NCT07076992

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 2, 2025

Last Update Submit

July 22, 2025

Conditions

NeonateCircumcision

Outcome Measures

Primary Outcomes (1)

  • Post circumcision bleeding

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

    2 hours postoperatively

Secondary Outcomes (2)

  • Wound healing

    7 days postoperatively

  • Parental satisfaction

    4 weeks postoperatively

Study Arms (2)

Group 1

EXPERIMENTAL

Patients will undergo circumcision by Plastibell (PB).

Procedure: Circumcision by Plastibell

Group 2

EXPERIMENTAL

Patients will undergo circumcision by the Gomco (GM).

Procedure: Circumcision by Gomco

Interventions

Circumcision by PlastibellPROCEDURE

Patients will undergo circumcision by Plastibell (PB).

Group 1
Circumcision by GomcoPROCEDURE

Patients will undergo circumcision by the Gomco (GM).

Group 2

Eligibility Criteria

AgeUp to 3 Months
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale infants undergoing circumcision
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohamed I Elmaadawy, MD

CONTACT

00201060245430Mohamed.elmaadawy@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 22, 2025

Study Start

July 22, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)