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A prospective multicenter randomized, parallel controlled, single-blind, superior efficacy trial to evaluate the safety and efficacy of urethral repair mesh for reconstruction of defective tissue in children undergoing hypospadias reconstructive surgery

A prospective multicenter randomized, parallel controlled, single-blind, superior efficacy trial to evaluate the safety and efficacy of urethral repair mesh for reconstruction of defective tissue in children undergoing hypospadias reconstructive surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037097
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

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

Conditions

Repair and reconstruction of defective tissue in children with hypospadias during urethroplasty

Interventions

Experimental group:of urethral repair mesh
Control group:Nil

Sponsors

Beijing Children's Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged <=5 years, male children; 2. Patients with congenital hypospadias were classified as intermediate type or proximal type; 3. For children who need urethral reconstruction and one-stage urethroplasty, the operation site is the first operation and the operation method is Duckett operation; 4. The patients with hypospadias should be treated with transverse urethral plate; 5. Preoperative examination of patients in accordance with the indications of the operation; 6. Patients who did not participate in other clinical trials within three months before the start of this trial; 7. Patients who voluntarily participate in and sign informed consent after obtaining full information.

Exclusion criteria

Exclusion criteria: 1. Patients with cryptorchidism; 2. Patients with glans width less than 1 cm; 3. The patients were treated with testosterone or androgen before operation; 4. Children who need Duplay operation; 5. Patients with severe liver diseases / systemic hematologic disorders; 6. For patients with severe heart disease and cardiac insufficiency, the researchers judged that they were not suitable for surgery; 7. The patients who used hormone continuously in the last three months were those who used immunosuppressant for a long time; 8. Patients with mental illness or mental disorder; 9. Patients with poor compliance and unable to carry out relevant examination and follow-up according to the test requirements; 10. Other children who did not meet the inclusion criteria determined by the researchers.

Design outcomes

Primary

MeasureTime frame
Effective in preventing urethral fistula;

Secondary

MeasureTime frame
Effective in preventing urethral diverticulum dilation;

Countries

China

Contacts

Public ContactNing Sun

Beijing Children's Hospital Affiliated to Capital Medical University

sunning@bch.com.cn+86 13370115011

Outcome results

None listed

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