Dilemma of Neonatal Circumcision in Egypt

Tanta University

Status: Enrolling

Conditions: Neonate; Circumcision

Treatments: Procedure: Circumcision by Gomco; Procedure: Circumcision by Plastibell

Study type: Interventional

Funder types: Other

Identifiers

NCT07076992

36264PR1075/1/25

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group 1

Experimental group

Description:

Patients will undergo circumcision by Plastibell (PB).

Treatment:

Procedure: Circumcision by Plastibell

Group 2

Experimental group

Description:

Patients will undergo circumcision by the Gomco (GM).

Treatment:

Procedure: Circumcision by Gomco