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Recruiting NCT07076992

Dilemma of Neonatal Circumcision in Egypt

No phase Interventional Neonate Circumcision

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Circumcision by Plastibell, Circumcision by Gomco.
Who it may be relevant to
Registry conditions: Neonate, Circumcision. Basic parameters: up to 3 months · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Dilemma of Neonatal Circumcision in Egypt: A Comparative Randomized Study

Overview

The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.

Detailed description

Circumcision of a male child is the most common surgery performed globally. The prevalence of circumcision in this part of the world is over 80%, with the majority conducted in the neonatal period. The techniques of circumcision are diverse, and the method of circumcision may account for the differences in the outcome of the procedure.

Circumcision has complications like all surgical procedures. These typically include early complications such as leakage, hemorrhage, wound infection, pain, and swelling. However, more serious problems such as prolonged bleeding and amputation of the glans penis may also be encountered.

Interventions

  • Procedure Circumcision by Plastibell
    Patients will undergo circumcision by Plastibell (PB).
  • Procedure Circumcision by Gomco
    Patients will undergo circumcision by the Gomco (GM).

Primary outcome measures

  • Post circumcision bleeding [Time frame: 2 hours postoperatively]
Secondary outcome measures (2)
  • Wound healing [Time frame: 7 days postoperatively]
  • Parental satisfaction [Time frame: 4 weeks postoperatively]

Eligibility criteria

Inclusion criteria

  • Male infants less than 3 months old.
  • Undergoing circumcision.

Exclusion criteria

  • Male infants more than 3 months old.
  • Infants with bleeding disorders.
  • Neonates with hypospadias, epispadias, micropenis, disorders of sex development (DSD)
  • Neonates with buried or webbed penis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07076992 · 36264PR1075/1/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗