| CTRI Number |
CTRI/2018/01/011140 [Registered on: 04/01/2018] Trial Registered Prospectively |
| Last Modified On: |
10/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Early repair of fistula in children after operation for hypospadias |
|
Scientific Title of Study
|
Early repair of small urethrocutaneous fistula in children after hypospadias surgery- A randomised controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachit Anand |
| Designation |
Junior Resident, Department of Pediatric Surgery |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no-60, Hostel no-7
AIIMS Gents Hostel, AIIMS
Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9654215906 |
| Fax |
|
| Email |
kanu.sachit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sachit Anand |
| Designation |
Junior Resident, Department of Pediatric Surgery |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no-60, Hostel no-7
AIIMS Gents Hostel, AIIMS
Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9654215906 |
| Fax |
|
| Email |
kanu.sachit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjan Dhua |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pediatric Surgery, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9871568690 |
| Fax |
|
| Email |
anjandhua@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V Ramalingaswami Bhawan
P.O Box 4911
Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research
V. Ramalingaswami Bhawan
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029
India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Sachit Anand |
All India Institute of Medical Sciences |
Out patient department,Pediatric Surgery department, AIIMS
New Delhi
DELHI |
9654215906
kanu.sachit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children with hypospadias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early repair of small fistula |
Early repair of small urethrocutaneous fistula manifesting within 4 weeks of catheter removal by application of a figure of eight stitch on OPD/day care basis |
| Comparator Agent |
Standard treatment |
Daily calibration of the neo-meatus and finger occlusion during micturition |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Male |
| Details |
(a) Have undergone primary urethroplasty for hypospadias at AIIMS
b) Fistula manifesting within four weeks after catheter removal
c) Single small (≤4 mm) UCF
|
|
| ExclusionCriteria |
| Details |
a) Wound infection with slough around the fistula
b) UCF > 4mm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome would be assessed by the comparison of the two groups with regards to number of patients having fistula |
At the end of 6 months of follow up in the two groups
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome shall be assessed by the number of patients allocated to the test arm who successfully receive the intervention without requiring another admission |
At the end of 6 months of follow up in the two groups |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/01/2018 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label randomised
controlled trial to determine the feasibility and efficavy of early
repair of small urethrocutaneous fistulae (≤4 mm) in children after hypospadias
surgery. Children
with small UC fistula developing within four weeks after catheter removal shall
be assessed for eligibility based on
inclusion/exclusion criteria. Following
informed parental consent, eligible children shall be randomised to receive a “figure
of eight†stitch while ensuring
allocation concealment. Randomized
control subjects who would only be subjected to traditional follow up with
neo-meatal calibration and finger occlusion micturition.
The patients shall be
followed during the study duration and monitored for recurrence of fistulas,
urinary stream and wound infection. |