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Hypospadias clinical trials

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NCT ID: NCT06180018 Not yet recruiting - Hypospadias Clinical Trials

Modified TIP (Snodgrass) Using Interrupted Sutures in Hypospadias

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Using interrupted sutures in TIP technique by Snodgrass in repair of hypospadias instead of continuous sutures

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.

NCT ID: NCT04533477 Not yet recruiting - Hypospadias Clinical Trials

Reconstructing Forked Corpus Spongiosum in Hypospadias Repair

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Hypospadias is one of the most common genital malformations in children. The high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. Surgery is the only way to repair hypospadias. Over 400 techniques have been described for hypospadias repair. However, the surgical success rate of hypospadias is still not ideal. Although the surgical success rate of distal hypospadias has reached more than 85%, the complications of proximal hypospadias are still as high as 30-68%. How to improve surgical skills and reduce the postoperative complications is quite a challenge for pediatric urologists. In the preliminary clinical work, the investigators have tried to apply the technique of reconstructing forked corpus spongiosum (FCS) in hypospadias repair with urethral plate preservation. It has been confirmed that this technique was effective in reducing postoperative complications of this type of hypospadias repair. In order to promote the technology of reconstructing FCS, the investigators need to perform this technology in various types of hypospadias and evaluate its true effectiveness. Therefore, the investigators need to design a prospective, randomized, parallel-controlled, single-blind, and superior clinical trial to analyze the efficacy of reconstructing FCS in hypospadias repair. In this study, the investigators will perform one-stage surgical repair on children with primary hypospadias by the same surgeon in Urology Department, Children's Hospital of Fudan University, Shanghai, China. Participants will be random grouped: Routine standardized surgery with reconstructing FCS group and Routine standardized surgery group. All participants will be closely followed up and regularly evaluated after surgery, including postoperative complications, HOSE objective score of cosmetic outcome and voiding function. By collecting all data and conducting statistical analysis, the investigators will evaluate the followings: (1) the correlation between the penile curvature and the development of FCS; (2) the effect of reconstructing FCS on the complications of primary hypospadias repair; (3) the effect of reconstructing FCS on the cosmetic outcome; (4) the influence of reconstructing FCS on postoperative voiding function. Based on this clinical randomized controlled study, the investigators intend to prove the feasibility and effectiveness of the new technology of reconstructing FCS in various types of hypospadias repair. The study will provide a reliable basis for the promotion of this technology for hypospadias repair in order to improve the quality of life for children with hypospadias.

NCT ID: NCT03911635 Not yet recruiting - Hypospadias Clinical Trials

Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias

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

Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis. Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations [1]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias [2]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty &quot; URAGPI&quot; versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion. B) Normal appearance of the penis. C) Good functional results.

NCT ID: NCT03698721 Not yet recruiting - Spina Bifida Clinical Trials

Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate

IMOPU
Start date: October 2018
Phase:
Study type: Observational

Different clinical conditions can require urinary bladder augmentation or replacement. Tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. Thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation. The investigators propose the use of urothelial cells obtained by Trans-Urethral Resection of Prostate or bladder (TURP) to obtain a tissue engineered urothelium in association with different scaffolds.

NCT ID: NCT02497963 Not yet recruiting - Hypospadias Clinical Trials

Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)

FGTIP-TIP
Start date: August 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.