corneal aberrations did not change significantly in either group. Corneal thickness increased slightly but

  16. Oral versus intramuscular cobalamin treatment in megaloblastic anemia: a single-center, prospective, randomized, open-label study.

    Science.gov (United States)

    Bolaman, Zahit; Kadikoylu, Gurhan; Yukselen, Vahit; Yavasoglu, Irfan; Barutca, Sabri; Senturk, Taskin

    2003-12-01

    Cobalamin (vitamin B12) deficiency, the most common cause of megaloblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (p.o.) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administration and lower cost. This study assessed the effects and cost of p.o. versus i.m. cobalamin treatment in patients with megaloblastic anemia due to cobalamin deficiency. This was a 90-day, prospective, randomized, open-label study conducted at the Division of Hematology, Department of Internal Medicine, Adnan Menderes University Research and Practice Hospital (Aydin, Turkey). Patients aged > or =16 years with megaloblastic anemia due to cobalamin deficiency were randomized to receive 1000-microg cobalamin p.o. once daily for 10 days (p.o. group) or 1000-microg cobalamin i.m. once daily for 10 days (i.m. group). After 10 days, both treatments were administered once a week for 4 weeks, and after that, once a month for life. Patients were assessed for the presence of reticulocytosis between treatment days 5 and 10 until it was detected. Therapeutic effectiveness was assessed by measuring hematologic parameters on days 0, 10, 30, and 90 and serum vitamin B12 concentration on days 0 and 90. The Mini-Mental State Examination was used before and after the B12 therapy for cognitive function assessment and 125-Hz diapozone was used for vibration threshold testing. Neurologic sensory assessment, including soft-touch and pinprick examinations, was used to identify neuropathy at baseline and study end. Tolerability was assessed using laboratory tests and patient interview. Cost was assessed using the cost of the study drug and of the injection. Sixty patients completed the study 26 in the p.o. group (16 men, 10 women; mean [SD] age, 60 [15] years) and 34 in the i.m. group (17 men, 17 women; mean [SD] age, 64 [10] years). Reticulocytosis was observed in all patients. In the p

  17. A review of the anatomy of the male continence mechanism and the cause of urinary incontinence after prostatectomy.

    Science.gov (United States)

    Moore, K N

    1999-03-01

    Radical prostatectomy was first described by Dr. Hugh Hampton Young in 1905 as a treatment for prostate cancer. Since that time, urinary incontinence has been reported as a significant postsurgical problem. With the expanding interest in continence therapy and an increase in the number of men undergoing prostate cancer surgery, there is a concomitant need for detailed consideration of the cause of postprostatectomy incontinence. Urinary leakage after radical prostatectomy is not, as traditionally thought, a simple case of stress urinary incontinence. Instead, it represents a complex, multifactorial problem that continues to challenge practitioners and researchers alike. An overview of the anatomy of the male continence mechanism is provided, followed by a discussion of the cause and risk factors implicated in postprostatectomy incontinence and suggestions for further research.

  18. Prospective evaluation of fluciclovine (18F) PET-CT and MRI in detection of recurrent prostate cancer in non-prostatectomy patients.

    Science.gov (United States)

    Akin-Akintayo, Oladunni; Tade, Funmilayo; Mittal, Pardeep; Moreno, Courtney; Nieh, Peter T; Rossi, Peter; Patil, Dattatraya; Halkar, Raghuveer; Fei, Baowei; Master, Viraj; Jani, Ashesh B; Kitajima, Hiroumi; Osunkoya, Adeboye O; Ormenisan-Gherasim, Claudia; Goodman, Mark M; Schuster, David M

    2018-05-01

    To investigate the disease detection rate, diagnostic performance and interobserver agreement of fluciclovine ( 18 F) PET-CT and multiparametric magnetic resonance imaging (mpMR) in recurrent prostate cancer. Twenty-four patients with biochemical failure after non-prostatectomy definitive therapy, 16/24 of whom had undergone brachytherapy, underwent fluciclovine PET-CT and mpMR with interpretation by expert readers blinded to patient history, PSA and other imaging results. Reference standard was established via a multidisciplinary truth panel utilizing histology and clinical follow-up (22.9 ± 10.5 months) and emphasizing biochemical control. The truth panel was blinded to investigative imaging results. Diagnostic performance and interobserver agreement (kappa) for the prostate and extraprostatic regions were calculated for each of 2 readers for PET-CT (P1 and P2) and 2 different readers for mpMR (M1 and M2). On a whole body basis, the detection rate for fluciclovine PET-CT was 94.7% (both readers), while it ranged from 31.6-36.8% for mpMR. Kappa for fluciclovine PET-CT was 0.90 in the prostate and 1.0 in the extraprostatic regions. For mpMR, kappa was 0.25 and 0.74, respectively. In the prostate, 22/24 patients met the reference standard with 13 malignant and 9 benign results. Sensitivity, specificity and positive predictive value (PPV) were 100.0%, 11.1% and 61.9%, respectively for both PET readers. For mpMR readers, values ranged from 15.4-38.5% for sensitivity, 55.6-77.8% for specificity and 50.0-55.6% for PPV. For extraprostatic disease determination, 18/24 patients met the reference standard. Sensitivity, specificity and PPV were 87.5%, 90.0% and 87.5%, respectively, for fluciclovine PET-CT, while for mpMR, sensitivity ranged from 50 to 75%, specificity 70-80% and PPV 57-75%. The disease detection rate for fluciclovine PET-CT in non-prostatectomy patients with biochemical failure was 94.7% versus 31.6-36.8% for mpMR. For extraprostatic disease detection

  19. Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

    Science.gov (United States)

    Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

    2009-11-01

    This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

  20. Increased prostate cancer specific mortality following radical prostatectomy in men presenting with voiding symptoms-A whole of population study.

    Science.gov (United States)

    Ta, Anthony D; Papa, Nathan P; Lawrentschuk, Nathan; Millar, Jeremy L; Syme, Rodney; Giles, Graham G; Bolton, Damien M

    2015-09-01

    Whole of population studies reporting long-term outcomes following radical prostatectomy (RP) are scarce. We aimed to evaluate the long-term outcomes in men with prostate cancer (PC) treated with RP in a whole of population cohort. A secondary objective was to evaluate the influence of mode of presentation on PC specific mortality (PCSM). A prospective database of all cases of RP performed in Victoria, Australia between 1995 and 2000 was established within the Victorian Cancer Registry. Specimen histopathology reports and prostate-specific antigen (PSA) values were obtained by record linkage to pathology laboratories. Mode of presentation was recorded as either PSA screened (PSA testing offered in absence of voiding symptoms) or symptomatic (diagnosis of PC following presentation with voiding symptoms). Multivariate Cox and competing risk regression models were fitted to analyze all-cause mortality, biochemical recurrence, and PCSM. Between 1995 and 2000, 2,154 men underwent RP in Victoria. During median follow up of 10.2 years (range 0.26-13.5 years), 74 men died from PC. In addition to Gleason score and pathological stage, symptomatic presentation was associated with PCSM. After adjusting for stage and PSA, no difference in PCSM was found between men with Gleason score ≤ 6 and Gleason score 3 + 4 = 7. Men with Gleason score 4 + 3 had significantly greater cumulative incidence of PCSM compared with men with Gleason score 3 + 4. Primary Gleason pattern in Gleason 7 PC is an important prognosticator of survival. Our findings suggest that concomitant voiding symptoms should be considered in the work-up and treatment of PC.

  1. Stratified analysis of 800 Asian patients after robot-assisted radical prostatectomy with a median 64 months of follow up.

    Science.gov (United States)

    Abdel Raheem, Ali; Kim, Dae Keun; Santok, Glen Denmer; Alabdulaali, Ibrahim; Chung, Byung Ha; Choi, Young Deuk; Rha, Koon Ho

    2016-09-01

    To report the 5-year oncological outcomes of robot-assisted radical prostatectomy from the largest series ever reported from Asia. A retrospective analysis of 800 Asian patients who were treated with robot-assisted radical prostatectomy from July 2005 to May 2010 in the Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea was carried out. The primary end-point was to evaluate the biochemical recurrence. The secondary end-point was to show the biochemical recurrence-free survival, metastasis-free survival and cancer-specific survival. A total of 197 (24.65%), 218 (27.3%), and 385 (48.1%) patients were classified as low-, intermediate- and high-risk patients according to the D'Amico risk stratification risk criteria, respectively. The median follow-up period was 64 months (interquartile range 28-71 months). The overall incidence of positive surgical margin was 36.6%. There was biochemical recurrence in 183 patients (22.9%), 38 patients (4.8%) developed distant metastasis and 24 patients (3%) died from prostate cancer. Actuarial biochemical recurrence-free survival, metastasis-free survival, and cancer-specific survival rates at 5 years were 76.4%, 94.6% and 96.7%, respectively. Positive lymph node was associated with lower 5-year biochemical recurrence-free survival (9.1%), cancer-specific survival (75.7%) and metastasis-free survival (61.9%) rates (P < 0.001). On multivariable analysis, among all the predictors, positive lymph node was the strongest predictor of biochemical recurrence, cancer-specific survival and metastasis-free survival (P < 0.001). Herein we report the largest robot-assisted radical prostatectomy series from Asia. Robot-assisted radical prostatectomy is confirmed to be an oncologically safe procedure that is able to provide effective 5-year cancer control, even in patients with high-risk disease. © 2016 The Japanese Urological Association.

  2. Proposed salvage treatment strategy for biochemical failure after radical prostatectomy in patients with prostate cancer: a retrospective study

    International Nuclear Information System (INIS)

    Miyake, Makito; Tanaka, Nobumichi; Asakawa, Isao; Morizawa, Yosuke; Anai, Satoshi; Torimoto, Kazumasa; Aoki, Katsuya; Yoneda, Tatsuo; Hasegawa, Masatoshi; Konishi, Noboru; Fujimoto, Kiyohide

    2014-01-01

    Treatment options for patients with recurrent disease after radical prostatectomy include salvage radiotherapy of the prostatic bed and/or androgen deprivation therapy. To establish an effective treatment strategy for recurrent disease after radical prostatectomy, we retrospectively analyzed the outcome of salvage radiation monotherapy in such cases. Data from 61 men who had undergone salvage radiation monotherapy for biochemical recurrent disease after radical prostatectomy were retrospectively reviewed. In all patients, salvage radiotherapy consisted of iraradiation to the prostatic bed (70 Gy) using three-dimensional conformal radiotherapy techniques. Treatment outcome was analyzed to identify predictive factors of salvage radiotherapy. The biochemical recurrence-free survival after salvage radiation monotherapy at 2 and 5 years was 55% and 38%, respectively. Cox proportional regression models revealed that the independent predictive factors for biochemical recurrence were Gleason Score ≥ 8, negative surgical margin, and PSA velocity ≥ 0.38 ng/mL/year. Negative surgical margin and PSA velocity ≥ 0.8 ng/mL/year were significantly associated with poor response in the serum PSA levels after salvage radiotherapy. Based on our findings, we propose a treatment strategy for biochemical recurrent disease after radical prostatectomy. Patients with Gleason score ≤ 7, positive surgical margin, and PSA velocity < 0.38 ng/mL/year are categorized the most favorable group, so that eradication by salvage radiation monotherapy could be expected. Other patients could be divided to two groups depending on surgical margin status and PSA velocity: 1) patients who might require combination of SRT and short-term androgen deprivation therapy and 2) patients who should be treated by androgen deprivation monotherapy

  3. Erectile function after radical prostatectomy

    DEFF Research Database (Denmark)

    Fode, Mikkel; Frey, Anders; Jakobsen, Henrik

    2016-01-01

    collected database and a cross-sectional, questionnaire-based study in patients following radical prostatectomy. Erectile function was assessed with the IIEF-5 and the question "Is your erectile function as good as before the surgery (yes/no)". Patients were included if they were sexually active before...

  4. Football as a treatment for hypertension in untrained 30-55-year-old men: a prospective randomized study

    DEFF Research Database (Denmark)

    Andersen, Lars Juel; Randers, Morten Bredsgaard; Westh, K.

    2010-01-01

    The present study investigated whether football has favorable effects in the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men. Twenty-five untrained males aged 31-54 year with mild-to-moderate hypertension were randomized to a football training group (FTG, two 1-h.......p.m.), whereas no change was observed for DAG. After 3 months, FTG had higher (Pattractive non-pharmacological supplement...... to the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men....

  5. A prospective randomized trial of two solutions for intrapartum amnioinfusion: effects on fetal electrolytes, osmolality, and acid-base status.

    Science.gov (United States)

    Pressman, E K; Blakemore, K J

    1996-10-01

    Our purpose was to compare the effects of intrapartum amnioinfusion with normal saline solution versus lactated Ringer's solution plus physiologic glucose on neonatal electrolytes and acid-base balance. Patients undergoing amnioinfusion for obstetric indications were randomized to receive normal saline solution or lactated Ringer's solution plus physiologic glucose at standardized amnioinfusion rates. Data were collected prospectively on maternal demographics, course of labor, and maternal and neonatal outcome. Arterial cord blood was obtained for analysis of electrolytes, glucose, osmolality, lactic acid, and blood gases. Control subjects with normal fetal heart rate patterns, and clear amniotic fluid not receiving amnioinfusion were studied concurrently. Data were collected on 59 patients (21 normal saline solution, 18 lactated Ringer's solution plus physiologic glucose, and 20 controls). Maternal demographics, course of labor, and neonatal outcome were similar in all three groups. Cesarean sections were performed more often in the amnioinfusion groups (33.3% for normal saline solution, 38.9% for lactated Ringer's solution plus physiologic glucose) than in the control group (5.0%), p amnioinfusion with either solution. Intrapartum amnioinfusion with normal saline solution or lactated Ringer's solution plus physiologic glucose has no effect on neonatal electrolytes or acid-base balance.

  6. Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study

    DEFF Research Database (Denmark)

    Vogt, Katja C; Uhlyarik, M; Schroeder, Torben V

    2007-01-01

    This study was a randomized-controlled trial comparing the standard type of dry dressing, Mepore, with moist wound healing, using a hydrofiber dressing, Aquacel, in primary closed wounds after vascular surgery. The endpoints were patient comfort, cost-effectiveness, infections, wound complications......, and length of hospital stay. One hundred and sixty patients were randomized to receive either Mepore or Aquacel dressing. There was no significant difference in patient comfort between the two groups, but a higher cost in the Aquacel group despite significantly fewer changes of dressings in these patients...

  7. A Prospective Randomized Controlled Trial of Nonpharmacological Pain Management During Intravenous Cannulation in a Pediatric Emergency Department.

    Science.gov (United States)

    Miller, Kate; Tan, Xianghong; Hobson, Andrew Dillon; Khan, Asaduzzaman; Ziviani, Jenny; OʼBrien, Eavan; Barua, Kim; McBride, Craig A; Kimble, Roy M

    2016-07-01

    Intravenous (IV) cannulation is commonly performed in pediatric emergency departments (EDs). The busy ED environment is often not conducive to conventional nonpharmacological pain management. This study assessed the use of Ditto (Diversionary Therapy Technologies, Brisbane, Australia), a handheld electronic device which provides procedural preparation and distraction, as a means of managing pain and distress during IV cannulation performed in the pediatric ED. A randomized controlled trial with 98 participants, aged 3 to 12 years, was conducted in a pediatric ED. Participants were recruited and randomized into 5 intervention groups as follows: (1) Standard Distraction, (2) PlayStation Portable Distraction, (3) Ditto Distraction, (4) Ditto Procedural Preparation, and (5) Ditto Preparation and Distraction. Children's pain and distress levels were assessed via self-reports and observational reports by caregivers and nursing staff across the following 3 time points: (1) before, (2) during, and (3) after IV cannulation. Caregivers and nursing staff reported significantly reduced pain and distress levels in children accessing the combined preparation and distraction Ditto protocol, as compared to standard distraction (P ≤ 0.01). This intervention also saw the greatest reduction in pain and distress as reported by the child. Caregiver reports indicate that using the combined Ditto protocol was most effective in reducing children's pain experiences while undergoing IV cannulation in the ED. The use of Ditto offers a promising opportunity to negotiate barriers to the provision of nonpharmacological approaches encountered in the busy ED environment, and provide nonpharmacological pain-management interventions in pediatric EDs.

  8. Variation of prostate-specific antigen expression in different tumour growth patterns present in prostatectomy specimens

    NARCIS (Netherlands)

    M.P.W. Gallee; E. Visser-de Jong (E.); J.A.G.M. van der Korput (J. A G M); Th.H. van der Kwast (Theo); F.J.W. ten Kate (Fiebo); F.H. Schröder (Fritz); J. Trapman (Jan)

    1990-01-01

    textabstractA series of 55 randomly chosen radical prostatectomy specimens was analyzed for expression of prostate-specific antigen (PSA) by immunohistochemical techniques. Tissue sections were selected in such a manner that in addition to glandular benign prostatic hyperplasia (BPH), one or more

  9. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

    Science.gov (United States)

    Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

    2013-02-15

    Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

  10. Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study

    Science.gov (United States)

    Chen, Ming; Bao, Yong; Ma, Hong-Lian; Wang, Jin; Wang, Yan; Peng, Fang; Zhou, Qi-Chao; Xie, Cong-Hua

    2013-01-01

    This prospective randomized study is to evaluate the locoregional failure and its impact on survival by comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) in combination with concurrent chemotherapy for locally advanced non-small cell lung cancer. It appears that higher dose could be delivered in IFRT arm than that in ENI arm, and IFRT did not increase the risk of initially uninvolved or isolated nodal failures. Both a tendency of improved locoregional progression-free survival and a significant increased overall survival rate are in favor of IFRT arm in this study. PMID:23762840

  11. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig

    2003-01-01

    INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed....... PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

  12. No effect of Osteoset, a bone graft substitute, on bone healing in humans: a prospective randomized double-blind study

    DEFF Research Database (Denmark)

    Petruskevicius, Juozas; Nielsen, Mette Strange; Kaalund, Søren

    2002-01-01

    We studied the effects of a newly marketed bone substitute, Osteoset, on bone healing in a tibial defect in humans. 20 patients undergoing an ACL (anterior cruciate ligament) reconstruction with bone-patella tendon-bone graft were block-randomized into 2 groups of 10 each. In the treatment group......, the tibial defect was filled manually with Osteoset pellets, in the control group the defect was left empty. CTs of the defect were taken on the first day after the operation, 6 weeks, 3 and 6 months postoperatively. We found about the same amount of bone in the defect in the Osteoset and control groups...... after 6 weeks, 3, and 6 months. In the control group, but not in the Osteoset group, the bone volume increased from 6 weeks to 3 months. The Osteoset pellets were almost resorbed after 6 weeks....

  13. Robot-assisted surgery in a broader healthcare perspective: a difference-in-difference-based cost analysis of a national prostatectomy cohort.

    Science.gov (United States)

    Hyldgård, Vibe Bolvig; Laursen, Karin Rosenkilde; Poulsen, Johan; Søgaard, Rikke

    2017-07-21

    To estimate costs attributable to robot-assisted laparoscopic prostatectomy (RALP) as compared with open prostatectomy (OP) and laparoscopic prostatectomies (LP) in a National Health Service perspective. Register-based cohort study of 4309 consecutive patients who underwent prostatectomy from 2006 to 2013 (2241 RALP, 1818 OP and 250 LP). Patients were followed from 12 months before to 12 months after prostatectomy with respect to service use in primary care (general practitioners, therapists, specialists etc) and hospitals (inpatient and outpatient activity related to prostatectomy and comorbidity). Tariffs of the activity-based remuneration system for primary care and the Diagnosis-Related Grouping case-mix system for hospital-based care were used to value service use. Costs attributable to RALP were estimated using a difference-in-difference analytical approach and adjusted for patient-level and hospital-level risk selection using multilevel regression. No significant effect of RALP on resource-use was observed except for a marginally lower use of primary care and fewer bed days as compared with OP (not LP). The overall cost consequence of RALP was estimated at an additional €2459 (95% CI 1377 to 3540, p=0.003) as compared with OP and an additional €3860 (95% CI 559 to 7160, p=0.031) as compared with LP, mainly due to higher cost intensity during the index admissions. In this study from the Danish context, the use of RALP generates a factor 1.3 additional cost when compared with OP and a factor 1.6 additional cost when compared with LP, on average, based on 12 months follow-up. The policy interpretation is that the use of robots for prostatectomy should be driven by clinical superiority and that formal effectiveness analysis is required to determine whether the current and eventual new purchasing of robot capacity is best used for prostatectomy. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  14. Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

    Science.gov (United States)

    Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

    2015-09-01

    To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

  15. The beneficial effects of Kampo medicine Dai-ken-chu-to after hepatic resection: a prospective randomized control study.

    Science.gov (United States)

    Nishi, Masaki; Shimada, Mitsuo; Uchiyama, Hideaki; Ikegami, Toru; Arakawa, Yusuke; Hanaoka, Jun; Kanemura, Hirofumi; Morine, Yuji; Imura, Satoru; Miyake, Hidenori; Utsunomiya, Toru

    2012-10-01

    After hepatic resection, delayed flatus and impaired bowel movement often cause problematic postoperative ileus. Kampo medicine, Dai-kenchu-to (DKT), is reported to have a various beneficial effects on bowel systems. The aim of this study was to prospectively evaluate effects of DKT after hepatic resection. Thirty-two patients who underwent hepatic resection between July 2007 and August 2008 in Tokushima University Hospital were prospectively divided into DKT group (n=16) and control group (n=16). In DKT group, 2.5 g of DKT was administered orally three times a day from postoperative day (POD) 1. Blood was examined on POD 1, 3, 5 and 7. Postoperative first flatus, bowel movement and full recovery of oral intake, hospital stays and complications were checked. In DKT group, levels of c-reactive protein and beta-(1-3)-D-glucan on POD 3 were significantly decreased (pDKT group (pDKT suppressed inflammatory reaction, stimulated bowel movement and improved oral intake after hepatic resection, which may decrease serious morbidity after hepatic resection.

  16. Does ethamsylate reduce haemorrhage in transurethral prostatectomy?

    Science.gov (United States)

    Lyth, D R; Booth, C M

    1990-12-01

    A double-blind, randomised trial of 44 consecutive patients undergoing transurethral prostatectomy demonstrated that ethamsylate (Dicynene) did not reduce blood loss during either the operative or the post- operative periods.

  17. Management of erectile dysfunction post-radical prostatectomy

    Directory of Open Access Journals (Sweden)

    Saleh A

    2015-02-01

    Full Text Available Alan Saleh, Hamid Abboudi, MB Ghazal-Aswad, Erik K Mayer, Justin A Vale Division of Surgery and Cancer, Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK Abstract: Radical prostatectomy is a commonly performed procedure for the treatment of localized prostate cancer. One of the long-term complications is erectile dysfunction. There is little consensus on the optimal management; however, it is agreed that treatment must be prompt to prevent fibrosis and increase oxygenation of penile tissue. It is vital that patient expectations are discussed, a realistic time frame of treatment provided, and treatment started as close to the prostatectomy as possible. Current treatment regimens rely on phosphodiesterase 5 inhibitors as a first-line therapy, with vacuum erection devices and intraurethral suppositories of alprostadil as possible treatment combination options. With nonresponders to these therapies, intracavernosal injections are resorted to. As a final measure, patients undergo the highly invasive penile prosthesis implantation. There is no uniform, objective treatment program for erectile dysfunction post-radical prostatectomy. Management plans are based on poorly conducted and often underpowered studies in combination with physician and patient preferences. They involve the aforementioned drugs and treatment methods in different sequences and doses. Prospective treatments include dietary supplements and gene therapy, which have shown promise with there proposed mechanisms of improving erectile function but are yet to be applied successfully in human patients. Keywords: erectile dysfunction, phosphodiesterase 5 inhibitors, vacuum erection devices, intraurethral suppositories, intracavernosal injections

  18. A Randomized 10-year Prospective Follow-up of Class II Nanohybrid and Conventional Hybrid Resin Composite Restorations

    DEFF Research Database (Denmark)

    van Dijken, Jan Wv; Pallesen, Ulla

    2014-01-01

    Purpose: To evaluate the 10-year durability of a nanohybrid resin composite in Class II restorations in a randomized controlled intraindividual comparison with its conventional hybrid resin composite predecessor. Materials and Methods: Each of 52 participants received at least two Class II...... restorations that were as similar as possible. The cavities were chosen at random to be restored with a nanohybrid resin composite (Excite/Tetric EvoCeram (TEC); n = 61) and a conventional hybrid (Excite/Tetric Ceram (TC); n = 61). The restorations were evaluated with slightly modified USPHS criteria...... investigated resin composites. Conclusion: The nanohybrid and the conventional hybrid resin composite showed good clinical effectiveness in extensive Class II restorations during the 10-year study....

  19. Virtual Reality Robotic Surgery Warm-Up Improves Task Performance in a Dry Lab Environment: A Prospective Randomized Controlled Study

    Science.gov (United States)

    Lendvay, Thomas S.; Brand, Timothy C.; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M.

    2014-01-01

    Background Pre-operative simulation “warm-up” has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. Study Design In a two-center randomized trial, fifty-one residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot. Once successfully achieving performance benchmarks, surgeons were randomized to either receive a 3-5 minute VR simulator warm-up or read a leisure book for 10 minutes prior to performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical and cognitive errors. Results Task time (-29.29sec, p=0.001, 95%CI-47.03,-11.56), path length (-79.87mm, p=0.014, 95%CI -144.48,-15.25), and cognitive errors were reduced in the warm-up group compared to the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32, p=0.020, 95%CI 0.06,0.59) were reduced after the dissimilar VR task. When surgeons were stratified by prior robotic and laparoscopic clinical experience, the more experienced surgeons(n=17) demonstrated significant improvements from warm-up in task time (-53.5sec, p=0.001, 95%CI -83.9,-23.0) and economy of motion (0.63mm/sec, p=0.007, 95%CI 0.18,1.09), whereas improvement in these metrics was not statistically significantly appreciated in the less experienced cohort(n=34). Conclusions We observed a significant performance improvement and error reduction rate among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on a more complex task (robotic

  20. Ultrasound-Guided Out-of-Plane vs. In-Plane Interscalene Catheters: A Randomized, Prospective Study

    OpenAIRE

    Schwenk, Eric S.; Gandhi, Kishor; Baratta, Jaime L.; Torjman, Marc; Epstein, Richard H.; Chung, Jaeyoon; Vaghari, Benjamin A.; Beausang, David; Bojaxhi, Elird; Grady, Bernadette

    2015-01-01

    Background: Continuous interscalene blocks provide excellent analgesia after shoulder surgery. Although the safety of the ultrasound-guided in-plane approach has been touted, technical and patient factors can limit this approach. We developed a caudad-to-cephalad out-of-plane approach and hypothesized that it would decrease pain ratings due to better catheter alignment with the brachial plexus compared to the in-plane technique in a randomized, controlled study. Objectives: To compare an out-...

  1. A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma

    Science.gov (United States)

    2016-05-01

    COMBAT study staff was made aware of a code 10 trauma return of a male patient who sustained an anterior left- chest stab wound. Paramedics enrolled the...Attenuation of Acute Coagulopathy of Trauma . PRINCIPAL INVESTIGATOR: Ernest E. Moore, MD CONTRACTING ORGANIZATION: University of Colorado Denver...Randomized Investigation of “Plasma First Resuscitation” for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma . 5b. GRANT NUMBER

  2. Preventive effect of feeding high-risk infants a casein hydrolysate formula or an ultrafiltrated whey hydrolysate formula. A prospective, randomized, comparative clinical study

    DEFF Research Database (Denmark)

    Halken, S; Høst, A; Hansen, L G

    1993-01-01

    In a prospective study of a 1-year birth cohort of 158 high-risk infants the effect of feeding breastmilk, a casein hydrolysate (Nutramigen) or a new ultrafiltrated whey hydrolysate (Profylac) on the development of cow milk protein allergy/intolerance (CMPA/CMPI) was assessed and compared. All...... the infants had biparental or severe single atopic predisposition, the latter combined with cord blood IgE > or = 0.5 kU/L. At birth all infants were randomized to Nutramigen or Profylac, which was used when breastfeeding was insufficient or not possible during the first 6 months of life. During the same...... period this regimen was combined with avoidance of solid foods and cow milk protein. All mothers had unrestricted diets and were encouraged to do breastfeeding only. Moreover, avoidance of daily exposure to tobacco smoking, furred pets and dust-collecting materials in the bedroom was advised. The infants...

  3. Washed cell salvage in surgical patients: A review and meta-analysis of prospective randomized trials under PRISMA.

    Science.gov (United States)

    Meybohm, Patrick; Choorapoikayil, Suma; Wessels, Anke; Herrmann, Eva; Zacharowski, Kai; Spahn, Donat R

    2016-08-01

    Cell salvage is commonly used as part of a blood conservation strategy. However concerns among clinicians exist about the efficacy of transfusion of washed cell salvage. We performed a meta-analysis of randomized controlled trials in which patients, scheduled for all types of surgery, were randomized to washed cell salvage or to a control group with no cell salvage. Data were independently extracted, risk ratio (RR), and weighted mean differences (WMD) with 95% confidence intervals (CIs) were calculated. Data were pooled using a random effects model. The primary endpoint was the number of patients exposed to allogeneic red blood cell (RBC) transfusion. Out of 1140 search results, a total of 47 trials were included. Overall, the use of washed cell salvage reduced the rate of exposure to allogeneic RBC transfusion by a relative 39% (RR = 0.61; 95% CI 0.57 to 0.65; P platelets, or rate of myocardial infarction and stroke. Washed cell salvage is efficacious in reducing the need for allogeneic RBC transfusion and risk of infection in surgery.

  4. Does a previous prostate biopsy-related acute bacterial prostatitis affect the results of radical prostatectomy?

    Science.gov (United States)

    Türk, Hakan; Ün, Sitki; Arslan, Erkan; Zorlu, Ferruh

    2018-01-01

    To The standard technique for obtaining a histologic diagnosis of prostatic carcinomas is transrectal ultrasound guided prostate biopsy. Acute prostatitis which might develop after prostate biopsy can cause periprostatic inflammation and fibrosis. In this study, we performed a retrospective review of our database to determine whether ABP history might affect the outcome of RP. 441 RP patients who were operated in our clinic from 2002 to 2014 were included in our study group. All patients' demographic values, PSA levels, biopsy and radical prostatectomy specimen pathology results and their perioperative/postoperative complications were evaluated. There were 41 patients in patients with acute prostatitis following biopsy and 397 patients that did not develop acute prostatitis. Mean blood loss, transfusion rate and operation period were found to be significantly higher in ABP patients. Hospitalization period and reoperation rates were similar in both groups. However, post-op complications were significantly higher in ABP group. Even though it does not affect oncological outcomes, we would like to warn the surgeons for potential complaints during surgery in ABP patients. Copyright® by the International Brazilian Journal of Urology.

  5. Does a previous prostate biopsy-related acute bacterial prostatitis affect the results of radical prostatectomy?

    Directory of Open Access Journals (Sweden)

    Hakan Türk

    Full Text Available ABSTRACT Objective To The standard technique for obtaining a histologic diagnosis of prostatic carcinomas is transrectal ultrasound guided prostate biopsy. Acute prostatitis which might develop after prostate biopsy can cause periprostatic inflammation and fibrosis. In this study, we performed a retrospective review of our database to determine whether ABP history might affect the outcome of RP. Materials and Methods 441 RP patients who were operated in our clinic from 2002 to 2014 were included in our study group. All patients’ demographic values, PSA levels, biopsy and radical prostatectomy specimen pathology results and their perioperative/ postoperative complications were evaluated. Results There were 41 patients in patients with acute prostatitis following biopsy and 397 patients that did not develop acute prostatitis. Mean blood loss, transfusion rate and operation period were found to be significantly higher in ABP patients. Hospitalization period and reoperation rates were similar in both groups. However, post-op complications were significantly higher in ABP group. Conclusion Even though it does not affect oncological outcomes, we would like to warn the surgeons for potential complaints during surgery in ABP patients.

  6. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

    Science.gov (United States)

    Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

    2015-11-01

    Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. A matched-pair comparison of single plus one port versus standard extraperitoneal laparoscopic radical prostatectomy by a single urologist

    Directory of Open Access Journals (Sweden)

    Dong-Xu Zhang

    2015-07-01

    Full Text Available We conducted this study to report on our initial experience and assess the safety, feasibility, and efficacy of extraperitoneal single plus one port laparoscopic radical prostatectomy (SPOPL-RP, and determine whether it shows any objective advantage over standard laparoscopic radical prostatectomy. From June 2009 to September 2011, 15 extraperitoneal SPOPL-RPs were performed through a 2–3-cm subumbilical longitudinal incision and another 5-mm trocar placed at the McBurney point. This cohort was compared with 37 contemporary patients who underwent standard extraperitoneal laparoscopic radical prostatectomy performed by the same urologist. Peri- and postoperative outcomes, including continence, potency, and scar length, were statistically analyzed. The two groups were comparable with respect to patient demographics, estimated blood loss, drainage time, duration of catheterization, catheterization rate >14 days, complication rate, postoperative hospitalization, and postoperative functional and oncologic outcomes (p > 0.05. The SPOPL-RP procedures had a longer mean operative time (170.1 minutes vs. 139.5 minutes, p = 0.005, but with fewer patients requiring analgesics (20% vs. 54.1%, p = 0.038 and earlier resumption of oral intake (20.7 hours vs. 26.8 hours, p = 0.037. The mean scar length in the SPOPL-RP group was much smaller (3.4 cm vs. 5.8 cm, p = 0.000 owing to the significant reduction of the skin incision. The peri- and postoperative outcomes of SPOPL-RP for low-risk prostate cancer are comparable to those with the standard laparoscopic approach. In addition, SPOPL-RP provides better postoperative pain control, faster recovery of bowel function, and smaller scar length than standard laparoscopy, albeit with a longer operative time.

  8. Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

    Science.gov (United States)

    Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

    2016-12-01

    The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

  9. The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study.

    Science.gov (United States)

    Ghandi, Sedigheh; Aflatoonian, Abbas; Tabibnejad, Nasim; Moghaddam, Mohammad Hossein Sojoodi

    2011-07-01

    Comparing the effects of metformin or orlistat on hormone, lipid profile and ovulation status in obese women with polycystic ovary syndrome. A total of 80 women were prospectively recruited to receive either metformin (n = 40) or orlistat (n = 40). Weight, BMI, waist, serum LH, total serum testosterone and lipid profile were assessed at baseline and after 3 months. The subjects' ovulatory status was assessed after 3 months. There was no significant difference in ovulation between the two treatment groups (30% vs 15%). Treatment with either drug showed a significant decline in body weight, BMI (Body Mass Index), and waist circumference, but the degree of decline in both groups was the same. Patients who were treated with orlistat, showed a significant reduction in total testosterone and serum lipid. Women in metformin group showed a significant reduction in serum LH. Both metformin and orlistat showed a similar effect on weight loss and ovulation rates.

  10. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy. A secondary analysis

    International Nuclear Information System (INIS)

    Jham, B.C.; Chen, H.; Carvalho, A.L.; Freire, A.R.

    2009-01-01

    The aim of this study was to determine the impact of bethanechol administration concomitant to radiotherapy (RT) on oral mucositis, candidiasis and taste loss. We performed a secondary analysis of a previously conducted prospective randomized trial which evaluated the effect of bethanechol on salivary gland dysfunction before, during, and after RT for head and neck cancer (HNC), in comparison to artificial saliva. Mucositis, candidiasis and taste loss were analyzed in 36 patients. Mucositis was scored using the World Health Organization (WHO) method; candidiasis was diagnosed by means of clinical examination, whereas taste loss was assessed by the patients' subjective report of absence of taste. No significant differences were observed between groups in relation to frequency and severity of mucositis or frequency of candidiasis and taste loss. In conclusion, bethanechol does not appear to reduce the incidence of mucositis, candidiasis, and taste loss when administered during RT. (author)

  11. Time from first detectable PSA following radical prostatectomy to biochemical recurrence: A competing risk analysis

    NARCIS (Netherlands)

    L. De Boo (Leonora); M. Pintilie (Melania); P. Yip (Paul); J. Baniel (Jack); N.E. Fleshner (Neil); D. Margel (David)

    2015-01-01

    textabstractIntroduction: In this study, we estimated the time from first detectable prostate-specific antigen (PSA) following radical prostatectomy (RP) to commonly used definitions of biochemical recurrence (BCR). We also identified the predictors of time to BCR. Methods: We identified subjects

  12. Intravenous paracetamol for relief of pain during transrectal-ultrasound-guided biopsy of the prostate: A prospective, randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Ozcan Kilic

    2015-11-01

    Full Text Available Transrectal-ultrasound-guided prostate biopsy (TRUS-PBx is the standard procedure for diagnosing prostate cancer. The procedure does cause some pain and discomfort; therefore, an adequate analgesia is necessary to ensure patient comfort, which can also facilitate good-quality results. This prospective, randomized, double-blinded, placebo-controlled study aimed to determine if intravenous (IV paracetamol can reduce the severity of pain associated with TRUS-PBx. The study included 104 patients, scheduled to undergo TRUS-PBx with a suspicion of prostate cancer, that were prospectively randomized to receive either IV paracetamol (paracetamol group or placebo (placebo group 30 minutes prior to TRUS-PBx. All patients had 12 standardized biopsy samples taken. Pain was measured using a 10-point visual analog pain scale during probe insertion, during the biopsy procedure, and 1 hour postbiopsy. All biopsies were performed by the same urologist, whereas a different urologist administered the visual analog pain scale. There were not any significant differences in age, prostate-specific antigen level, or prostate volume between the two groups. The pain scores were significantly lower during probe insertion, biopsy procedure, and 1 hour postbiopsy in the paracetamol group than in the placebo group. In conclusion, the IV administration of paracetamol significantly reduced the severity of pain associated with TRUS-PBx.

  13. Prostatectomy-based validation of combined urine and plasma test for predicting high grade prostate cancer.

    Science.gov (United States)

    Albitar, Maher; Ma, Wanlong; Lund, Lars; Shahbaba, Babak; Uchio, Edward; Feddersen, Søren; Moylan, Donald; Wojno, Kirk; Shore, Neal

    2018-03-01

    Distinguishing between low- and high-grade prostate cancers (PCa) is important, but biopsy may underestimate the actual grade of cancer. We have previously shown that urine/plasma-based prostate-specific biomarkers can predict high grade PCa. Our objective was to determine the accuracy of a test using cell-free RNA levels of biomarkers in predicting prostatectomy results. This multicenter community-based prospective study was conducted using urine/blood samples collected from 306 patients. All recruited patients were treatment-naïve, without metastases, and had been biopsied, designated a Gleason Score (GS) based on biopsy, and assigned to prostatectomy prior to participation in the study. The primary outcome measure was the urine/plasma test accuracy in predicting high grade PCa on prostatectomy compared with biopsy findings. Sensitivity and specificity were calculated using standard formulas, while comparisons between groups were performed using the Wilcoxon Rank Sum, Kruskal-Wallis, Chi-Square, and Fisher's exact test. GS as assigned by standard 10-12 core biopsies was 3 + 3 in 90 (29.4%), 3 + 4 in 122 (39.8%), 4 + 3 in 50 (16.3%), and > 4 + 3 in 44 (14.4%) patients. The urine/plasma assay confirmed a previous validation and was highly accurate in predicting the presence of high-grade PCa (Gleason ≥3 + 4) with sensitivity between 88% and 95% as verified by prostatectomy findings. GS was upgraded after prostatectomy in 27% of patients and downgraded in 12% of patients. This plasma/urine biomarker test accurately predicts high grade cancer as determined by prostatectomy with a sensitivity at 92-97%, while the sensitivity of core biopsies was 78%. © 2018 Wiley Periodicals, Inc.

  14. The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

    Science.gov (United States)

    Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

    2015-12-01

    A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

  15. Best laser for prostatectomy in the year 2013

    OpenAIRE

    Pankaj N Maheshwari; Nitin Joshi; Reeta P Maheshwari

    2013-01-01

    Lasers have come a long way in the management of benign prostatic hyperplasia. Over last nearly two decades, various different lasers have been utilized for prostatectomy. Neodymium: yttrium-aluminum-garnet laser that started this journey, is no longer used for prostatectomy. Holmium laser can achieve transurethral enucleation of the prostatic adenoma producing a fossa that can be compared with the fossa after Freyer's prostatectomy. Green light laser has a short learning curve, is nearly blo...

  16. Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

    Science.gov (United States)

    Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

    2016-03-01

    Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and mature striae of the abdomen. © 2016 Wiley Periodicals, Inc.

  17. Statin use and risk of disease recurrence and death after radical prostatectomy.

    Science.gov (United States)

    Keskiväli, Teemu; Kujala, Paula; Visakorpi, Tapio; Tammela, Teuvo L J; Murtola, Teemu J

    2016-04-01

    Statins have been linked with improved prostate cancer survival and lower risk of recurrence in men treated with radiation therapy. However, the association is unclear for surgically-treated men. We studied the risk of prostate cancer recurrence and death by statin usage after radical prostatectomy in a cohort of prostate cancer patients treated with radical prostatectomy. A cohort of 1,314 men who underwent curative-intent radical prostatectomy at the Tampere University Hospital, Tampere, Finland during 1995-2009 were linked to national prescription database to obtain detailed information on statin purchases. The risk of PSA recurrence and death (overall and prostate cancer-specific) by statin use before and after the surgery were evaluated using Cox regression with model adjustment for tumor characteristics, total cholesterol and simultaneous use of antidiabetic and antihypertensive drugs. Tissue expression of putative prognostic markers were measured from a subgroup of 323 men. During the median follow-up of 8.6 years after surgery 484 men recurred, while 244 men died (32 due to prostate cancer). In general statin use before or after prostatectomy was not associated with risk of disease recurrence or death. Tissue expression of Ki-67 and ERG modified the association between statin use and risk of disease recurrence; the risk estimates were lower in men with Ki-67 expression above the median (P for interaction 0.001 and 0.004 for statin use before and after prostatectomy, respectively) and no ERG expression in the tumor tissue (P for interaction 0.006 and 0.011). Statin use generally did not affect prostate cancer prognosis after prostatectomy. The effect on disease recurrence may depend on tumor properties, such as proliferation activity. Thus possible future prospective studies should recognize and enroll subgroups of prostate cancer patients most likely to benefit from statins. © 2015 Wiley Periodicals, Inc.

  18. Hemodialysis without Systemic Anticoagulation: A Prospective Randomized Trial to Evaluate 3 Strategies in Patients at Risk of Bleeding

    Science.gov (United States)

    Guéry, Bruno; Alberti, Corinne; Servais, Aude; Harrami, Elarbi; Bererhi, Lynda; Zins, Brigitte; Touam, Malik; Joly, Dominique

    2014-01-01

    Objective In this clinical trial, we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization. Methods This open-label monocentric randomized « n-of-one » trial, conducted in a single tertiary care center, recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions. All patients underwent hemodialysis with an AN69ST dialyzer, and were administered three alternative dialysis procedures in a random sequence: intermittent saline flushes, constant saline infusion, or pre-dialysis heparin coating of the membrane. The primary outcome was the need to interrupt the dialysis session because of clotting events due to either (i) a complete coagulation of the circuit; (ii) a partial coagulation of the circuit; (iii) a>50% rise over baseline in the venous pressure. Results At the end of the inclusion period (May, 2007 to December, 2008), the number of patients to include (n = 75) was not reached: only 46 patients were included and underwent randomization. The study was terminated, and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data. Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events: odds ratio 0.3 (CI 95% 0.2 to 0.6; p3 h dialysis sessions and for having complete blood restitution. There were no significant effects of the dialysis procedure on weight loss, online ionic dialysance, and adverse events. Conclusion Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation. However, results are not generalizable safely to patients with active bleeding, since weak heparinemia, not assessed in this study, may occur. Trial Registration ClinicalTrials.gov NCT00473109. PMID

  19. A prospective randomized study of conservative versus surgical treatment of unstable palmar plate disruption in the proximal interphalangeal finger joint

    DEFF Research Database (Denmark)

    Werlinrud, Jens Christian; Petersen, Kirstin; Lauritsen, Jens

    2013-01-01

    study in which 83 patients were randomly assigned into 2 groups: (1) conservative treatment with a rigid splint for 2 weeks, (2) surgical reattachment of the palmar plate in local anesthesia followed by 2 weeks of immobilization in a plaster cast. Both groups were thereafter treated by taping...... to the neighboring finger for 3 weeks. With regard to hyperextension instability, stiffness, and pain, there is no significant difference in outcome between patients with traumatic palmar plate lesions and hyperextension instability treated with surgical repair and patients treated conservatively with a splint. We...

  20. Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

    Science.gov (United States)

    Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

    2015-09-01

    Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with

  1. Intravenous Lidocaine for Effective Pain Relief After a Laparoscopic Colectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

    Science.gov (United States)

    Ahn, EunJin; Kang, Hyun; Choi, Geun Joo; Park, Yong Hee; Yang, So Young; Kim, Beom Gyu; Choi, Seung Won

    2015-01-01

    A perioperative intravenous lidocaine infusion has been reported to decrease postoperative pain. The goal of this study was to evaluate the effectiveness of intravenous lidocaine in reducing postoperative pain for laparoscopic colectomy patients. Fifty-five patients scheduled for an elective laparoscopic colectomy were randomly assigned to 2 groups. Group L received an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Group C received the same dosage of saline at the same time. Postoperative pain was assessed at 2, 4, 8, 12, 24, and 48 hours after surgery by using the visual analog scale (VAS). Fentanyl consumption by patient-controlled plus investigator-controlled rescue administration and the total number of button pushes were measured at 2, 4, 8, 12, 24, and 48 hours after surgery. In addition, C-reactive protein (CRP) levels were checked on the operation day and postoperative days 1, 2, 3, and 5. VAS scores were significantly lower in group L than group C until 24 hours after surgery. Fentanyl consumption was lower in group L than group C until 12 hours after surgery. Moreover, additional fentanyl injections and the total number of button pushes appeared to be lower in group L than group C (P < 0.05). The CRP level tended to be lower in group L than group C, especially on postoperative day1 and 2 and appeared to be statistically significant. The satisfaction score was higher in group L than group C (P = 0.024). Intravenous lidocaine infusion during an operation reduces pain after a laparoscopic colectomy. PMID:25785316

  2. Hartmann's Procedure or Primary Anastomosis for Generalized Peritonitis due to Perforated Diverticulitis: A Prospective Multicenter Randomized Trial (DIVERTI).

    Science.gov (United States)

    Bridoux, Valerie; Regimbeau, Jean Marc; Ouaissi, Mehdi; Mathonnet, Muriel; Mauvais, Francois; Houivet, Estelle; Schwarz, Lilian; Mege, Diane; Sielezneff, Igor; Sabbagh, Charles; Tuech, Jean-Jacques

    2017-12-01

    About 25% of patients with acute diverticulitis require emergency intervention. Currently, most patients with diverticular peritonitis undergo