NCT02481492

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: Male
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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

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

Interventions

Type	Name	Description
DEVICE	No flip technique of Shang Ring circumcision	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.
DEVICE	Flip technique of Shang Ring circumcision	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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-06-25
• Last updated: 2017-01-24

Locations

2 sites across 1 country: China