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

NCT01477593 | Completed Phase 4 DMC

• 1 other identifier: NMU-124
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Circumcision

Keywords

circumcision, chinese children, pain

Outcome Measures

Primary Outcomes (1)

• operation time

  within operation

Secondary Outcomes (1)

• pain score

  within operation

Study Arms (3)

Group I

EXPERIMENTAL

Procedure: circumcision with Shenghuan in Yan's method

Group II

ACTIVE COMPARATOR

Procedure: circumcision with Shenghuan in Peng's method

Group III

ACTIVE COMPARATOR

Procedure: conventional method with incision

Interventions

circumcision with Shenghuan in Yan's method PROCEDURE

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.

Group I

circumcision with Shenghuan in Peng's method PROCEDURE

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.

Group II

conventional method with incision PROCEDURE

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.

Group III

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with phimosis or redundant prepuce

You may not qualify if:

• Children with genital tract infection or deformity,
• congenital diseases,
• hematological diseases,
• or other general diseases

Sponsors & Collaborators

• Feng Pan: lead

MeSH Terms

Conditions

Pain

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Attending Doctor

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: November 22, 2011
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 10, 2013

Record last verified: 2013-04