| 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
|
|
|
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
|
|
|
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. |