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CTRI Number  CTRI/2025/04/084730 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Outcomes of Two Repair Methods with or without Extra Tissue Layer in Hypospadias Surgery 
Scientific Title of Study   Comparing Outcomes of Tubularized Incised Plate Urethroplasty in Hypospadias with or without De-epithelialized Dorsal Preputial Dartos Flap as an Intervening Layer- A Pilot Randomized Controlled 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  Uppaluri Jahnavi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room no - 106, Ayush block, Department of Pediatric Surgery, All India Institute of Medical Sciences, Bibinagar, Hyderabad metropolitan city.

Hyderabad
TELANGANA
508126
India 
Phone  8639108163  
Fax    
Email  jahnavireddy.u83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shasanka Shekhar Panda 
Designation  Professor and HOD 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 106, Ayush block, Department of Pediatric Surgery All India Institute of Medical Sciences, Bibinagar, Hyderabad metropolitan city.

Hyderabad
TELANGANA
508126
India 
Phone  9873542072  
Fax    
Email  drshasankaiims06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Uppaluri Jahnavi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 106 Ayush block, Department of Pediatric Surgery, All India Institute of Medical Sciences, Bibinagar, Hyderabad metropolitan city.

Hyderabad
TELANGANA
508126
India 
Phone  8639108163  
Fax    
Email  jahnavireddy.u83@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bibinagar, Hyderabad metropolitan city. Telangana 508126 
 
Primary Sponsor  
Name  UPPALURI JAHNAVI 
Address  All India Institute of Medical Sciences, Bibinagar, Hyderabad metropolitan city. 
Type of Sponsor  Other [PRIMARY INVESTIGATOR] 
 
Details of Secondary Sponsor  
Name  Address 
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 
Uppaluri Jahnavi  All India Institute of Medical Sciences  Room no 106, Ayush block, Department of Pediatric Surgery, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region
Nalgonda
TELANGANA 
8639108163

jahnavireddy.u83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tubularized Incised Plate Urethroplasty in Hypospadias without De-epithelialized Dorsal Preputial Dartos Flap as an intervening layer  A feeding tube of appropriate size is inserted, and the new urethral opening is marked. The penis is degloved. The urethral plate is incised and tubularized over IFT, followed by urethroplasty and spongioplasty. The glans and surrounding skin are then closed in layers without any intervening layer. 
Intervention  Tubularized Incised Plate Urethroplasty in Hypospadias with De-epithelialized Dorsal Preputial Dartos Flap as an Intervening Layer.  A feeding tube of appropriate size is inserted, and the new urethral opening is marked. The penis is degloved. The urethral plate is incised and tubularized over IFT, followed by urethroplasty and spongioplasty. In this group , a De-epithelialized Dorsal Preputial Dartos Flap is added as an intervening layer. The glans and surrounding skin are then closed in layers. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Male 
Details  Children of age 1 to 12 years.
Children with hypospadias who are eligible for single stage Tubularized Incised Plate Urethroplasty.
Urethral plate width more than 6mm.
Children who have not undergone circumcision.
Children who have not undergone prior hypospadias repair.
Children whose parents are willing to provide informed written consent.
 
 
ExclusionCriteria 
Details  Children with hypospadias with chordee.

Children requiring staged procedure, onlay flap repair.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the combined incidence of postoperative complications i.e., urethrocutaneous fistula and glans dehiscence in Tubularized Incised Plate urethroplasty with or without the use of de-epithelialized dorsal preputial dartos flap as an intervening layer at 6 months follow-up after surgery.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the aforementioned groups for the following outcomes:
a.Intra operative outcomes
Duration of surgery (in minutes)
Intra operative blood loss (in millilitres)
Injury to dorsal neurovascular bundle
b.Postoperative outcomes
Surgical site infection
Skin necrosis.
Duration of dressing
Duration of catheterisation
Duration of hospital stay
2.To evaluate the cosmetic appearance of penis & meatal orientation using Hypospadias Objective Penile Evaluation (HOPE) score at 6 month follow-up after surgery.
 
Intraoperative outcomes are noted at the time of surgery
Postoperative outcomes are noted at 2 weeks after surgery.
Cosmetic evaluation is done at 6 months after surgery. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 2 
Date of First Enrollment (India)   16/04/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 is one of the most common genitourinary birth defects, occurring in around 1 in 300 male births. Surgery is the sole treatment option for hypospadias. The most common and baffling problem that occurs after hypospadias repair is the urethrocutaneous fistula (UCF), and its treatment is very challenging. Hence to lessen the incidence of this complication various techniques using vascularised soft tissue flaps in between neourethra and skin as an intervening layer are being practiced. Although various advantages and disadvantages of the intervening layer have been reported, definitive evidence to establish its superiority in reducing post-hypospadias repair complications remains lacking. To address this, we designed a Pilot Randomized Controlled Trial to evaluate and compare the surgical and cosmetic outcomes of Tubularized Incised Plate (TIP) urethroplasty in hypospadias with or without de-epithelialized dorsal preputial dartos flap as an intervening layer. The objectives of the study are to compare the combined incidence of postoperative complications i.e., urethrocutaneous fistula and glans dehiscence and to compare the intra operative outcomes, post operative outcomes along with cosmetic appearance using Hypospadias Objective Penile Evaluation (HOPE) score in Tubularized Incised Plate urethroplasty with or without the use of de-epithelialized dorsal preputial dartos flap as an intervening layer at 6 months follow-up after surgery.

 
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