Perioperative Bleeding During Recurrent Hypospadias Repair
Conditions
Brief summary
This study aims to fill that gap by evaluating the efficacy and safety of intravenous TXA in children undergoing redo hypospadias surgery, potentially establishing a new standard of care
Interventions
DRUGsingle intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy. It will be administered intravenously in the same manner and over the same duration as the intervention drug to maintain blinding.
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
Male children aged 1 year to 10 years Scheduled for surgical repair of recurrent hypospadias Classified as ASA physical status I or II.
Exclusion criteria
Known personal or family history of bleeding disorders or thrombophilia. Documented history of seizures or epilepsy. Known allergy or hypersensitivity to tranexamic acid. Concurrent use of anticoagulant medications or other antifibrinolytics. Significant renal impairment (eGFR \< 60 mL/min/1.73m²).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative blood loss | INTRAOPERATIVE | This will be quantified using the gravimetric method. All surgical sponges and gauzes will be weighed before use and after being soaked with blood. The difference in weight (1 gram = 1 mL of blood) will be summed to calculate the total blood loss. Suctioned fluids will be measured, and the amount of irrigation fluid used will be subtracted to determine the volume of blood loss collected via suction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical field visibility | INTRAOPERATIVE | Assessed intraoperatively by the primary surgeon at predefined intervals using the Fromme scale (also known as the Boezaart scale), a validated 5-point scale ranging from 0 (no bleeding) to 4 (severe bleeding, surgery not possible). |
| Surgeon satisfaction with the surgical field visibility | INTRAOPERATIVE | To be assessed post- operatively using a 5-point Likert scale (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied). |
| Total operative time | INTRAOPERATIVE | Measured in minutes from the time of skin incision to the application of the final dressing. |
| Incidence of postoperative bleeding complications | within 7 days of surgery. | Defined as the occurrence of a clinically significant hematoma (requiring drainage or causing wound compromise) or other bleeding event requiring intervention within 7 days of surgery. |
Countries
Egypt
Outcome results
None listed