Alisklamp and Dorsal Slit Sleeve Circumcision

Circumcision Clinical Trial

Official title:

Comparison of Alisklamp and Dorsal Slit Sleeve Circumcision: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06177834
• Other study ID #: NecmiKadiogluH
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Circumcision

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