| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N508||Other specified disorders of malegenital organs, |
|
|
Intervention / Comparator Agent
|
|
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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
|
|
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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
|
|
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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
|
|
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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.
|