Dilemma of Neonatal Circumcision in Egypt
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeUp to 3
SponsorTanta University
About this trial
The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male infants less than 3 months old.
Undergoing circumcision.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Circumcision by Plastibell
Procedure/SurgeryPatients will undergo circumcision by Plastibell (PB).
Circumcision by Gomco
Procedure/SurgeryPatients will undergo circumcision by the Gomco (GM).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post circumcision bleeding
All infants will be followed up for 2 hours for early detection and management of post circumcision bleeding.
Time frame
2 hours postoperativelySecondary outcomes
1
Wound healing
Superficial wound healing will be assessed on the 7th post-operative day.
Time frame
7 days postoperatively2
Parental satisfaction
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)
Time frame
4 weeks postoperativelySponsors and contacts
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Source ClinicalTrials.gov