Comparative Study Between Autologous Platelet-rich Fibrin Membrane and Local Flaps as Intervening Layer in Management of Distal Hypospadias.

BACKGROUND/PURPOSE: The most frequent complication following hypospadias correction is fistula formation. Recently, fibrin glue has been employed as a 2nd layer covering the urethroplasty resulting in a reduction in the incidence of fistulas. Platelet-rich fibrin (PRF) is an autologous growth factor-rich source. Although the authors recommend the use of additional layers in hypospadias correction, there remains a controversy. In a trial to address this issue, our research was conducted to compare the accessibility of urethroplasty coverage using PRF to traditional local flaps, aiming to prevent fistula formation in hypospadias repair. PATIENTS AND METHODS: This is a prospective single-blinded randomized controlled study that involved 60 hypospadias cases admitted to Mansoura University Children Hospital's Pediatric Surgery department between March 2021 and March 2023. These 60 cases were randomly divided into 2 equal groups: (group A platelet-rich fibrin coverage membrane & group B local dartos flap as an additional layer). Both groups were compared regarding the rate of complications. All cases were evaluated regarding age at repair, type of hypospadias, urethral plate width, length of urethroplasty, and size of the 2nd layer. The blood loss and operative time were documented and post-operatively; the cases were assessed for the repair intactness, shape, and size of the neo-meatus, existence of any post-operative problems such as urethral fistula, urethral stricture, meatal stenosis, failure of the repair, or diverticulum. Statistical analysis was carried out following data collection. RESULTS: The median length of the 2nd layer in group A was 20 mm (range 15-23 mm) and in group B was 22.5 mm (range 19.5-25 mm) and the difference between the two groups was statistically significant (p = 0.012∗), while its median width in group A was 10 mm (range 10-11 mm) and in group B was 15 mm (range 10-18 mm) and also there was statistically significant difference (p = 0.001∗). The mean operative time in group A was 95.73 ± 11.9 min and in group B was 102.33 ± 10.32 min and there was a statistically significant difference (P < 0.001). The length of hospital stay in group A was 5.47 ± 1.11 days and in group B was 5.47 ± 0.89 days. The urethral fistula was detected in 4 cases of group A (13.3%) and 3 cases of group B (10%). The failure of repair was similar, one case of each group (3.3%). The meatal stenosis was reported in only one case of group A (3.4%) and 7 cases of group B (24.1%) (P = 0.02∗) and the difference was statistically significant. There were no reports of urethral strictures among the cases in either group over the follow-up period (mean 9 months, range 5-17 months). CONCLUSION: PRF patch may be employed as a coverage layer over the urethroplasty in repair of the distal hypospadias, especially in cases without accessible vascular flap with comparable outcome to traditional local flaps. TYPE OF STUDY: A prospective single blinded randomized controlled trial (computer-generated numbers method). LEVEL OF EVIDENCE: Level 2.

Trans-Abdominal Pre-Peritoneal (TAPP) Approach for Anatomical Repair of Direct Inguinal Hernia in Children, Could it Be the New Standardized Approach?

BACKGROUND: The incidence of direct inguinal hernia in the pediatric population is relatively low and is usually discovered intraoperatively, rendering it unfamiliar to most pediatric surgeons. The traditional approach involves directly addressing the peritoneal defect, which includes dissecting the sac and repairing the peritoneum, reinforced with the umbilical ligament. In this paper, we present our experience with a novel approach to anatomical repair utilizing a non-mesh transabdominal preperitoneal (TAPP) approach. METHODS: This a retrospective case series of direct inguinal hernia that were operated laparoscopically using the novel approach of repair from January 2018 to January 2024. Data were analyzed for demographics, presentation, type of defect, operative time, complications, and recurrence. The new approach utilizes the pre-peritoneal approach to delineate the exact facial defect then, primary anatomical repair is established using 2/0 non-absorbable braided sutures. Finally, closure of the peritoneum was performed using running 4/0 absorbable sutures. This is a retrospective case series of direct inguinal hernias that were operated on laparoscopically using the novel repair approach from January 2018 to January 2024. Data were analyzed for demographics, presentation, type of defect, operative time, complications, and recurrence. The new approach employs the pre-peritoneal approach to accurately delineate the fascial defect, followed by primary anatomical repair using 2/0 non-absorbable braided sutures. Finally, the peritoneum is closed using running 4/0 absorbable sutures. RESULTS: Data from nine cases were included. Six cases were on right side, and three cases were on left side. Patients were predominantly boys (8 boys and 1 girl). The mean age at operation was 25.1 months (range:11 month to 5 years). Four patients had previous indirect inguinal hernia repair on the same side. The mean operative time was 34 ± 9 min. No intraoperative complications occurred. The median follow up period was 24 months with no recurrence was detected in any of the cases. CONCLUSION: The non-mesh TAPP approach offers excellent exposure of the fascial structures, facilitating accurate identification and repair of the defect. Despite being technically demanding, it allows for the establishment of a robust anatomical repair. No recurrences occurred in the study group; however, a longer follow up and a larger sample are needed to provide more reliable evaluation. LEVEL OF EVIDENCE: III.

Interstitial Ectopic Pregnancy: Laparoscopic Cornuostomy.

STUDY OBJECTIVE: To demonstrate and discuss the technique of cornuostomy for surgical management of interstitial ectopic pregnancy. DESIGN: Stepwise demonstration of the technique with narrated video footage. SETTING: Tertiary referral center in Manchester, United Kingdom. INTERVENTION: Interstitial ectopic pregnancies are rare but are associated with a higher mortality rate than other ectopic pregnancies [1,2]. It occurs when the fertilized embryo implants in the interstitial portion of the fallopian tube traversing the vascularized myometrium. When undiagnosed they present late in the second trimester associated with rupture and catastrophic bleeding, with a mortality rate of 2% to 2.5%.2 Diagnosis requires a degree of vigilance from the ultrasound operator because it is commonly misdiagnosed as intrauterine pregnancies. Surgical management options include laparoscopic cornual resection or cornuostomy. There is no consensus on the optimal surgical technique but cornuostomy is a more conservative approach associated with less disruption to uterine anatomy and loss of myometrium [3,4]. A 22-year-old gravida 4 woman presented at 7 weeks' gestation with right iliac fossa pain. Initial serum human chorionic gonadotropin was 18 136 IU/L. Transvaginal ultrasound scan showed an empty endometrial cavity and an echogenic "donut"-shaped mass within the right interstitial space, within the uterine serosa but outside the endometrial cavity (Supplemental Video 1). At laparoscopy the diagnosis of a right interstitial ectopic pregnancy was confirmed (Supplemental Video 2). Vasopressin 20 IU diluted in 80 mL of normal saline was injected around the base of the ectopic pregnancy. Monopolar diathermy was used to incise the overlying serosa followed by hydrodissection to separate the ectopic gestational sac from the myometrial attachment. The resulting defect was inspected and closed in 2 layers. Total operating time was 46 minutes. CONCLUSION: Although there is no clear evidence to guide the management of all interstitial ectopic pregnancies, an individualized approach taking into account the woman's previous history and future fertility plans and wishes is essential. In this case, given the woman's previous contralateral salpingectomy and her wishes for a conservative approach, a laparoscopic cornuostomy was likely the best option.

Children and Young People's Health Partnership (CYPHP) Evelina London model of care: protocol for an opportunistic cluster randomised controlled trial (cRCT) to assess child health outcomes, healthcare quality and health service use.

INTRODUCTION: Children and young people (CYP) in many high-income settings have poor healthcare outcomes, especially those with long-term conditions (LTCs). Emergency and outpatient hospital service use is increasing unsustainably. To address these problems, the Children and Young People's Health Partnership (CYPHP) has developed and is evaluating an integrated model of care as part of a health systems strengthening programme across two boroughs of London, UK that are characterised by mixed ethnic populations and varying levels of deprivation. The CYPHP Evelina London model of care comprises proactive case-finding and triage, specialist clinics and transformative education and training for professionals working with CYP. Services are delivered by multidisciplinary health teams with an emphasis on increased coordination across primary, community and hospital settings and integration of physical and mental healthcare that accounts for the CYP's social context. METHODS AND ANALYSIS: The phased roll out of the CYPHP Evelina London model allows an opportunistic population-based evaluation using a cluster randomised controlled trial design. Seventy general practices across two London boroughs, grouped into 23 clusters, were randomised to provide either the CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2 years postimplementation. A population-level evaluation will use routinely collected pseudonymised healthcare data to conduct a service-use analysis for all CYP registered with a participating general practice (n=~90 000) with the rate of non-elective admissions as the primary outcome. We will seek consent from a subset of this population, with specific conditions (target n=2138) to assess the impact on patient-reported outcomes using the Paediatric Quality of Life Inventory (PedsQL) and Warwick-Edinburgh Mental Well-Being Scale (WEBWMS) as, respectively, the child- and parent-related primary outcomes. ETHICS AND DISSEMINATION: Ethics approval obtained from South West-Cornwall & Plymouth Research Ethics Committee. Results will be submitted for publication in peer-reviewed journals. Findings will be generalisable to community-based models of care, especially in urban settings. Our process evaluation will identify barriers and enablers of implementation and delivery of care salient to the context and condition. TRIAL REGISTRATION NUMBER: NCT03461848; Pre-results.

The Children and Young People's Health Partnership Evelina London Model of Care: process evaluation protocol.

INTRODUCTION: Children and young people (CYP) in the UK have poor health outcomes, and there is increasing emergency department and hospital outpatient use. To address these problems in Lambeth and Southwark (two boroughs of London, UK), the local Clinical Commissioning Groups, Local Authorities and Healthcare Providers formed The Children and Young People's Health Partnership (CYPHP), a clinical-academic programme for improving child health. The Partnership has developed the CYPHP Evelina London model, an integrated healthcare model that aims to deliver effective, coordinated care in primary and community settings and promote better self-management to over approximately 90 000 CYP in Lambeth and Southwark. This protocol is for the process evaluation of this model of care. METHODS AND ANALYSIS: Alongside an impact evaluation, an in-depth, mixed-methods process evaluation will be used to understand the barriers and facilitators to implementing the model of care. The data collected mapped onto a logic model of how CYPHP is expected to improve child health outcomes. Data collection and analysis include qualitative interviews and focus groups with stakeholders, a policy review and a quantitative analysis of routine clinical and administrative data and questionnaire data. Information relating to the context of the trial that may affect implementation and/or outcomes of the CYPHP model of care will be documented. ETHICS AND DISSEMINATION: The study has been reviewed by NHS REC Cornwall & Plymouth (17/SW/0275). The findings of this process evaluation will guide the scaling up and implementation of the CYPHP Evelina London Model of Care across the UK. Findings will be disseminated through publications and conferences, and implementation manuals and guidance for others working to improve child health through strengthening health systems. TRIAL REGISTRATION NUMBER: NCT03461848.

Introducing a proforma to improve clinical care in trauma surgery.

INTRODUCTION: Accurate trauma operative details are an important part of the care of trauma patients. This study evaluated the adequacy of handwritten operative notes for trauma patients and whether they comply with the standards set by the Royal College of Surgeons of England for optimizing clinical practice in a busy district general hospital. PATIENTS AND METHODS: Fifty consecutive sets of handwritten trauma operative notes were reviewed prospectively. A standardized printed proforma was introduced and then another 50 consecutive sets of notes were reviewed. The results were analysed using the Student t-test to obtain two-tailed P values comparing the mean difference between percentages of missing data for both cycles. RESULTS: Out of 24 parameters examined, 19 showed improvement after introducing the standardized proforma in trauma surgical notes. There was an overall significant improvement in the studied parameters (P= 0.0134), with a mean difference of 19.3% of missing data for both cycles. CONCLUSIONS: These results suggest that a standardized prestructured operative note proforma in trauma surgery is a useful tool in recording the operative data, thus helping to improve the medical care provided. It would also provide medicolegally sound evidence of a procedure when needed and so be more beneficial for the surgeon if routinely used. The authors recommend its regular use in different surgical specialties.

Targeting Neovascularization in Ischemic Retinopathy: Recent Advances.

Pathological retinal neovascularization (RNV) is a common micro-vascular complication in several retinal diseases including retinopathy of prematurity, diabetic retinopathy, age-related macular degeneration and central vein occlusion. The current therapeutic modalities of RNV are invasive and although they may slow or halt the progression of the disease they are unlikely to restore normal acuity. Therefore, there is an urgent need to develop treatment modalities, which are less invasive and therefore associated with fewer procedural complications and systemic side effects. This review article summarizes our understanding of the pathophysiology and current treatment of RNV in ischemic retinopathies; lists potential therapeutic targets; and provides a framework for the development of future treatment modalities.

Relation between single serum progesterone assay and viability of the first trimester pregnancy.

This study was designed to detect the relation between serum progesterone and viability of pregnancy during the first trimester. Prospective study carried out in Al-Rashid Maternity and Ahmadi Kuwait oil company hospitals, over three years from February 2009 to February 2012. Two hundred and Sixty (260) pregnant women were hospitalized due to vaginal bleeding and/or abdominal pain during the first trimester of their pregnancies and were included in this study. Women included in this study were; sure of dates, conceived spontaneously with no history of infertility and had a positive serum pregnancy test. 2 ml blood samples were taken for women included in this study for serum progesterone assay. Women included in this study were followed by ultrasound for the viability of the pregnancy till the end of first trimester and the outcome of their pregnancy were recorded, while women with exogenous progesterone support or multiple pregnancies or suspected ectopic pregnancy or Hydatiform mole were excluded from this study. Data were collected and statistically analyzed to detect the relationship between serum progesterone level and viability of pregnancy during the first trimester. The mean age of the studied population was 32.7 ± 5.1 years, the mean gestational age at progesterone assay was 9.7 ± 0.5 week and by the end of the first trimester, women included in this study were classified according to the viability of their pregnancies into; viable pregnancy group 178 (68.5%) cases and non-viable pregnancy group (ended by miscarriage) 82 (31.5%) cases. The mean serum progesterone of the studied population was significantly high in viable pregnancy group (46.5 ± 7.4 ng/ml) compared to non-viable pregnancy group (9.9 ± 4.8 ng/ml), (p <0.05). In this study; 6.7% of viable pregnancies had serum progesterone level <10 ng/ ml, while 20.7% of non-viable pregnancies had serum progesterone level >10 ng/ml, the serum progesterone at cut off level 10 ng/ml was 79.3% sensitive to diagnose non-viable pregnancy and was 93.3% specific to diagnose viable pregnancy. Also, in this study; 1.1% of viable pregnancies had serum progesterone level <20 ng/ ml, while 4.8% of non-viable pregnancies had serum progesterone level >20 ng/ml, the serum progesterone at cut off level 20 ng/ml was 95.1% sensitive to diagnose non-viable pregnancy and was 98.9% specific to diagnose viable pregnancy. Serum progesterone is a reliable marker for early pregnancy failure and single assay of its serum level can differentiate between viable and non-viable pregnancies.

Factors affecting outcome of tubularized incised plate (TIP) urethroplasty: single-center experience with 500 cases.

PURPOSE: To review our experience of tubularized incised plate (TIP) urethroplasty in children with hypospadias defects. METHODS: Of 500 children (mean age 6 years) who received a TIP urethroplasty, 439 (87.8%) had primary hypospadias and 61 had one failed previous repair. The hypospadias defects were coronal in 110 (22%), distal penile in 261 (52.2%), midpenile in 78 (15.6%) and proximal in 51 (10.2%). Chordee was present in 98 (19.6%) patients. Presence of complications requiring re-operation and overall general appearance was recorded. RESULTS: The mean (SD, range) follow-up was 34 (18, 7-77) months. Overall success rate was 81.4%. Re-operation was required in 93 patients (18.6%); for urethrocutaneous fistula in 47 (9.4%), complete disruption of the repair in 32 (6.4%) and meatal stenosis in 14 (2.8%). In univariate analysis, complications were significantly higher in stented repairs, posterior hypospadias, those with no neourethral coverage (spongioplasty), and repairs early in the study. The last three factors were the only significant independent risk factors in multivariate analysis. CONCLUSIONS: TIP is a reliable method for treating both distal and proximal hypospadias and is suitable for both primary and re-operative cases with a low rate of complications. A significantly better outcome is achieved with distal hypospadias, covering the neourethra with the mobilized corpus spongiosum (spongioplasty) or a flap, and experience. Stenting of the repair, patient age, or previous failed repair has no statistically significant impact on outcome.

A single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.

BACKGROUND: Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. OBJECTIVE: The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine by statistical analysis of the pharmacokinetic parameters C(max), AUC from 0 to 72 hours after dosing (AUC(0-72)), and AUC(0-infinity) as required by the Egyptian health authority for the marketing of a generic product. METHODS: This bioequivalence study was carried out in healthy male volunteers using a single-dose, randomized, 2-way crossover design under fasting conditions. Statistical analysis of the pharmacokinetic parameters C(max), AUC(0-72), and AUC(0-infinity) was conducted to determine bioequivalence (after log-transformation of data using analysis of variance and 90% CIs) and to gain marketing approval in Egypt. The formulations were considered to be bioequivalent if the log-transformed ratios of the 3 pharmacokinetic parameters were within the predetermined bioequivalence range (ie, 80%-125%), as established by the US Food and Drug Administration (FDA). Both the test product (Trademark: Integrol((R)) [Global Napi Pharmaceuticals, Cairo, Egypt]) and the reference product (Trademark: Zyprexa((R)) [Eli Lilly and Company, Basingstoke, Hampshire, United Kingdom]) were administered as 10-mg tablets with 240 mL of water after an overnight fast on 2 treatment days, separated by a 2-week washout period. After dosing, serial blood samples were collected for 72 hours. Plasma samples were analyzed using a sensitive, reproducible, and accurate liquid chromatography-tandem mass spectrometry method capable of quantitating olanzapine in the range of 0.167 to 16.7 ng/mL, with a lower limit of quantitation of 0.167 ng/mL. Adverse events were reported by the volunteers as instructed or observed by the resident physician, and were recorded, tabulated, and evaluated. RESULTS: Twenty-four healthy adult male volunteers participated in this study. Their mean (SD) age was 24.7 (6.2) years (range, 19-41 years), mean weight was 73.4 (6.7) kg (range, 64-89 kg), and mean height was 174.25 (4.6) cm (range, 168-186 cm). Values for C(max), AUC(0-72), AUC(0-infinity), T(max), t(1/2), and the terminal disposition rate constant were found to be in agreement with previously reported values. The differences between the 2 products did not reach statistical significance at P

Surgical management of failed pyeloplasty in children: single-center experience.

PURPOSE: To evaluate the outcome of secondary surgical procedures for the management of failed pyeloplasty in children. MATERIALS AND METHODS: Between 1996 and 2007, 590 cases of primary ureteropelvic junction (UPJ) obstruction underwent open dismembered pyeloplasty at our center. Of these patients, 18 (3%) with recurrent UPJ obstruction (14 males, 4 females; age range: 2-15 years) have undergone management of failed pyeloplasty. Secondary intervention was by open operative procedure in all cases. Clinical and radiological outcomes were assessed. Success was defined as both symptomatic relief and radiographic resolution of obstruction at last follow up. RESULTS: Follow up ranged from 8 to 41 months (mean 28). The overall salvage rate was 89%. Secondary reoperative surgery was successful in 16 patients: dismembered pyeloplasty in 14 patients (78%) and ureterocalyceal anastomosis in 2 (11%). Nephrectomy was necessitated in 2 patients (11%). No perioperative complications were encountered. All patients showed stability of renal function on radiological follow up without evidence of obstruction and with no further symptoms. CONCLUSION: Persistent UPJ obstruction after pyeloplasty is an uncommon complication. Secondary procedures have a very high success rate with excellent functional results. Nephrectomy is indicated in rare cases of severely deteriorated renal function.