Male CircumcisionNCT03634358
Bipolar Scissors for Circumcision
A study testing Bipolar scissors and classic scalpel in people with Male Circumcision, run by Zagazig University.
Trial summary
comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method Read more about this study
- Who is it for?
- Ages 40 days to 18 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- Bipolar scissors and classic scalpel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 10 Jan 2018
- 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 to 18 months
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Male infant between 40 days and 18 month old
- parents' request and approval of circumcision
Who cannot join
- previous attempts of circumcision or revision cases
- bleeding tendency
- congenital anomalies involving genitalia
- age below 40 days (expected Vit. K deficiency) or above 18 month old.
About this study
Official title: Bipolar Scissors Versus Classic Method for Circumcision
comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method
Read the detailed description
A prospective, randomized study, comparing two different techniques for pediatric male circumcision: the bipolar diathermy scissors technique with that of a classic scalpel technique. Study included male infants from 40 days old up to 18 month old. They were reviewed regarding Operative time, bleeding, complications, postoperative pain and morbidity. Differences in the outcome were compared.
- Conditions
- Male Circumcision
- Being tested
- Bipolar scissors, classic scalpel
- Keywords
- bipolar, scalpel, foreskin, prepuce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar scissorsProcedure or surgery
classic scalpelProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bipolar scissors group | Active comparator | Group of male infants undergoing circumcision using bipolar scissors to separate the foreskin Receives: Procedure: Bipolar scissors |
| Classic scalpel group | Active comparator | Group of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding Receives: Procedure: classic scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative bleeding
occurrence of active bleeding after circumcision
Measured: A week
Secondary outcomes (5)
Post-operative pain
pain after operation as assessed and described by parents (through a questionnaire) by the Neonatal/Infant Pain Scale (NIPS): It is composed of six (6) indicators.
- facial expression
- cry
- breathing patterns
- arms
- legs
- state of arousal Each behavioral indicator is scored with 0 or 1 except "cry", which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants should be observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7. Pain Level is determined as: 0-2 = mild to no pain. 3-4 = mild to moderate pain >4 = severe pain
Measured: A week
wound complications
occurrence of infection, necrosis or skin loss around wound
Measured: Two weeks
Cosmetic outcome
Presence or absence of scar
Measured: Two month
Operative time
Duration of procedure of both techniques
Measured: Operative time
Over or under correction
Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jan 2016
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male CircumcisionStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing Outcomes of two different surgical techniques between two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, yousef ahmed el-ayman, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634358
- Sponsor's protocol ID
- ZagazigUH
- Status last verified
- Aug 2018
- First submitted
- 13 Jan 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mendez-Gallart R, Estevez E, Bautista A, Rodriguez P, Taboada P, Armas AL, Pradillos JM, Varela R. Bipolar scissors circumcision is a safe, fast, and bloodless procedure in children. J Pediatr Surg. 2009 Oct;44(10):2048-53. doi: 10.1016/j.jpedsurg.2009.06.008.
PubMed 19853772
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Scissors Versus Classic Method for Circumcision
- ClinicalTrials.gov ID
- NCT03634358
- Acronym / sponsor ID
- ZagazigUH
- Conditions
- Male Circumcision
- Keywords
- bipolar, scalpel, foreskin, prepuce
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 16 Aug 2018 (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.
comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method
Detailed description
A prospective, randomized study, comparing two different techniques for pediatric male circumcision: the bipolar diathermy scissors technique with that of a classic scalpel technique. Study included male infants from 40 days old up to 18 month old. They were reviewed regarding Operative time, bleeding, complications, postoperative pain and morbidity. Differences in the outcome were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparing Outcomes of two different surgical techniques between two groups
| Arm | Type | Receives |
|---|---|---|
| Bipolar scissors group | Active comparator | Procedure: Bipolar scissorsGroup of male infants undergoing circumcision using bipolar scissors to separate the foreskin |
| Classic scalpel group | Active comparator | Procedure: classic scalpelGroup of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding |
Who may qualify
- Ages
- 40 days to 18 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male infant between 40 days and 18 month old
- parents' request and approval of circumcision
Key exclusion criteria (4 listed)
- previous attempts of circumcision or revision cases
- bleeding tendency
- congenital anomalies involving genitalia
- age below 40 days (expected Vit. K deficiency) or above 18 month old.
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 |
|---|---|---|
| Bipolar scissors | Procedure or surgery | Bipolar scissors group |
| classic scalpel | Procedure or surgery | Classic scalpel group |
Primary outcome
Post-operative bleeding
Time frame: A week
occurrence of active bleeding after circumcision
5 secondary outcomes
Post-operative pain
Time frame: A week
wound complications
Time frame: Two weeks
Cosmetic outcome
Time frame: Two month
Operative time
Time frame: Operative time
Over or under correction
Time frame: 2 month
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 Aug 2018.
- Background: PubMed 19853772Mendez-Gallart R, Estevez E, Bautista A, Rodriguez P, Taboada P, Armas AL, Pradillos JM, Varela R. Bipolar scissors circumcision is a safe, fast, and bloodless procedure in children. J Pediatr Surg. 2009 Oct;44(10):2048-53. doi: 10.1016/j.jpedsurg.2009.06.008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar scissors and classic scalpel in people with Male Circumcision, run by Zagazig University.
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 2 inclusion and 4 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Post-operative bleeding (time frame: A week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634358, which also lists 1 linked publication.
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 Aug 2018.