A Phase 4 interventional study of circumcision with Shenghuan in Yan's method and circumcision with Shenghuan in Peng's method in Circumcision, sponsored by Feng Pan. Completed. Open to male participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2013-04-10.
Sponsored by Feng Pan · Phase 4, Interventional, and Treatment
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.
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This study's enrollment of 120 is above the median of 66 across 8,493 interventional studies indexed under Pain.
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Procedure: circumcision with Shenghuan in Yan's method
Procedure: circumcision with Shenghuan in Peng's method
Procedure: conventional method with incision
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.
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.
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.
operation time
Time frame: within operation
pain score
Time frame: within operation
No study locations are listed for this record.
The record gives a start of Jul 2009, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Feng Pan