| CTRI Number |
CTRI/2026/03/106982 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| 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
|
In Children with Hypospadias, Comparing Two Tissue Covering Methods in Surgery and Their Effect on Healing and Complications |
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Scientific Title of Study
|
Comparative Efficacy of Tunica Vaginalis Flap Versus Preputial Dartos Flap in Tubularized Incised Plate (TIP) Urethroplasty for Hypospadias: A 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 |
Saurabh Singh |
| Designation |
Senior Resident , MCH Urology |
| Affiliation |
AIIMS Patna |
| Address |
OPD block , 3 rd floor
Department of Urology
AIIMS Patna , Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
7903784138 |
| Fax |
|
| Email |
itssaurabh912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin Chandra |
| Designation |
Associate Proffesor ,Department of Urology |
| Affiliation |
AIIMS Patna |
| Address |
OPD block , 3 rd floor
Department of Urology
AIIMS Patna , Phulwarisharif
Patna
BIHAR
801507
India |
| Phone |
8442840839 |
| Fax |
|
| Email |
ccchandra2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Chandra |
| Designation |
Associate Proffesor ,Department of Urology |
| Affiliation |
AIIMS Patna |
| Address |
OPD block , 3 rd floor
Department of Urology
AIIMS Patna , Phulwarisharif
BIHAR
801507
India |
| Phone |
8442840839 |
| Fax |
|
| Email |
ccchandra2001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
OPD block , 3 rd floor
Department of Urology
AIIMS Patna , Phulwarisharif, Patna ,Bihar India
Pin code -801507 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Singh |
AIIMS Patna |
OPD block , 3 rd floor
Department of Urology
AIIMS Patna , Phulwarisharif
Patna
BIHAR |
7903784138
itssaurabh912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AII INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N489||Disorder of penis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TIP urethroplasty with Dartos Fascia Flap |
Intraoperative findings including external urethral meatus (EUM), urethral plate characteristics (length, width, and development), stretched penile length, and prepuce characteristics are documented.
The patient is placed in the supine position, and the genital area is prepared and draped under sterile conditions. Skin markings are made at the coronal margin and along the urethral plate according to the planned meatal location.
A circumcoronal incision is made approximately 2 mm below the meatus, and the penis is degloved up to the penile root to expose the urethral plate. The Gittes test is performed to assess penile chordee or torsion, and any curvature is corrected if present.
A midline incision is made along the urethral plate from the native meatus to its distal end. The urethral plate is then tubularized over a catheter using subepithelial running sutures with 5-0 PDS, beginning distally and progressing proximally to form the neourethra.
A dorsal preputial dartos fascia flap is carefully dissected from the dorsal prepuce and penile shaft while preserving its vascularity. The flap is buttonholed and transposed ventrally to cover the neourethra, providing a well-vascularized intermediate protective layer.
Glansplasty is performed to create the new meatus using 5-0 PDS sutures. Excess prepuce is excised if circumcision is planned, and the shaft skin is closed with interrupted subepithelial 5-0 PDS sutures in a tension-free manner.
If foreskin reconstruction is performed, the inner prepuce, dartos fascia, and outer shaft skin are approximated in layers. The remaining skin incision is closed neatly.
A sterile dressing is applied, and the patient is shifted to recovery for postoperative monitoring. |
| Comparator Agent |
TIP urethroplasty with Tunica Vaginalis Flap |
The patient is placed in the supine position, and the genital region is prepared and draped under sterile conditions. Skin markings are made at the coronal margin and along the urethral plate according to the planned meatal position.
A circumcoronal incision is made approximately 2 mm below the meatus, and the penis is degloved up to the penile root to fully expose the urethral plate. The Gittes test is performed to assess penile chordee or torsion, and any curvature is corrected if present.
A midline incision of the urethral plate is made from the native meatus to the distal end of the plate. The urethral plate is then tubularized over a catheter using subepithelial running sutures with 5-0 PDS, beginning distally and progressing proximally to form the neourethra.
A Tunica Vaginalis Flap (TVF) is harvested from the parietal layer of the ipsilateral tunica vaginalis through a small scrotal incision. The flap is carefully dissected while preserving its vascularity and transposed ventrally to cover the neourethra as an intermediate protective layer.
Glansplasty is performed to create the new meatus at the desired position using 5-0 PDS sutures. Excess prepuce is excised if circumcision is planned, and the shaft skin is closed with interrupted subepithelial 5-0 PDS sutures in a tension-free manner.
If foreskin reconstruction is undertaken, the inner prepuce, tunica vaginalis flap, and outer shaft skin are approximated in layers to restore the foreskin. The remaining skin incision is closed neatly.
A sterile dressing is applied, and the patient is shifted to recovery for postoperative monitoring. |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age: Male patients aged between 1 and 25 years.
Well-developed prepuce, scrotum, and bilateral testes.
Urethral Plate Development: The urethral plate should be appropriately developed for the patient’s age.
Hypospadias Severity: Patients with distal and mid-shaft hypospadias are eligible for inclusion.
Informed Consent: Written informed consent must be provided by the parents or legal guardians of the patient.
|
|
| ExclusionCriteria |
| Details |
Genitourinary Malformations: Patients with genitourinary malformations or significant associated anomalies, such as bilateral undescended testes or bladder exstrophy.
Urethral Transection: Patients requiring urethral transection intraoperatively.
Staged Urethroplasty: Patients who require staged urethroplasty.
Previous Surgery: Patients with a history of previous surgery on the male genitalia.
Severe Coexisting Medical Conditions: Patients with severe coexisting medical conditions, including severe prematurity, chromosomal anomalies, or systemic diseases that may impair healing.
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the postoperative complications of Tunica Vaginalis Flap (TVF) versus Preputial Dartos Flap (PDF) in Tubularized Incised Plate (TIP) urethroplasty for hypospadias.
Postoperative complication includes-
Urethrocutaneous fistulas.
Wound dehiscence .
Prepuce-related complications.
Meatal stenosis.
|
1 week(baseline),1 month ,3 month and 6 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Cosmetic Outcomes: To assess the cosmetic outcomes using (Pediatric Penile Perception Score) and HOPE (Hypospadias Objective Penile Evaluation) score.
Functional Outcomes: To compare functional outcomes using uroflometry parameters in both early and up till 6-month follow-ups in patients who undergo TIP urethroplasty with TVF and PDF.
Operative Time and Surgical Considerations: To compare the operative time required for the TVF and PDF procedures
|
1 week,1 month , 3 months,6 months |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [itssaurabh912@gmail.com].
- For how long will this data be available start date provided 30-03-2026 and end date provided 01-05-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Brief Summary Hypospadias is a common congenital anomaly in males characterized by an abnormal location of the urethral meatus on the ventral surface of the penis. Surgical repair is required to restore normal urinary function, penile appearance, and long-term functional outcomes. Tubularized Incised Plate (TIP) urethroplasty is currently the most widely accepted surgical technique for distal and mid-penile hypospadias repair. A key step in TIP urethroplasty is the placement of a vascularized tissue flap over the neourethra to reduce postoperative complications such as urethrocutaneous fistula, meatal stenosis, wound dehiscence, and poor cosmetic outcomes. Traditionally, the Preputial Dartos Flap (PDF) has been used for this purpose due to its easy availability and straightforward harvesting from the dorsal preputial tissue. However, limitations such as inadequate tissue in some cases, compromised vascularity, and higher risk of complications including fistula formation and meatal stenosis have been reported. The Tunica Vaginalis Flap (TVF), harvested from the parietal layer of the tunica vaginalis of the testis, is a well-vascularized tissue that may provide superior coverage and improved healing of the neourethra. Although TVF has been increasingly used in hypospadias surgery, its routine use in primary TIP urethroplasty remains controversial because it requires additional surgical dissection and may be associated with scrotal morbidity. This study aims to compare the efficacy and safety of tunica vaginalis flap versus preputial dartos flap as an intermediate layer in TIP urethroplasty through a randomized controlled trial. The primary objective is to compare postoperative complication rates, particularly urethrocutaneous fistula formation. Secondary outcomes include cosmetic appearance, functional urinary outcomes, and operative time. This prospective randomized study will help generate evidence regarding the optimal tissue flap for neourethral coverage in hypospadias repair. The findings may contribute to improved surgical decision-making and better postoperative outcomes in children undergoing TIP urethroplasty.
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