CircumcisionPhase 4NCT01477593
Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail
A Phase 4 study testing circumcision with Shenghuan in Yan's method, circumcision with Shenghuan in Peng's method and conventional method with incision in people with Circumcision, run by Feng Pan.
Trial summary
Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide. Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed routinely in every male newborn. The benefits from it vastly outweigh the risks. Read more about this study
- Who is it for?
- Ages 3 to 11 years, men only
- Conditions the study is for
- Circumcision
- What is being tested?
- circumcision with Shenghuan in Yan's method, circumcision with Shenghuan in Peng's method and conventional method with incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2011
- Phase
- Phase 4
- 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 3 to 11 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children with phimosis or redundant prepuce
Who cannot join
- Children with genital tract infection or deformity,
- congenital diseases,
- hematological diseases,
- or other general diseases
About this study
Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide. Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually, more and more Chinese male are willing to undergo it with themselves and their sons. But there are also some complications with circumcision, such as pain, edema, infection, and hemorrhage. Considering of that, physicians continually manage to improve their surgical methods and analgesic techniques.
In the study of Peng, a disposable minimally invasive circumcision anastomosis device named Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was introduced to be applied in circumcision. And they concluded that method was quicker, safer and less pain than the conventional techniques of incision. In present study, we carry out a randomized controlled trail, using a different method as Peng introduced with this device in children's circumcision (Yan's), compared with the method as Peng used and the conventional technique in our hospital, and then observe the outcomes.
- Conditions
- Circumcision
- Being tested
- circumcision with Shenghuan in Yan's method, circumcision with Shenghuan in Peng's method, conventional method with incision
- Keywords
- circumcision, chinese children, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circumcision with Shenghuan in Yan's methodProcedure or surgery
The foreskin is first separated from the glans.Then the inner ring is placed between them and over the glans. After adjusting the position of inner ring to retain 0.5cm inner foreskin, the operator install the outer ring over the foreskin and combine them together. Removal of excess foreskin is then performed upon the device.
circumcision with Shenghuan in Peng's methodProcedure or surgery
The foreskin is first separated from the glans. Then the inner ring is placed on the outer layer of foreskin. Next, the rim of the foreskin is clamped with blood vessel forceps at the 3, 6, 9 and 12 o'clock points. An urologist and an assistant each hold two clamps to widen the opening of the foreskin, and pull it over the inner ring. After the inner and outer layers of the foreskin and the frenulum are symmetrically positioned, the assistant install the outer ring over the foreskin and gently combine it together. Removal of excess foreskin is then performed below the device.
conventional method with incisionProcedure or surgery
The procedure of conventional circumcision involve transection of the excess foreskin with reservation of 0.5cm inner foreskin, haemostasis by electrocautery and suture of skin edges with 4-0 absorption sutures.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Not described Receives: Procedure: circumcision with Shenghuan in Yan's method |
| Group II | Active comparator | Not described Receives: Procedure: circumcision with Shenghuan in Peng's method |
| Group III | Active comparator | Not described Receives: Procedure: conventional method with incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
Measured: within operation
Secondary outcomes (1)
pain score
Measured: within operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJun 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Pan, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477593
- Sponsor's protocol ID
- NMU-124
- Status last verified
- Apr 2013
- First submitted
- 18 Nov 2011
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT01477593
- Acronym / sponsor ID
- NMU-124
- Conditions
- Circumcision
- Keywords
- circumcision, chinese children, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Feng PanUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide. Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually, more and more Chinese male are willing to undergo it with themselves and their sons. But there are also some complications with circumcision, such as pain, edema, infection, and hemorrhage. Considering of that, physicians continually manage to improve their surgical methods and analgesic techniques.
In the study of Peng, a disposable minimally invasive circumcision anastomosis device named Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was introduced to be applied in circumcision. And they concluded that method was quicker, safer and less pain than the conventional techniques of incision. In present study, we carry out a randomized controlled trail, using a different method as Peng introduced with this device in children's circumcision (Yan's), compared with the method as Peng used and the conventional technique in our hospital, and then observe the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: circumcision with Shenghuan in Yan's method |
| Group II | Active comparator | Procedure: circumcision with Shenghuan in Peng's method |
| Group III | Active comparator | Procedure: conventional method with incision |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with phimosis or redundant prepuce
Key exclusion criteria (4 listed)
- Children with genital tract infection or deformity,
- congenital diseases,
- hematological diseases,
- or other general diseases
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 |
|---|---|---|
| circumcision with Shenghuan in Yan's methodThe foreskin is first separated from the glans.Then the inner ring is placed between them and over the glans. After adjusting the position of inner ring to retain 0.5cm inner foreskin, the operator install the outer ring over the foreskin and combine them together. Removal of excess foreskin is then performed upon the device. | Procedure or surgery | Group I |
| circumcision with Shenghuan in Peng's methodThe foreskin is first separated from the glans. Then the inner ring is placed on the outer layer of foreskin. Next, the rim of the foreskin is clamped with blood vessel forceps at the 3, 6, 9 and 12 o'clock points. An urologist and an assistant each hold two clamps to widen the opening of the foreskin, and pull it over the inner ring. After the inner and outer layers of the foreskin and the frenulum are symmetrically positioned, the assistant install the outer ring over the foreskin and gently combine it together. Removal of excess foreskin is then performed below the device. | Procedure or surgery | Group II |
| conventional method with incisionThe procedure of conventional circumcision involve transection of the excess foreskin with reservation of 0.5cm inner foreskin, haemostasis by electrocautery and suture of skin edges with 4-0 absorption sutures. | Procedure or surgery | Group III |
Primary outcome
operation time
Time frame: within operation
1 secondary outcome
pain score
Time frame: within operation
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 10 Apr 2013.
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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 Phase 4 study testing circumcision with Shenghuan in Yan's method, circumcision with Shenghuan in Peng's method and conventional method with incision in people with Circumcision, run by Feng Pan.
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 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 10 Apr 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
operation time (time frame: within operation). 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 10 Apr 2013.