Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05144659 |
| Other study ID # |
Al-Azhar DFOF versus TIOF |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Al-Azhar University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in
pediatrics. The preputial onlay island flap technique has been popularized for hypospadias
repair as a result of offering a consistent combination of excellent cosmetic results and
acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to
be the most common complications, in addition to other complications, and can be attributed
to the affection of flaps vascularity. Some authors describe a technique that resolves some
of these problems by combining the unique benefits of the double-faced preputial flaps.
This study aimed to evaluate double faced preputial onlay island flap technique for
complication rate, outcomes for urinary stream, and cosmetic results.
Description:
Type of study: prospective RCT
Review of literature:
- Different previous techniques for the repair of various levels of penile shaft
hypospadias with chordee.
- Demonstration of two different well-established techniques for repair of anterior,
mid-penile, and posterior penile hypospadias without or with mild curvature.
- Disadvantages of two-stage urethroplasty or technique as transverse inner preputial
onlay island flap that involves dissection of the flap from its dorsal preputial tissue
(as it affects the flap vascularity).
- Merits of single-stage urethroplasty double-faced preputial onlay island flap (as it
combines the benefits of vascularized pedicled flap, provides better functional and
cosmetic results, and low complication rate).
This study will be conducted at pediatric surgery department at Al-Houssain and Sayed Galal
University Medical Centers, in the period from May 2019 to February 2021, on 68 male patients
with anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
Patients will be investigated by routine laboratory tests for fitness for surgery. All of
them will undergo one-stage repair using either of 2 techniques of urethroplasty;
double-faced preputial onlay island flap versus transverse inner preputial onlay island flap.
Written informed consent will be signed by the parents of all participants in the study.
Institutes of the study: A multicenter study at pediatric surgery departments, Al-Azhar
University Medical Centers in Cairo, Egypt.
Number of cases: Sixty-eight male patients. Time frame: 3 years.
Ethical Consideration:
The protocol will be discussed and approved by the Ethics and Institutional Review Board
Committee at the investigators' hospitals. The procedures and the aim of the study will be
clearly explained to the patient and the family. Written informed consent will be obtained
before enrollment of the patients into the study. The family's refusal to give consent for
one-stage repair is respected but does not deprive the patient of getting surgical care by
two-stage repair.
Preoperative preparation:
All patients will be subjected to history taking, clinical examination, and necessary
laboratory investigations (CBC, Coagulation profile, Urinalysis). Participants will receive a
dose of single broad-spectrum antibiotic 30 min-1 hour before surgery.
Patients will be randomly divided (using non-transparent closed envelope randomization
method) into two equal groups, each will include 34 patients; Group A will undergo double
faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay
island flap. All operations were done by the same surgical team.
Follow-up: patients will be followed-up at OPD at 1, 3, 12, and 24 months, for incidence of
any complications. HOSE score questionnaire will be used for the evaluation of outcomes.
Statistical Analysis:
Data will be presented as mean, standard deviation, number & percentage. For qualitative
data, Chi-square test (X2) is used to compare between the two groups and independent-samples
t-test of significance is used when comparing between two means. The significance level is
set at P <0.05. Statistical analysis will be performed using statistical package for social
sciences (SPSS) version 23.0, IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA.
Discussion:
It will focus on one-stage repair for anterior, mid-penile, and posterior penile hypospadias
without or with mild penile curvature using double-faced preputial onlay island flap in
comparison to inner preputial onlay island flap.
The results obtained from this study will be compared between both groups and with those
reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by
Hypospadias Objective Scoring Evaluation (HOSE) questionnaire evaluation tool. Finally, the
investigators will conclude the reconstructive technique that gives the better results and
least morbidity.
