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

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

Detailed Description
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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.

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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Device: No flip technique of Shang Ring circumcision
* Device: Flip technique of Shang Ring circumcision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No flip technique<br>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. | Device: No flip technique of Shang Ring circumcision<br>* 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.<br>|
| Experimental: Flip technique<br>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. | Device: Flip technique of Shang Ring circumcision<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 
| Adverse events | The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circumcision, Male, Shang Ring, Children, Foreskin