Prospective Nonrandomized Controlled Study Research Articles

Effect of stress inoculation training on psychological state and the fertility quality of life in infertility patients

Objective To explore the effects of stress inoculation training (SIT) on anxiety, coping style and the infertility quality of life of the female patients. Methods This study was a prospective non randomized control study. Totally 126 female infertility patients who were hospitalized in a ClassⅢ Grade A hospital from September 2017 to June 2018 were selected as the study objects. According to the order of admission, they were divided into control group and intervention group, with 63 cases in each group. The control group received routine nursing intervention, and the intervention group received 2 months of SIT on the basis of routine nursing. Before and after intervention, the patients in the two groups were assessed with the State-Trait Anxiety Inventory (STAI) , Trait Coping Style Questionnaire (TCSQ) and Fertility Quality of Life Questionnaire (FertiQoL) . Results After 2 months of SIT, the scores of S-AI and T-AI in STAI of the intervention group were (38.91±10.54) , (38.98±8.43) , the score of PC in TCSQ was (36.40±6.80) , the scores of emotional subscale, the treatment environment subscale and the treatment tolerability subscale in FertiQoL were (68.24±9.68) , (69.10±7.86) , (66.98±14.63) , the scores of the treatment FertiQoL and the total FertiQoL were (68.04±8.36) , (69.92±6.80) respectively, which were better than those in the control group with statistical significance (P<0.05) . Conclusions SIT can reduce the anxiety state of patients with infertility, improve the positive response of patients, and improve the quality of reproductive life of patients, but it still suggests that medical staff should pay attention to the long-term relationship between husband and wife and social relations of patients with infertility. Key words: Infertility; Coping style; Anxiety; Stress inoculation training; Fertility quality of life

Systematic Review of l-glutamine for Prevention of Vaso-occlusive Pain Crisis in Patients with Sickle Cell Disease.

l-glutamine was approved by the U.S. Food and Drug Administration (FDA) for sickle cell disease (SCD) in 2017. A vaso-occlusive crisis (VOC) occurs in persons with SCD and is associated with acute pain episodes. This systematic review summarizes the evidence for l-glutamine in the prevention of VOC and associated pain in patients with SCD. Medline, Embase, and International Pharmaceutical Abstracts were searched for records reporting on l-glutamine use in persons with SCD. Eligibility criteria identified primary reports of investigations conducted in humans who were administered l-glutamine, reported on outcomes related to VOC or associated pain, published in English, and were available as full text. All relevant efficacy, safety, participant demographic data, and study method characteristics were extracted and documented. Risk-of-bias assessments were conducted using the Risk of Bias in Non-Randomized Studies-of Interventions (ROBINS-I) tool and the revised Cochrane risk-of-bias tool for randomized studies. Three studies assessing the effect of exogenous l-glutamine administration in patients with SCD met eligibility criteria: one prospective nonrandomized controlled study and two prospective randomized controlled trials. Rate of VOC and related hospitalizations were reduced in patients receiving l-glutamine, although some conflicting results were noted between studies. l-glutamine was generally well tolerated. Limitations of one or more of the eligible studies included small sample size, nonblinding, and study groups that differed at baseline. l-glutamine has limited high-quality evidence supporting its use. Although l-glutamine is FDA approved for the prevention of frequent episodes of VOC pain, only one randomized controlled trial has strong evidence to support this indication. Based on the results of a systematic review, l-glutamine may be considered for patients unable to receive hydroxyurea or in addition to hydroxyurea for reduction in VOC and associated pain.

Incipient observation of cornea astigmatism after combined cataract phacoemulsification and Callisto Eye-assisted arcuate keratotomy

Objective: To research the change of cornea astigmatism after combined cataract phacoemulsification and Callisto Eye-assisted arcuate keratotomy and to assess the effectiveness and safety of this surgery for improving patients' uncorrected visual acuity. Methods: Prospective interventional non-randomized controlled study. Consecutive cataract patients with cornea astigmatism greater than 0.75 D were recruited at the southern part of Beijing Tongren Hospital, Capital Medical University and Beijing Tongren Eye Center, between October 2017 and March 2018, and were divided into the experimental group and the controlled group. In the experimental group the patients are further divided into three subgroups of A(0.75-1.24 D), B(1.25-1.74 D) and C(≥1.75 D) according to the degrees of their cornea astigmatism before surgery. The combined cataract phacoemulsification and Callisto Eye-assisted arcuate keratotomy were performed for the experimental group with the depth and length of the corneal arcuate incision differing in subgroups, while only cataract phacoemulsification was performed for the control group. The complications on and after the surgery were observed and the change of cornea astigmatism and uncorrected visual acuity in three months after surgery were recorded. Independent sample t test was used for statistical analysis. Results: A total of 108 patients (108 eyes) were enrolled, including 46 males and 62 females, the age was (68±11) years old.The experimental group included 76 eyes of 76 patients (subgroup A 38 eyes, subgroup B 18 eyes, subgroup C 20 eyes). The controlled group included 32 eyes of 32 patients. The preoperative cornea astigmatism and postoperative cornea astigmatism of the experimental group are (1.54±0.90) D and 0.62 (0.36-0.95) D. The change of cornea astigmatism of the experimental group is (1.15±0.58) D. The index of correction and flattening are 0.97±0.20 and 0.61±0.31 respectively, the error of axial deviation is 9.55°±5.22°. The index of success is 0.51±0.36. In the experimental group, subgroup C has the highest correction efficiency of corneal astigmatism (axial deviation error 8.07°±3.13°, flattening index 0.72±0.31) which is followed by subgroup B, and subgroup A ranked the last one (axial deviation error 10.27°±6.47°, flattening index 0.42±0.30).The uncorrected distance visual acuity (logarithm of the minimum angle of resolution) of the experimental group and the control group are significantly different (0.15±0.12 vs. 0.24±0.17, t=-4.129, P<0.01). None of the patients recruited have complications including poor wound healing and cornea penetration and cornea edema and cystoid macular edema on or after the surgery. Conclusions: Combined cataract phacoemulsification and Callisto Eye-assisted arcuate keratotomy are of favorable effect on improving the uncorrected visual acuity and have relatively good accuracy and predictability on the correction of cornea astigmatism. It is a safe surgery with considerable efficency. (Chin J Ophthalmol, 2019, 55: 502-508).

Non-pharmacological pain-relieving treatment in pregnant women with dorsopathies

The present study assesses the effectiveness of the relief of pain syndrome in pregnant women with dorsopathies by using an isometric kinesitherapy complex. The analyzed groups differed in the type of the performed exercise, with the first group attending a course of isometric kinesitherapy procedures (group 1) or the second group undertaking a course of therapeutic gymnastics in pregnant women with dorsopathies. The duration of each course was 7.5 hours (3 times a week for a period of 5 weeks, a total of 15 procedures), classes were conducted under the supervision by a doctor of therapeutic physical training. 170 pregnant women were examined with the average age of: Me = 31 (LQ = 26; UQ = 38) years (р &gt; 0.05 between the groups). The low back pain (LBP) was assessed using the Oswestry questionnaire, the EuroQol 5-D questionnaire, the visual analogue scale (VAS), the verbal rating scale, the McGill short questionnaire and a medico-social form. The level of disability was assessed by using the results of the Oswestry questionnaire. Completing the questionnaires and the scales was made before the first kinesitherapy procedure (a complex of isometric exercises) and therapeutic gymnastics and completing it again after the last procedure, respectively. A prospective non-randomized controlled study was conducted in which p = 0.05 was taken as the value of statistical significance level for this study (p). The data analysis yielded statistically significant results confirming the effectiveness of the complex of isometric exercises aiming at relieving the pain in pregnant women with dorsopathies. In group 1, a decrease of the low back pain (LBP) was detected 2.47 times more often than in group 2 with p = 0.001.

Safety and Efficacy of Regional Citrate Anticoagulation during Plasma Adsorption Plus Plasma Exchange Therapy for Patients with Acute-on-Chronic Liver Failure: A Pilot Study

Background: Patients with acute-on-chronic liver failure (ACLF) might be at risk for citrate accumulation during plasma adsorption plus plasma exchange (PE) therapy with regional citrate anticoagulation (RCA). Objectives: To assess the safety and efficacy of RCA during double plasma molecular adsorption system (DPMAS) plus PE therapy for patients with ACLF. Method: A prospective nonrandomized controlled pilot study was conducted at West China Hospital of Sichuan University. Patients with ACLF were enrolled to heparin anticoagulation (HA) group and RCA group. Serial blood samples were taken. Patients were followed up for 3 months. Results: Twenty-four patients with 94 sessions of HA and 28 patients with 106 sessions of RCA were enrolled. RCA method did not affect the therapeutic efficacy, the function of extracorporeal circulation, and the prognosis of these patients. The occurrences of citrate accumulation in RCA group were 0.0, 67.0, 100.0, 34.0, and 0.0% before DPMAS therapy, at the end of DPMAS therapy, immediately after PE therapy, 2 h after PE therapy, and the next morning, while that in HA group were 0.0, 0.0, 100.0, 7.4, and 0.0%, respectively. The occurrences of citrate accumulation at the end of DPMAS therapy and at 2 h after PE therapy in RCA group were much higher than that in HA group (67.0 vs. 0.0%, p = 0.000; 34.0 vs. 7.4%, p = 0.000, respectively). Although the trend of citrate accumulation in RCA group was much more obvious than that in HA group during and after DPMAS plus PE therapy (p = 0.000), the values on the next morning were similar between the 2 groups (p > 0.05). The main alteration of acid–base status was metabolic alkalosis with no difference between the 2 groups. Conclusions: RCA might be safe and effective in patients with ACLF receiving plasma adsorption plus PE therapy. RCA method might offer an alternative anticoagulation method for them.

Anterior Cruciate Ligament Reconstruction with Hamstring Tendons Has no Deleterious Effect on Hip Extension Strength.

Hamstring tendons are secondary hip extensors. Their harvest for graft in anterior cruciate ligament (ACL) reconstruction may create deleterious effect on hip extension strength. This is of particular importance in sports that need powerful hip extension force like climbing and sprinting. Due to scarcity of a comprehensive study in this area, we designed this prospective study to evaluate hip extension strength following ACL reconstruction using different types of grafts. Fifty eight patients were enrolled in this prospective non-randomized case control study to compare isokinetic hip extension strength following ACL reconstruction with different graft types. Twenty patients in group A (both Semitendinosus and Gracilis tendons autograft (ST-G)), 14 patients in group B (Tibialis Posterior tendon allograft (Allograft)), 12 patients in group C (bone-patellar tendon-bone autograft (BPTB)) and 12 patients in group D (only semitendinosus autograft (ST)) were studied. Hip extension strength was tested post-operatively at three- and six-month periods using a Biodex isokinetic testing machine at a speed of 30 degree per second in operated (cases) and non-operated (controls) limbs. There was a significant increase in hip extension force between three and six month intervals in all four groups and in both operated (case) and non-operated (control) limbs (P<0.05, 95% CI). However, there was more increase in case limbs in comparison to control limbs. There was no significant difference in hip extension strength among all four groups (both in case and control limbs) in the third- and the sixth-month post-operative tests. Graft type had no effect on hip extension strength following ACL reconstruction, and the harvest of one or both hamstrings had no deleterious effect on hip extension force. III.

MON-LB051 Non-inferiority Clinical Trial on Gonadotropinversus Pulsatile Gonadotropin-releasing Hormone Infusion Therapy in Male Adolescent Patient with Congenital Hypogonadotropic Hypogonadism

Context We investigate the efficacy and safety of non-inferiority clinical trial for human chorionic gonadotropin/ human menopausal gonadotropin (HCG/HMG) versus pulsatile gonadotropin-releasing hormone (GnRH) which has not been evaluated on non-inferiority clinical trial in puberty boys with CHH. Objective To compare the efficacy and security of two different treatments in male adolescent patient with congenital hypogonadotropic hypogonadism (CHH) . To explore the standardization of early treatment and it is possible clinical recommended regimen. Methods For this prospective cohort nonrandomized controlled study, male adolescent CHH patients were recruited and categorized into HCG/HMG(group 1) and GnRH (group 2) groups. All patients were treated for 3-12months. The study was divided into research period (3 months of treatment) and extension period (3 to 12 months of treatment). Testicular volume (TV), penile length(PL), blood sex hormones levels, height, body weight, and other related laboratory indices were measured and evaluated. In this study, we observe the therapeutic effect within 3 months and also collect partial extended period data for providing further research experience. Results All CHH patients were treated for over 3 months. At the beginning, the average age of patients, the testicular volume, penile length, penile diameter in group 1 and group 2 were 15.3±1.9 years VS 14.2±1.5 years, 2.5±1.4ml VS 2.7±1.5ml, 4.8±1.3cm VS 4.2±1.4cm and 1.6±0.4cm VS 1.5±0.4cm. The difference of two groups was not statistically significant. After 3 months treatment, the testicular volume, penile length, penile diameter, the growth of testicular volume, the growth of penile length and the growth of penile diameter in group 1 and group 2 were 5.1±2.7ml VS 4.6±2.7ml , 6.9±1.7cm VS 5.1±1.6cm, 2.5±0.5cm VS 1.9±0.6cm,2.0±1.6 cm 和1.0±0.8cm, 0.9±0.5cmand0.3±0.4cm. The difference of two groups was not statistically significant. There was no significant difference in height, body weight, or BMI between the two treatments. Based on the principles of hypothesis-test, mean value M-0.25625, standard error(SE) = 0.69319,M±1.96, Se=-0.25625±1.3586524,(-1.161,1.10). The growth differential of testicular volume between group 1 and group 2 was less than 2ml in (P<0.05) . It can be inferred that group 1 is not inferior to group 2. There was no significant difference in efficacy comparison in some of the patients were treated after 6-12 months in both groups. There was no significant difference in side effects in both groups. Conclusions In this clinical trial, 3 months was an observation period. Short-term therapeutic indicated adolescent patients with CHH were effectively treated with HCG/HMG and GnRH. We discovered that the effect of HCG/HMG was as good as GnRH in treating adolescent boys with CHH. This therapeutic schedule can be used in more patients. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Intraoperative adjunctive techniques to reduce seroma formation in laparoscopic inguinal hernioplasty: a systematic review.

Seroma formation is the most common postoperative complication after laparoscopic inguinal hernia repair. Recurrence and seroma formation may be difficult to distinguish. Many adjunctive techniques with which to reduce the incidence of seroma formation after laparoscopic inguinal repair have been described in the literature; however, the evidence for using intraoperative adjunctive techniques is limited. Therefore, the present systematic review was performed to evaluate the effects and limitations of adjunctive techniques used during laparoscopic inguinal hernia repair. Major databases (PubMed, Embase, Springer, and Cochrane Library) were searched using the terms "seroma," "laparoscopic inguinal hernia", "TAPP", "TEP", "inguinal hernia", "tack", "barbed suture", "drainage", "Endoloop technique", and "fibrin sealant". All studies involving adults undergoing laparoscopic/endoscopic inguinal hernioplasty with at least one intervention designed to reduce seroma formation were included. Of the 965 studies identified, 8 met the inclusion criteria. Six adjunctive techniques were described in the literature. Transversalis fascia (TF) inversion with tacking: one prospective non-randomized controlled study revealed a lower incidence of postoperative seroma after TF inversion with tacking for direct inguinal hernias (4.17% vs. 14.29%, P < 0.05). Endoloop technique: one prospective study of 76 cases involving this technique revealed a low incidence of seroma formation (3.9% at 2weeks) in direct hernias. Barbed suture closure of TF: one prospective study of 36 direct hernias reported only one clinical palpable seroma that resolved 1month later. Surgical drains: three trials reported the results of drains, and the pooling results demonstrated significantly less seroma formation in patients with surgical drains (2.1 vs. 23.8%; odds ratio 0.12; 95% confidence interval 0.08-0.19; P < 0.0001). Fibrin sealant: one prospective clinical study of 40 patients with indirect inguinal hernias reported a lower volume (P < 0.001) and lower incidence (5% vs. 15%) of seroma formation in the fibrin group. Distal sac fixation technique: in one prospective study of six patients with large inguinoscrotal hernias, one patient developed a seroma on postoperative day 8. Seroma formation is a natural process that cannot be completely prevented following laparoscopic inguinal hernioplasty, especially in patients with direct and large indirect inguinal hernias. Some intraoperative adjunctive techniques are effective in reducing clinically palpable seroma formation in select patients. More randomized controlled trials are needed for further evaluation.

Reoperations After Bariatric Surgery in 26 Years of Follow-up of the Swedish Obese Subjects Study

Bariatric surgery is an established treatment for obesity, but knowledge on the long-term incidence of revisional surgery is scarce. To determine the incidence and type of revisional surgery after bariatric surgery in 26 years of follow-up of participants in the Swedish Obese Subjects (SOS) study. The SOS study is a prospective nonrandomized controlled study comparing bariatric surgery (banding, vertical banded gastroplasty [VBG], and gastric bypass [GBP]) with usual care. The bariatric surgeries in the SOS study were conducted at 25 public surgical departments in Sweden. Men with body mass index values of 34 or higher and women with body mass indexes of 38 or higher were recruited to the surgery group of the SOS study between September 1, 1987, and January 31, 2001, and follow-up continued until December 31, 2014. Data analysis occurred from November 2016 to April 2018. Banding, VBG, or GBP. Revisional surgeries, analyzed using data from questionnaires, hospital records, and the Swedish National Patient register through December 31, 2014. A total of 2010 participants underwent surgery. The age range was 37 to 60 years. A total of 376 participants underwent banding (18.7%), while 1365 had VBG (67.9%) and 266 had GBP (13.2%). During a median follow-up of 19 years, 559 participants (27.8%) underwent first-time revisional surgery, including 354 conversions to other bariatric procedures (17.6%), 114 corrective surgeries (5.6%), and 91 reversals to normal anatomy (4.5%). Revisional surgeries (conversions, corrective surgery, and reversals) were common after banding (153 of 376 [40.7%]) and VBG (386 of 1365 [28.3%]) but relatively rare after GBP (20 of 266 [7.5%]). Patients who had banding and VBG primarily underwent conversions to GBP or reversals. Incidence of reversals was 5 times higher after banding than after VBG (40.7% vs 7.5%; unadjusted hazard ratio, 5.19 [95% CI, 3.43-7.87]; P < .001). Corrective surgeries were equally common irrespective of the index surgery (72 of 1365 patients who had VBG [5.3%]; 23 of 376 patients who had banding [6.1%]; 19 of 266 patients who had GBP [7.1%]). Revisional surgery indications, including inadequate weight loss, band-associated complications (migration, stenosis, and slippage), staple-line disruptions, and postsurgical morbidity, varied depending on index surgery subgroup. Most corrections occurred within the first 10 years, whereas conversions and reversals occurred over the entire follow-up period. Corrective surgeries occur mainly within the first 10 years and with similar incidences across all 3 surgical subgroups, but indications varied. Conversions (mainly to GBP) and reversals occurred after many years and were most frequent after banding and VBG, reflecting a higher overall revisional surgery demand after these operations.

Perioperative rh-endostatin with chemotherapy improves the survival of conventional osteosarcoma patients: a prospective non-randomized controlled study.

ObjectiveAnti-angiogenic drugs are an emerging treatment option against malignant tumors. The aim of this study was to determine whether the addition of perioperative rh-endostatin to chemotherapy could improve the probability of distant metastasis-free survival (DMFS) and overall survival (OS) in patients newly diagnosed with non-metastatic conventional osteosarcoma.MethodsThis was a controlled non-randomized clinical study that included 388 patients without clinically detectable metastatic disease enrolled from January 2008 to April 2012. The control treatment group had 272 patients; 180 were male and 92, female, with a median age of 17 years. The treatment group had 58 patients; 36 were male and 22, female, with a median age of 16 years. The control group received preoperative chemotherapy followed by surgery and postoperative chemotherapy. The treatment group received 4 cycles of rh-endostatin perioperatively in addition to chemotherapy as per the control group. Patients were followed up from 6-101 months with a median follow-up period of 50.2 months.ResultsThe 5-year DMFS of the control group (61%) was significantly lower than that of the rh-endostatin group (79%) (P = 0.013). The 5-year OS of the control group (74%) was significantly lower than that of the rh-endostatin treatment group (87%) (P = 0.029). No difference in adverse drug reactions was found between these 2 groups. ConclusionsThe addition of perioperative rh-endostatin to chemotherapy could significantly improve the DMFS and OS of patients with non-metastatic osteosarcoma.

Apical U-shape splitting technique for undercut areas of the anterior alveolar ridge: a prospective non-randomized controlled study

The aim of this study was to investigate a novel apical U-shape splitting technique for horizontal bone augmentation in undercut areas and to compare its efficacy with that of guided bone regeneration (GBR). This was a prospective non-randomized controlled clinical trial. A total of 36 patients, who presented with a labial undercut that was not able to house a normally inclined implant, underwent the new technique or GBR. Radiographic and clinical data were obtained preoperatively, immediately after surgery, and 12 months after surgery. Pairwise comparisons of changes in ridge width gain, marginal bone loss, and pink aesthetic score were performed; correlations with pristine ridge morphology were investigated. The results showed similar marginal bone loss in the two groups. The overall ridge width gains in the new technique group (2.56±1.92mm) and GBR group (0.73±1.21mm) differed significantly (P<0.05). The pink aesthetic score was higher for the new technique group (11.75±1.22) than for the GBR group (9.25±1.86) (P<0.01). The morphology of the concavity had different impacts on regeneration in the two groups. The apical U-shape splitting technique, as a safe and effective alternative to GBR, provided a significant increase in bone volume gain where labial fenestration was inevitable during implant placement.

New vertebral fractures after osteoporotic vertebral compression fracture between balloon kyphoplasty and nonsurgical treatment PRISMA

Because of aging of population, osteoporotic vertebral compression fracture (OVCF) appears an increasing incidence rate. Conservative therapy (CT) and balloon kyphoplasty (BKP) have been used to treat OVCFs. However, an increase in new vertebral compression fractures at nontreated levels following BKP is of concern. It is still not clear whether new fractures were a result of BKP and the purpose of this meta-analysis was to evaluate the new fractures risk after BKP compared with CT. An exhaustive literature search of PubMed, EMBASE, and the Cochrane Library was conducted to identify randomized controlled trials and prospective nonrandomized controlled study that compared BKP with CT for patients suffering OVCF. A random-effect model was used. Results were reported as standardized mean difference or risk ratio with 95% confidence interval. Twelve studies were included and there was no significant difference in total new fractures (P = .33) and adjacent fractures (P = .83) between 2 treatments. Subgroup analyses did not demonstrate significant differences in follow-up period, mean age, anti-osteoporosis therapy, and the proportion of women. Our systematic review revealed that an increased risk of fracture of vertebral bodies was not associated with BKP compared with CT.

Comparison of Therapeutic Efficacy Between Isolated Encephaloduroarteriosynangiosis and Medical Treatment in Patients with Atherosclerotic Middle Cerebral Artery Occlusion

Encephaloduroarteriosynangiosis (EDAS) as a form of indirect revascularization has been recently proposed as a potentially promising alternative for patients with intracranial atherosclerotic disease (ICAD). The object of this study was to compare the prognostic roles between isolated EDAS and medical therapy in patients with atherosclerotic middle cerebral artery occlusion (MCAO). From January 2014 to June 2017, 125 patients with atherosclerotic MCAO were enrolled in this prospective nonrandomized controlled cohort study. Patients who underwent EDAS (n= 60) were compared with those treated medically (n= 65). Early and late adverse events and functional outcomes including memory ability were compared between groups. During 23.7 months of mean follow-up, rates of adverse events, including ischemic events in the territory of the qualifying middle cerebral artery, and death from any causes, were not significantly different in patients treated with EDAS and with medical therapy (6.7% vs. 12.3%; P=0.285). Landmark analyses showed that at initial 6-month follow-up, there was no significant difference for adverse event rates, whereas the opposite finding was shown for the subsequent period (EDAS 1/57 [1.7%] vs. medical management 7/64 [10.9%]; P= 0.024). The P value for the interaction between time (first 6 months vs. subsequent period) was 0.044. No significant differences were found with respect to neural function status and cognitive ability. In the long-term, isolated EDAS can be considered effective and safe for patients with atherosclerotic MCAO, whereas it may need additional medical therapy support in the short-term.

Improving Patient Compliance With Mechanical Venous Thromboembolism Prophylaxis.

Venous thromboembolic events (VTE) occurring in the postoperative period are serious yet preventable conditions. Multiple studies have demonstrated that the risk of postoperative VTE can be successfully reduced with mechanical prophylaxis and/or chemoprophylaxis. Patients are often noncompliant with mechanical prophylaxis in the postoperative period. We performed a prospective nonrandomized controlled study to determine if providing an educational pamphlet would increase knowledge and compliance with mechanical VTE prophylaxis. Patients receiving the educational pamphlet were more likely to rate their knowledge of VTE prophylaxis as "very good" when compared to the control group (73.1% vs. 30.2%, p < .001). Patients were also more likely to be compliant with mechanical prophylaxis in the educational group (53.9% vs. 30.2%, p = .014). Our study demonstrated that providing a simple educational pamphlet increased patient knowledge regarding VTE prophylaxis and increased compliance with mechanical prophylaxis.

Patient‘s perspective on long‐term complications after superficial parotidectomy for benign lesions: Prospective analysis of a 2‐year follow‐up

Evaluation of patients' perspective on long-term complications after superficial parotidectomy for benign lesions. A prospective nonrandomized controlled multicenter study. Three university-based tertiary referral centers (Departments of Otorhinolaryngology of Cologne, Jena and Giessen; all in Germany). 130 adult patients, who underwent a primary superficial parotidectomy for benign tumors of the parotid gland, were consecutively included from 09/2010 to 05/2012. 61 patients completed every follow-up examination. Complications were evaluated using the validated German-language questionnaire Parotidectomy Outcome Inventory 8 at six, 12 and 24months after surgery. Pain intensity was assessed on a numeric rating scale (NRS) at each follow-up visit. At 6months after surgery, 90% characterized hypoesthesia as the most disturbing problem, followed by fear of revision surgery (57%) and scar (56%). Facial palsy (14%) posed the minor problem. Hypoesthesia improved significantly during the follow-up period (all P<.05), but still posed a problem for 78% of the patients after 2years. Pain, which initially bothered 53% of the patients, significantly decreased, whereas impairment due to Frey's syndrome significantly increased during the follow-up (6 vs 24months; P=.002 and P=.001, respectively). Scar, substance loss, xerostomia, facial palsy, and anxiety affected patients with unvarying severity during the 2years (all P>.05). From patients' perspective, sensation loss posed the major subjective problem after superficial parotidectomy. Appearance of the scar, and fear of revision surgery impaired more than 50% of the patients in their daily life without significant improvement during the 2years postoperatively. Although superficial parotidectomy is a highly standardized and safe procedure, limited parotidectomy for proven benign parotid salivary gland neoplasms is more likely to result in patients with minimal or no displeasing complications.

Prospective multicenter non-randomized controlled study on intraosseous stability and healing period for dental implants in the posterior region

BackgroundA current implant body surface was treated with “rough processing” by sandblasting and acid etching for the purposes of obtaining more reliable osseointegration and shortening the treatment period. Various reports have examined the healing period with the use of these implant bodies, but a consensus opinion has not yet been obtained. The purpose of this study is to evaluate the relationship between insertion torque (IT) and implant stability quotient (ISQ) at implant treatment using the current rough-surfaced implant. We evaluated the implant treatment sites with ISQ values, IT values, and voxel values.MethodsParticipants in this study comprised 26 patients (10 males, 16 females; mean age, 55.5 years) who received posterior region dental implants at Tokyo Dental College Hospital or Fukuoka Dental College Hospital. For all participants, pretreatment computed tomography and determination of bone quality from voxel values were performed. Thirty-two implant bodies were inserted into the posterior region, and insertion torque was measured. ISQ was also measured at 0, 2, 4, 6, 8, and 12 weeks postoperatively.ResultsEight implant bodies in the maxilla and 24 in the mandible were inserted. All ISQ values increased, exceeding 60 by 6 weeks postoperatively. For insertion torque < 30 N cm, ISQ increased significantly after 8 weeks. For ≥ 30 N cm, the ratio at which high ISQ values appeared increased significantly after 6 weeks. Compared with the treatment area with insertion torque < 40 N cm, the treatment area ≥ 40 N cm showed a significantly higher voxel value.ConclusionsNo significant relationship was found between the insertion torque value and the ISQ value. Also, it was suggested that the ISQ value was considered to be an important indicator for observing the treatment state of the implant.

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.