Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail

Circumcision Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477593
• Other study ID #: NMU-124
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2011
• Last updated: April 8, 2013
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 11 Years

Eligibility

Inclusion Criteria:

• Children with phimosis or redundant prepuce

Exclusion Criteria:

• Children with genital tract infection or deformity,

• congenital diseases,

• hematological diseases,

• or other general diseases

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Circumcision

Intervention

Procedure:
• circumcision with Shenghuan in Yan's method
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 method
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 incision
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Feng Pan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time		within operation	Yes
Secondary	pain score		within operation	Yes