[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617527":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":32,"studyPopulation":23,"armGroups":33,"interventions":46,"overallOfficials":56,"centralContacts":61,"locations":67,"responsibleParty":104,"collaborators":107,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":23,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":89,"whyStopped":23,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"National Children's Medical Center, Uzbekistan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of postoperative urethral complications","Incidence of postoperative urethral complications, defined as the occurrence of meatal stenosis requiring dilation or surgical intervention and\u002For urethrocutaneous fistula identified on clinical examination.","6 months postoperatively",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Incidence of urethral stricture","Presence of urethral stricture confirmed clinically or by imaging during follow-up.",{"measure":18,"description":19,"timeFrame":12},"Cosmetic outcome assessed by HOSE score","Standardized postoperative photographs were assessed by two blinded external pediatric urologists using the Hypospadias Objective Scoring Evaluation (HOSE) system. HOSE scores range from 5 to 16 points, with higher scores indicating better cosmetic outcomes.",{"measure":21,"description":22,"timeFrame":12},"Maximum urinary flow rate (Qmax)","Maximum urinary flow rate (Qmax), measured in milliliters per second (mL\u002Fs), assessed by uroflowmetry. Higher values indicate better urinary flow.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"SINGLE",[31],"OUTCOMES_ASSESSOR","This is a prospective, multicenter, single-blinded randomized controlled trial designed to compare fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty using autologous platelet-rich fibrin (PRF) with grafted tubularized incised plate (G-TIP) urethroplasty in children with distal hypospadias and an unfavorable urethral plate.\n\nMale children aged 6 months to 84 months with primary or redo distal hypospadias and mild penile curvature will be eligible for inclusion. Participants will be randomized in a 1:1 ratio to undergo either F-TIP urethroplasty with intraoperative application of autologous PRF or standard G-TIP urethroplasty without PRF.\n\nAutologous PRF will be prepared intraoperatively from the patient's peripheral blood using a standardized centrifugation protocol and applied to the incised urethral plate prior to tubularization.\n\nParticipants will be followed postoperatively for the assessment of surgical complications, functional outcomes, and cosmetic results according to predefined outcome measures.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"F-TIP Urethroplasty","EXPERIMENTAL","Participants will undergo fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty. Autologous platelet-rich fibrin will be prepared intraoperatively and applied to the incised urethral plate and fixed with PDS 6\u002F0-7\u002F0 suture prior to tubularization.",[39],"Procedure: Fibrin-Enhanced TIP Urethroplasty",{"label":41,"type":42,"description":43,"interventionNames":44},"G-TIP Urethroplasty","ACTIVE_COMPARATOR","Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.",[45],"Procedure: Grafted TIP Urethroplasty",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":23},"PROCEDURE","Fibrin-Enhanced TIP Urethroplasty","Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.",[35],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":23},"Grafted TIP Urethroplasty","Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.",[41],[57],{"name":58,"affiliation":59,"role":60},"Zafar Abdullaev, MD, PhD","National Children's Medical Center, Tashkent, Uzbekistan","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":23,"email":66},"Zafar Abdullaev, MD PhD","CONTACT","+998-90-909-9911","Abdullaev.med@gmail.com",[68,87],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Dr. Cipto Mangunkusumo Hospital","NOT_YET_RECRUITING","Jakarta","DKI Jakarta","10430","Indonesia","ID",{"type":77,"coordinates":78},"Point",[79,80],106.84513,-6.21462,{"lat":80,"lon":79},[83],{"name":84,"role":64,"phone":85,"phoneExt":23,"email":86},"Dr. Cipto Mangunkusumo General Hospital Jakarta, Indonesia Pediatric Urology Department","+6285935071599","anggariskyraharja@gmail.com",{"facility":88,"status":89,"city":90,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"National Children's Medical Center","RECRUITING","Tashkent","100020","Uzbekistan","UZ",{"type":77,"coordinates":95},[96,97],69.21627,41.26465,{"lat":97,"lon":96},[100],{"name":101,"role":64,"phone":102,"phoneExt":102,"email":103},"National Children's Medical Center Pediatric Urology department","+998950047777","abdullaev.med@gmail.com",{"type":60,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Zafar Abdullaev","Head of the Pediatric Urology Department",[108],{"name":109,"class":6},"Dr Cipto Mangunkusumo General Hospital","100617527","fibrin-enhanced-tip-versus-grafted-tip-urethroplasty-in-distal-hypospadias-100617527",false,"NCT07319780","Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias","A Multicenter Randomized Controlled Trial Comparing Fibrin-Enhanced Tubularized Incised Plate (F-TIP) and Grafted Tubularized Incised Plate (G-TIP) Urethroplasty in Distal Hypospadias With Unfavorable Urethral Plates","FTIP-RCT","Inclusion Criteria:\n\n* Male children aged 6 months to 84 months\n* Primary or redo distal hypospadias\n* Unfavorable urethral plate\n* Penile curvature less than 45 degrees after degloving\n* Eligibility for tubularized incised plate urethroplasty\n\nExclusion Criteria:\n\n* Disorders of sex development or ambiguous genitalia\n* Severe penile curvature requiring urethral plate transection\n* Previous graft-based urethroplasty\n* Active local or systemic infection at the time of surgery\n* Known bleeding or platelet disorders\n* Inability to comply with postoperative follow-up","MALE","6 Months","84 Months",{"count":122,"type":123},100,"ESTIMATED","INTERVENTIONAL",[126],"NA","Hypospadias is a common congenital condition in boys in which the opening of the urethra is located on the underside of the penis. Distal hypospadias is the most common form and is usually treated surgically using tubularized incised plate (TIP) urethroplasty. In boys with an unfavorable urethral plate, graft-augmented techniques (G-TIP) are often used; however, postoperative complications such as urethrocutaneous fistula and narrowing of the urethral opening (meatal stenosis) may still occur.\n\nPlatelet-rich fibrin (PRF) is a biological material obtained from the patient's own blood that contains natural growth factors and may help improve tissue healing. This study aims to evaluate whether the use of PRF during surgery can reduce postoperative complications and improve surgical outcomes in children undergoing hypospadias repair.",[129,130],"Distal Hypospadias","Hypospadias",[132,133,134,135,136,137],"Hypospadias repair","Tubularized incised plate","Platelet-rich fibrin","PRF","Grafted TIP","Pediatric urology","2026-01-28",{"date":140,"type":141},"2026-01-30","ACTUAL",{"date":143,"type":141},"2026-01-05",{"date":145,"type":123},"2028-12-25",{"name":5,"class":6},2]