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Hypospadias clinical trials

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NCT ID: NCT05936853 Active, not recruiting - Pediatric ALL Clinical Trials

The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)

EPIVA
Start date: August 3, 2023
Phase: N/A
Study type: Interventional

More than half a million children have an anaesthetic each year in the UK. Though anaesthesia is usually thought to be safe and necessary to improve health, concerns remain the effects that the drugs used may have on brain development in children and the potential long-term consequences for health. The two techniques used to keep someone asleep during anaesthesia are either giving the appropriate drugs through a small plastic tube into a vein or introducing different drugs into the lungs in gas form. Gene expression is the process by which instructions in DNA are used to make products such as proteins. Anaesthetic drugs may change how a child's genes are expressedÍž a process called epigenetics. Studies have shown that different anaesthetic drugs can cause epigenetic changes in animals and affect the processing ability of their brains. This study will focus on children aged under 3 undergoing general anaesthesia for planned hypospadias surgery (a developmental condition where the look and function of the penis may not be completely normally). Participants will either receive their general anaesthetic in gas form or through directly into their veins - both techniques are commonly used. A small blood sample (between 1 and 2 teaspoons) will be collected at the start and end of the operation whilst under anaesthetic. Samples will be analysed to look for any changes in signals on DNA (epigenetic changes) and other markers. Further analysis may then look at other measures of gene expression and additional processes/markers that could be affected. There is relatively less medical research carried out in children and this work will show whether this type of study is possible in this age-group and provide information for future trials. It will help towards improving our understanding of the effects of anaesthesia ultimately help doctors and families make better informed decisions.

NCT ID: NCT05922605 Recruiting - Pediatrics Clinical Trials

Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

Start date: June 20, 2023
Phase: Phase 4
Study type: Interventional

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious. Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

NCT ID: NCT05837000 Recruiting - Dexmedetomidine Clinical Trials

Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair

Start date: May 15, 2023
Phase: Phase 4
Study type: Interventional

Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.

NCT ID: NCT05742529 Completed - Clinical trials for Distal Penile Hypospadias

Cosmotic Outcome of Distal Penile Hypospidias Repair Using Stitch by Stitch Glanuloplasty Versus TIP

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Hypospadias is generally defined as the combination of three anatomic anomalies of penis, which are an abnormal ventral opening of the urethral orifice, ventral curvature of the penis, and abnormal distribution of the foreskin around the glans with a ventrally deficient hooded foreskin . It is estimated that about 1 in every 200 babies is born with hypospadias in the United States, making it one of the most common birth defects. In newborn males, hypospadias is the second most common congenital anomaly after undescended testis. Due to incomplete closure of the penile structures during embryogenesis, the urethral opening is displaced along the ventral side of the penis . Most hypospadias occur as an isolated condition, but associated anomalies include uni/bilateral cryptorchidism and micropenis . Duckett proposed the most commonly used classification; i.e., nearly 70% of hypospadias are either glanular or distally located on the penis and are considered a mild form, whereas the remainder is more severe and complex The main goal for hypospadias repair is to achieve both cosmetic and functional normality. Reasons for treating hypospadias include spraying of urinary stream, inability to urinate in standing position, curvature leading to difficulties during intercourse, fertility issues because of difficulty with sperm deposition, and decreased satisfaction with genital appearance. Current guidelines consider optimal age for hypospadias repair somewhere between 6 and 18 months, depending on the severity and the need for multiple procedures . Penile biometrical parameters, like a small glans width and narrow urethral plate, are some of the anatomical factors associated with increased postoperative complications and form a technical challenge . Functional outcome was considered satisfactory when the patient could micturate an ideal stream of urine (single, compact, rifled, non-dispersed urinary stream of adequate caliber) without straining. Cosmetic outcome was considered satisfactory when a straight penis was obtained with a vertical slit like, wide, smooth external meatus at the tip of a conical glans . The normal meatus is a vertical slit with smooth and sharp edges that is centrally located within the glans penis . The literature lacks standardization of techniques for hypospadias repair and uniform definitions of complications and outcome assessment . Many surgical techniques have been described for glans closure and meatoplasty with variable outcomes, but none of them fits all patients with hypospadias; each procedure has its limitations and demands specific selection criteria. Duckett described the "meatal advancement and glanuloplasty incorporated" (MAGPI) procedure. The two essential elements of MAGPI are meatoplasty and glanuloplasty. However, many researchers reported a high incidence of partial meatal regression in their patients following the MAGPI procedure. In 1928, Mathieu described a single-stage, meatal based flap technique to repair the distal forms of hypospadias but results in flat meatus. In 2000 Boddy and Samuel reported the "V-incision" sutured MAVIS technique to provide a cosmetically acceptable natural slit-like meatus in Mathieu cases Rich et al. in 1989 described a urethral plate incision (hinging) as a modification of the Mathieu repair to improve the cosmetic outcome of the neo-meatus. It helps in achieving a slit-like vertical meatus. Nevertheless, a healthy wide urethral plate with no scarring is essential for a successful outcome Snodgrass extended the concept of urethral plate hinging by incising the whole urethral plate in the midline from the hypospadias meatus distally. It helps in the tabularization of the plate with a good cosmetic outcome. -stitch by stitch technique: Operative technique :starts with penile degloving, preparation of the flap (Site of hypospadic meatus is determined after degloving). Creation of a narrow strip of the urethral plate with wide glanular wings is done using bilateral incisions which are extended to the tip of the glans. The width of the urethral plate is about 3 mm then we suture the flap to the narrow urethral plate in two layers in continuous manner using vicryl 6/0 over a suitable plastic catheter. Triangular (Vshape) area of the distal part of the flap is excised a the midline. After this we anastomose the flap to thetip of the glans. The glans appears opened in the midline as inverted V shape. Closure of the glans is finished in the midline using three mattress interrupted sutures with another three simple stitches are used in between

NCT ID: NCT05727969 Completed - Pain Clinical Trials

Dexmedetomidine Infusion and Surgical Pleth Index In Pediatrics

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

This non-invasive dimensionless score index -SPI-reflects the Patients' sympathetic response to surgical stimulation. Its effectiveness in detecting the balance between nociceptor activation and analgesia was not only reported but also, was reported to be superior to the other parameters like blood pressure and heart rate. SPI value is correlated to pain and ranges from 0 to 100, higher values indicate strong surgical stimulus. Its value is obtained from photoplethysmographic amplitude (PPGA) and heart rate (HR) data from pulse oximetry measurement. Prediction of the severity of postoperative pain using SPI in both adults and children has been reported by several studies. So, the authors hypothesize that dexmedetomidine infusion without giving a bolus dose may affect the SPI in pediatrics undergoing hypospadias repair.

NCT ID: NCT05708989 Suspended - Hypospadias Clinical Trials

Caudal vs. Pudendal Block in Peds GU

Start date: March 6, 2023
Phase: Phase 4
Study type: Interventional

This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.

NCT ID: NCT05666206 Recruiting - Hypospadias Clinical Trials

Efficacy of Fibrin Sealant in Hypospadias Surgery

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study was to evaluate if application of a fibrin sealant over the urethroplasty suture line for waterproofing instead of a dartos vascularized pedicled flap to reduce complications and improve the outcome in hypospadias repair.

NCT ID: NCT05632536 Completed - Post Operative Pain Clinical Trials

Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery

Start date: December 21, 2022
Phase: N/A
Study type: Interventional

The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane block and caudal block in patients undergoing hypospadias surgery.We will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA. In our study, we seek answers to the following questions: - Which of the sacral erector spinae plane block and caudal block applied to patients undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other? - Which of the sacral erector spinae plane block and caudal block applied to patients undergoing hypospadias surgery is superior in duration of analgesia? After general anesthesia is administered to the participants, one of the 2 blocks will be administered in a randomized manner and the relevant data will be recorded.Our research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 patients from the ASA I-II pediatric patient group aged between 6 months and 7 years, who will undergo hypospadias surgery in our hospital between December 2022-December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 patients.

NCT ID: NCT05569863 Not yet recruiting - Hypospadias Clinical Trials

Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence

ASHOKA
Start date: November 14, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to develop and validate a digital pattern recognition system based on artificial neural network to determine various parameters in hypospadias. The main question it aims to answer is: How accurate is the digital pattern recognition system based on artificial neural network to determine various parameters in hypospadias? Participants in this study are hypospadias patients aged < 18 years old. The guardian (and the patient, if applicable) will be informed about the study and asked for consent. The digital picture of participants' penis will be taken from different angles according to the predetermined angle. The clinical characteristics of the photographed penis are then inputted and used to train a customized artificial neural network (ANN). The machine is then used to predict various hypospadias parameters presenting at the patients' penis. The accuracy of the machine is then compared to the measurement done by pediatric urologists.

NCT ID: NCT05528276 Not yet recruiting - Penile Hypospadias Clinical Trials

Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?

Start date: August 29, 2022
Phase: N/A
Study type: Interventional

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.