No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya.
10-12岁男孩的No-flip ShangRing包皮环切术: 肯尼亚随机临床试验的结果。
- 作者列表："Al Hussein Alawamlh O","Awori QD","Barone MA","Kim SJ","Goldstein M","Li PS","Lee RK
BACKGROUND:Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya. METHODS:We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately. RESULTS:All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes. CONCLUSION:No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa. TRIAL REGISTRATION:ClinicalTrials.gov registration # NCT02390310.
背景: 最近人们的注意力转向使用器械辅助男性包皮环切术，以帮助扩大撒哈拉以南非洲的男性包皮环切服务，越来越重视年轻群体。我们评估了在肯尼亚参加两项随机临床试验的10至12岁男孩亚组中使用尚宁进行包皮环切术的情况。 方法: 我们对197名年龄在10 ~ 12岁的男孩进行了结果的子分析; 一个子集参加了两项随机临床试验，以评估在男性和男孩中使用无翻盖尚格林包皮环切术。一项试验评估了包皮环切术后7天的shangrying的自发脱离与计划移除。第二项试验比较了局部麻醉与注射麻醉与尚格林包皮环切术的使用。除了基线特征外，还分别收集和分析每个试验的数据。 结果: 所有受试者均成功行包皮环切术。在每个试验中，两组之间的包皮环切术持续时间、需要背侧切口的参与者、不良事件发生率、伤口完全愈合时间和参与者满意度相似.自发性上饶市脱离所需的平均时间为14.82 ± 3.76天。表面麻醉在施用时 (0.64 ± 1.71 vs. 1.55 ± 2.21，p = 0.03) 以及术后 (0.54 ± 0.88 vs. 1.72 ± 1.56，p<0.0001) 显示出显著较低的平均疼痛评分。局部麻醉剂的中位停留时间为43 (IQR: 35.5-60) 分钟，而注射麻醉剂起效的中位时间为2.04 (IQR: 1.72-3.09) 分钟。 结论: No-flip ShangRing包皮环切术在青少年男孩中具有积极的安全性，特别是年龄在10-12岁之间。在该年龄组中，自发装置脱离和表面麻醉的使用显示出有希望的结果。这可能有可能进一步提高ShangRing包皮环切术的可接受性，从而加速撒哈拉以南非洲男性包皮环切术服务的升级。 试验注册: clinicaltrials.Gov注册号 # nct02390310。
METHODS::Veterinary educators use models to allow repetitive practice of surgical skills leading to clinical competence. Canine castration is a commonly performed procedure that is considered a Day One competency for a veterinarian. In this study, we sought to create and evaluate a canine pre-scrotal closed castration model and grading rubric using a validation framework of content evidence, internal structure evidence, and relationship with other variables. Veterinarians (n = 8) and students (n = 32) were recorded while they performed a castration on the model and provided survey feedback. A subset of the students (n = 7) then performed a live canine castration, and their scores were compared with their model scores. One hundred percent of the veterinarians and 91% of the students reported that the model was helpful in training for canine castration. They highlighted several areas for continued improvement. Veterinarians' model performance scores were significantly higher than students', indicating that the model had adequate features to differentiate expert from novice performance. Students' performance on the model strongly correlated with their performance of live castration (r = .82). Surgical time was also strongly correlated (r = .70). The internal consistency of model and live rubric scores were good at .85 and .94, respectively. The framework supported validation of the model and rubric. The canine castration model facilitated cost-efficient practice in a safe environment in which students received instructor feedback and learned through experience without the risk of negatively affecting a patient's well-being. The strong correlation between model and live animal performance scores suggests that the model could be useful for mastery learning.
METHODS:PURPOSE:To investigate whether hexaminolevulinate-based (HAL) bladder tumor resection (TURBT) impacts on outcomes of patients with primary non-muscle-invasive bladder cancer (NMIBC) who were eventually treated with radical cystectomy (RC). METHODS:A total of 131 consecutive patients exhibiting NMIBC at primary diagnosis were retrospectively investigated whether they had undergone any HAL-guided TURBT prior to RC. Uni- and multivariable analyses were used to evaluate the impact of HAL-TURBT on cancer-specific (CSS) and overall survival (OS). The median follow-up was 38 months (IQR 13-56). RESULTS:Of the 131 patients, 69 (52.7%) were managed with HAL- and 62 (47.3%) with white light (WL)-TURBT only prior to RC. HAL-TURBT was associated with a higher number of TURBTs prior to RC (p = 0.002) and administration of intravesical chemotherapy (p = 0.043). A trend towards a higher rate of tumor-associated immune cell infiltrates in RC specimens (p = 0.07) and a lower utilization rate of post-operative systemic chemotherapy (p = 0.10) was noted for patients who were treated with HAL-TURBT. The 5-year CSS/OS was 90.9%/74.5% for the HAL-group and 73.8%/55.8% for the WL-group (p = 0.042/0.038). In multivariable analysis, lymph node tumor involvement (p = 0.007), positive surgical margins (p = 0.001) and performance of WL-TURBT only (p = 0.040) were independent predictors for cancer-specific death. CONCLUSIONS:The present data suggest that the resection of NMIBC under HAL exerts a beneficial impact on outcomes of patients who will need to undergo RC during their course of disease. This finding may be due to improved risk stratification as the resection under HAL may allow more patients to be treated timely and adequately.
METHODS:PURPOSE:To investigate the incidence of inguinal hernia following radical prostatectomy we compared the incidence after open retropubic radical prostatectomy with the incidence after the laparoscopic and robot-assisted radical prostatectomies, and using control groups. MATERIALS AND METHODS:We included all original articles on studies providing data on inguinal hernia incidence in patients treated with radical prostatectomy for localized prostate cancer. PubMed® and EMBASE® were searched on February 28, 2018. A meta-analysis was done as a weighted and pooled estimate of the incidence of inguinal hernia. The bias risk was assessed using the Newcastle-Ottawa Scale for cohort studies and the Cochrane Collaboration tool for randomized clinical trials. RESULTS:We included 54 studies with a total of 101,687 patients. The estimated incidence of inguinal hernia was 13.7% (95% CI 12.0-15.4) after open retropubic radical prostatectomy, 7.5% (95% CI 5.2-9.8) after laparoscopic radical prostatectomy and 7.9% (95% CI 5.0-10.9) after robot-assisted laparoscopic radical prostatectomy. In studies comparing the incidence of inguinal hernia after open prostatectomy vs no treatment the incidence was significantly higher in the radical prostatectomy group (11.7%, 95% CI 9.2-14.2 vs 3.3%, 95% CI 2.0-4.6). Two of 3 studies showed a significantly higher incidence after laparoscopic and robot-assisted radical prostatectomies compared with a control group. Most studies of intraoperative inguinal hernia prevention techniques demonstrated a significantly lower inguinal hernia incidence in the experimental group. Inguinal hernias that developed after radical prostatectomy were primarily indirect (81.9%, 95% CI 75.3-88.4). CONCLUSIONS:We found a high incidence of inguinal hernia following radical prostatectomy and hernias were primarily of the indirect type. The highest incidence of inguinal hernia was noted after open radical prostatectomy, followed by laparoscopic and robot-assisted radical prostatectomies. There was no significant difference between the laparoscopic and robot-assisted groups. The incidence of inguinal hernia was significantly higher after open radical prostatectomy than in control groups with some evidence to support the same finding for the laparoscopic and robot-assisted approaches. Promising results have been reported in studies of intraoperative prophylactic surgical techniques to reduce the postoperative incidence of inguinal hernia.