We need a prospective varicocelectomy trial.
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ABSTRACT:
SUBMITTER: Trussell JC
PROVIDER: S-EPMC4052753 | biostudies-literature | 2014 Jun
REPOSITORIES: biostudies-literature
Publications
We need a prospective varicocelectomy trial.
Trussell J C JC Ohl Dana A DA Krawetz Stephen A SA Snyder Peter J PJ Polotsky Alex J AJ Patrizio Pasquale P Christman Gregory M GM
Fertility and sterility 20140414 6
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Project description:ObjectiveTo review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy versus intrauterine insemination (IUI) for treatment of male infertility and to suggest means for improving future study recruitment.DesignSurvey of Reproductive Medicine Network (RMN) participating sites.SettingReproductive Medicine Network.Patient(s)None.Intervention(s)None.Main outcome measure(s)Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails.Result(s)This study screened seven and enrolled three couples, with the first couple randomized on June 30, 2010. The study was subsequently stopped on March 30, 2011. The following themes were cited most frequently by sites and therefore determined to be most likely to have played a role in suboptimal recruitment: [1] men must be screened at the beginning of a couple's infertility evaluation, [2] inclusion of infertile women who had failed previous fertility interventions appeared to be associated with the couple's intolerance of a placebo arm, and [3] an apparent bias against the use of unstimulated IUI cycles indicated a prejudicial preference for surgical intervention in the male partner.Conclusion(s)Improved recruitment may be realized through screening infertile men as early as possible while minimizing study-related time commitments. Focused patient education may promote improved equipoise and acceptance of a placebo arm in male infertility studies. Creative approaches to implementing varicocelectomy trials must be considered in addition to having a network of motivated researchers who carry a high volume of possible study participants because very large numbers may need to be screened to complete the clinical trial enrollment.
| S-EPMC3243664 | biostudies-literature
Project description:Varicocelectomy is the most commonly performed surgical procedure for the treatment of male infertility. Although several different techniques for varicocele repair have been described in the literature, microsurgical varicocelectomy performed through a subinguinal or inguinal incision is recognized as the gold-standard approach for varicocelectomy, due to high success rates with minimal complications. Standard indications for varicocelectomy include palpable varicocele(s), with one or more abnormal semen parameters, and, for the couple trying to conceive, in the setting of normal or correctable female infertility. However, varicocele repair is often recommended and undertaken for reasons other than infertility, including low serum testosterone, testicular pain, testicular hypotrophy and poor sperm DNA quality. This article reviews the technical aspects of microsurgical varicocelectomy, and its indications in adults and adolescents.
| S-EPMC3739135 | biostudies-literature
Project description:BackgroundVaricocele occurs as a result of dilatation of the pampiniform plexus in the spermatic veins. In this study, our primary aim was to evaluate the effect of Transversalis Fascia Plane Block (TFPB) on pain scores in the postoperative period in patients undergoing varicocelectomy surgery, and our secondary aim was to evaluate the effect of TFPB on analgesic consumption.MethodsThe study was initiated following local ethics committee approval, and sixty ASA I-II patients > 18y scheduled to undergo varicocelectomy and who consented to participation were enrolled. Before the procedure, the patients were randomly assigned two groups: Transversalis Fascia Plan block group (Group TFPB) or surgical incision site infiltration group (Group I).All surgeries were carried out under general anesthesia, and microsurgery using the subinguinal approach. After surgical suturing, TFPB and local infiltration blocks were applied prior to termination of anesthesia.For each block, 20 mL of 0.25% bupivacaine was utilized. Patients' demographic information, passive and active VAS ratings after surgery, usage of non steroidal anti-inflammatory medications and rescue analgesia, and the requirement for rescue analgesia, were recorded.ResultsA total of 60 patients were included in the study. In terms of demographic data, there was no difference between the groups. At all hours, there was a statistically significant decrease in favor of Group TFPB in terms of active and passive VAS scores (p < 0.001), non steroidal anti-inflammatory analgesic use (p < 0.05), and tramadol requirement (p < 0.001).ConclusionThis study has shown that TFPB can provide a more effective analgesia when compared to surgical site infiltration.
| S-EPMC9903451 | biostudies-literature
Project description:ObjectiveTo assess the efficacy of simvastatin 80 mg/day versus placebo in patients with noninfectious nonanterior uveitis receiving prednisolone ≥ 10 mg/day.DesignRandomized, double-masked, controlled trial.SubjectsAdult patients with noninfectious nonanterior uveitis on oral prednisolone dose of ≥ 10 mg/day.MethodsPatients were randomly assigned at a 1:1 ratio to receive either simvastatin 80 mg/day or placebo. A total of 32 patients were enrolled (16 in each arm), all of whom completed the primary end point, and 21 reached the 2-year visit (secondary end points).Main outcome measuresThe primary end point was mean reduction in the daily prednisolone dose at 12 months follow-up. Secondary end points were mean reduction in prednisolone dose at 24 months, percent of patients with a reduction in second-line immunomodulatory agents, time to disease relapse, and adverse events.ResultsOur results show that simvastatin 80 mg/day did not have a significant corticosteroid-sparing effect at 12 months (estimate: 3.62; 95% confidence interval [CI]: -8.15 to 15.38; P = 0.54). There was no significant difference between the groups with regard to prednisolone dose or change in dose at 12 and 24 months. There was no difference between the 2 groups in percent of patients with reduction in second-line agent by 24 months. Among patients who achieved disease quiescence, the median time to first relapse was longer for those receiving simvastatin (38 weeks, 95% CI: 14-54) than placebo (14 weeks, 95% CI: 12-52), although this was not statistically significant. There was no significant difference in adverse events or serious adverse events between the 2 groups.ConclusionsSimvastatin 80 mg/day did not have an effect on the dose reduction of corticosteroids or conventional immunomodulatory drugs at 1 and 2 years. The results suggest that it may extend the time to disease relapse among those who achieve disease quiescence.Financial disclosuresThe author(s) have no proprietary or commercial interest in any materials discussed in this article.
| S-EPMC10336795 | biostudies-literature
Project description:ObjectiveTo evaluate the impact of vitamin E supplementation on sperm analysis results in patients post-varicocelectomy.Martials and methodThis single-center, triple-blind, randomized controlled trial was conducted at Imam Reza Hospital, Mashhad, Iran. Ninety male patients, aged 15-25 years, with infertility and varicocele grade 2 or 3, were randomized into two groups. The intervention group received 400 units of vitamin E daily for 3 months, while the control group received a placebo. Sperm analysis was conducted before and 3 months after the intervention. Statistical analyses were performed using SPSS version 23, with significance set at P < 0.05.ResultsA total of 90 patients were enrolled and equally randomized into two groups (n = 45 per group). The mean age was 30.68 ± 6.31 years. Post-intervention, the improvement in sperm motility was significantly higher in the vitamin E group compared to the placebo group (P = 0.03). Both groups showed significant improvements in sperm motility, count, and morphology from pre- to post-intervention (P < 0.001).ConclusionVitamin E supplementation post-varicocelectomy is associated with improved sperm parameters, suggesting potential benefits in the management of male infertility related to varicocele. However, varicocelectomy alone also results in significant improvements.Trial registrationThis study is registered at the Iranian Registry of Clinical Trials (IRCT20200911048689N1). Registered on October 10, 2020.
| S-EPMC11786367 | biostudies-literature
Project description:The main goal of the present randomized clinical trial was to investigate the effects of subcutaneous administration of two different local anesthetics at trocar incision sites at the abdominal wall in combination with intraoperative intraperitoneal instillation of local anesthetics, on the character of postoperative pain, in adolescents who underwent laparoscopic varicocelectomy. A total of 60 patients with a median age of 16 years, who received laparoscopic varicocele repair, were included in this randomized clinical trial. The patients were randomly assigned to three study groups receiving 2% lidocaine, 0.5% levobupivacaine, or the control group. The Visual Analogue Scale (VAS) was used by a blinded nurse at four different time points (2, 6, 12 and 24 h after the surgery) to measure pain intensity. The significant effect of time on the pain intensity (p = 0.001) was found. Additionally, the interaction between time and different local analgesics (p < 0.001) was observed. In patients in whom 0.5% levobupivacaine has been used, significantly lower VAS pain scores were recorded at each time point assessed, in comparison with the patients who received 2% lidocaine or the patients from the control group in whom no local anesthetic was applied (p < 0.001). Furthermore, in patients in whom 2% lidocaine was administrated, significantly lower pain levels according to VAS were reported than in those from the control group, except for the time point at 24 h after surgery when pain levels were comparable. Concerning the postoperative pain control, the number of patients who requested oral analgesics postoperatively was significantly lower in the group of patients in whom local anesthetic was administrated intraoperatively (2% lidocaine-n = 4, 20%; 0.5% levobupivacaine-n = 1, 5%) compared to the patients who did not receive any local anesthetic during the surgery (n = 13; 65%) (p < 0.001). A significant reduction in postoperative pain intensity and analgesics consumption in patients undergoing laparoscopic varicocelectomy who received intraoperative local anesthetic was observed. The best effect on postoperative pain intensity, according to the VAS score, was achieved by 0.5% levobupivacaine.
| S-EPMC8622504 | biostudies-literature
Project description: Not available
| S-EPMC11840342 | biostudies-literature
Project description:The influence of varicocele and microsurgical varicocelectomy on semen quality remains unclear. Few studies have investigated the relationship between semen metabolism and the abnormalities in reproductive function caused by varicocele, however, there is no study on the changes of semen metabolism after microsurgical varicocelectomy. Here, we used the non-targeted and targeted metabolic analysis to investigate the different metabolites in seminal plasma within normal, varicocele, and varicocelectomy groups. We clearly showed that varicocele significantly affects semen metabolism, and microsurgical varicocelectomy can reverse this metabolic abnormality. Moreover, we characterized the landscape of three dipeptides in the seminal plasma of patients with varicocele that have not been identified previously in human tissues or biofluids. Interestingly, the levels of these three dipeptides decreased after microsurgical varicocelectomy coincident with an improvement in semen quality. Western blotting confirmed the downregulation of DPEP3 (dipeptidase 3) in the varicocele group and the upregulation of DPEP3 in the varicocelectomy group. Furthermore, we found that eight metabolites may be helpful to distinguish varicocele patients from normal subjects. Our results may be applied to earlier diagnosis or to predict the outcome of microsurgery for varicocele.
| S-EPMC8956711 | biostudies-literature
Project description:This was a prospective clinical trial testing the ability of gene expression models of drug sensitivity that were developed in human and canine cell lines and applied to outcomes in dogs treated with adjuvant carboplatin and/or doxorubicin. Tumor samples were collected prospectively, and gene expression analysis was conducted using Affymetrix Canine Genome 2.0 Arrays.
2021-07-20 | GSE180303 | GEO
Project description:BackgroundThis study compared the use of two commonly utilized dural closure techniques used in augmentation duraplasty for Chiari malformation I (CM I) and evaluated their efficacy and outcome in terms of quality of life assessments.MethodsThis prospective randomized study compared sutureless (DuraGen) and suturable (Dura-Guard) techniques in CM I decompression. Clinical parameters, cost analysis, and SF-36 Quality of Life Questionnaire (QLQ) were utilized to assess outcome.ResultsThirty-four patients were enrolled. Average age was 38.7 ± 12.2 years (mean ± SD (Standard Deviation)) and 82% of patients were female. Sixteen patients received DuraGen and 18 Dura-Guard. Age and gender were similar among groups. Postoperative complications did not differ between groups. Operative cost and time were less for DuraGen, whereas hospital stay was less with Dura-Guard, neither was statistically significant. Average QLQ scores at months 1, 2, and 3 improved in both groups. Dura-Guard patients showed greater improvement in quality of life at month 2 (P < 0.05) but groups did not differ at final survey. All patient's physical health (P < 0.005) and function (P < 0.005) were significantly improved. Outcome did not differ between groups and all patients showed significant improvement (P < 0.05).ConclusionBoth techniques are effective in reaching the goals of decompressive surgery for CM I and did not differ in quality of life at final survey. All patients showed significant improvement in physical function, physical health, and outcome following surgery. With all variables being equal the choice of duraplasty material may be based upon surgeon's preference.
| S-EPMC3604813 | biostudies-literature