Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique

January 20, 2017 updated by: Li Fang, Ningbo No. 1 Hospital
This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The boys between 7 and 12 years old seeking for circumcision in The Affiliated Hospital of Medicine School of Ningbo University will be evaluated. Those who match the inclusion criteria and without exclusion criteria will be recruited.

The investigators will perform randomization preoperatively. participants were distributed into No Flip Group and Flip Group correspondingly according to a table of random number.

All of the procedures will be performed by a specific study surgeon in the hospital operation room. An assistant will take the pictures and recorder the parameters needed. In both groups, participants will be measured twice by a scale plate of holes, the diameter of penis with the foreskin noneverted and the diameter of exposed glans. Local anesthesia will be administered to the dorsal penile nerve using 2% lidocaine. The operation will not begin until the anesthesia is satisfied. The proper ring will be chosen according to different strategies of two groups. Participants will stay in hospital for 24 hours after operation. Pain during operation, half a hour post-operation and 24 hours will be evaluated, adverse events at hospital will be recorded carefully as well.

Participants will be advised to return usually at 7th, 14th, 21st, 28th and 90th post-operative days. However, if the wound does not heal completely 28 days post-operatively, the participant will be asked come to visit weekly until complete healing. All of the assessments will be performed and recorded by the lead investigator.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Ningbo NO.1 hospital
      • Ningbo, Zhejiang, China, 315000
        • The Affiliated Hospital of Medical College, Ningbo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Aged between 7 years and 12 years(inclusive);
  • Must be accompanied by the parent or legally acceptable representative (LAR), who freely agrees with participation of the child into the study;
  • Must tolerate local anesthesia;
  • Must be in good general health;
  • Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
  • Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
  • Parent or LAR must agree the study staff to take photos during operation or follow-up if necessary, and
  • Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information

Exclusion Criteria:

  • Has a known allergy or sensitivity to lidocaine or other local anesthesia;
  • Takes a medication that would be a contraindication for elective surgery (e.g anticoagulant , steroid);
  • Has known bleeding/clotting disorder (e.g. hemophilia);
  • Has an active genital infection, anatomic abnormality or other condition(e.g. concealed penis, hypospadias, epispadia, micropenis);
  • Is currently participating in another biomedical research study; or
  • Participants under other condition (e.g. severe obesity, diabetes or sickle cell anemia) should be excluded from this study in the opinion of the surgeon.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No flip technique
One group of boys will undergo a circumcision with no flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will detach spontaneously without intervention, and the participants are asked to have a visit soon after ring detached. The last scheduled follow-up visit is at 90 days.
Device: No flip technique of Shang Ring circumcision
Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the glands, inner ring is placed into foreskin cavity, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Ring is detached spontaneously.
Experimental: Flip technique
One group of boys will undergo a circumcision with flip technique of Shang Ring Circumcision and receive regular follow-up to evaluate pain, operation associated adverse events, wound healing time. The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 90 days.
Device: Flip technique of Shang Ring circumcision
Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the penis, inner ring is placed around the penis, flip foreskin over the inner ring, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Remove the ring 7days postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score on the Visual Analog Scale
Time Frame: 28 days
The pain during and after the two circumcision methods will be compared. Visual Analogue Scale(VAS) will be used to evaluate the pain during operation, 30min post-operatively, 24h post-operatively, ring detachment and during the recovery period.
28 days
Adverse events
Time Frame: 3 months
The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete healing
Time Frame: 3 months
The healing time will be observe by study primary investigator. The usually following time is once a week during the first month and then 3 months later. However, if the wound does not heal completely 28 days post-operatively, the participant will be asked come to visit weekly until complete healing.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Collaborators

The Affiliated Hospital of Medical College, Ningbo University

Investigators

  • Principal Investigator: Yue Cheng, MD, Ningbo No. 1 Hospital
  • Study Director: Jianhua He, MD, The Affiliated Hospital of Medical College, Ningbo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBDYYY2015001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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