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Hypospadias clinical trials

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NCT ID: NCT06275646 Completed - Hypospadias Clinical Trials

Comparison Of Outcome Of Different Layers in Hypospadias Surgery

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

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

NCT ID: NCT06187363 Completed - Hypospadias Clinical Trials

Redo Repair in Disrupted Hypospadias

Start date: January 1, 2019
Phase:
Study type: Observational

Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures

NCT ID: NCT05960123 Completed - Hypospadias Clinical Trials

Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).

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: 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: NCT05253456 Completed - Hypospadias Clinical Trials

Modified Second Layer Repair for Distal Penile Hypospadias

Start date: March 1, 2018
Phase: Phase 2
Study type: Interventional

to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias

NCT ID: NCT05144659 Completed - Hypospadias Clinical Trials

Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics

DFOF#TIOF
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to be the most common complications, in addition to other complications, and can be attributed to the affection of flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double-faced preputial flaps. This study aimed to evaluate double faced preputial onlay island flap technique for complication rate, outcomes for urinary stream, and cosmetic results.

NCT ID: NCT05056311 Completed - Hypospadias Clinical Trials

Engaging Families to Improve the Care of Patients With Hypospadias

Start date: June 9, 2021
Phase: N/A
Study type: Interventional

Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach. A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.

NCT ID: NCT04946058 Completed - Clinical trials for Distal Penile Hypospadias (Disorder)

Hybrid Mathieu Urethroplasty

Start date: March 31, 2012
Phase: N/A
Study type: Interventional

the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.