CircumcisionNCT06177834
Alisklamp and Dorsal Slit Sleeve Circumcision
A study testing Alisklamp and Dorsal slit circumcision technique in people with Circumcision, run by Mustafa Azizoğlu at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 minute to 18 years, men only
- Conditions the study is for
- Circumcision
- What is being tested?
- Alisklamp and Dorsal slit circumcision technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- male patients between 0-2 years and 6-18 years
Who cannot join
- 2-6 years, several penil chordee, hypospadias, previous penil surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Circumcision
- Being tested
- Alisklamp, Dorsal slit circumcision technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlisklampDevice
Alisklamp
Dorsal slit circumcision techniqueOther
In this group, included the patients who will operated with dorsal slit circumcision technique
| Study group | Role | What they receive |
|---|---|---|
| Classical dorsal slit circumcision technique | Active comparator | In this group, the patients who will operated with dorsal sleeve slit circumcision technique. Receives: Other: Dorsal slit circumcision technique |
| Alisklamp | Experimental | In this group, the patients who will operated with Alisklamp technique. Receives: Device: Alisklamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Healing time
Measured: 2 weeks
infections
wound infections
Measured: 2 weeks
wound dehiscence
wound dehiscence
Measured: 2 weeks
skin tunnel
presense of the number of skin tunnel
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start20 Dec 2023
- Primary completion20 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Azizoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mustafa Azizoğlu, Necmi Kadıoğlu Hospital
- Investigators
- Mustafa Azizoğlu, Principal investigator, Necmi Kadıoğlu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177834
- Sponsor's protocol ID
- NecmiKadiogluH
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alisklamp and Dorsal Slit Sleeve Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06177834
- Acronym / sponsor ID
- NecmiKadiogluH
- Conditions
- Circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mustafa AzizoğluUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical dorsal slit circumcision technique | Active comparator | Other: Dorsal slit circumcision techniqueIn this group, the patients who will operated with dorsal sleeve slit circumcision technique. |
| Alisklamp | Experimental | Device: AlisklampIn this group, the patients who will operated with Alisklamp technique. |
Who may qualify
- Ages
- 1 minute to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- male patients between 0-2 years and 6-18 years
Key exclusion criteria (1 listed)
- 2-6 years, several penil chordee, hypospadias, previous penil surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlisklampAlisklamp | Device | Alisklamp |
| Dorsal slit circumcision techniqueIn this group, included the patients who will operated with dorsal slit circumcision technique | Other | Classical dorsal slit circumcision technique |
Primary outcome
Healing time
Time frame: 2 weeks
Healing time
infections
Time frame: 2 weeks
wound infections
wound dehiscence
Time frame: 2 weeks
wound dehiscence
skin tunnel
Time frame: 1 month
presense of the number of skin tunnel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Azizoğlu principal investigator
Necmi Kadıoğlu State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alisklamp and Dorsal slit circumcision technique in people with Circumcision, run by Mustafa Azizoğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.