CircumcisionNCT04092998
Circumcision With Use of Thermocautery and Histopathological Changes
A study testing Thermocautery circumcision in people with Circumcision, run by Assiut University at 1 site in Egypt.
Trial summary
Histo pathological changes that occurs in thermo cautery circumcision and the range of damage prepuce from thermal effect in comparison with scalpel circumcision Read more about this study
- Who is it for?
- Ages 40 days and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision
- What is being tested?
- Thermocautery circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 20 May 2022
- 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 40 days and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all male gender
Who cannot join
- females
- micro penis
- hypospedias
- epispedias
- ambigilious genitalia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histopathological Changes and Surgical Complications in Thermocautery Circumcision
Histo pathological changes that occurs in thermo cautery circumcision and the range of damage prepuce from thermal effect in comparison with scalpel circumcision
Read the detailed description
Circumcision is one of the most commonly performed surgical procedures worldwide. It is known that more than one million children are circumcised annually in the USA alone . Moreover, the WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS . Because of this, thousands of people have been circumcised by many migratory circumcision teams, especially in Africa.
Considering that 1 200 000 children are born annually in Turkey and 51% of them are male, on the basis of data from the Turkish Institute of Statistics, it may be speculated that about 60 000 circumcisions are performed annually in Turkey.
However, the circumcision procedure cannot be performed in health institutions as a routine procedure because of health regulations. When the Social Security Institute incorporated circumcision into the social insurance coverage in 2007, it led to circumcision being performed in the health institutions. Health institutions that were already burdened cannot meet the demands for circumcision. Thus, the search has begun for faster and reliable circumcision techniques with fewer complications. The present study aimed to compare bipolar thermal cautery-assisted circumcision technique, considered to be capable of meeting such demands, with the classical circumcision technique.
Aim of Work This study is aiming to assess the outcome of using thermo cautery in circumcision
Surgical Steps:
small skin incision over prepuce by thermo cautery
stitching if there is bleeding
Insertion of a urinary catheter if suspect uretheral injury
- Conditions
- Circumcision
- Being tested
- Thermocautery circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermocautery circumcisionProcedure or surgery
Also called scalpel circumcision
Histopathological changes from thermocautery circumcision
| Study group | Role | What they receive |
|---|---|---|
| Thermocautery VS scalpel circumcision | Experimental | Thermocautery circumcision in comparison to circumcision with traditional scalpel Receives: Procedure: Thermocautery circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
early wound complications
wound infection (with or without removal of the mesh) wound necrosis wound hematoma bleeding
Measured: 1 week
late wound complications
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
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 posted17 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion20 Oct 2020 (estimated)
- Study completion20 May 2022 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- male infant presented for Circumcision
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed gamal, Assiut University
- Investigators
- gamal makhlouf, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092998
- Sponsor's protocol ID
- Circumcision
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age , sex , clinical diagnosis
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Changes and Surgical Complications in Thermocautery Circumcision
- ClinicalTrials.gov ID
- NCT04092998
- Acronym / sponsor ID
- Circumcision
- Conditions
- Circumcision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 20 May 2022 (estimated)
- First posted
- 17 Sep 2019 (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.
Histo pathological changes that occurs in thermo cautery circumcision and the range of damage prepuce from thermal effect in comparison with scalpel circumcision
Detailed description
Circumcision is one of the most commonly performed surgical procedures worldwide. It is known that more than one million children are circumcised annually in the USA alone . Moreover, the WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS . Because of this, thousands of people have been circumcised by many migratory circumcision teams, especially in Africa.
Considering that 1 200 000 children are born annually in Turkey and 51% of them are male, on the basis of data from the Turkish Institute of Statistics, it may be speculated that about 60 000 circumcisions are performed annually in Turkey.
However, the circumcision procedure cannot be performed in health institutions as a routine procedure because of health regulations. When the Social Security Institute incorporated circumcision into the social insurance coverage in 2007, it led to circumcision being performed in the health institutions. Health institutions that were already burdened cannot meet the demands for circumcision. Thus, the search has begun for faster and reliable circumcision techniques with fewer complications. The present study aimed to compare bipolar thermal cautery-assisted circumcision technique, considered to be capable of meeting such demands, with the classical circumcision technique.
Aim of Work This study is aiming to assess the outcome of using thermo cautery in circumcision
Surgical Steps:
small skin incision over prepuce by thermo cautery
stitching if there is bleeding
Insertion of a urinary catheter if suspect uretheral injury
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- male infant presented for Circumcision
| Arm | Type | Receives |
|---|---|---|
| Thermocautery VS scalpel circumcision | Experimental | Procedure: Thermocautery circumcisionThermocautery circumcision in comparison to circumcision with traditional scalpel |
Who may qualify
- Ages
- 40 days and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all male gender
Key exclusion criteria (5 listed)
- females
- micro penis
- hypospedias
- epispedias
- ambigilious genitalia
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 |
|---|---|---|
| Thermocautery circumcisionAlso: scalpel circumcisionHistopathological changes from thermocautery circumcision | Procedure or surgery | Thermocautery VS scalpel circumcision |
Primary outcome
early wound complications
Time frame: 1 week
wound infection (with or without removal of the mesh) wound necrosis wound hematoma bleeding
late wound complications
Time frame: 1 month
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: Yes. age , sex , clinical diagnosis
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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.
gamal makhlouf study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermocautery circumcision in people with Circumcision, run by Assiut University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Sep 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed gamal (01007717127, mohamedgamalhassan0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early wound complications (time frame: 1 week). The study lists 2 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 20 Sep 2019.