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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06177834
Other study ID # NecmiKadiogluH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2023
Est. completion date March 1, 2024

Study information

Verified date April 2024
Source Necmi Kadioglu Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study the plan is to compare the circumcision performed with Alisklamp versus Dorsal Slit Sleeve method in terms of age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.


Description:

The study compares two circumcision techniques in children: the dorsal sleeve slit method and the alisclamp method. The dorsal sleeve slit technique, conducted under local anesthesia for about 20-30 minutes, involves cutting the penile skin dorsally, removing excess skin and prepuce, and suturing with 5/0 vicryl. The alisclamp method, also under local anesthesia, entails retracting the penile skin, placing a clamp, excising excess prepuce, and sending the patient home. The clamp is removed after 48 hours without anesthesia, with the total procedure lasting under 5 minutes. This research assesses these methods based on factors like age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date March 1, 2024
Est. primary completion date January 20, 2024
Accepts healthy volunteers No
Gender Male
Age group 1 Minute to 18 Years
Eligibility Inclusion Criteria: male patients between 0-2 years and 6-18 years Exclusion Criteria: 2-6 years, several penil chordee, hypospadias, previous penil surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Alisklamp
Alisklamp
Other:
Dorsal slit circumcision technique
In this group, included the patients who will operated with dorsal slit circumcision technique

Locations

Country Name City State
Turkey Mustafa Azizoglu Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Mustafa Azizoglu

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing time Healing time 2 weeks
Primary infections wound infections 2 weeks
Primary wound dehiscence wound dehiscence 2 weeks
Primary skin tunnel presense of the number of skin tunnel 1 month
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