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

Feng Pan

Status and phase: Completed; Phase 4

Conditions: Circumcision

Treatments: Procedure: circumcision with Shenghuan in Yan's method; Procedure: circumcision with Shenghuan in Peng's method; Procedure: conventional method with incision

Study type: Interventional

Funder types: Other

Identifiers

NCT01477593

NMU-124

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Male

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Group I

Experimental group

Treatment:

Procedure: circumcision with Shenghuan in Yan's method

Group II

Active Comparator group

Treatment:

Procedure: circumcision with Shenghuan in Peng's method

Group III

Active Comparator group

Treatment:

Procedure: conventional method with incision