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CTRI Number  CTRI/2022/12/048556 [Registered on: 28/12/2022] Trial Registered Prospectively
Last Modified On: 25/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparing the difference in results of uroflowmetry parameters between single stage and staged hypospadias repair. 
Scientific Title of Study   A comparative study on the uroflowmetry parameters between single stage and staged hypospadias repair. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwin Kumar C 
Designation  Senior Resident 
Affiliation  Dept of Pediatric Surgery AIIMS Raipur 
Address  Dept of Pediatric Surgery AIIMS Raipur 492010
Dept of Pediatric Surgery AIIMS Raipur 492010
Raipur
CHHATTISGARH
492010
India 
Phone  9961346494  
Fax    
Email  drashwinc@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nitin Borkar 
Designation  Additional Professor 
Affiliation  Dept of Pediatric Surgery AIIMS Raipur 
Address  Dept of Pediatric Surgery AIIMS Raipur 492010
Dept of Pediatric Surgery AIIMS Raipur 492010
Raipur
CHHATTISGARH
492010
India 
Phone  9961346494  
Fax    
Email  drnitinborkar25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwin Kumar C 
Designation  Senior Resident 
Affiliation  Dept of Pediatric Surgery AIIMS Raipur 
Address  Dept of Pediatric Surgery AIIMS Raipur 492010
Dept of Pediatric Surgery AIIMS Raipur 492010
Raipur
CHHATTISGARH
492010
India 
Phone  9961346494  
Fax    
Email  drashwinc@yahoo.com  
 
Source of Monetary or Material Support  
Dept of Pediatric Surgery, AIIMS Raipur 
 
Primary Sponsor  
Name  Dept of Pediatric Surgery, AIIMS Raipur 
Address  Dept of Pediatric Surgery, AIIMS Raipur 
Type of Sponsor  Government medical college 
 
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 
Dr Ashwin Kumar C  AIIMS Raipur  Dept of Pediatric Surgery AIIMS Raipur
Raipur
CHHATTISGARH 
9961346494

drashwinc@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N508||Other specified disorders of malegenital organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  14.00 Year(s)
Gender  Male 
Details  1. All patients undergoing single stage and staged hypospadias repairs during the study period
 
 
ExclusionCriteria 
Details  1. Failed repair (glans dehiscence)
2. Urethrocutaneous fistula
3. Patients operated outside the study setting at any point
4. Patients referred to our institute for complications
• Preexisting neurological bladder
• Meatal Stenosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
OBJECTIVE

Perform uroflowmetry test on study subjects on Day10, Day 30 and Day 60 after removal of catheter.

Compare the uroflowmetry parameters between two study groups - single stage and staged hypospadias repair

Analyze the results of the comparative study and find out if any statistical difference in uroflowmetry parameters between two study groups.

Study if there is any change - either improvement or deterioration of parameter values in course of time.
 
Outcome is assessed at the end of study period. 18 Months from the beginning of study. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   02/01/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hypospadias is defined as the opening of meatus on the ventral side of the shaft of the penis. Until today there are more than 300 different surgical techniques with several modifications. Urethral stricture, urethral stenosis, urethrocutaneous fistula, chordee, are some of the few delayed complications after hypospadias surgery. Urethral stenosis is a common complication and can lead to long term effects on the bladder which can even potentially end in chronic kidney disease. Uroflowmetry is a simple easy to use noninvasive test which can be used for the early diagnosis of urethral stenosis / stricture emerging after hypospadias. Usually in staged hypospadias repair there is long length of neourethra created. It can provide resistance to urine flow compared to small length in single stage hypospadias repair. We in this study aim to compare the uroflowmetry parameters after single stage and staged hypospadias surgery done in our institute. We also propose to find out any difference in the uroflowmetry values in the follow-up of hypospadias operated as single stage and staged repair.

 
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