Human Immunodeficiency VirusNCT02481492

Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique

A study testing No flip technique of Shang Ring circumcision and Flip technique of Shang Ring circumcision in people with Human Immunodeficiency Virus, run by Ningbo No. 1 Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision. Read more about this study

Who is it for?: Ages 7 to 12 years, men onlyHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: No flip technique of Shang Ring circumcision and Flip technique of Shang Ring circumcision
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesChina
Study dates: Jun 2015to Dec 2015
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 7 to 12 years
Men only
Healthy volunteers accepted
Child

Who may be able to join

Aged between 7 years and 12 years(inclusive);
Must be accompanied by the parent or legally acceptable representative (LAR), who freely agrees with participation of the child into the study;
Must tolerate local anesthesia;
Must be in good general health;
Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
Parent or LAR must agree the study staff to take photos during operation or follow-up if necessary, and
Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information

Who cannot join

Has a known allergy or sensitivity to lidocaine or other local anesthesia;
Takes a medication that would be a contraindication for elective surgery (e.g anticoagulant , steroid);
Has known bleeding/clotting disorder (e.g. hemophilia);
Has an active genital infection, anatomic abnormality or other condition(e.g. concealed penis, hypospadias, epispadia, micropenis);
Is currently participating in another biomedical research study; or
Participants under other condition (e.g. severe obesity, diabetes or sickle cell anemia) should be excluded from this study in the opinion of the surgeon.

Trial locations and contacts

2 sites in 1 country.

China2 sites

The Affiliated Hospital of Medical College, Ningbo University
Ningbo, Zhejiang, 315000
Ningbo NO.1 hospital
Ningbo, Zhejiang, 315010

Other trials in China

About this study

This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

Read the detailed description

The boys between 7 and 12 years old seeking for circumcision in The Affiliated Hospital of Medicine School of Ningbo University will be evaluated. Those who match the inclusion criteria and without exclusion criteria will be recruited.

The investigators will perform randomization preoperatively. participants were distributed into No Flip Group and Flip Group correspondingly according to a table of random number.

All of the procedures will be performed by a specific study surgeon in the hospital operation room. An assistant will take the pictures and recorder the parameters needed. In both groups, participants will be measured twice by a scale plate of holes, the diameter of penis with the foreskin noneverted and the diameter of exposed glans. Local anesthesia will be administered to the dorsal penile nerve using 2% lidocaine. The operation will not begin until the anesthesia is satisfied. The proper ring will be chosen according to different strategies of two groups. Participants will stay in hospital for 24 hours after operation. Pain during operation, half a hour post-operation and 24 hours will be evaluated, adverse events at hospital will be recorded carefully as well.

Participants will be advised to return usually at 7th, 14th, 21st, 28th and 90th post-operative days. However, if the wound does not heal completely 28 days post-operatively, the participant will be asked come to visit weekly until complete healing. All of the assessments will be performed and recorded by the lead investigator.

Conditions: Human Immunodeficiency Virus
Being tested: No flip technique of Shang Ring circumcision, Flip technique of Shang Ring circumcision
Keywords: Circumcision, Male, Shang Ring, Children, Foreskin
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No flip technique of Shang Ring circumcisionDevice
Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the glands, inner ring is placed into foreskin cavity, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Ring is detached spontaneously.
Flip technique of Shang Ring circumcisionDevice
Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the penis, inner ring is placed around the penis, flip foreskin over the inner ring, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Remove the ring 7days postoperatively.

Study groups in NCT02481492
Study group	Role	What they receive
No flip technique	Experimental	One group of boys will undergo a circumcision with no flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will detach spontaneously without intervention, and the participants are asked to have a visit soon after ring detached. The last scheduled follow-up visit is at 90 days. Receives: Device: No flip technique of Shang Ring circumcision
Flip technique	Experimental	One group of boys will undergo a circumcision with flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 90 days. Receives: Device: Flip technique of Shang Ring circumcision

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain score on the Visual Analog Scale
The pain during and after the two circumcision methods will be compared. Visual Analogue Scale(VAS) will be used to evaluate the pain during operation, 30min post-operatively, 24h post-operatively, ring detachment and during the recovery period.
Measured: 28 days
Adverse events
The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded.
Measured: 3 months

Secondary outcomes (1)

Time to complete healing
The healing time will be observe by study primary investigator. The usually following time is once a week during the first month and then 3 months later. However, if the wound does not heal completely 28 days post-operatively, the participant will be asked come to visit weekly until complete healing.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Dec 2015

First posted25 Jun 2015 (estimated)
Study startJun 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies 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: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02481492
Sponsor's protocol ID: NBDYYY2015001
Status last verified: Jan 2017
First submitted: 22 Jun 2015
Last updated: 24 Jan 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yue C, Ze-Jun Y, Wu KR, Su XJ, Hu JS, Ma JW, Guo CM, Fang HW, Su R, Zhang Y, Zhang QH. A randomized clinical study of circumcision with a ring device versus conventional circumcision. J Urol. 2012 Nov;188(5):1849-54. doi: 10.1016/j.juro.2012.07.048. Epub 2012 Sep 19.
PubMed 22999700
Cheng Y, Peng YF, Liu YD, Tian L, Lu NQ, Su XJ, Yan ZJ, Hu JS, Lee R, Kim HH, Sokal DC, Li PS. [A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China]. Zhonghua Nan Ke Xue. 2009 Jul;15(7):584-92. Chinese.
PubMed 19694369
Yan B, You H, Zhang K, Tang HY, Mao W, He GH, Yin ZG. [Circumcision with the Chinese Shang Ring in children: outcomes of 824 cases]. Zhonghua Nan Ke Xue. 2010 Mar;16(3):250-3. Chinese.
PubMed 20369555
Barone MA, Awori QD, Li PS, Simba RO, Weaver MA, Okech JO, Aduda AO, Cherutich P, Muraguri N, Wekesa JM, Nyanchoka J, Perchal P, Masson P, Lee R, Goldstein M, Kioko J, Lusi O, Sokal DC. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):e82-9. doi: 10.1097/QAI.0b013e31824ea1f2.
PubMed 22343180
Masson P, Li PS, Barone MA, Goldstein M. The ShangRing device for simplified adult circumcision. Nat Rev Urol. 2010 Nov;7(11):638-42. doi: 10.1038/nrurol.2010.167. Epub 2010 Oct 12.
PubMed 20938437
Cheng Y, Wu K, Yan Z, Yang S, Li F, Su X. Long-term follow-up for Shang Ring male circumcision. Chin Med J (Engl). 2014;127(10):1879-83.
PubMed 24824249
Cheng Y, Wu K, Yan Z, Guo C, Ma J, Su X, Yang S. How to choose appropriate ring size for Shang Ring male circumcision. J Acquir Immune Defic Syndr. 2012 Dec 15;61(5):606-9. doi: 10.1097/QAI.0b013e318273aec9.
PubMed 23018373
Pan L, Zhang A, Shen R, Wang Z. Acceptability of early infant male circumcision among Chinese parents: strategy implications of HIV prevention for China. BMC Public Health. 2012 Sep 4;12:738. doi: 10.1186/1471-2458-12-738.
PubMed 22946988
Peng YF, Cheng Y, Wang GY, Wang SQ, Jia C, Yang BH, Zhu R, Jian SC, Li QW, Geng DW. Clinical application of a new device for minimally invasive circumcision. Asian J Androl. 2008 May;10(3):447-54. doi: 10.1111/j.1745-7262.2008.00411.x.
PubMed 18385906
Wu X, Wang Y, Zheng J, Shen W, Yan JA, Ji H, Li X, Zhang H, Zhou Z. A report of 918 cases of circumcision with the Shang Ring: comparison between children and adults. Urology. 2013 May;81(5):1058-63. doi: 10.1016/j.urology.2012.11.046. Epub 2013 Mar 7.
PubMed 23465168

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique
ClinicalTrials.gov ID: NCT02481492
Acronym / sponsor ID: NBDYYY2015001
Conditions: Human Immunodeficiency Virus
Keywords: Circumcision, Male, Shang Ring, Children, Foreskin
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Ningbo No. 1 HospitalUniversity, hospital or other
Collaborators: The Affiliated Hospital of Medical College, Ningbo University
Study start: Jun 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 25 Jun 2015 (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.

This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

Detailed description

The investigators will perform randomization preoperatively. participants were distributed into No Flip Group and Flip Group correspondingly according to a table of random number.

Study design

Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No flip technique	Experimental	Device: No flip technique of Shang Ring circumcisionOne group of boys will undergo a circumcision with no flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will detach spontaneously without intervention, and the participants are asked to have a visit soon after ring detached. The last scheduled follow-up visit is at 90 days.
Flip technique	Experimental	Device: Flip technique of Shang Ring circumcisionOne group of boys will undergo a circumcision with flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 90 days.

Who may qualify

Ages: 7 to 12 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Aged between 7 years and 12 years(inclusive);
Must be accompanied by the parent or legally acceptable representative (LAR), who freely agrees with participation of the child into the study;
Must tolerate local anesthesia;
Must be in good general health;
Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;

Key exclusion criteria (6 listed)

Has a known allergy or sensitivity to lidocaine or other local anesthesia;
Takes a medication that would be a contraindication for elective surgery (e.g anticoagulant , steroid);
Has known bleeding/clotting disorder (e.g. hemophilia);
Has an active genital infection, anatomic abnormality or other condition(e.g. concealed penis, hypospadias, epispadia, micropenis);
Is currently participating in another biomedical research study; or

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
No flip technique of Shang Ring circumcisionMeasure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the glands, inner ring is placed into foreskin cavity, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Ring is detached spontaneously.	Device	No flip technique
Flip technique of Shang Ring circumcisionMeasure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the penis, inner ring is placed around the penis, flip foreskin over the inner ring, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Remove the ring 7days postoperatively.	Device	Flip technique

Primary outcome

Pain score on the Visual Analog Scale
Time frame: 28 days
The pain during and after the two circumcision methods will be compared. Visual Analogue Scale(VAS) will be used to evaluate the pain during operation, 30min post-operatively, 24h post-operatively, ring detachment and during the recovery period.
Adverse events
Time frame: 3 months
The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded.

1 secondary outcome

Time to complete healing
Time frame: 3 months

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 24 Jan 2017.
Background: PubMed 22999700Yue C, Ze-Jun Y, Wu KR, Su XJ, Hu JS, Ma JW, Guo CM, Fang HW, Su R, Zhang Y, Zhang QH. A randomized clinical study of circumcision with a ring device versus conventional circumcision. J Urol. 2012 Nov;188(5):1849-54. doi: 10.1016/j.juro.2012.07.048. Epub 2012 Sep 19.
Background: PubMed 19694369Cheng Y, Peng YF, Liu YD, Tian L, Lu NQ, Su XJ, Yan ZJ, Hu JS, Lee R, Kim HH, Sokal DC, Li PS. [A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China]. Zhonghua Nan Ke Xue. 2009 Jul;15(7):584-92. Chinese.
Background: PubMed 20369555Yan B, You H, Zhang K, Tang HY, Mao W, He GH, Yin ZG. [Circumcision with the Chinese Shang Ring in children: outcomes of 824 cases]. Zhonghua Nan Ke Xue. 2010 Mar;16(3):250-3. Chinese.
Background: PubMed 22343180Barone MA, Awori QD, Li PS, Simba RO, Weaver MA, Okech JO, Aduda AO, Cherutich P, Muraguri N, Wekesa JM, Nyanchoka J, Perchal P, Masson P, Lee R, Goldstein M, Kioko J, Lusi O, Sokal DC. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):e82-9. doi: 10.1097/QAI.0b013e31824ea1f2.
Background: PubMed 20938437Masson P, Li PS, Barone MA, Goldstein M. The ShangRing device for simplified adult circumcision. Nat Rev Urol. 2010 Nov;7(11):638-42. doi: 10.1038/nrurol.2010.167. Epub 2010 Oct 12.
Background: PubMed 24824249Cheng Y, Wu K, Yan Z, Yang S, Li F, Su X. Long-term follow-up for Shang Ring male circumcision. Chin Med J (Engl). 2014;127(10):1879-83.
Background: PubMed 23018373Cheng Y, Wu K, Yan Z, Guo C, Ma J, Su X, Yang S. How to choose appropriate ring size for Shang Ring male circumcision. J Acquir Immune Defic Syndr. 2012 Dec 15;61(5):606-9. doi: 10.1097/QAI.0b013e318273aec9.
Background: PubMed 22946988Pan L, Zhang A, Shen R, Wang Z. Acceptability of early infant male circumcision among Chinese parents: strategy implications of HIV prevention for China. BMC Public Health. 2012 Sep 4;12:738. doi: 10.1186/1471-2458-12-738.
Background: PubMed 18385906Peng YF, Cheng Y, Wang GY, Wang SQ, Jia C, Yang BH, Zhu R, Jian SC, Li QW, Geng DW. Clinical application of a new device for minimally invasive circumcision. Asian J Androl. 2008 May;10(3):447-54. doi: 10.1111/j.1745-7262.2008.00411.x.
Background: PubMed 23465168Wu X, Wang Y, Zheng J, Shen W, Yan JA, Ji H, Li X, Zhang H, Zhou Z. A report of 918 cases of circumcision with the Shang Ring: comparison between children and adults. Urology. 2013 May;81(5):1058-63. doi: 10.1016/j.urology.2012.11.046. Epub 2013 Mar 7.
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.

Yue Cheng, MD principal investigator

Ningbo No. 1 Hospital

Jianhua He, MD study director

The Affiliated Hospital of Medical College, Ningbo University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 6 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Pain score on the Visual Analog Scale (time frame: 28 days). 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?

On the ClinicalTrials.gov record for NCT02481492, which also lists 10 linked publications.

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 24 Jan 2017.