Bladder Exstrophy-Epispadias Complex
Conditions
Keywords
Platelet-Rich Fibrin, Bladder Exstrophy, Penopubic Fistula, Pediatric Urology, Randomized Controlled Trial, Wound Healing
Brief summary
Bladder exstrophy-epispadias complex (BEEC) is a rare condition in which the bladder and surrounding structures do not form normally. Surgery is required to close the bladder and restore normal anatomy, but complications such as penopubic fistula and wound breakdown are common after repair. Platelet-rich fibrin (PRF) is a material obtained from a patient's own blood that contains healing factors and may improve wound healing. This prospective randomized controlled study evaluates whether applying autologous PRF during primary bladder exstrophy repair can reduce postoperative complications compared with standard surgical closure alone. Twenty pediatric patients with primary BEEC undergoing surgical repair were randomly assigned to either a PRF group or a non-PRF (control) group. The main outcome measured was the occurrence of penopubic fistula after surgery, along with other postoperative complications. The results of this study aim to help determine whether PRF is a safe and effective adjunct in bladder exstrophy repair.
Detailed description
This is a single-center, prospective, randomized controlled clinical trial conducted in the Pediatric Urology Department of the National Children's Medical Center between 2022 and 2025. The study enrolled 20 male patients with primary bladder exstrophy-epispadias complex undergoing initial surgical repair. Patients with cloacal variants and complicated cases were excluded. Participants were randomly allocated using a computer-generated random number sequence into two groups: the PRF group (n = 12), in which autologous platelet-rich fibrin was applied during bladder neck repair, and the non-PRF control group (n = 8), in which standard wound closure was performed without PRF. In the PRF group, 5-10 mL of venous blood was collected intraoperatively and centrifuged to prepare a PRF membrane, which was applied over the bladder neck before pubic symphysis closure. Both groups underwent standardized surgical repair techniques, including complete primary repair or modified staged repair as indicated. The primary outcome was the incidence of penopubic fistula formation. Secondary outcomes included wound dehiscence, hospital stay, and postoperative complications. Patients were followed postoperatively according to the institutional protocol. This study was approved by the Institutional Review Board of the National Children's Medical Center (Approval No.: 052022/14), and informed consent was obtained from the parents or legal guardians of all participants.
Interventions
BIOLOGICALAutologous Platelet-Rich Fibrin
Autologous platelet-rich fibrin prepared intraoperatively from 5-10 mL of the patient's venous blood using centrifugation at (3000 rpm for 10 min) to produce a PRF and applied over the bladder neck before pubic symphysis closure during primary bladder exstrophy repair.
PROCEDUREStandard Surgical Closure
Standard primary bladder exstrophy repair closure performed without the use of platelet-rich fibrin.
Sponsors
National Children's Medical Center, Uzbekistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a parallel-group randomized controlled trial in which participants were assigned in a 1:1 ratio to either receive autologous platelet-rich fibrin during bladder exstrophy repair or undergo standard surgical closure without PRF. Outcomes were compared between the two independent groups
Eligibility
Sex/Gender
MALE
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male patients diagnosed with primary bladder exstrophy-epispadias complex (BEEC) * Age from birth up to 18 years * Patients undergoing primary surgical repair of bladder exstrophy * Written informed consent provided by parents or legal guardians
Exclusion criteria
* Patients with cloacal variants of bladder exstrophy * Patients with complicated or recurrent bladder exstrophy * Patients who previously underwent bladder exstrophy repair * Patients with severe associated congenital anomalies that could affect wound healing * Patients with coagulation abnormalities * Patients with severe anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Penopubic Fistula | from 3 month to 6 month | Occurrence of clinically confirmed penopubic fistula following primary bladder exstrophy repair in the PRF and non-PRF groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wound Dehiscence | Within 6 months after surgery | Occurrence of postoperative wound dehiscence after primary bladder exstrophy repair in the PRF and non-PRF groups. |
Countries
Uzbekistan
Outcome results
None listed