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NCT Number: NCT07076992

Dilemma of Neonatal Circumcision in Egypt

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

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Key information

Conditions

Neonate Circumcision

Age range

Up to 3 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohamed I Elmaadawy, MD

CONTACT

[email protected]

00201060245430

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Circumcision by Plastibell

Procedure

Patients will undergo circumcision by Plastibell (PB).

Circumcision by Gomco

Procedure

Patients will undergo circumcision by the Gomco (GM).

Primary outcomes

  1. Post circumcision bleeding

    Time frame: 2 hours postoperatively

    All infants will be followed up for 2 hours for early detection and management of post circumcision bleeding.

Secondary outcomes

  1. Wound healing

    Time frame: 7 days postoperatively

    Superficial wound healing will be assessed on the 7th post-operative day.

  2. Parental satisfaction

    Time frame: 4 weeks postoperatively

    Degree of parental satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed I Elmaadawy, MD

CONTACT

[email protected]

00201060245430

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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