Alisklamp and Dorsal Slit Sleeve Circumcision

April 12, 2024 updated by: Mustafa Azizoğlu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34430
        • Mustafa Azizoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Classical dorsal slit circumcision technique
In this group, the patients who will operated with dorsal sleeve slit circumcision technique.
Other: Dorsal slit circumcision technique
In this group, included the patients who will operated with dorsal slit circumcision technique
Experimental: Alisklamp
In this group, the patients who will operated with Alisklamp technique.
Device: Alisklamp
Alisklamp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing time
Time Frame: 2 weeks
Healing time
2 weeks
infections
Time Frame: 2 weeks
wound infections
2 weeks
wound dehiscence
Time Frame: 2 weeks
wound dehiscence
2 weeks
skin tunnel
Time Frame: 1 month
presense of the number of skin tunnel
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Azizoğlu

Investigators

  • Principal Investigator: Mustafa Azizoğlu, Necmi Kadıoğlu State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Actual)

January 20, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • NecmiKadiogluH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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