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

Phase 4

Completed

• Conditions: Circumcision
• Interventions: Procedure: circumcision with Shenghuan in Peng's method; Procedure: conventional method with incision; Procedure: circumcision with Shenghuan in Yan's method

• Registration Number: NCT01477593
• Lead Sponsor: Feng Pan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	circumcision with Shenghuan in Peng's method	-
Group III	conventional method with incision	-
Group I	circumcision with Shenghuan in Yan's method	-

Primary Outcome Measures

Name	Time	Method
operation time	within operation

Secondary Outcome Measures

Name	Time	Method
pain score	within operation