Dilemma of Neonatal Circumcision in Egypt

NCT ID: NCT07076992

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Neonate Circumcision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

Patients will undergo circumcision by Plastibell (PB).

Group Type EXPERIMENTAL

Circumcision by Plastibell

Intervention Type PROCEDURE

Patients will undergo circumcision by Plastibell (PB).

Group 2

Patients will undergo circumcision by the Gomco (GM).

Group Type EXPERIMENTAL

Circumcision by Gomco

Intervention Type PROCEDURE

Patients will undergo circumcision by the Gomco (GM).

Interventions

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Circumcision by Plastibell

Patients will undergo circumcision by Plastibell (PB).

Intervention Type PROCEDURE

Circumcision by Gomco

Patients will undergo circumcision by the Gomco (GM).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

3 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ibrahim Ahmed Elmaadawy

Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed I Elmaadawy, MD

Role: CONTACT

00201060245430

Facility Contacts

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Mohamed I Elmaadawy, MD

Role: primary

00201060245430

Other Identifiers

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36264PR1075/1/25

Identifier Type: -

Identifier Source: org_study_id

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