Medical Ethics Committee Approval Research Articles

A Comparative Study between Ultrasound Guided Pectoral Nerve Block Type II versus Intravenous Patient Controlled Analgesia for Intra-Operative and Post-Operative Analgesia in Patients Undergoing Modified Radical Mastectomy

Abstract Background Breast surgery is becoming more and more common. Patients are often middle-aged women and with high public awareness around issues of breast cancer. The numbers are increasing. Breast surgery is an exceedingly common procedure and associated with an increased incidence of acute and chronic pain. Regional anaesthesia techniques may improve post-operative analgesia for patients undergoing breast surgery. Aim of the Work The primary aim of this study is to compare the efficacy of PECS block versus PCA with iv morphine to provide prolonged post-operative analgesia. The secondary objective is to identify the side effects of both techniques as post-operative analgesic techniques. Patients and Methods This study is a randomized clinical trial study conducted in Ain-shams University Hospitals, Cairo, Egypt for 6 months after medical ethical committee approval. The participants were allocated randomly into two groups of 25 patients each: group A: Patients received general anaesthesia followed by PECS block at the end of the operation before extubation, group B: Patients received general anaesthesia followed by the PCA at the end of surgery after extubation. Results The VAS score in the PECS group was statistically significantly lower at the 1st, 2nd and 4th hours. In this case, the use of PECS for postoperative analgesia is as effective as intravenous Morphine PCA in pain treatment, but with less systemic side effect as the nausea and vomiting is significantly higher in the PCA group than the PECS group at the 6th hour, however, the need of intra operative opioids in PCA group is significant. Conclusion In modified radical mastectomy, PECS block is as effective as intravenous Morphine PCA in pain treatment. Compared with intravenous PCA, PECS block can be considered as a more preferable method because it can avoid the systemic actions of morphine used for PCA, and can decrease the need of analgesia intra-operative, however PCA analgesic effect last longer, less invasive technique and easier to be used while PECS block require hand skills and limited to 24 hours analgesia only.

The Impact of Administration of Chlorpheniramine/Paracetamol versus Paracetamol Only on the Postoperative Agitation after Orofacial Cleft Repair Procedures in Pediatrics

Abstract Background term “emergence delirium” first appeared in medical literature in early 1960s. While it is frequently used interchangeably with emergence agitation, it is described as temporary dissociated state of consciousness following anaesthesia discontinuation. Aim and Objectives aim was to study the role of pre-emptive Chlorpheniramine as an adjuvant to paracetamol in the prevention of emergence agitation in orofacial cleft repair surgeries. Studied cases& techniques: study was prospective, Randomized, Double-Blind Clinical research done at Ain-shams University Hospitals, Cairo, Egypt for 6 months after Medical Ethical Committee approval for children within 3 month up to 18 years with cleft lip or/with cleft palate. Results On comparison of facial express score between group A & group B, group A showed significant decrease in facial express score compared to group B as the median (IQR) facial express score in group A was 2.0 (2.0- 4.0) and 4.0 (2.0-8.0) in group B. Conclusion We deduced that preoperative chlorpheniramine 0.2 mg/kg and paracetamol 15mg/kg before skin incision is effective medication that can be used to stop or decrease severity of emergence agitation while causing minimal cardio- respiratory depression. It also enhanced quality of healing in post-anesthesia care unit.

Expression of Concern: Polymorphisms of the Serotonin Transporter Gene and Their Relation to Premature Ejaculation in Individuals from Iran.

No AccessJournal of UrologyExpression of Concern10 Jan 2023Expression of Concern: Polymorphisms of the Serotonin Transporter Gene and Their Relation to Premature Ejaculation in Individuals from Iranis a expression-of-concern ofPolymorphisms of the Serotonin Transporter Gene and Their Relation to Premature Ejaculation in Individuals from Iran Mohammad Reza Safarinejad Mohammad Reza SafarinejadMohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003111AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "Expression of Concern: Polymorphisms of the Serotonin Transporter Gene and Their Relation to Premature Ejaculation in Individuals from Iran." The Journal of Urology, Publish Ahead of Print, pp. – Study received local medical ethical committee approval. From the Urology and Nephrology Research Center, Shahid Beheshti University (MC), Tehran, Iran© 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology16 Apr 2009Polymorphisms of the Serotonin Transporter Gene and Their Relation to Premature Ejaculation in Individuals from Iran Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author Expand All Study received local medical ethical committee approval. Advertisement PDF downloadLoading ...

Expression of Concern: Evaluation of Semen Quality, Endocrine Profile and Hypothalamus-Pituitary-Testis Axis in Male Patients With Homozygous β-Thalassemia Major.

No AccessJournal of UrologyExpression of Concern10 Jan 2023Expression of Concern: Evaluation of Semen Quality, Endocrine Profile and Hypothalamus-Pituitary-Testis Axis in Male Patients With Homozygous β-Thalassemia Majoris a expression-of-concern ofEvaluation of Semen Quality, Endocrine Profile and Hypothalamus-Pituitary-Testis Axis in Male Patients With Homozygous β-Thalassemia Major Mohammad Reza Safarinejad Mohammad Reza SafarinejadMohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003116AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "Expression of Concern: Evaluation of Semen Quality, Endocrine Profile and Hypothalamus-Pituitary-Testis Axis in Male Patients With Homozygous β-Thalassemia Major." The Journal of Urology, Publish Ahead of Print, pp. – Study received local medical ethical committee approval. From the Urology and Nephrology Research Center, Shahid Beheshti University (M.C), Tehran, Iran© 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology18 Apr 2008Evaluation of Semen Quality, Endocrine Profile and Hypothalamus-Pituitary-Testis Axis in Male Patients With Homozygous β-Thalassemia Major Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author Expand All Study received local medical ethical committee approval. Advertisement PDF downloadLoading ...

Expression of Concern: Effects of the Reduced Form of Coenzyme Q10 (Ubiquinol) on Semen Parameters in Men with Idiopathic Infertility: a Double-Blind, Placebo Controlled, Randomized Study.

No AccessJournal of UrologyExpression of Concern10 Jan 2023Expression of Concern: Effects of the Reduced Form of Coenzyme Q10 (Ubiquinol) on Semen Parameters in Men with Idiopathic Infertility: a Double-Blind, Placebo Controlled, Randomized Studyis a expression-of-concern ofEffects of the Reduced Form of Coenzyme Q10 (Ubiquinol) on Semen Parameters in Men with Idiopathic Infertility: a Double-Blind, Placebo Controlled, Randomized Study Mohammad Reza Safarinejad, Shiva Safarinejad, Nayyer Shafiei, and Saba Safarinejad Mohammad Reza SafarinejadMohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author , Shiva SafarinejadShiva Safarinejad More articles by this author , Nayyer ShafieiNayyer Shafiei More articles by this author , and Saba SafarinejadSaba Safarinejad More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003143AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "Expression of Concern: Effects of the Reduced Form of Coenzyme Q10 (Ubiquinol) on Semen Parameters in Men with Idiopathic Infertility: a Double-Blind, Placebo Controlled, Randomized Study." The Journal of Urology, Publish Ahead of Print, pp. – Supported by the Kaneka Company, Japan. Study received medical ethics committee approval. Supplementary material for this article can be obtained at www.safarinejad.com. From the Clinical Center for Urological Disease Diagnosis, and a private clinic specializing in urological and andrological genetics, Tehran, Iran© 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology15 Jun 2012Effects of the Reduced Form of Coenzyme Q10 (Ubiquinol) on Semen Parameters in Men with Idiopathic Infertility: a Double-Blind, Placebo Controlled, Randomized Study Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author Shiva Safarinejad More articles by this author Nayyer Shafiei More articles by this author Saba Safarinejad More articles by this author Expand All Supported by the Kaneka Company, Japan. Study received medical ethics committee approval. Supplementary material for this article can be obtained at www.safarinejad.com. Advertisement PDF downloadLoading ...

Clinical analysis of alcoholic pellagra: A single‐center retrospective study

Pellagra caused by niacin deficiency in alcoholics can be easily misdiagnosed because of similar symptoms to other alcohol-related diseases and the lack of the classical triad of signs. This study aimed to define the clinical presentation of alcoholic pellagra for early diagnosis and timely treatment. The clinical data of 16 alcohol-dependent patients who had pellagra and treated in our hospital from January 2002 to December 2019 were retrospectively analyzed. The local medical ethics committee approval (Medical Ethics Committee of Affiliated Hospital of XuZhou Medical University, XYFY2020-KL247-02) for this study has been obtained. The main complaints of the 16 patients were skin lesions (six cases), diarrhea (six cases), and mental disorders (four cases). Then, 13 cases had typical skin lesions, and 3 patients had a full spectrum of diarrhea, dementia, and dermatitis (3D). In terms of the main diagnosis, 2 patients had pellagra and Wernicke's encephalopathy, 3 patients had pellagra and alcohol-withdrawal syndrome, and the other patients had pellagra. After sufficient amounts of niacin and multivitamin B were given, clinical symptoms improved rapidly, and no sequelae were observed during follow-up. Pellagra is rarely manifested as a full 3D spectrum, with only one or two characteristics, which lack diagnostic specificity, especially in individuals with alcoholism. Physicians should maintain a high degree of suspicion of niacin deficiency in alcoholics. Alcohol-dependent patients with pellagra may be accompanied by complications of Wernicke's encephalopathy and alcohol-withdrawal syndrome. Prompt identification and timely treatment with a sufficient amount of niacin in combination with other vitamins and a certain amount of Zn can achieve a good prognosis of pellagra.

The novel oral gonadotropin-releasing hormone receptor antagonist relugolix is a new option for controlled ovarian stimulation cycles.

PurposeRelugolix is an oral gonadotropin‐releasing hormone antagonist (GnRHant), which was first introduced in 2019. This study investigated the effects of the conventional injectable GnRHant formulation and this new oral GnRHant formulation on controlled ovarian stimulation (COS) cycles.MethodsRelugolix was administered in 126 cycles and conventional GnRHant injection was administered in 658 cycles (controls). The follicle stimulation was performed by an antagonist method, and for final oocyte maturation, recombinant human chorionic gonadotropin (rHCG), or gonadotropin‐releasing hormone agonist (GnRHa), or both (dual trigger) were selected. The number of retrieved oocytes was counted and then they were evaluated for subsequent development up to cleavage stage.ResultsThe number of retrieved oocytes which was the primary outcome of this research was affected by the combination of GnRHant type and the final oocyte maturation agent. The combination of relugolix and a GnRHa trigger showed a significantly lower number of retrieved oocytes (p < 0.001) than the other combinations.ConclusionsRelugolix is a new option for COS cycles, but should be carefully combined with the final maturation agent.Clinical trial approvalThis study was conducted after approval by the Medical Corporation Sankeikai Institutional Ethics Committee (approval number: 2019‐34).

P–442 Cancer does not adversely affect oocyte maturation in vitro with the exception of breast cancer

Abstract Study question Do different types of cancer affect the success of oocyte maturation in vitro compared to infertile women included in the in vitro fertilization (IVF) program? Summary answer Cancer does not adversely affect oocyte maturation in vitro, with the exception of breast cancer, compared to infertile women in the in vitro fertilization program. What is known already Vitrification and storage of oocytes in liquid nitrogen is one of the real options for maintaining reproductive function in cancer patients. Despite careful hormonal stimulation of the ovaries, however, the proportion of oocytes is immature and lost to the patient. In vitro maturation of oocytes can play an important role in resolving immature oocytes and increasing the chances of conception in cancer patients. Moreover, it can mean a safe way to store oocytes when ovarian hormonal stimulation could worsen the disease. Therefore, the aim of this study was to determine whether different types of cancer affect oocyte in vitro maturation. Study design, size, duration After ovarian stimulation in 18 cancer patients, the number and maturity of oocytes were compared to 21 infertile patients in the IVF program over a three-year period. In both groups, 119 germinal vesicle-GV oocytes were matured in vitro to compare the maturation rate. After IVF in a subset of 17 infertile patients, the fertilization of in vitro and in vivo matured oocytes was compared in the same cycles. The procedure was considered in cancer patients. Participants/materials, setting, methods In this prospective study, forty-five GV oocytes in cancer patients and 74 GV oocytes in infertile patients underwent in vitro maturation procedure. Each oocyte was matured in vitro in the MediCult IVM System by conditioning in LAG medium and maturation for up to 28 hours in IVM medium with added hormones FSH and hCG, in coculture with cumulus cells from mature oocytes in the same patients. Oocytes were fertilized by intracytoplasmic sperm injection (ICSI). Main results and the role of chance After controlled ovarian hormonal stimulation, 198 oocytes were retrieved in cancer patients and 259 oocytes in infertile women and there were no significant differences in the number of retrieved oocytes, proportion of degenerated oocytes and proportion of GV oocytes. In cancer patients, the proportion of oocytes that matured in vitro was lower than in infertile patients (66.0 vs. 80.0%), but the difference was not significant. Among cancer patients, the oocyte maturation rate tended to be lower in patients with breast cancer than in patients with other cancers (54.5% vs. 81.2%; difference not significant). However, in patients with breast cancer, significantly fewer oocytes matured in vitro than in infertile patients (54.5% vs. 80.0%; P &amp;lt; 0.05, Chi-Square test) even though they tended to be younger (29.3 ± 7.4 vs. 33.4 ± 5.0 years; non-significant difference). After in vitro maturation, there was a 13% increase in mature oocyte yield in cancer patients and a 20.1% increase in infertile women with no significant difference observed. After ICSI in a subset of infertile women, there was approximately the same fertilization rate between oocytes matured in vitro and in vivo (55.1% vs. 57.0%) in the same cycles. Limitations, reasons for caution For ICSI in oocytes matured in vitro, we had to use semen collected the day before, while oocytes matured in vivo were fertilized with fresh semen in the same cycle. Therefore, we could not compare the development of embryos in both groups. Wider implications of the findings: In vitro maturation of oocytes in connection with their vitrification or vitrification of embryos after their fertilization appears to be a valuable way to maintain the fertility of young cancer patients, but a worse outcome is expected in breast cancer patients. Trial registration number National Medical Ethical Committee Approval, No. 0120–222/2016–2; KME 115/04/16.

Levobupivacaine Versus Hyperbaric Bupivacaine in SpinalAnesthesia for Hypospedias Surgery in Children

AbstractBackground: We have conducted this study to comparebetween levobupivacaine and hyperbaric bupivacaine inSpinal Anesthesia (SA) for hypospedius surgery in childrenregarding efficacy, hemodynamics, complications incidence,number of children that needed propofol infusion and surgeon'ssatisfaction.Aim of Study: Study comparing between levobupivacaineand hyperbaric bupivacaine in Spinal Anesthesia (SA) forhypospadius surgery in children regarding efficacy, hemody-namics, complications incidence, number of children thatneeded propofol infusion and surgeon's satisfaction.Patient and Methods: This study was done in Al-ZahraaUniversity Hospital from January 2019-January 2020. Afterobtaining Medical Ethical Committee approval and writteninformed consents from parents of all patients in the study;Thirty patients aged (4-10 years) ASA I and II, scheduled forelective hypospedius surgeries under spinal anesthesia (SA)were divided into two equal groups in a randomized controlledfashion. Group L (n=15) received 0.3mg/kg levobupivacaine (0.5%) and group H (n=15) received 0.3mg/kg hyperbaricbupivacaine (0.5%). Hemodynamics [Mean Arterial BloodPressure (MAP), Heart Rate (HR)], onset and duration ofsensory and motor block, surgeon's satisfaction, number ofpatients needed propofol infusion and side effects were re-corded for each patient.Results: The results of the present study demonstratedthat, levobupivacaine produces definitely rapid regression ofunwanted motor blockade and faster onset of sensory blockadecompared to hyperbaric bupivacaine with negligible changesregarding other parameters.Conclusion: We conclude that SA performed with lev-obupivacaine and hyperbaric bupivacaine are effective inproviding adequate quality of SA for hypospedias surgery inchildren, so, levobupivacaine can be a good alternative inhypospadias surgeries in children.

Oral premedication in children: Comparison of combination of midazolam-ketamine and oral midazolam- A Randomised trial

Introduction: Premedication with sedative drugs is often used in paediatric practice as one of the modalities to reduce preoperative anxiety in children undergoing surgery. It reduces both patient and parental anxiety and improves overall satisfaction. Also, provides anterograde amnesia and reduces postoperative behavioral changes and adverse outcomes in children. The ideal premedication in children should be readily acceptable and should have speedy and reliable onset with negligible side effects. Materials and Methods: After obtaining institutional medical ethics committee approval, sixty ASA physical status I or II children, aged 1-8 years scheduled for elective surgery were randomly allocated into one of the two groups. Group M (n=30): received preservative free oral midazolam 0.5mg/kg (1ml=5mg) + acetaminophen based syrup (5ml=120mg) upto maximum value of 0.4ml/kg. Group MK (n=30): received preservative free oral midazolam 0.25 mg/kg (1ml=5mg)with 3mg/kg oral ketamine(1ml=50mg) + acetaminophen based syrup (5ml=120mg) upto maximum value of 0.4ml/kg. Results: Combination of midazolam0.25mg/kg and ketamine3mg/kg provided faster onset and higher degree of sedation, comparable incidence of satisfactory parental separation and mask acceptance without any added side effects in comparison to midazolam 0.5mg/kg. Conclusion: Addition of low dose ketamine to midazolam as a premedication provides adequate sedation. Keywords: Premedication, Midazolam, Ketamine, Pediatric patients, Sedation

Assessment of lumbar disc herniaton using fractional anisotropy in diffusion tensor imaging along with conventional T2-weighted imaging.

To assess the usefulness of diffusion tensor imaging and its fractional anisotropy map along with conventional T2-weighted imaging in evaluating the anisotropic water diffusion variations of annulus fibres involved in herniation disc pathology. Seventy-five patients with previous medical ethics committee approval and informed consent experiencing low back pain were selected for this prospective randomised blinded trial. Lumbar disc fractional anisotropy maps were obtained acquiring diffusion tensor sequences on a 3T machine. The matrix of nucleus pulposus and structures of annulus fibres were analysed using fractional anisotropy textural features to highlight any presence of lumbar disc herniation. Observer variability and reliability between two neuroradiologists were evaluated. The χ2 test, two-tailed t test and linear regression analysis were used to focus differences in patients' demographic data and magnetic resonance imaging findings. Annular fissures with extrusions were identified using diffusion tensor imaging in 10 out of 17 discs (study group) previously assessed as bulging discs using conventional magnetic resonance imaging. Eighteen extrusions out of 39 (study group) disc levels were identified on diffusion tensor imaging compared to eight extrusions highlighted on T2-weighted imaging (P < 0.01). All eight (study group) disc extrusions evaluated on T2-weighted imaging showed annular fissures on diffusion tensor imaging. Seven out of 14 (study group) protrusions highlighted on T2-weighted imaging had no annular fissures on diffusion tensor imaging; thirty-six disc levels in the control group had no evidence of annular fissures on diffusion tensor imaging (P > 0.01). The addition of diffusion tensor imaging sequences and fractional anisotropy mapping to a conventional magnetic resonance imaging protocol could be useful in detecting annular fissures and lumbar disc herniation.

Hearing loss among children with sickle cell anaemia in Uganda

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; A case control was carried out to study the prevalence, the pattern and associated factors of hearing loss among Ugandan children with sickle cell anaemia.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; One hundred and thirty-two children known sickle cell and one hundred thirty aged matched non-SCA controls were recruited after medical ethics committee approval and informed consent. Two obtain information on socio-demographic characteristics, history, and examination of the participants, a structured questionnaire was administered. Pure tone audiometry (PTA) was used to assess the hearing in a sound-treated room. &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; Twenty-two of the children had hearing impairment compared to 6 controls. Prevalence of hearing loss found among children with SCA was 17% but in the control group the prevalence found was 5%. Sensorineural hearing loss (SNHL) affected 39%, conductive (CHL) 25% and mixed (MHL) 14% among cases compared to CHL 7%, SNHL 7% and MHL 7% among the controls. The hearing loss varied from mild to moderate (95%). All sickle cell children had high-frequency hearing loss. There was a statistically significant association of hearing loss and neurologic motor deficit.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Sickle patients are at risk of developing hearing loss as the study demonstrated a difference in hearing threshold in children living with sickle cell anaemia and the controls. High frequencies were more affected. The neurologic motor deficit was highly associated with hearing loss among patients with SCA compared to controls.&lt;/p&gt;

Evaluation of effectiveness of the PlasmaJet surgical device in the treatment of advanced stage ovarian cancer (PlaComOv-study): study protocol of a randomized controlled trial in the Netherlands

BackgroundThe most important goal for survival benefit of advanced stage ovarian cancer is to surgically remove all visible tumour, because complete cytoreductive surgery (CCS) has been shown to be associated with prolonged survival.In a remarkable number of women, CCS is very challenging. Especially in women with many small metastases on the peritoneum and intestinal surface, conventional CCS with electrosurgery is not able to be “complete” in removing safely all visible tumour.In this randomized controlled trail (RCT) we investigate whether the use of the PlasmaJet Surgical Device increases the rate of CCS, and whether this indeed leads to a longer progression free and overall survival.The main research question is: does the use of the PlasmaJet Surgical Device in surgery for advanced stage ovarian cancer result in an increased number of complete cytoreductive surgeries when compared with conventional surgical techniques. Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, Quality of Life, disease-free survival, overall survival, percentage colostomy, cost-effectiveness.MethodsThe study design is a multicentre single-blinded superiority RCT in two university and nine non-university hospitals in The Netherlands. Three hundred and thirty women undergoing cytoreductive surgery for advanced stage ovarian carcinoma (FIGO Stage IIIB-IV) will be randomized into two arms: use of the PlasmaJet (intervention group) versus the use of standard surgical instruments combined with electrocoagulation (control group). The primary outcome is the rate of complete cytoreductive surgery in both groups.Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, Quality of Life, disease-free survival, overall survival, percentage colostomy, cost-effectiveness. Quality of life will be evaluated using validated questionnaires at baseline, at 1 and 6 months after surgery and at 1, 2, 3 and 4 years after surgery.DiscussionWe hypothesize the additional value of the use of the PlasmaJet in CCS for advanced stage epithelial ovarian cancer. More knowledge about efficacy, side effects, recurrence rates, cost effectiveness and pathology findings after using the PlasmaJet Device is advocated. This RCT may aid in this void.Trial registrationDutch Trial Register NTR6624. Registered 18 August 2017.Medical Ethical Committee approval number: NL62035.078.17 (Medical Ethical Committee Erasmus Medical Centre Rotterdam).

Transesophageal echocardiography-assisted transcatheter device closure of apical muscular ventricular septal defect.

Transesophageal echocardiography-assisted transcatheter device closure of apical muscular ventricular septal defect.

Impact of Interleukin-6 and Interleukin-10 Gene Polymorphisms on Inhibitor Development in Patients with Moderate and Severe Hemophilia a

Background:An important complication of administration of factor VIII concentrates to treat or prevent bleeding,is the development of autoantibodies that block the activity of the relevant factor (inhibitors). These inhibitory antibodies occur in approximately 25 % of patients with severe hemophilia A. Inhibitors are much less common in patients with mild or moderate disease. Recently, significant progress has been made in our understanding of the mechanisms that lead to inhibitor formation. Polymorphisms of the immune response genes have been suggested to be contributing determinants of the inhibitor risk. Previous immunogenetic studies have shown the implication of human leukocyte antigen (HLA) alleles and some of the cytokine polymorphisms in inhibitors formation such as IL-6 and IL-10.Aim:This study aimed to investigate the associations between interleukin-6 gene promoter polymorphism at position (−174 G/C), interleukin-10 gene promoter polymorphism at position (-1082G/A) and susceptibility of patients with hemophilia A to develop factor VIII inhibitors.Methods and subjects:After medical ethical committee approval, the present study was conducted on 50moderate and severehemophilia A males aged ≤ 18 years who are attending hematology outpatient clinic of Alexandria University Children's Hospital at El-Shatby. The 50 children were undergoing a)Detailed history taking, with special emphasis on: Age of the patient at the time of diagnosis, clotting activity of factor VIII, Age at first exposure to factor VIII, Type and dose of administered factor VIII concentrate. Exposure days (EDs), Age at first surgical intervention, Detection of factor VIII inhibitors b)Laboratory investigations: Identification of genetic variant IL-6 (rs1800795) , IL-10 ( rs1800896 ) using real time PCR.Results:Thirtyone (72.1%) patients had severe hemophilia and 19 (27.9%) had moderate Hemophilia. Eight (16%) of the studied patients were inhibitor positive.As regard interleukin-6 gene promoter polymorphism at position (−174 G/C), the frequency of G allele was greater than C allele in patients who developed inhibitors (χ2= 0.63) with P value = 1.000. regarding interleukin-10 gene promoter polymorphism at position (-1082G/A), the frequency of G allele was greater than A allele in patients who developed inhibitors (χ20.75) with P value = 0.891.There was no statistically significantdifference as regards interleukin-6 polymorphism at position (−174 G/C), interleukin-10 polymorphism at position (-1082G/A) between inhibitor positive and inhibitor negative patients.Conclusion:There was no relation between interleukin-6 polymorphism at position (−174 G/C) , interleukin-10 polymorphism at position (-1082G/A)and the development of factor VIII inhibitors in patients with hemophilia A despite of the high frequency of G allele among inhibitors corresponding to the previous studies done . Further studies are recommended with larger cohort and other SNPs. DisclosuresHassab:Global Blood Therapeutics: Research Funding.

ANTIBACTERIAL ACTIVITY OF BIFIDOBACTERIA ISOLATED FROM INFANT FAECES

Antibacterial activity of bifidobacteria isolated from Mongolian infant faeces was elucidated on pathogenic intestinal bacteria for the development of a new antibacterial bifidobacteria, the permission for which was granted by the Mongolian Medical Ethics Committee Approval (MMECA). A total of forty-nine single colonies were obtained from 3 samples by using a BL medium enrichment. Among them, 29 isolates had Gram−positive, catalase−negative properties, and maul−like or Y−shaped morphology, and then, 20 Bifidobacterium breve and 9 Bifidobacterium longum strains were detected by the B. breve and B. longum specific primers. Organic acids produced by the isolated bifidobacteria in their cell-free supernatants were quantitatively analyzed by a spectrophotometric absorbance at 340 nm, suggesting that D−lactic, L−lactic, and acetic acids were produced, and the pH of the supernatants was at 3.86−4.55. The isolated bifidobacteria showed antibacterial activity toward Escherichia coli and Salmonella typhimurium as high as that of a standard bifidobacteria, however, lower activity against Staphylococcus aureus. The antibacterial activity was probably due to the production of organic acids.

Long-Term Follow-Up After Pyrocarbon Disc Interposition for Thumb CMC Osteoarthritis

There is no financial information to disclose. The pyrocarbon disc has been designed for the surgical treatment of CMC thumb joint osteoarthritis Eaton and Littler 2 to 3. It is hypothesized that interposition of the implant will preserve height, stability, strength, and movement after surgery as much as possible. Our study evaluated the long-term results after pyrocarbondisc implant as interposition hemiarthroplasty for CMC thumb joint osteoarthritis for Eaton and Littler grade 2 or 3 osteoarthritis. Between 2006 and 2014, 237 thumbs were operated in our centers. After medical ethical committee approval, all eligible patients were approached to participate in the study. As primary outcome, patient reported outcome measurements were obtained, such as pain, function, satisfaction and quality of life, measured with the 5 questionnaires (PRWHE, MHQ, DASH, SF-36 and questions to measure satisfaction). As secondary outcome, power, range of motion, and position of the disc in the thumb were evaluated. These data were obtained by hand measurements and radiology evaluation. A total of 190 thumbs in 158 patients were included in the study. The preliminary results showed an average follow-up of 7 years (range 2–11 years). The mean age at operation was 59.3 years. Of the 190 placed pyrodiscs, 16 (8.4%) were removed because of ongoing problems after operation. Of the 174 thumbs in 142 patients, the preliminary results showed a median DASH of 18 and a median PRWHE of 14.5. The MHQ had a total score of 74. Satisfaction with the operation and results scored 9.0 (on a Likert scale of 1–10). The median JAMAR was 21.9 (100% of the contralateral grip power), the key pinch was 4.8, the tip pinch was 3.2, and the 3-point pinch was 4.0 (98%, 98%, and 97% of the contralateral hand, respectively). Range of motion with Kapandji was 9.0. This is the first study with long-term follow-up after pyrocarbon disc interposition for the treatment of CMC1 osteoarthritis grade 2 to 3 in more than 150 thumbs. The preliminary results show:•a high level of patient satisfaction•preservation of movement and strength•no loss of height of the first metacarpal•no luxation of the implants during the follow-up period of an average of 7 years

Is DVT prophylaxis necessary after oncology lower limb surgery? A pilot study

Background Deep vein thrombosis (DVT) has been independently associated with both malignant diseases and orthopaedic surgery. Therefore, orthopaedic oncology patients may be at a high risk for thromboembolic events. However, less emphasis is given to this group of patients compared to the patients undergoing total hip and knee replacement. The objective of this study is to determine the incidence of DVT and their risk factors in patients undergoing orthopaedic oncology lower limb surgery without prophylaxis.Questions/purposes(1) What is the incidence of DVT in patients who underwent orthopaedic oncology surgery for the lower limb? (2) What are the risk factors related to DVT in patients who underwent oncology surgery of the lower limb surgery? (3) This is a pilot study to determine if further trial is warranted.MethodsThis is a prospective study. All sequential patients undergoing orthopaedic oncology operations from the period of 1st October 2013 till 30th September 2014 were recruited for the study with their consent. Their demographic data, diagnosis and surgery were documented. Thirty-eight patients who underwent lower limb surgeries for orthopaedic oncology indications were included in the study. No tourniquet was used in these lower limb surgeries. There were 24 men and 14 women with a mean age of 36 years (11–75). All potential risk factors were also identified and documented. All patients were not given any form of DVT prophylaxis (mechanical and chemical) before and after operation as this is a standard protocol in our center and a Medical Ethics Committee approval was taken for this study. DVT surveillance was performed 1 day before operation and 2 weeks after operation with ultrasound Doppler. Patients diagnosed with DVT via ultrasound Doppler were subsequently scheduled for CTPA to look for pulmonary embolism (PE).ResultsDVT was detected in two patients (5 %). Both patients were asymptomatic and they both had proximal thrombosis. One patient (2.6 %) was diagnosed with non-fatal PE and was asymptomatic. PE was detected incidentally by staging computed tomography scan and the patient had negative ultrasound Doppler of the operated and non-operated limb for DVT. We did not carry out a statistical analysis as the study population with DVT and pulmonary embolism is small.ConclusionsThe incidence of DVT in patients after undergoing orthopaedic oncology lower limb surgery was low even without prophylaxis at our center. Further investigation with larger sample size is needed to validate our results and identify the risk factors.Level of evidenceLevel III descriptive study.

TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): study protocol for a randomized controlled trial.

BackgroundCervical intraepithelial neoplasia (CIN) is the premalignant condition of cervical cancer. Whereas not all high grade CIN lesions progress to cervical cancer, the natural history and risk of progression of individual lesions remain unpredictable. Therefore, high-grade CIN is currently treated by surgical excision: large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as acute haemorrhage, prolonged bleeding, infection and preterm birth in subsequent pregnancies. These complications could be prevented by development of a non-invasive treatment modality, such as topical imiquimod treatment.The primary study objective is to investigate the efficacy of topical imiquimod 5 % cream for the treatment of high-grade CIN and to develop a biomarker profile to predict clinical response to imiquimod treatment. Secondary study objectives are to assess treatment side-effects, disease recurrence and quality of life during and after different treatment modalities.Methods/designThe study design is a randomized controlled trial. One hundred forty women with a histological diagnosis of high-grade CIN (CIN 2–3) will be randomized into two arms: imiquimod treatment during 16 weeks (experimental arm) or immediate LLETZ (standard care arm). Treatment efficacy will be evaluated by colposcopy with diagnostic biopsies at 20 weeks for the experimental arm. Successful imiquimod treatment is defined as regression to CIN 1 or less, successful LLETZ treatment is defined as PAP 1 after 6 months. Disease recurrence will be evaluated by cytology at 6, 12 and 24 months after treatment. Side-effects will be evaluated using a standardized report form. Quality of life will be evaluated using validated questionnaires at baseline, 20 weeks and 1 year after treatment. Biomarkers, reflecting both host and viral factors in the pathophysiology of CIN, will be tested at baseline with the aim of developing a predictive biomarker profile for the clinical response to imiquimod treatment.DiscussionTreatment of high-grade CIN lesions with imiquimod in a selected patient population may diminish complications as a result of surgical intervention. More knowledge on treatment efficacy, side effects and long-term recurrence rates after treatment is necessary.Trial registrationEU Clinical Trials Register EU-CTR2013-001260-34. Registered 18 March 2013.Medical Ethical Committee approval number: NL44336.068.13 (Medical Ethical Committee Maastricht University Hospital, University of Maastricht).Affiliation: Maastricht University Hospital.Registration number ClinicalTrials.gov: NCT02329171.

Altered long- and short-range functional connectivity in the patients with end-stage renal disease: a resting-state functional MRI study.

To investigate alterations of functional connectivity density (FCD) in patients with end-stage renal disease (ESRD) by using resting-state functional magnetic resonance imaging (rs-fMRI). Medical research ethics committee approval from Jinling hospital and written informed consent from each subject were obtained. Forty six patients with ESRD, consisting of 21 patients minimal nephrotic encephalopathy (MNE) and 25 non-nephro-encephalopathy (non-NE), as well as 23 healthy controls underwent rs-fMRI. Neuropsychological tests were performed in all subjects, while laboratory tests were performed in ESRD patients. A voxel-wise whole brain functional connectivity analysis was used to generate long- and short-range FCD maps. The maps among MNE, non-NE, and healthy controls groups were compared by using one-way analysis of variance tests. A multiple regression analysis was performed to evaluate the correlations between FCD and the variables of neuropsychological or laboratory tests. Compared with healthy controls, non-NE showed decreased long-range FCD mainly in parietal lobe. Moreover, MNE showed further decreased long-range FCD in bilateral middle prefrontal cortex (MPFC), anterior cingulate cortex (ACC) and right superior frontal gyrus. Meanwhile, non-NE showed decreased short-range FCD mainly in frontal cortex, and further reduction in bilateral ACC and right superior parietal gyrus in MNE. In addition, patients with ESRD mainly exhibited increased long-range FCD in left temporal lobe and caudate; and increased short-range FCD in bilateral orbitofrontal cortex and temporal gyri (P<0.05, AlphaSim corrected). The number connection test type A score, serum creatinine, urea, and dialysis duration showed negative correlation with FCD in some brain regions, while the digital symbol test scores positively correlated with short-range FCD in left inferior parietal lobule (all P<0.05, AlphaSim corrected). The prominent long- and short-range FCD reduction was found mainly in default mode network (DMN) and bilateral frontal and parietal lobes, while the progressively decreased long- and short-range FCD in ACC/MPFC and the long-range FCD in left superior frontal gyrus from non-NE to MNE was associated with cognition dysfunction in ESRD patients.