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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481492
First Posted: June 25, 2015
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Affiliated Hospital of Medical College, Ningbo University
Information provided by (Responsible Party):
Li Fang, Ningbo No. 1 Hospital
  Purpose
This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

Condition Intervention
Human Immunodeficiency Virus Device: No flip technique of Shang Ring circumcision Device: Flip technique of Shang Ring circumcision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique

Further study details as provided by Li Fang, Ningbo No. 1 Hospital:

Primary Outcome Measures:
  • 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.

  • Adverse events [ Time Frame: 3 months ]
    The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded.


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: June 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481492


Locations
China, Zhejiang
The Affiliated Hospital of Medical College, Ningbo University
Ningbo, Zhejiang, China, 315000
Ningbo NO.1 hospital
Ningbo, Zhejiang, China, 315010
Sponsors and Collaborators
Ningbo No. 1 Hospital
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
  More Information

Additional Information:
Publications:

Responsible Party: Li Fang, M.D., Ningbo No. 1 Hospital
ClinicalTrials.gov Identifier: NCT02481492     History of Changes
Other Study ID Numbers: NBDYYY2015001
First Submitted: June 22, 2015
First Posted: June 25, 2015
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li Fang, Ningbo No. 1 Hospital:
Circumcision, Male
Shang Ring
Children
Foreskin

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases