Prospective Nonrandomized Controlled Study Research Articles

Final analyses of the prospective controlled trial on the efficacy of uracil and tegafur/leucovorin as an adjuvant treatment for stage II colon cancer with risk factors for recurrence using propensity score-based methods (JFMC46-1201).

The efficacy of adjuvant chemotherapy for high-risk stage II colon cancer (CC) has not been well established. Using propensity score matching, we previously reported that the 3-year disease-free survival (DFS) rate was significantly higher in patients treated with uracil and tegafur plus leucovorin (UFT/LV) against surgery alone. We report the final results, including updated 5-year overall survival (OS) rates and risk factor analysis outcomes. In total, 1902 high-risk stage II CC patients with T4, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, and/or < 12 dissected lymph nodes were enrolled in this prospective, non-randomized controlled study based on their self-selected treatment. Oral UFT/LV therapy was administered for six months after surgery. Of the 1880 eligible patients, 402 in Group A (surgery alone) and 804 in Group B (UFT/LV) were propensity score-matched. The 5-year DFS rate was significantly higher in Group B than in Group A (P = 0.0008). The 5-year OS rates were not significantly different between groups. The inverse probability of treatment weighting revealed significantly higher 5-year DFS (P = 0.0006) and 5-year OS (P = 0.0122) rates in group B than in group A. Multivariate analyses revealed that male sex, age ≥ 70years, T4, < 12 dissected lymph nodes, and no adjuvant chemotherapy were significant risk factors for DFS and/or OS. The follow-up data from our prospective non-randomized controlled study revealed a considerable survival advantage in DFS offered by adjuvant chemotherapy with UFT/LV administered for six months over surgery alone in individuals with high-risk stage II CC. Japan Registry of Clinical Trials:jRCTs031180155(date of registration: 25/02/2019), UMIN Clinical Trials Registry:UMIN000007783 (date of registration: 18/04/2012).

Clinical efficacy of complex antioxidant therapy for pelvic varicose veins in women: A prospective non-randomized controlled study

Aim. To evaluate the clinical efficacy of complex antioxidant therapy (CAT) in the treatment of patients with pelvic varicose veins (PVV). Materials and methods. Patients with PVV (n=150) were divided into groups 1 and 2 of 75 subjects; the groups were comparable. Treatment in both groups included standard therapy with one of the venotropic agents (60 days). Patients of group 1 additionally received CAT for 30 days (1 course), in total 3 courses with 2-month intervals. Results. When assessing the parameters of the lipoperoxidation system (antioxidant protection) in group 1 during CAT combined with standard venotropic therapy, there was a statistically significant decrease in the levels of lipid hydroperoxides (p0.0001), diene conjugates (p=0.001), malonic dialdehyde (p0.0001), an increase in the levels of catalase (p0.0001), superoxide dismutase (p0.0001), glutathione peroxidase (p0.0001), glutathione reductase (p0.0001), glutathione-S-transferase (p=0.002) and the reduced glutathione content (p=0.032) compared to levels before treatment. The above group showed a decrease in the diameter of the pelvic varicose veins: internal iliac (p0.001), ovarian (p0.0001) and arcuate (p0.001), an increase in their blood flow velocity (p=0.003, 0.041, and 0.040, respectively), a decrease in the duration of retrograde flow to 0.3 cm. There was a decrease in pelvic pain (p0.0001), dysmenorrhea (p=0.024), dyspareunia (p=0.037), the frequency of irregular menstruation (p=0.031), an improvement in quality of life (p=0.047), pregnancy rate (p=0.013), the number of live births (p=0.004), and the duration of remission (p=0.047). Conclusion. The use of a combination of antioxidants superoxide dismutase 250 mg 2 times a day, acetyl-glutathione at 100 mg 2 times a day, and astaxanthin 400 mg/day for 30 days in 3 courses with 2-month intervals combined with venotropic therapy can significantly improve the treatment outcomes of patients with PVV.

Comparative safety and efficacy of percutaneous radiofrequency thermocoagulation and percutaneous balloon compression in CT-guided and local anesthesia for recurrent trigeminal neuralgia.

There are several ways to treat trigeminal neuralgia (TN); however, TN may recur after treatment. Although microvascular decompression (MVD) is considered an effective treatment for trigeminal neuralgia, patients with recurrence may not be willing to undergo craniotomy. This study compared the safety and efficacy of percutaneous radiofrequency thermocoagulation and percutaneous balloon compression for treating recurrent trigeminal neuralgia. This was a prospective non-randomized controlled study. A total of 52 with recurrent TN were scheduled to undergo surgery in our Hospital from January-June 2021. The patients were classified into percutaneous radiofrequency thermocoagulation (PRT) and percutaneous balloon compression (PBC) groups based on the treatment. All surgeries were performed under computed tomography guidance and local anesthesia. Post-operative complications were also observed. Pain was assessed using the visual analog scale (VAS) and Barrow Neurological Institute (BNI) scale. Efficacy indices were evaluated at 3, 6, 12, and 18 months after surgery. During follow-up, the efficacy rates of the two methods within 18 months were 76.0 and 88.9%, respectively. All patients had hypoesthesia on the affected side, and no severe complications. Notably, 5 patients (20%) in the PRT group with multiple-branch pain, including the first branch of the trigeminal nerve (V1) pain in the PRT group, received radiofrequency therapy for the supraorbital notch (foramen) after puncture of the foramen ovale. However, multiple pain episodes resolved with only one operation in the PBC group. CT-guided percutaneous radiofrequency thermocoagulation and percutaneous balloon compression under local anesthesia may be good options for treating recurrent trigeminal neuralgia. Percutaneous balloon compression may be recommended when multiple branches are involved, particularly in cases of V1 neuralgia.

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).

The impact of New Families home visiting program on first-time mothers’ quality of life and its association with social support: a non-randomized controlled study

BackgroundThe transition to motherhood is characterized by physical, psychological, social, and relational changes. Quality of life (QoL) changes substantially during this transition. Higher QoL is associated with social support, essential for coping with the challenges and changes of becoming a mother. An early universal home visiting program (New Families) is developed to strengthen and support families. The study aims to evaluate the impact of New Families on first-time mothers’ QoL and to investigate the association between their QoL, social support, and selected possible predictive factors.MethodsA prospective non-randomized controlled study with parallel group design. Child Health Services in five city districts of Oslo were matched in intervention and control groups. First-time mothers were allocated based on the residential area and assessed at pregnancy week 28 (N = 228), six weeks postpartum (N = 184), and three months postpartum (N = 167). Measures of the World Health Organization Quality of Life brief, Perinatal Infant Care Social Support Scale, and background variables were collected from October 2018 to June 2020. Multivariate linear regression models were applied to examine intervention impact and assess associations.ResultsOur data did not reveal a significant association between New Families intervention and the QoL levels of first-time mothers at three months postpartum. Thus, we analyzed the whole sample together. Emotional support was significantly associated with higher QoL levels in the physical health (B = 0.19, 95%CI [0.04 to 0.34]) and social relationships (B = 0.40, 95%CI [0.20 to 0.60]) domains. Appraisal support was significantly associated with higher QoL levels in the psychological (B = 0.34, 95%CI [0.18 to 0.50]) and environment (B = 0.33, 95%CI [0.19 to 0.48]) domains. QoL levels in pregnancy were significantly associated with QoL levels postpartum, showing small to medium effect size (ES = 0.30 to 0.55), depending on the domain.ConclusionsFurther research, including qualitative interviews, could provide more insights into the impact of New Families on QoL. A positive association between QoL levels in pregnancy and postpartum suggests that postnatal interventions targeting improved QoL could potentially improve postpartum QoL. Emotional and appraisal support seems beneficial for first-time mothers’ QoL and could be provided and facilitated by public health nurses.Trial registrationclinicaltrial.gov NCT04162626.

Use of sirolimus as an adjuvant therapy for kidney transplant recipients with high-risk cutaneous squamous cell carcinomas: a prospective non-randomized controlled study

RESUMO Introdução: Pesquisas anteriores demonstraram benefícios da conversão tardia para inibidores de mTOR contra carcinomas espinocelulares cutâneos (CECs) em receptores de transplante renal (RTR), apesar da baixa tolerabilidade. Este estudo investigou se a conversão gradual para monoterapia com sirolimo sem dose de ataque modificou o curso da doença com melhor tolerabilidade. Métodos: Esse estudo prospectivo exploratório incluiu RTR não sensibilizados com mais de 12 meses pós-transplante, uso contínuo de terapia imunossupressora baseado em inibidor de calcineurina (CNI) associado a micofenolato de sódio ou azatioprina, com lesões de CECs de mau prognóstico. Comparou-se densidades de incidência de CECs de alto risco durante 3 anos após conversão para monoterapia com sirolimo à um grupo não randomizado com CECs classificados conforme os mesmos critérios de gravidade do grupo sirolimo, mas inadequado/não disposto à conversão. Resultados: Foram incluídos 44 pacientes (83% homens, idade média 60 ± 9,7 anos, 62% com fototipo de pele II, tempo médio pós-transplante 9 ± 5,7 anos). 25 pacientes foram convertidos para SRL e 19 indivíduos mantidos em CNI. Foi observado tendência de diminuição da densidade de incidência de todos CECs no grupo SRL e de aumento no grupo CNI (1,49 a 1,00 lesões/paciente-ano; 1,74 a 2,08 lesões/paciente-ano; p = 0,141). A densidade de incidência de lesões moderadamente diferenciadas diminuiu significativamente no grupo SRL enquanto aumentou significativamente no grupo CNI (0,31 a 0,11 lesões/paciente-ano; 0,25 a 0,62 lesões/paciente-ano; p = 0,001). No grupo SRL não houve descontinuação do sirolimo, nenhum episódio de rejeição aguda e nenhuma formação de DSA de novo. Função renal permaneceu estável. Conclusões: Esse estudo sugere que a monoterapia com sirolimo pode ser útil como terapia adjuvante de CECs de alto risco em RTR. A estratégia de conversão usada foi bem tolerada e segura em relação aos principais desfechos do transplante a médio prazo.

Neutrophil extracellular traps-associated markers in malignant neoplasms of the female reproductive system after surgical treatment and adjuvant chemotherapy

Introduction. Studies evidence about a relation between increased circulating free DNA (cfDNA) concentrations and chemotherapy, the majority of which have been focused on considering a tumor as a source of cfDNA. It has been suggested that neutrophils also contribute to this process, as cancer-related cfDNA characteristics resemble those of neutrophil extracellular traps (NETs). Therefore, the elevated concentration of cfDNA observed in chemotherapy patients may be associated with NETosis.Aim: assessment of NETosis markers in surgical treatment and adjuvant chemotherapy of patients with malignant neoplasms of the female reproductive system.Materials and Methods. A prospective non-randomized interventional controlled study was carried out by enrolling 111 patients with malignant breast diseases and female genital organs of various localizations and stages hospitalized for elective surgical treatment or chemotherapy course. The control group included 33 healthy women. 69 patients underwent surgical treatment. Adjuvant chemotherapy with paclitaxel and carboplatin was performed in 25 patients with ovarian cancer and 17 patients with breast cancer. In cancer patients, citrullinated histone H3 (citH3) and myeloperoxidase (MPO) were chosen as NETosis biomarkers allowing to distinguish NETs from other tumor-derived cfDNA thereby improving quality of research study. The concentration of NETosis markers was assessed before surgery or onset of chemotherapy upon admission to hospital and 14 days after surgery or 14 days after the second course of chemotherapy.Results. In all patients, the concentrations of NETosis markers before the start of therapy were significantly increased compared to the control group as well as 14 days after surgical treatment and 14 days after the second course of chemotherapy. However, in surgical patients, no significantly increased concentration of NETosis markers postvs. pre-surgery magnitude was observed. Upon that, patients underwent 2 courses of chemotherapy vs. baseline level were found to have significantly elevated magnitude of NETosis markers.Conclusion. The study revealed the relationship between administration of paclitaxel-containing chemotherapy in patients with ovarian cancer and breast cancer and a rise in NETs level. Chemotherapy is an essential component for management of patients with malignant neoplasms of the female reproductive system, therefore, development of new strategies to lower a risk of thrombosis and resistance to it is of crucial importance.

Applications of Near-Infrared Fluorescence Imaging and Angiography of Inferior Vesical Artery in Laparoscopic Lateral Lymph Node Dissection: A Prospective Nonrandomized Controlled Study

BACKGROUND: Near-infrared imaging with indocyanine green has been used to guide lateral lymph node dissection, yet its efficacy and benefits need further investigation. OBJECTIVE: To investigate the efficacy and feasibility of near-infrared fluorescence imaging and angiography of the inferior vesical artery in laparoscopic lateral lymph node dissection. DESIGN: A prospective nonrandomized controlled study. SETTINGS: Single-center study. PATIENTS: Patients with lower rectal cancer who underwent total mesorectal excision plus lateral lymph node dissection. MAIN OUTCOME MEASURES: A cohort of 108 patients was enrolled. After propensity score matching, 29 patients in the near-infrared group and 50 patients in the non–near-infrared group were matched. The total number of harvested lateral lymph nodes, positive lateral lymph nodes, inferior vesical artery preservation, and postoperative urinary function were compared. RESULTS: After propensity score matching, both groups had similar baseline characteristics. The total number of harvested lateral lymph nodes in the near-infrared group was significantly higher (12 vs 9, p = 0.013), but positive lateral lymph nodes were similar between the 2 groups (1 vs 1, p = 0.439). The inferior vesical artery preservation ratio was significantly increased with the aid of indocyanine green angiography (93.1% vs 56.0%, p &lt; 0.001). The non–near-infrared group required more days for urinary catheter removal than the near-infrared group (5 vs 4, p = 0.046). Urinary recatheterization tended to occur more frequently in the non–near-infrared group, with a marginally significant trend (16% vs 0%, p = 0.059). The non–near-infrared group tended to have more cases with residual urine volume ≥50 mL than the near-infrared group (20.0% vs 3.4%, p = 0.087), especially in the bilateral dissection subgroup (41.2% vs 0%, p = 0.041). LIMITATIONS: Small sample size. CONCLUSIONS: Near-infrared imaging increased the number of harvested lateral lymph nodes, whereas real-time indocyanine green fluorescence angiography ensured the preservation of the inferior vesical artery and tended to improve postoperative urinary function.

Direct Anatomic Registration in Computer-Assisted Total Hip Arthroplasty Improves Accuracy of Acetabular Cup Alignment.

Computer-assisted total hip arthroplasty using direct anatomic registration (DAR) with acetabular center axis software is an alternative method to the indirect anterior pelvic plane method. The software maps the center of hip rotation and orientation of the native acetabulum in 3 dimensions. This study aimed to evaluate the accuracy of acetabular cup alignment using DAR navigation combined with a mechanical guide device (MGD). This prospective nonrandomized controlled study included 106 patients who underwent primary cementless total hip arthroplasty through the posterolateral approach. Fifty-four patients in the study group underwent DAR combined with MGD, whereas 52 patients underwent MGD only for acetabular cup positioning. Plain radiographs of both hips and computerized tomographic scans were obtained 2 months postoperatively for the evaluation of acetabular cup inclination and anteversion, respectively. The acetabular cup alignment in the study group was within the Lewinnek safe zone more than that in the control group (81.5% vs 59.6%, P < .05). The study group had a mean inclination angle of 43.88° (standard deviation [SD] 5.38) and anteversion angle of 12.82° (SD 5.99), whereas the control group had 41.10° (SD 6.79) and 12.82° (SD 9.53), respectively. There were no significant differences in estimated blood loss, length of stay, and Harris hip scores at preoperative and 3 and 6 months postoperatively, except for the operative time, which was longer in the study group (P < .01). There was 1 posterior hip dislocation in each group. DAR navigation combined with MGD provides better accuracy for acetabular cup positioning within the Lewinnek safe zone compared with the conventional technique.

Analysis of the reports of low-concentration atropine in controlling myopia in children

To evaluate the efficacy of 0.01% atropine to slow the progression of myopia in children. We searched PubMed, Embase, ClinicalTrials.gov, CNKI, Cqvip and Wan fang databases from inception to January 2022, including RCTs (randomized controlled trials) and non-RCTs (non-randomized controlled trials). The search strategy was 'myopia' OR 'refractive error' and 'atropine.' Two researchers independently reviewed the articles, and stata12.0 was used for meta-analysis. The Jadad score was used to assess the quality of RCT, and the Newcastle-Ottawa scale was used for non-RCTs. Five RCTs and two non-RCTs (1 prospective non-randomized controlled study, 1 retrospective cohort study) were identified (including 1000 eyes). Results of the meta-analysis showed statistical heterogeneity among the 7 included studies (P=0. 026, I2 =47.1%). According to different durations of atropine use-4 months, 6 months and greater than 8 months, subgroup analysis results showed that the axial elongation of all experimental groups relative to control groups were respectively -0.03mm (95% [CI], (confidence interval), -0.07 to 0.01), -0.07mm (95% [CI], -0.10 to -0.05), -0.09mm (95% [CI], -0.12 to -0.06). Each P was greater than 0.05, which indicated that there is little heterogeneity among the subgroups. In this meta-analysis of the short-term efficacy of atropine in myopia patients, it was found that there was little heterogeneity when grouped by usage time. It is suggested that the use of atropine in the treatment of myopia is not only related to its concentration but also related to the duration of use.

The effect of emergency department pharmacists on drug overuse and drug underuse in patients with an ADE-related hospitalisation: a controlled intervention study

BackgroundDrug overuse or drug underuse are the most common causes of adverse drug events and can lead to hospital admissions. Using clinical pharmacists in the emergency department may improve patient safety as they are specialised in recognising of adverse drug events and tackling drug overuse and drug underuse. This study tested the effect of an emergency department pharmacist on the number of medication changes for drug overuse and drug underuse taking place in patients with an adverse drug event-related hospitalisation following an emergency department visit.MethodsA multicenter prospective non-randomized controlled intervention study was conducted in a university hospital and a general teaching hospital. Trained emergency department pharmacists included patients in the intervention group with a hospital admission related to an adverse drug event. The interdisciplinary intervention consisted of a pharmacist-led medication review, patient counselling regarding medication, and information transmission to general practitioners and community pharmacies after discharge. The control patients were also admitted after an emergency department visit and received the usual care. The primary outcome was the number of medication changes for drug overuse and drug underuse that took place during hospital admission and persisted 6 months thereafter. Poisson regression analysis was used to estimate the difference in these medication changes between the intervention group and the control group.ResultsA total of 216 patients were included (intervention group 104, control group 112). In the intervention group, 156 medication changes for drug overuse and drug underuse persisted 6 months after admission compared to 59 in the control group (adjusted rate ratio 1.22 [95%CI 1.01-1.49] p = 0.039).ConclusionEmergency department pharmacists do contribute to reduction of drug overuse and drug underuse of medication in patients with a hospitalisation related to adverse drug events after an emergency department visit.

A Case-Control Study on the Changes in High-Sensitivity C-Reactive Protein and Tumor Necrosis Factor-Alpha Levels with Surgical Treatment of OSAS.

Obstructive sleep apnea syndrome (OSAS) is a common but underdiagnosed condition with significant health and economic implications for society. Inflammatory mediators are proposed to be associated with the presence and severity of OSAS and contribute to morbidity and mortality. This paper details a prospective non-randomized case control study of a cohort of subjects, who underwent surgical treatment of OSAS and were enrolled to assess the sleep parameters and blood levels of selected inflammatory markers at pre-operative and post-operative time points, also comparing them to the levels in a control group. A total of 25 study subjects and 18 control subjects were enrolled. Median values and interquartile range (IQR) of the apnea-hypopnea index (AHI) in the study group pre-operatively and post-operatively were 34 (18.5-45.5) and 13.3 (7.5-27.3), while in the control group 1.4 (1.0-2.1) per hour. The mean (IQR) hs-CRP levels (mg/L) were 1.782 (0.941-5.594) and 1.980 (0.990-5.445) in the study group, pre-operatively and post-operatively, respectively, while 0.891 (0.767-1.436) in the control group. The mean (IQR) TNF-α levels (pg/mL) were 7.999 (6.137-9.216) and 6.614 (5.534-7.460) pre-and post-operatively, respectively, and were 6.000 (5.026-6.823) in the control group. Results demonstrated that both inflammatory markers, hs-CRP and TNF-α, are higher in subjects with OSAS compared to the controls, and their levels decrease, but are still higher than the controls, after successful surgical treatment. Further analysis including the body mass index and age demonstrated that these changes were significant for TNF-α, but not hs-CRP.

Effects of physical rehabilitation on exercise tolerance in post-COVID patients: results of an open controlled trial

The issue of physical rehabilitation of post-COVID patients stays relevant up to this day. Most publications discuss inpatient rehabilitation and only few publications describe outpatient physical rehabilitation of such patients.The aim. Our study was performed to investigate efficacy of outpatient physical rehabilitation of post-COVID patients with lung injury.Methods. This was a prospective non-randomized open controlled study. All patients with COVID-19-associated lung injury were referred to supervised outpatient rehabilitation program. We analyzed 6-minute walk test (6-MWT) results, evaluation of dyspnea using Borg scale and assessment of oxygen saturation (SpO2) using pulse oxymeter before and after walking.Results. The rehabilitation group included 24 patients and the control group included 6 patients. The baseline and demographic findings did not differ significantly between the groups. The 6-minute distance (6-MWD) (р = 0.000018), heat rate at rest (р = 0.017) and after walking (р = 0.017), dyspnea after walking (р = 0.017), oxygen saturation at rest (р = 0.030) and after walking (р = 0.0021) improved significantly in the rehabilitation group and did not change significantly in the control group. At the end of the study, 6-MWD increased by 63.2 ± 36.3 m in the rehabilitation group compared to 14.0 ± 28.8 m in the control group (р = 0,01) and exertional dyspnea score increased by 0 (0 – 1) compared to 1 (1 – 2) in the control group (p = 0.033).Conclusion. Supervised outpatient physical rehabilitation in outpatient settings can accelerate physical recovery in post-COVID patients with lung injury.

The role of intraoperative electron radiotherapy in centrally located hepatocellular carcinomas treated with narrow-margin (

BackgroundPostoperative radiotherapy (RT) is known to play an important role in the treatment of hepatocellular carcinomas (HCCs), but the specific role of intraoperative electron radiotherapy (IOERT) in HCCs remains unclear. The aim of this study was to investigate the safety and efficacy of IOERT in centrally located HCCs treated with narrow-margin (<1 cm) hepatectomy.MethodsThis was a single-center, phase 2, prospective non-randomized controlled study, including 268 patients with centrally located HCCs who underwent narrow-margin hepatectomy. The patients were subsequently allocated to the IOERT group (n=59) or to the control group (n=65). The primary outcome of the study was to compare recurrence-free survival (RFS) between the IOERT group and the control group, and the secondary outcome was to compare overall survival (OS) rate between the two groups.ResultsOf 268 patients enrolled, a total of 124 were included in the study: 59 in IOERT group, 65 in control group. The 1-, 2-, 3-year RFS rates were 79.3%, 62.1% and 45.8% for patients in the IOERT group, and 47.6%, 28.6%, and 22.9% for patients in the control group, respectively (P=0.025). The 1-, 2-, and 3-year OS rates were 100.0%, 94.9%, and 83.7% for patients in the IOERT group, and 92.3%, 87.5%, and 79.4% for patients in the control group, respectively (P=0.314). Subgroup analysis of MVI (+) patients revealed that RFS and OS are significantly prolonged in the IOERT subgroup as compared to the control, whereas there was no significant difference of RFS and OS between the two groups in MVI (−) patients.ConclusionsIOERT for centrally located HCCs with concurrent narrow-margin hepatectomy was feasible and safe. Statistically better RFS rate was observed in the IOERT group compared to the control group. Subgroup analysis revealed that IOERT was more beneficial for postoperative survival of HCC patients with MVI.Trial RegistrationChiCTR-TRC-12002802; www.who.int/ictrp.

MO572: Effects of Ketoanalogues on the Evolution of Bone Mineral Metabolism in Patients With Advanced Chronic Kidney Disease

Abstract BACKGROUND AND AIMS There is a mounting volume of evidence on the efficacy of ketoanalogues associated with low protein diets, concerning the nephroprotective effects in patients with advanced chronic kidney disease (CKD). The important number of capsules daily ingested associated with their important calcium content would potentially affect the bone mineral metabolism of this group of patients. The aim of this study is to investigate the effects of ketoanalogues on the evolution of the bone mineral metabolism parameters in patients with advanced CKD. METHOD This is a prospective non-randomized controlled comparative study of two groups of patients. The results are shown as mean ± ESM. The first group (intervention) (20 patients, 12/8 M/F, mean age 71.9 ± 2.9, 10 with diabetes) was treated with ketoanalogues associated with a low protein diet and the control group (17 patients, 9/8 M/F, mean age 68.2 ± 3.3, 8 with diabetes) had a conventional follow-up of CKD. We studied the evolution of the body weight, renal function (glomerular filtration rate measured by the CKD-EPI formula in mL/min/1.73 m2), 24 h proteinuria, salt and protein consumption, serum albumin, serum prealbumin, alkaline reserve, serum phosphate levels, serum parathormone levels and calcium levels corrected for serum albumin at baseline as well as 6, 12 and 24 months post-inclusion. We performed a T-test for independent groups in order to study the differences between the two groups in every time point of the study. P-values &amp;lt; 0.05 were considered statistically significant. RESULTS The results are shown in the Table 1. There were no differences between the two groups at baseline. There was a significant nephroprotective effect of the ketoanalogues after 12 and 24 months. Alkaline reserve and serum calcium levels were significantly higher in the intervention group after 6, 12 and 24 months. Serum phosphate and serum parathormone levels were significantly higher in the control group 6 months, 1 and 2 years after the baseline. All patients were treated with the appropriate agents for the correction of the perturbed study parameters. During the 2-year follow-up, four patients from the study group (two pre-emptive renal transplantations, one death from oncologic causes and one start of dialysis) and eight patients from the control group (three deaths and five dialysis initiations) quitted the study. CONCLUSION In conclusion, the treatment with ketoanalogues and low protein diet has a significantly positive impact on the bone mineral metabolism of the patients with advanced CKD. It is unknown whether this is due to the high calcium content of the capsules or from the fact that the renal function is better preserved in the intervention group

Evaluation of a whole process management model based on an information system for cancer patients with pain: A prospective nonrandomized controlled study

ObjectiveThe aim of this study was to evaluate the effects of whole process management model interventions based on information system benefits reported by patients with cancer pain. MethodsWe performed a quantitative, prospective nonrandomized controlled design from June to October 2020. A total of 124 cancer patients with pain were enrolled. Patients in the experimental group received a whole process management model intervention based on an information system compared to the control group who received routine cancer pain management. Data were collected at baseline and after a four-week follow-up, acting as a test-retest control. The primary outcome was pain management quality, which was measured using the American Pain Society Patient Outcome Questionnaire-Chinese version (APS-POQ-C). Secondary outcomes were patient-related attitudinal barriers and analgesic adherence. The Barrier Questionnaire (BQ) and a single-item questionnaire were used. Chi-square tests were used to compare the pain intensity and analgesic adherence, independent sample t-test and Mann–Whitney U test were performed to test the differences in the pain management quality and patient-related attitudinal barriers between control and experimental groups. ResultsBaseline characteristics and outcomes of the participants did not differ significantly (P ​> ​0.05). Primary outcomes were changes in four aspect of the quality of pain management (APS-POQ-C) between the two groups (P ​< ​0.05). Patients in the whole process management group reported significantly better pain control and perception of care than the control group. With respect to secondary endpoints, a significant difference in favor of the experimental group was found for barriers (P ​< ​0.05) and medication adherence (60.0% vs. 40.0%; P ​< ​0.05) after the interventions. ConclusionsThe whole process management of patients with cancer pain effectively improves patient-reported quality of pain management, reduces patient-perceived barriers, enhances patient adherence to analgesic drugs and is worthy of clinical application.

Management of Meige’s syndrome by facial and trigeminal nerve combing followed by transplantation of autologous adipose-derived mesenchymal stem cells: a prospective nonrandomized controlled study

Increasing attention has recently been focused on reducing abnormal neuroexcitability in patients with Meige’s syndrome using nerve combing surgery. However, nerve injury caused by nerve combing is of critical concern. Animal studies have shown that stem cells can repair cranial nerves; autologous adipose-derived mesenchymal stem cells have been proved to be safe and effective in clinical trials. A total of 38 patients with Meige’s syndrome were enrolled in this prospective nonrandomized controlled study and divided into a non–stem cell group (n = 30) and a stem cell group (n = 8). Patients in the non-stem cell group underwent facial and trigeminal nerve combing only; patients in the stem cell group underwent adipose-derived mesenchymal stem cell implantation after facial and trigeminal nerve combing. A blepharospasm disability index score was used to evaluate effectiveness of the surgery, and a House–Brackmann grade was used to evaluate facial nerve injury. These data were recorded before the operation and at 7 days, 3 months, and 6 months after the operation. The overall improvement percentage of blepharospasm was 93% at 6-month follow-up in the non-stem cell group. A greater number of nerve combing events during the operation led to better outcomes but increased risk of facial paralysis. Patients in the stem cell group had better facial nerve function at the 6-month follow-up (House–Brackmann grade, P = 0.003) and better blepharospasm improvement at 3 and 6 months than those in the non–stem cell group (blepharospasm disability index score, P = 0.003 and P < 0.001, respectively). Cerebrospinal fluid protein analysis showed that levels of several cytokines were significantly increased after adipose-derived mesenchymal stem cell transplantation, including interleukin-6 (P < 0.01) and interferon gamma-induced protein 10 (P < 0.0001) and the growth factors insulin-like growth factor-1 (P < 0.0001), insulin-like growth factor-binding protein-1 (P < 0.0001), growth/differentiation factor-15 (P < 0.001), and angiopoietin-like 4 (P < 0.001). Facial and trigeminal nerve combing combined with adipose-derived mesenchymal stem cell transplantation is a safe and effective remedy to improve recovery from Meige’s syndrome.

Socket shield technique: An unconventional method for immediate implant placement - A review.

The aim of this review is to present the currently available studies on the treatment outcome of socket shield technique (SST) with an attempt to compare it with the conventional technique for immediate implant placement. An electronic search was performed using PubMed, Google Scholar, and Cochrane databases. All relevant human studies reporting the treatment outcome of SST in conjunct with immediate implant placement were included. In vitro studies, case reports, reviews, systematic reviews and articles not related to SST were excluded. The initial electronic database search identified 606 articles. After removing the duplicates, reading the titles and abstracts, 19 articles were eligible for full-text reading. Two case series were excluded as the specific treatment outcomes of the clinical cases were not mentioned. Further, one article was included after hand searching of the reference lists. Eighteen articles were included for the final review. These 18 articles consisted of 15 full texts and 3 abstracts. Out of them, 3 were randomized controlled trials, 7 were retrospective studies, 4 were prospective studies, 1 was a prospective case series, 1 was a prospective nonrandomized controlled study and 2 were comparative studies. This review concludes that though the implant survival rate may be comparable in SST and the conventional technique, the SST seems to perform better in terms of bone preservation, esthetic outcome, and patient satisfaction. Furthermore, further randomized clinical trials are required to generate strong evidence for recommending SST over the conventional technique for long-lasting successful treatment outcomes with immediate implants.

Determinants of endometrial fluid collection during in vitro fertilization cycles and outcome of embryo transfer following endometrial drainage: A prospective nonrandomized control study at Nisa Premier Hospital, Jabi, Abuja, North Central Nigeria

Determinants of endometrial fluid collection during in vitro fertilization cycles and outcome of embryo transfer following endometrial drainage: A prospective nonrandomized control study at Nisa Premier Hospital, Jabi, Abuja, North Central Nigeria

A web app based-music intervention (MUSIC-CARE) reduces sedative requirement and anxiety during coronary angioplasty

Coronary angiography is a procedure in which patients tend to present with a moderately high level of stress and anxiety. The present investigation sought to examine the impact of a patient controlled music listening intervention by mobile application (Music-Care) on sedative consumption as primary endpoint, and on pain, anxiety and satisfaction levels. This is a prospective non-randomized controlled clinical study. Patients scheduled to undergo coronary angioplasty under local anesthesia and sedation were recruited. A 76 patients were included, 54 were assigned under the music arm and 22 under the control arm. Medication intake during the procedure has been reported as well as anxiety as measured by numeric rating score and APAIS, pain and satisfaction scores. Music group was administered "U" sequence during the procedure. Patients under music took significantly less midazolam medication (median 1 vs 3 mg in control, p&lt;0.01). Additionally, there was a significant difference (p&lt;0.01) on anxiety (Mmusic = 2.9, Mcontrol = 4.2, p &lt;0.01) but not in pain score. Almost all of the patients from the music group (98%) were satisfied (score ≥ 4) vs 91% in control group. Music-Care program application provides a 2/3 reduction in midazolam sedation during coronary angiography under local anesthesia and sedation. Furthermore, cardiologists appreciated this technique and suggested it to assist with their procedure in ambulatory practice.