Alisklamp and Dorsal Slit Sleeve Circumcision

Not Applicable

Completed

• Conditions: Circumcision
• Interventions: Other: Dorsal slit circumcision technique; Device: Alisklamp

• Registration Number: NCT06177834
• Lead Sponsor: Mustafa Azizoğlu

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-10
• Study Start: 2023-12-20
• Study First Posted: 2023-12-20
• Primary Completion: 2024-01-20
• Study Completion: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Classical dorsal slit circumcision technique	Dorsal slit circumcision technique	In this group, the patients who will operated with dorsal sleeve slit circumcision technique.
Alisklamp	Alisklamp	In this group, the patients who will operated with Alisklamp technique.

Primary Outcome Measures

Name	Time	Method
infections	2 weeks	wound infections
wound dehiscence	2 weeks	wound dehiscence
Healing time	2 weeks	Healing time
skin tunnel	1 month	presense of the number of skin tunnel

Trial Locations

Locations (1)

Mustafa Azizoğlu; 🇹🇷 Istanbul, Turkey