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CTRI Number  CTRI/2025/03/082271 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized Factorial Trial 
Public Title of Study   Outcome Comparison: Tabularized Incised Plate Urethroplasty vs Urethral Advancement with Glanuloplasty in Pediatric Patients  
Scientific Title of Study   Outcome Analysis of Tubularized Incised Plate Urethroplasty & Urethral Advancement with Glanuloplasty for Distal Hypospadias in Pediatric Patients of a Tertiary Care Center in Nagpur: A Prospective Open-label Randomized trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nilesh Nagdeve 
Designation  Additional Professor  
Affiliation  AIIMS Nagpur 
Address  Department of pediatric surgery , MIHAN , SUMTHANA ,DAHEGOAN AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9823972764  
Fax    
Email  nileshnagdeve@aiimsnagpur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Harshal Madavi 
Designation  senior resident  
Affiliation  AIIMS Nagpur 
Address  Department of pediatric surgery , MIHAN , SUMTHANA ,DAHEGOAN AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  7350460421  
Fax    
Email  mharshal04@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Harshal Madavi 
Designation  senior resident  
Affiliation  AIIMS Nagpur 
Address  Department of pediatric surgery , MIHAN , SUMTHANA ,DAHEGOAN AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  7350460421  
Fax    
Email  mharshal04@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical science Nagpur , plot no 2 sector 20 mihan Nagpur Maharashtra 441108 
 
Primary Sponsor  
Name  Dr Nilesh Nagdeve 
Address  All India institute of medical science Nagpur , plot no 2 sector 20 mihan Nagpur Maharashtra 441108 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Harshal Madavi  All India institute of medical science Nagpur , plot no 2 sector 20 mihan Nagpur Maharashtra 441108 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshal Madavi  All India Institute of Medical Science Nagpur  opd 420 pediatric surgery All India Institute of Medical Science , Mihan Nagpur 441108
Nagpur
MAHARASHTRA 
7350460421

mharshal04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Science Nagpur Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: Q541||Hypospadias, penile, (3) ICD-10 Condition: Q647||Other and unspecified congenital malformations of bladder and urethra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tubularized Incised Plate Urethroplasty   outcome of Tubularized Incised Plate Urethroplasty Distal Hypospadias in Pediatric Patients in single time intervention and duration is single operative period  
Intervention  Urethral Advancement with Glanuloplasty  Outcome Analysis for Distal Hypospadias in Pediatric Patients .Patients in single time intervention and duration is single operative period  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Children under 18 years of age with distal hypospadias
2.Patients with minimal chordee on clinical examination, and less than 20 degrees measured during artificial erection test intraoperatively.
 
 
ExclusionCriteria 
Details  1.Re-do surgeries for failed hypospadias repair
2.Parents not consenting
3.Glandular hypospadias
4.Patients with Disorders of Sexual Development
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the outcomes in terms of success rate and complication, following tubularised incised plate urethroplasty and Urethral Advancement Glansplasty techniques for distal hypospadias repair in the pediatric population  Patient will be followed up in the outpatient clinic 15 days, 1 month ,and 3 months after operation. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the cosmetic outcomes following TIPU & UAG for distal hypospadias.
2.To compare parental response regarding the postoperative course & cosmesis following these two operative techniques
 
Patient will be called to the outpatient clinic 15 days, 1 month , & 3 months after operation for follow-up using Hypospadias Objective Penile Evaluation (HOPE-score) & • Mureau questionnaire for assessment of parental satisfaction  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hypospadias a common congenital anomaly affecting the male genitourinary system. It is characterized by the abnormal placement of the urethral meatus on the ventral surface of the penis . It occurs in approximately 1 in 250 live male births worldwide, with potentially higher prevalence rates in certain populations, including India (1). This anomaly not only affects physical appearance but also has implications for urinary function and psychological well-being.

Hypospadias is categorised according to the location of urethral meatus in various subcategories of which distal hypospadias is more common position of meatus. There are more than 200 reconstructive procedures described for hypospadias repair with their pros and cons. However, over the last thirty years, the tabularised incised plate urethroplasty (TIPU) described by Snodgrass has gain a popularity and is one of the most commonly performed procedure now a days.  The procedure  creates a neourethra by longitudinally incising and tabularising the urethral plate.(2) The problems with TIPU are comparatively high rates of stricture and fistula following surgery.(3)  Urethral advancement with Glanuloplasty (UAG) is another surgical technique in which the native urethral meatus along with  the bulbous and pendulous segments urethra is advanced to the tip of the glans penis.(4) First described by Beck, the procedure has undergone many modifications over the years.(5) The advantages of this procedure are less risk of post-operative fistula and stricture formation.However, there is only one study which compares the outcome following these procedures.(6)

In order to fill the gap in the literature, this prospective randomized trial is planned with the following aim and objectives

 

 
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