Prospective Nonrandomized Controlled Study Research Articles

The efficacy and tolerability of scalp cooling in preventing chemotherapy-induced alopecia in patients with breast cancer receiving anthracycline and taxane-based chemotherapy in an Asian setting.

Scalp cooling has been shown in several studies to be an effective method in preventing chemotherapy-induced alopecia (CIA). Data on the use of scalp cooling in Asian countries are limited, and evidence for its use and efficacy among our patients are not available. The aim of this study was to assess the effectiveness and tolerability of scalp cooling among breast cancer patients in our study population. Consecutive breast cancer patients receiving FE75C, FE100C, FE100C-D, docetaxel75 or docetaxel, and cyclophosphamide (TC) at our treatment center were recruited and allocated to the treatment (scalp cooling, DigniCapTM system) or control group in this prospective nonrandomized controlled study. The assessment of alopecia was carried out using the World Health Organization grading system and clinical photographs. Seventy patients were recruited, but only 25 completed the study and were evaluable for analysis. Five of 12 patients (42%) in the scalp cooling group managed to preserve hair. Two of three patients who received FE75C and TC regimens had minimal hair loss. All patients treated with FE100C had severe hair loss. Half of all patients who received scalp cooling throughout chemotherapy rated the treatment as reasonably well tolerated. The most common reason for discontinuing scalp cooling was intolerance to its side effects. Scalp cooling is potentially effective in reducing CIA caused by docetaxel, TC, and FE75C chemotherapy regimen. However, it was not well tolerated by our study population. The dropout rate was high, and this needs to be taken into consideration when pursuing further trials in a similar setting.

Concomitant nevirapine impacts pharmacokinetic exposure to the antimalarial artemether-lumefantrine in African children.

BackgroundThe antiretroviral drug nevirapine and the antimalarial artemisinin-based combination therapy artemether-lumefantrine are commonly co-administered to treat malaria in the context of HIV. Nevirapine is a known inhibitor of cytochrome P450 3A4, which metabolizes artemether and lumefantrine. To address the concern that the antiretroviral nevirapine impacts the antimalarial artemether-lumefantrine pharmacokinetics, a prospective non-randomized controlled study in children presenting with uncomplicated malaria and HIV in sub-Saharan Africa was carried out.MethodsParticipants received artemether-lumefantrine (20/120 mg weight-based BID) for 3 days during nevirapine-based antiretroviral therapy (ART) co-administration (158–266 mg/m2 QD). HIV positive participants who were not yet on ART drugs were also enrolled as the control group. The target enrollment was children aged 3–12 years (n = 24 in each group). Intensive pharmacokinetics after the last artemether-lumefantrine dose was assessed for artemether, its active metabolite dihydroartemisinin, and lumefantrine. Pharmacokinetic parameters (area under the plasma concentration vs. time curve (AUC), maximum concentration and day 7 lumefantrine concentrations) were estimated using non-compartmental methods and compared to controls.ResultsNineteen children (16 on nevirapine and three not on ART) enrolled. Fifteen of the 16 (aged 4 to 11 years) on nevirapine-based ART were included in the pharmacokinetic analysis. Due to evolving WHO HIV treatment guidelines, insufficient children were enrolled in the control group (n = 3), so the pharmacokinetic data were compared to a historical control group of 20 HIV-uninfected children 5–12 years of age who also presented with malaria and underwent identical study procedures. Decreases of pharmacokinetic exposure [as estimated by AUC (AUC0-8hr)] were marginally significant for artemether (by -46%, p = 0.08) and dihydroartemisinin (-22%, p = 0.06) in the children on nevirapine-based ART, compared to when artemether-lumefantrine was administered alone. Similarly, peak concentration was decreased by 50% (p = 0.07) for artemether and 36% (p = 0.01) for dihydroartemisinin. In contrast, exposure to lumefantrine increased significantly in the context of nevirapine [AUC0-120hr:123% (p<0.001); Cday7:116% (p<0.001), Cmax: 95% (p<0.001)].ConclusionsNevirapine-based ART increases the exposure to lumefantrine in pre-pubescent children with a trend toward diminished artemether and dihydroartemisinin exposure. These findings contrast with other studies indicating NVP reduces or results in no change in exposure of antimalarial drugs, and may be specific to this age group (4–12 years). Considering the excellent safety profile of artemether-lumefantrine, the increase in lumefantrine is not of concern. However, the reduction in artemisinin exposure may warrant further study, and suggests that dosage adjustment of artemether-lumefantrine with nevirapine-based ART in children is likely warranted.

Comparing effects of cervical anterior approach and laminoplasty in surgical management of cervical ossification of posterior longitudinal ligament by a prospective nonrandomized controlled study

IntroductionThe laminoplasty has been the most widely used surgical method for OPLL. In recent years, increasing attention has been drawn to the anterior operative approaches for surgical treatment of cervical OPLL. However, which method is the optimum selection for therapy of cervical OPLL is still obscure. Therefore, we performed this prospective nonrandomized clinical study in patients with multilevel cervical myelopathy due to OPLL and compare the therapeutic efficiency of laminoplasty and anterior approach (cervical discectomy and/or cervical corpectomy) in the management of multilevel cervical OPLL. HypothesisThere is no difference in clinical effects between anterior cervical spine surgery and laminoplasty in the treatment of multilevel cervical OPLL. Material and methodsA total of 150 consecutive patients with multilevels of cervical OPLL underwent anterior approaches (ACDF, ACCF and HDF) from July 2010 to June 2014, which were enrolled in this study. During the same period, one hundred and two patients receiving the laminoplasty were enrolled in the study. The clinical effects, alignment and range of motion (ROM) of cervical spine in patients of the anterior group and posterior group were assessed, respectively. The effects of high signals in T2 weighed MRI scans and percentage of spinal canal stenosis in these patients were also evaluated. Finally, postoperative complications regarding each group were analyzed. ResultsAlthough significant differences in types of OPLL and preoperative sagittal alignment of cervical spine occurred in the two groups (P<0.05), clinical effects of the two groups were similar (P>0.05). The cervical curvature in laminoplasty group showed significant decrease at final follow-up (P<0.05). For ROM of cervical spine, no significant alteration was observed in both groups. The high T2 weighed signals and rate of spinal canal stenosis can influence clinical effects of both anterior group and laminoplasty group. In addition, significantly higher complication rate was observed in laminoplasty group compared with anterior group (P<0.05). DiscussionBoth anterior and laminoplasty approaches can be considered effective and safe procedures in the treatment of the multilevel OPLL. However, the anterior approach with relatively lower incidence of postoperative complications is a better choice for cases with poor cervical curvature and serious spinal canal stenosis. Type of study and level of proofLevel 3 nonrandomized, controlled clinical trials.

Application of multimodal analgesia in radical gastrectomy for gastric cancer patients: a prospective nonrandomized controlled study

To compare the postoperative analgesia efficacy, rehabilitation parameters and complication between multimodal analgesia and traditional analgesia after radical gastrectomy for gastric cancer patients. Patients with gastric cancer who underwent surgery in our hospital from October 2016 to December 2016 were enrolled in this prospective study. According to the non-randomized method, patients were assigned to multimodal analgesia group(n=32) and traditional analgesia group(n=33) in gastric cancer treatment team A and B in Department of Gastrointestinal Surgery, West China Hospital, Sichuan University. The treatment measures of group A were as follows: (1) The ratio of 1/1 diluted ropivacaine (100 mg, 10 ml) was infiltrated around the incision before abdomen closure, with incision sutured layer by layer. (2) Parecoxib sodium (40 mg) was injected intravenously every 12 hours after operation for 5 days. (3) Oxycodone-acetaminophen tablet was given orally on the first day or the second day after operation, 50 mg twice a day. (4) Patient-controlled analgesia was not used after operation. Patients in group B received direct suture of incision and patient-controlled analgesia. The pain score, postoperative rehabilitation and 30-day postoperative complications were collected and analyzed. Multimodal analgesia group had lower pain scores at 1 d (4.8±0.9), 2 d (4.3±1.0), 3 d (2.9±0.8), 4 d (2.4±0.7) and 5 d (1.7±0.7) after surgery, as compared to traditional analgesia group (5.9±0.9, P=0.000), (5.1±0.7, P=0.001), (3.9±0.8, P=0.000), (3.0±0.6, P=0.000), (2.6±0.7, P=0.000), with significant difference. Postoperative hospital stay [(8.2±1.6) days vs. (10.6±2.2) days, P=0.000], time to ambulation [(47.5±13.8) days vs. (66.2±16.8) days, P=0.000], time to first flatus [(76.4±25.2) days vs. (120.0±29.9) days, P=0.000], time to first defecate [(117.3±42.2) days vs. (159.7±30.7) days, P=0.000] and time to first fluid diet [(83.8±21.6) days vs. (141.9±33.9) days, P=0.000] in the multimodal analgesia group were significantly shorter than those in the traditional analgesia group. There was no significant difference between the two groups with respect to 30-day postoperative complication rate(9.4% vs. 9.1%, P=1.000). Multimodal analgesia can significantly reduce the postoperative pain and is beneficial to rehabilitation, meanwhile it does not increase the risk of postoperative complications. Multimodal analgesia is safe and effective for gastric cancer patients undergoing radical gastrectomy.

Learning Curve Associated With an Automated Laparoscopic Suturing Device Compared With Laparoscopic Suturing.

Laparoscopic suturing has proved to be a challenging skill to master which may prevent surgical procedures from being started, or completed, in a minimally invasive fashion. The aim of this study is to compare the learning curves between traditional laparoscopic techniques with a novel suturing device. In this prospective single blinded nonrandomized controlled crossover study, we recruited 19 general surgery residents ranging from beginner (PGY1-2, n = 12) to advanced beginner (PGY3-5, n = 7). They were assigned to perform a knot tying and suturing task using either Endo360 or traditional laparoscopic technique (TLT) with needle holders before crossing over to the other method. The proficiency standards were developed by collecting the data for task completion time (TCT in seconds), dots on target (DoT in numbers), and total deviation (D in mm) on 5 expert attending surgeons (mean ± 2SD). The test subjects were "proficient" when they reached these standards 2 consecutive times. Number of attempts to complete the task was collected for Endo360 and TLT. A significant difference was observed between mean number of attempts to reach proficiency for Endo360 versus TLT ( P = .0027) in both groups combined, but this was not statistically significant in the advanced beginner group. TCT was examined for both methods and demonstrated significantly less time to complete the task for Endo360 versus TLT ( P < .0001). There were significantly less DoT for Endo360 as compared with TLT ( P < .0001), which was also associated with significantly less D ( P < .0001) indicating lower accuracy with Endo360. However, no significant difference was observed between the groups for increasing number of trials for both DoT and D. This novel suturing device showed a shorter learning curve with regard to number of attempts to complete a task for the beginner group in our study, but matched the learning curve in the advanced beginner group. With regard to time to complete the task, the device was faster in both groups.

Results of transanal mesorectumectomy in patients with rectal cancer

Objective : comparative analysis of specific perioperative features and pathological characteristics of the removed sample after laparoscopic total mesorectumectomy (Lap-TME) and transanal total mesorectumectomy (Ta-TME). Materials and methods . A prospective non-randomized controlled study was carried out from November 2013 until September 2016. Patients with сТ1–4aN0–2M0 cancer of low- or medium-ampullar section of rectum were enrolled. Results . 55 and 54 patients were included in the Ta-TME and Lap-TME groups respectively. Duration of surgery was 285 min (Ta-TME group) and 260 min (Lap-TME group); median volume of blood loss was less than 100 ml; duration of hospital stay after surgery was 7 days in both groups. 1 (1.8 %) patient from Ta-TME group and 3 (5.6 %) patients from the control group had conversion to open surgery (р = 0.223). Transanal removal of the sample was done in 53.7 % of the cases in Ta-TME group and 25.5 % of the cases in Lap-TME group (p = 0.008). Complications were registered in 27,3 and 24,1 % of the patients respectively (р = 0,436). 90.9 % of the patients from Ta-TME group had Grade 2–3 quality of mesorectumectomy, while in Lap-TME group this parameter was 85.2 % (p = 0.266). Circumferential resection margin damage was observed in 7.3 % of cases from Ta-TME group and 9.3 % of cases from Lap-TME group (p = 0.488). Conclusion . Ta-TME does not worsen short-term oncological results. Further randomized studies are required to identify those patients who would benefit from bottoms up mesorectumectomy.

Effect of double-J stent indwelling time in treatment of ureteric calculi complicated with infection

To evaluate the effect and double-J stent indwelling time in the treatment of acute upper urinary tract infection caused by ureteral calculi. A prospective non-randomized controlled study was carried out. From January 2011 to August 2015, a total of 142 patients treated in Department of Urology of Shanghai First People's Hospital for ureteral calculi with systematic inflammatory response syndrome were divided into double-J stent indwelling 7 days group (n=63) and double-J stent indwelling > 7 days group (n=79). The preoperative routine blood test, urinalysis, and urine culture, the urinalysis and urine culture immediately after double-J indwelling, and the routine blood test, urinalysis, and urine culture 7 days after indwelling were compared between the two groups. Postoperative complications after lithotripsy were analyzed. There were no statistically significant differences in preoperative blood white blood cell (WBC) count, urine WBC count, and positive bacterial culture between the two groups (all P>0.05). Seven days after double-J stent indwelling, significant improvement was seen in both the 7 d group and the >7 d group in blood WBC count, urine WBC count, and positive urine culture [(8.1±1.7) vs (14.8±3.1) ×10(9)/L, (356±44) vs (3 077±643)/μl, 1.6% vs 52.4%; (7.9±1.1) vs (15.1±3.8) ×10(9)/L, (363±52) vs (3 122±805)/μl, 3.8% vs 48.1%], and infection was managed effectively, while no statistically significant inter-group differences were observed. There was no significant difference in stone clearance rate between the two groups (96.8% vs 96.2%, P>0.05). There was no significant difference in the incidence of postoperative complications, especially infectious complications (all P>0.05). Indwelling double-J stents for 7 days could effectively manage the infection in patients with acute upper urinary tract infection secondary to ureteral calculi. These patients can be treated with lithotripsy safely. The time of double-J stent indwelling could be shortened.

Is Serum Total LDH Evaluation Able to Differentiate between Alimentary Lymphoma and Inflammatory Bowel Disease in a Real World Clinical Setting?

ContextAn increase in enzyme lactate dehydrogenase (LDH) in serum is a negative prognostic factor for survival in cats affected by lymphoma. Measuring LDH at the time of diagnosis has been studied for differentiating neoplastic disease from non-neoplastic disease in dogs. Inflammatory bowel disease (IBD) and alimentary lymphoma are common diseases in cats.ObjectiveThe aim of this study was to determine whether elevation of total LDH occurred in cats with alimentary lymphoma and non-neoplastic gastrointestinal disease, such as IBD, and to evaluate whether this enzyme is useful in supporting the differential diagnosis of these specific diseases.Materials and MethodsA prospective non-randomized controlled study was carried-out in a real world setting of three Italian private veterinary clinics. Seventy-one client-owned cats with a history of chronic gastrointestinal symptoms were enrolled; 33 cats were histologically diagnosed as having alimentary lymphoma and 38 cats as having IBD. Serum samples of total LDH analysis were measured.ResultsGender (P = 0.016) and age (P = 0.046) were found to be significant factors influencing the differentiation of serum total LDH between cats with alimentary lymphoma and those with IBD. Despite low diagnostic accuracy in the overall population (63%), a cut-off value of serum total LDH ranging from 0.85- to 1.04-times the upper reference limit showed good capability (accuracy >80%) of differentiating these two conditions in neutered males and cats younger than 8 years of age (AUC: 0.805, 0.833; sensitivities: 76.9%, 83.3%; specificities: 80.0%, 76.5%; PPV: 76.9%, 55.6%; NPV: 80.0%, 92.9%; respectively).ConclusionsAlthough our study showed that gender and age are significant factors in differentiating serum total LDH between cats with alimentary lymphoma and those with IBD, this test had poor diagnostic accuracy in differentiating between these two conditions in the overall population.

Todetermine the effects of addition of magnesium sulphate to Bupivacaine-fentanyl spinal anaesthesia with respect to sensory and motor blockade

Background: One of the recent additions to the list of adjuvants that are used intrathecally, is Magnesium. It may improve the quality and duration of spinal anaesthesia. It acts by blocking the N-methyl-D-asparate (NMDA) channels in a voltage dependent way, reducing NMDA – induced currents. While the systemic use of Magnesium sulphate (MgSO4) reduces the postoperative opioid requirements, its intrathecal use is not evaluated extensively. Objectives: To determine the effect of addition of magnesium sulphate to Bupivacaine – fentanyl spinal anaesthesia with respect to onset of sensory and motor blockade, duration of analgesia and adverse effects if any. Methods: A prospective non-randomized controlled study was designed to compare the effects of addition of 50 mg of Magnesium sulphate (MgSO4) to Bupivacaine – fentanyl spinal anaesthesia. All adult patients undergoing lower abdominal and lower limb surgeries under Spinal Anaesthesia in the department of anaesthesiology at Vijayanagar Institute of Medical Sciences (VIMS), Bellary were included in the study. Results: The mean onset of sensory and motor blockade, peak sensory time were comparable between the two groups (p>0.05) however there was statistically significant difference between the groups with respect to duration of analgesia (128±8.6 min in fentanyl group and 136±13.1 min in fentanyl magnesium group, p=0.001) and the sedation score (p=0.001). Conclusions: Addition of magnesium sulfate (50 mg) to intrathecal fentanyl (25 ?g) for elective lower abdominal and limb surgeries has prolonged the duration of fentanyl analgesia without any significant side effects. Keywords: Bupivacaine, Fentanyl, Spinal anaesthesia, Sensory and motor blockad

Dominant Eye and Visual Evoked Potential of Patients with Myopic Anisometropia.

A prospective nonrandomized controlled study was conducted to explore the association between ocular dominance and degree of myopia in patients with anisometropia and to investigate the character of visual evoked potential (VEP) in high anisometropias. 1771 young myopia cases including 790 anisometropias were recruited. We found no significant relation between ocular dominance and spherical equivalent (SE) refraction in all subjects. On average for subjects with anisometropia 1.0–1.75 D, there was no significant difference in SE power between dominant and nondominant eyes, while, in SE anisometropia ≥1.75 D group, the degree of myopia was significantly higher in nondominant eyes than in dominant eyes. The trend was more significant in SE anisometropia ≥2.5 D group. There was no significant difference in higher-order aberrations between dominant eye and nondominant eye either in the whole study candidates or in any anisometropia groups. In anisometropias >2.0 D, the N75 latency of nondominant eye was longer than that of dominant eye. Our results suggested that, with the increase of anisometropia, nondominant eye had a tendency of higher refraction and N75 wave latency of nondominant eye was longer than that of dominant eye in high anisometropias.

Neuroprotection of the rat’s retinal ganglion cells against glutamate-induced toxicity

Purpose Glutamate is one of the contributors to retinal ganglion cells degeneration. The potential neuroprotective function of taurine, which is an endogenous amino acid molecule in the retina, was investigated. Materials and methods A prospective comparative nonrandomized controlled study was conducted from November 2012 to January 2015. A total of 24 adult male albino rats were divided into four groups. Balanced salt solution (BSS) (0.1 ml) was injected intravitreally in the control group, and 0.1 ml of glutamate (40 nmol) was injected once intravitreally in the glutamate group. Taurine of 25 mg/kg was injected once intraperitoneally in the taurine group. In the fourth group, 0.1 ml of glutamate was injected intravitreally, and at the same time, each rat received taurine intraperitoneally. Three days after the injection, animals were killed, and eyes were enucleated and processed for histopathological and immunohistochemical staining for glial fibrillary acidic protein, synaptophysin, vascular endothelial growth factor, and caspase-3. Results Extensive damage and disruption of the structure of the retina with significant decrease in the mean total, outer, and inner retinal thickness and ganglion cell counts was found following glutamate intravitreal injection, with significant improvement of this picture in the taurine and the combined groups (P Conclusion Taurine protects the retina against glutamate excitotoxicity and could have clinical implications in protecting the ganglion cells from several ophthalmic diseases such as glaucoma and diabetic retinopathy.

Treatment Rationale and Study Design for Clinical Trial on the Efficacy of UFT/LV for Stage II Colorectal Cancer With Risk Factors for Recurrence (JFMC46-1201)

BackgroundThe usefulness of adjuvant chemotherapy for stage II colon cancer has not been established. Meanwhile, the presence of stage II colon cancer with high-risk factors for recurrence has been reported. To our knowledge, no prospective study of adjuvant chemotherapy for stage II colon cancer with high-risk factors has been implemented to date. Patients and MethodsThis study is a prospective nonrandomized controlled study based on patients' selection of treatment option, including randomized therapeutic decision-making, to evaluate the usefulness of adjuvant chemotherapy with tegafur-uracil (UFT) with leucovorin (LV) for stage II colon cancer with high-risk factors for recurrence, compared with surgery alone. Five courses of UFT/LV therapy will be given as follows: UFT (300 mg/m2/d) with LV (75 mg/d) will be orally administered in 3 doses per day. Treatment will be received daily for 28 days, followed by a 7-day rest or will be received daily for 5 days, followed by a 2-day rest. For both regimens, 1 course will last 5 weeks, and 5 courses will be given. The primary end point is disease-free survival. A propensity score matching will be conducted based on 7 variables that represent risk factors to minimize selection bias in a comparison between the nonrandomized arms. For this nonrandomized comparison, a target sample size is set at 1200 (400 and 800 patients for the surgery alone and UFT/LV groups, respectively) and 1720 patients will be enrolled. In this study we aim to evaluate the therapeutic usefulness of adjuvant chemotherapy with UFT/LV for stage II colorectal cancer with risk factors for recurrence.

Prospective controlled pilot study of arteriovenous fistula placement using the novel Optiflow device

Arteriovenous fistula (AVF) maturation failure remains a significant problem with reported early failure rates around 50%. Suboptimal hemodynamics, variable surgical skills, and technique dependency are widely believed to contribute to AVF nonmaturation. The Optiflow (Bioconnect Systems, Ambler, Pa) is a novel anastomotic device placed in situ that has potential for improving hemodynamics and standardizing AVF placement. We report results from a prospective nonrandomized controlled pilot study designed to investigate the safety and performance of the Optiflow. Forty-one participants underwent AVF formation using either a 3-mm or 4-mm Optiflow and 39 matched control participants underwent AVF formation using the standard technique at two sites. Patients were observed for 90 days after AVF placement. The primary end point was unassisted maturation, which was defined as an outflow vein with a diameter ≥5 mm and blood flow ≥500 mL/min measured by Doppler ultrasound. The secondary performance end point was unassisted patency, and the primary safety end point was freedom from device-related serious adverse events. Unassisted maturation rates at 14, 42, and 90 days were 76%, 72%, and 68%, respectively, for the Optiflow group and 67%, 68%, and 76%, respectively, in the control group (P = .38, .69, and .47 at 14, 42, and 90 days). There was a trend to earlier maturation (assessed at 14 days) in the 4-mm Optiflow group compared with the control group (P = .059). There were no device-related serious adverse events. Maturation results for both the Optiflow and control groups were highly favorable compared with historical assisted maturation rates of approximately 50%. The Optiflow appears to be safe and effective in the placement of AVFs, with high maturation rates.

Clinical outcome evaluation of selective laser trabeculoplasty as the initial therapy for primary open angle glaucoma

Background Selective laser trabeculoplasty (SLT) is one of common therapies for early-stage primary open angle glaucoma (POAG).However,it always been used as a method of treating medically uncontrolled open angle glaucoma in China.So the assessment of efficacy of SLT as the initial therapy for POAG is still lack.Objective This clinical study was to compare the efficacy of SLT in early-stage POAG eyes with or without primary medical therapy.Methods A prospective non-randomized controlled study was designed.Sixty-five eyes of 37 patients with early-stage POAG were divided into without pre-treated group (30 eyes of 16 patients) and with pretreated group (35 eyes of 21 patients).SLT was performed on the inferior trabecular meshwork of 180° in all the patients aged 12-57 years old using a 532 nm frequency-doubled,Q-switched Nd:YAG laser with the pulse 3 ns,spot diameter 400 μm.The emitting energy was set from an initial energy of 0.6 mJ to decreased energy successively at 0.1 mJ interval till bubbles coming out.The following-up was 6 months.Primary outcome of SLT included the changes of intraocular pressure (IOP) and effective rate,and the secondary outcome included the perimetry and C/D value.The safety index was evaluated as the incidence of irritative symptom.Results After SLT 1 day to 6 months,the IOP was lower than that before SLT in all the patients (all at P＜0.05).The IOP was (24.03± 3.76)mmHg and (19.18±3.86)mmHg respectively at preoperation and postoperative 1 month in without pretreated group,with a mean decreasing value of (4.85 ±4.31)mmHg,in with pretreated group,the IOP was (23.63±4.29)mmHg at preoperation and (17.07±4.15)mmHg at postoperative 1 month,with a mean difference of (6.28±3.57)mmHg,with a significant difference in the IOP lowing value between the two groups (P =0.045),but there were no significant differences in the IOP lowing value between without and with pretreated groups in 1 hour,1 day,3 months and 6 months after SLT (all at P＞0.05).The effective rate was 75.00％ and 76.67％ in without and with pretreated groups respectively at the end of following-up (P =0.882).No obvious changes were seen in visual field and C/D value before and after SLT in both groups.Also,no serious complication was found in the patients during the following-up duration.Conclusions SLT has a good outcome in lowing-IOP for early stage POAG.There is no obvious impact to the clinical efficacy of SLT whether with or without the primary administration of anti-glaucomatous eye drops.Long-term effect of SLT remains to be observed. Key words: Glaucoma, open angle/surgery; Intraocular pressure; Laser therapy/method; Trabeculectomy/method; Selective laser trabeculoplasty; Prospective study

Effect of Tai Chi on Cognitive Performance in Older Adults: Systematic Review and Meta‐Analysis

To summarize and critically evaluate research on the effects of Tai Chi on cognitive function in older adults. Systematic review with meta-analysis. Community and residential care. Individuals aged 60 and older (with the exception of one study) with and without cognitive impairment. Cognitive ability using a variety of neuropsychological testing. Twenty eligible studies with a total of 2,553 participants were identified that met inclusion criteria for the systematic review; 11 of the 20 eligible studies were randomized controlled trials (RCTs), one was a prospective nonrandomized controlled study, four were prospective noncontrolled observational studies, and four were cross-sectional studies. Overall quality of RCTs was modest, with three of 11 trials categorized as high risk of bias. Meta-analyses of outcomes related to executive function in RCTs of cognitively healthy adults indicated a large effect size when Tai Chi participants were compared with nonintervention controls (Hedges' g = 0.90; P = .04) and a moderate effect size when compared with exercise controls (Hedges' g = 0.51; P = .003). Meta-analyses of outcomes related to global cognitive function in RCTs of cognitively impaired adults, ranging from mild cognitive impairment to dementia, showed smaller but statistically significant effects when Tai Chi was compared with nonintervention controls (Hedges' g = 0.35; P = .004) and other active interventions (Hedges' g = 0.30; P = .002). Findings from nonrandomized studies add further evidence that Tai Chi may positively affect these and other domains of cognitive function. Tai Chi shows potential to enhance cognitive function in older adults, particularly in the realm of executive functioning and in individuals without significant impairment. Larger and methodologically sound trials with longer follow-up periods are needed before more-definitive conclusions can be drawn.

Effect of yoga therapy on physical and psychological quality of life of perimenopausal women in selected coastal areas of Karnataka, India.

Background:Perimenopausal period is characterized by a continuous decline in ovarian function due to which women are vulnerable to various physical and psychological symptoms affecting their quality of life. Currently these symptoms are managed by hormone replacement therapy. However, hormonal therapy can cause complications including malignancy which has resulted in search for various alternative therapies to improve the quality of life (QOL). Yoga is one such alternative therapy shown to enhance the QOL at all stages of human life associated with the chronic illness. There are very few scientific studies regarding the effect of yoga on perimenopause and in this study we investigated the effects of yoga therapy on physical and psychological symptoms using the standardized questionnaire.Objective:To study the effect of yoga therapy on physical, psychological, vasomotor and sexual symptoms of perimenopause.Materials and Methods:It is a prospective non-randomized control study of 216 perimenopausal women with 12 weeks of intervention. The subjects were divided in two groups with either yoga therapy [n = 111] or exercise [n = 105] as the interventional tool. The symptoms control and QOL before and after intervention in both the groups were assessed by using the menopausal QOL questionnaire.Results:The perimenopausal symptoms in all the four domains were improved by yoga therapy, thus significantly improving the overall QOL compared to the control group.Conclusion:This study clearly demonstrates the effectiveness of yoga therapy in managing the distressing perimenopausal symptoms. It is easy, safe, non-expensive alternative therapy helping the well-being of perimenopausal women and must be encouraged in the regular management of perimenopausal symptoms.

Ankle Arthroscopy

More than 10,000 ankle arthroscopy procedures are performed in the United Kingdom annually. Tourniquet use is thought to allow improved visibility and reduce operative time. However this is not without risk as it predisposes to neurovascular injury. The purpose of our study was to establish the feasibility of a subsequent larger randomized controlled trial, to test the hypothesis that tourniquet use might be unnecessary in ankle arthroscopy. We performed a prospective nonrandomized case control study on 63 patients undergoing ankle arthroscopy to assess the feasibility of a randomized control trial comparing tourniquet versus no tourniquet. All patients had a tourniquet placed on the thigh and a standard arthroscopic technique. In 1 group (n = 31) the tourniquet was routinely inflated, whereas in a second group (n = 32) the tourniquet was not inflated. Demographic data, intraoperative fluid pressures, and visibility were recorded, as were any intraoperative or postoperative complications. There were no significant differences between the 2 groups with respect to duration of operation, maximum intraoperative fluid pressures or visibility, and postoperative complications. In no cases where a tourniquet was not used did the surgeon need to inflate the tourniquet during the case. Most orthopaedic surgeons continue to use a tourniquet routinely for ankle arthroscopy, presumably on the belief that a clear operative view can be achieved only with a tourniquet. The findings of our feasibility study revealed that ankle arthroscopy was possible without the use of a tourniquet. We propose a randomized clinical trial to determine the best option for patient care. Level III, comparative series.

Lower incidence of unexpected in-hospital death after interprofessional implementation of a bedside track-and-trigger system

BackgroundIn-hospital patients may suffer unexpected death because of suboptimal monitoring. Early recognition of deviating physiological parameters may enable staff to prevent unexpected in-hospital death. The aim of this study was to evaluate short- and long-term effects of systematic interprofessional use of early warning scoring, structured observation charts, and clinical algorithms for bedside action. MethodsA prospective non-randomized controlled study of unexpected in-hospital death before and after implementation of a clinical intervention in a medical and surgical ward setting at an urban Danish university hospital. Information was obtained over three four-month study periods – a pre-interventional one in 2009 (1st March–30th June), and two postinterventional ones in 2010 (1st September–31st December) and 2011 (1st March–30th June). The incidence of unexpected patient death, the primary study outcome, was calculated as the rate of unexpected patient mortality based on in-hospital risk time. ResultThe adjusted unexpected patient mortality rate was significantly lower during the second postinterventional study period than before the intervention, 17 versus 61 per 100 adjusted patient years (P=0.013), corresponding to a rate ratio of 0.271 (95% confidence interval (CI) 0.097–0.762). A tendency to reduced unexpected mortality was found during the first postinterventional study period (25 versus 61 per 100 adjusted patient years, P=0.053; rate ratio 0.404, CI 0.161–1.012). ConclusionClinical intervention comprising systematic monitoring practice, early warning scoring, an observation chart, and an algorithm for bedside management, implemented by interprofessional teaching, training, and optimization of communication and collaboration, may significantly reduce unexpected in-hospital mortality.

Perioperative outcomes after totally robotic gastric bypass: a prospective nonrandomized controlled study

BackgroundPerioperative short-term outcomes could be improved after totally robotic Roux-en-Y gastric bypass (TR-RYGBP) compared with conventional laparoscopic gastric bypass. MethodsThis is a nonrandomized controlled prospective study (N = 200) to evaluate perioperative short-term outcomes. The primary endpoint was to investigate risk factors for 30-day surgical complications. ResultsMean total operative time was shorter in patients who underwent TR-RYGBP (130 vs 147 minutes; P < .0001). However, postoperative surgical complications rate (13% vs 1%; P = .001), and mean overall hospital stay (9.3 vs 6.7 days; P < .0001) were higher after TR-RYGBP. By multivariate analysis, robotic surgery (hazard ratio [HR] = 15.1; 95% confidence interval [CI], 2.8 to 280; P = .01), and conversion to laparotomy (HR = 18.8; 95% CI, 1.7 to 250.8; P = .014) were independent risk factors for 30-day surgical complications. ConclusionsAlthough robotic gastric bypass reduces mean operative time, TR-RYGBP is associated with an increased postoperative surgical complications rate and longer hospitalization.

Coexistence of Internal Carotid Artery Stenosis in Patients with Abdominal Aortic Aneurysm

Background and ObjectivesAbdominal Aortic Aneurysm (AAA) and carotid disease have medical and social significance, considering their morbidity, disability, and economic consequences. The study objectives were to determine the prevalence of asymptomatic internal carotid artery (ICA) lesions ≥70% in patients with AAA, the correlation of AAA diameter with the degree of ICA stenosis and symptoms, and the importance of preventive ultrasound checkups.Subjects and MethodsA prospective non-randomized controlled study including 740 patients, aged from 18-85 years, who were suitable for the inclusion and exclusion criteria and reported at the vascular laboratory of the Institute for Vascular and Endovascular Surgery, Clinical Center of Serbia from 1st of December 2011 to the 1st of November 2012.ResultsThe prevalence of asymptomatic ICA stenosis ≥70% in patients with AAA is 10.8%. Male representatives have more symptomatic ICA stenosis ≥70%. Patients with small aneurysms more often have asymptomatic ICA stenosis ≥70%. The occurrence of symptoms of carotid disease was more prevalent among patients with ICA stenosis ≥70% compared to the group with stenosis <70%. There was no correlation found between the grade of ICA stenosis with the size of AAA.ConclusionThe prevalence of asymptomatic ICA stenosis ≥70% in patients with AAA is found to be 10.8%. Male patients with ICA stenosis ≥70% more often had symptoms of carotid disease. In the smaller aneurysms, ICA stenosis ≥70% occurs frequently, but without the symptoms of carotid disease, and there was no correlation between the size of AAA and the grade of ICA stenosis. Clinical implications of ICA imaging in patients with previously diagnosed AAA is necessary.