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NCT04142632
Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations. In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term. This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.
NCT07404722
The correction of ventral curvature in hypospadias follows a stepwise principle. Clinically, in some cases of hypospadias, residual severe ventral curvature (VC ≥ 30°) persists even after thorough skin degloving and transection of the urethral plate, due to the unbalanced development of the ventral and dorsal tunica albuginea of the corpus cavernosum. In such cases, ventral tunica albuginea incision and corporoplasty with a graft are mandatory. Although the currently commonly used pedicled Tunica Vaginalis Flap (TVF) corporoplasty can effectively correct the curvature, it requires additional dissection of the scrotum and tunica vaginalis sac. This prolongs the operative time and poses risks of donor-site complications, such as testicular retraction and scrotal hematoma. The novel Urethral Plate Flap (UPF) corporoplasty utilizes local pedicled urethral plate tissue for homologous repair. This study adopts a prospective, single-center, randomized, controlled, double-blind, non-inferiority trial design, enrolling 90 subjects. The aim is to verify that the therapeutic efficacy of the UPF technique in correcting such residual severe ventral curvature is non-inferior to that of TVF, while demonstrating significant advantages in surgical efficiency and donor-site safety. This study aims, through a single-center, double-blind, RCT design, and under the strict indication of "residual severe ventral curvature after urethral plate transection," to verify efficacy via a "non-inferiority" hypothesis, and to verify safety and efficiency via a "superiority" hypothesis. The goal is to provide Level I evidence for the update of hypospadias guidelines, while simultaneously exploring the establishment of postoperative imaging evaluation standards.
NCT06520423
This multicenter randomized controlled trial aims to determine whether urethral stent tube irrigation, combined with urinary catheter drainage, prevents postoperative wound infections compared to urinary catheter drainage alone in adolescents with hypospadias.
NCT07286786
The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. The main question it aims to answer is: Is there a difference in analgesic efficacy between sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias surgery? Eighty six pediatric patients (ages 1-7 years, ASA I-II) scheduled for hypospadias repair under general anesthesia were included in this prospective randomized study. Both blocks were performed using 0.25% bupivacaine, at doses of 0.5 mL/kg for our study. Pain was assessed using the FLACC scale at 1, 2, 4, 6, 12 and 24 hours postoperatively.
NCT06628375
This study aims to demonstrate the impact of Endocrine-Disrupting Chemicals (EDCs) on the risk of hypospadias incidence. It is a multicenter comparative case-control study, involving two groups. The first group consists of biological mothers who have given birth to children with hypospadias (Case Group), while the second group consists of biological mothers who have given birth to children without any malformations (Control Group). Through an integrative approach that combines a direct toxicological study of numerous pollutants present during pregnancy, and a comprehensive exposome assessment using validated tools, this study can significantly enhance our understanding and prevention of this malformation.
NCT03593720
The investigator will collect data on penile and glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery.
NCT02495090
Hypospadias is the second most common malformation of the male genitalia and consists in a congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus position may be located anywhere along the penile shaft, but more severe forms of hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior represents approximately 70% of all the diagnosed cases. The frequency of family reached depend on the severity of hypospadias. The number of children which have hypospadias mutation discovered by classical technique is low. Families are often the cause of the discovery of new genes involved in sexual differentiation because they allow comparison of genomes of related persons, and detect more easily mutations.
NCT07121764
This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery. The study will compare two types of caudal injections: One group will receive Bupivacaine alone, a commonly used local anesthetic. The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer. The main question the researchers want to answer is: Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children? Researchers will also look at: How long it takes before the child needs the first dose of pain medicine after surgery How much pain medicine is used in the first 24 hours How long any movement problems (motor block) last Whether there are any side effects Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received. Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours. The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.
NCT07086963
This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery. the investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.
NCT03102554
This study seeks to identify genetic causes of conditions that affect the gonads and genitals, and to study the impact on families of receiving genetic results.
NCT07006922
Methods We conducted a prospective randomized controlled study at the Pediatric Urology Department of Cairo University Specialized Pediatric Hospital between July 2024 and January 2025 . The study included boys undergoing primary repair of distal penile hypospadias. Ethical approval was obtained from the institution's review board, and informed consent was secured from the parents or legal guardians of all participants. The study included distal penile hypospadias (glandular, coronal, or subcoronal meatus). Exclusion criteria were: proximal or mid-penile hypospadias, any history of prior hypospadias repair, bleeding or coagulation disorders and other significant genitourinary anomalies. The participants were randomly allocated into two equal groups using simple randomization (sealed envelope method). Group A (PRP group) underwent repair with the STAR technique plus an intermediate PRP covering layer. Group B (Control group) underwent repair using the same technique but without PRP. All surgeries were performed by the same pediatric urologist, an experienced surgeon in hypospadias repair, to eliminate inter-surgeon variability. All patients were operated on under general anesthesia with caudal block analgesia. A standard STAR hypospadias repair was carried out in each case as described by Seleim (10). In brief, the STAR technique involves anatomical reassembly of penile tissues guided by the topography of the glans and corpus spongiosum (the exclusive zipping-up of the unfolded spongiosal plate). A fine-tipped tenotomy scissor used for dissection, starting at the apex of the hypoplastic "V" and extending into the ventral edges of the hooded prepuce on each side, following the demarcation lines. Then, a midline cutting back of the ventral hypoplastic urothelial sheet from the hypospadias meatus to the point of spongiosal bifurcation was made . Excision of the hypoplastic skin ridge all the way from the point of bifurcation till each ipsilateral ventral endpoint of the glanular meatal marks to maximize the epithelialized endoluminal surface of the newly zipped-up spongiosal plate. An interrupted single -layedred spongioplasty ( zipper closure) using 6/0 Vicryl Absorbable sutures (13mm needle, Ethicon Inc, Somerville, New Jersey) is applied over a naeleton catheter . Lastly, the glansplasty is done using 3 slanting sutures. In Group A, before skin closure, a PRP layer was applied over the neourethra, whereas in Group B the repair proceeded directly to skin closure without PRP. PRP Preparation and Application In Group A patients, approximately 5-10 mL of the child's blood was drawn from a peripheral vein at the start of the operation. The blood was collected into a sterile tube without anticoagulant additives and immediately centrifuged at \~3000 rpm for 20 minutes. This process separated the blood into three components: an upper platelet-poor plasma, a middle platelet-rich plasma, and a bottom red blood cell layer. The platelet-rich plasma fraction was then isolated. After the neourethra was constructed and prior to skin closure, the PRP was applied directly as a liquid/gel onto the repair site covering the neourethra. In a few minutes, PRP forms a clot-like gel layer. No additional dartos or fascia flaps were used in either group, in keeping with the STAR technique's usual practice. Postoperative Care and Follow-up All patients had a compressive dressing applied, which was removed on the third postoperative day. A urethral stent catheter was left in place to divert urine; this was kept for 7 days postoperatively. Broad-spectrum prophylactic antibiotics were given while the catheter was in situ. Parents were instructed on catheter care and advised to ensure the child avoided straddling activities. After catheter removal, the urinary stream was observed to ensure it was not deviated or weak. Patients were followed up weekly for at least 4 weeks after surgery, and then monthly up to 3 months. At each follow-up visit, the penis was examined for any complications including urethrocutaneous fistula, meatal stenosis, wound infection, glans dehiscence, and persistent edema or flap necrosis. Cosmetic and functional outcomes were evaluated at the 1-month visit and again at 3 months using the HOSE score, which assigns points for meatal location, meatal shape, urinary stream, erection straightness, and overall appearance. A higher HOSE score (maximum 16) indicates a more favorable outcome. Outcome Measures The primary outcome measure was the occurrence of urethrocutaneous fistula within the follow-up period. Key secondary outcomes included incidence of other complications (edema, infection, meatal stenosis, glans dehiscence), the operative time (skin-to-skin surgical duration in minutes), and the cosmetic outcome (HOSE score and meatal configuration). Statistical Analysis Data were analyzed using the statistics software, SPSS software (IBM SPSS, v25). Continuous variables like age and operative time were not normall
NCT06705699
The aim of this research is to compare the surgical outcomes of urethral mobilization and the Mathieu technique in treating distal penile hypospadias. The study will evaluate complication rates such as fistula formation and meatal stenosis, assess functional outcomes related to urinary stream quality, and analyze cosmetic results including the appearance of the neomeatus. Ultimately, the goal is to provide evidence-based guidance for choosing the most appropriate technique to optimize surgical outcomes and patient satisfaction.
NCT06700629
Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair
NCT06687252
Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. However, to date, there is no consensus on etiological research and standardized management of these patients and their families, once VDG has been detected. The value of multidisciplinary management has already been demonstrated, but a number of grey areas remain: the frequency of false-positive ultrasound findings, the place of invasive antenatal diagnostic tests, the role left to parents during the diagnostic process, the frequency of associated malformations discovered post-natally, and how to prepare for immediate management at birth. The aim of this study is to improve the management of patients and their families as soon as a Disorders of Sexual Development is detected antenatally. The primary objective is to describe the management, particularly complementary investigations performed in the antenatal management of ultrasound diagnoses of Disorders of Sexual Development over the last 10 years. The secondary objectives are : * To determine the correlation between pre- and post-natal morphological phenotype and the proportion of false positives in antenatal ultrasound diagnosis. * To characterize prenatally diagnosed Disorders of Sexual Development * To determine the proportion of isolated prenatally-diagnosed Disorders of Sexual Development that turn out not to be isolated during postnatal follow-up. * The evaluation of the care pathway : * To establish the frequency of prenatal psychological support for parents * To establish the role of parents in prenatal diagnosis strategy decisions at our center
NCT06405763
We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm
NCT06275646
To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied
NCT06180018
Using interrupted sutures in TIP technique by Snodgrass in repair of hypospadias instead of continuous sutures
NCT02162810
The primary objective of this study is to determine the efficacy of administering a course of postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair as prevention against complications. Specifically, the study aims to assess if the steroids i) decrease the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) improve the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus).
NCT06165120
Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum. Hypospadias is one of the most common congenital malformations of the male genitourinary system, with a reported global incidence of 0.6-34.2 per 10,000 live births. There is more than one classification for hypospadias. Most commonly, hypospadias is classified into proximal \& distal hypospadias which mainly affects the decision for the corrective procedure. Correction of proximal hypospadias remains a surgical challenge, which is mainly due to the pathological features of proximal hypospadias including a more proximal meatus, severe ventral chordee, and the need to transect the urethral plate during the operation. The use of a 2-stage repair was found to achieve more satisfactory functional and cosmetic outcomes for proximal hypospadias with severe ventral chordee . Bracka repair, first described in 1995 by Bracka, is a 2-stage repair which uses grafts. This procedure has been improved over time, and recently it has been associated with satisfactory outcomes in proximal hypospadias with severe ventral curvature. Staged transverse preputial island flap urethroplasty (STPIF), first reported by Chen et al., is another 2-stage repair using flaps based on the traditional transverse preputial island flap (TPIF). STPIF has been shown to reduce the difficulty of surgery and the complication rate in management of proximal hypospadias. Thus, both Bracka repair and STPIF are valuable 2-stage methods, and both have achieved promising results. However, there are no available clear comparative data for determination which method has a better outcome and less complications in treating proximal hypospadias. This study compares Bracka's procedure using preputial grafts and STPIF (Staged Preutial Island Flap) procedure using preputial flaps in surgical correction of proximal hypospadias with marked ventral curvtaure.
NCT05528276
Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate \& good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.