Determination of the effect of autologous platelet rich fibrin gel on surgical outcomes in hypospadias repair in pediatric patients

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054859

Enrollment

Registered

2023-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q549- Hypospadias, unspecified

Interventions

Intervention1: Urethroplasty for distal/mid penile hypospadias: standard urethroplasty surgery (TIP)using tunica vaginalis or dartos flap Control Intervention1: Hypospadias surgery (TIP urethroplasty)

Eligibility

Inclusion criteria

Inclusion criteria: All index patients aged < 18 years with distal or mid penile hypospadias presenting in the pediatric surgery outpatient department and eventually undergoing surgical correction for the same will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients >18 years of age 2. Patients with platelet disorders & coagulopathies. 3. Patients who received preoperative topical androgens. 4. Patients with proximal penile hypospadias. 5. Patients previously operated elsewhere presenting with complications like urethrocutaneous fistulas, meatal stenosis, glans dehiscence etc

Design outcomes

Primary

Measure	Time frame
To assess the effect of use of autologous platelet rich fibrin gel on complication rates in pediatric patients undergoing hypospadias repair. Timepoint: At initial presentation in OPD and 2 weeks and 4 weeks post operatively	—

Secondary

Measure	Time frame
1. To determine effect of use of platelet rich fibrin gel on incidence of complications such as fistula formation, dehiscence, meatal stenosis & surgical site infections in pediatric patients undergoing hypospadias repair. 2. To determine effect of use of platelet rich fibrin gel on cosmetic outcomes using the HOPE (Hypospadias Objective Penile Evaluation) & HOSE (Hypospadias Objective Scoring Evaluation) scores in all patients undergoing surgery for hypospadias correction for postoperative assessment. Timepoint: to be completed in 1.5 years	—

Measure

Time frame

1. To determine effect of use of platelet rich fibrin gel on incidence of complications such as fistula formation, dehiscence, meatal stenosis & surgical site infections in pediatric patients undergoing hypospadias repair. 2. To determine effect of use of platelet rich fibrin gel on cosmetic outcomes using the HOPE (Hypospadias Objective Penile Evaluation) & HOSE (Hypospadias Objective Scoring Evaluation) scores in all patients undergoing surgery for hypospadias correction for postoperative assessment. Timepoint: to be completed in 1.5 years

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Countries

India

Contacts

Public ContactDr Somya Bhatt

AIIMS Jodhpur

jadhavavinash99@gmail.com8209908126

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026