Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598215
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
proximal hypospadias presents a serious anomaly for both infants and their care givers a variety of techniques were described through decades None of them is completely curable hundred of modifications were adopted to the original techniques during the current study we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure
Detailed Description:
two groups of infants diagnosed with proximal hypospadias will be allocated in two groups group A will include cases of who will be operated upon using hybrid Duckett urethroplasty group B will include patients who will be operated upon using modified duckett urethroplasty
recruitment in either group will be done using sealed envelop method in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis the tube will be secured in place however no proximal anastomosis with the meatus the anastomosis will be scheduled six months later In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session the primary out come will be completion of the procedure and restoration of the urethral continuity secondary out come will the cosmetic appearance
recruitment in either group will be done using sealed envelop method in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis the tube will be secured in place however no proximal anastomosis with the meatus the anastomosis will be scheduled six months later In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session the primary out come will be completion of the procedure and restoration of the urethral continuity secondary out come will the cosmetic appearance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None