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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Feng Pan, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT01477593

First received: November 18, 2011

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Circumcision	Procedure: circumcision with Shenghuan in Yan's method Procedure: circumcision with Shenghuan in Peng's method Procedure: conventional method with incision	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Circumcision

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

operation time [ Time Frame: within operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pain score [ Time Frame: within operation ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	July 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group I	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.
Active Comparator: Group II	Procedure: 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.
Active Comparator: Group III	Procedure: 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.

Eligibility

Ages Eligible for Study:	3 Years to 11 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Feng Pan, Clinical Attending Doctor, Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT01477593 History of Changes
Other Study ID Numbers:	NMU-124
Study First Received:	November 18, 2011
Last Updated:	April 8, 2013
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

circumcision, chinese children, pain

ClinicalTrials.gov processed this record on May 22, 2013

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