| 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
|
|
|
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
|