Alisklamp and Dorsal Slit Sleeve Circumcision

NCT ID: NCT06177834

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Circumcision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Classical dorsal slit circumcision technique

In this group, the patients who will operated with dorsal sleeve slit circumcision technique.

Group Type ACTIVE_COMPARATOR

Dorsal slit circumcision technique

Intervention Type OTHER

In this group, included the patients who will operated with dorsal slit circumcision technique

Alisklamp

In this group, the patients who will operated with Alisklamp technique.

Group Type EXPERIMENTAL

Alisklamp

Intervention Type DEVICE

Alisklamp

Interventions

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Alisklamp

Alisklamp

Intervention Type DEVICE

Dorsal slit circumcision technique

In this group, included the patients who will operated with dorsal slit circumcision technique

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

male patients between 0-2 years and 6-18 years

Exclusion Criteria

2-6 years, several penil chordee, hypospadias, previous penil surgery
Minimum Eligible Age

1 Minute

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Azizoğlu

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Azizoğlu

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mustafa Azizoğlu

Role: PRINCIPAL_INVESTIGATOR

Necmi Kadıoğlu State Hospital

Locations

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Mustafa Azizoğlu

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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NecmiKadiogluH

Identifier Type: -

Identifier Source: org_study_id

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