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

NCT02481492 | Completed DMC

• 1 other identifier: NBDYYY2015001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

Conditions

Human Immunodeficiency Virus

Keywords

Circumcision, Male; Shang Ring; Children; Foreskin

Outcome Measures

Primary Outcomes (2)

• Pain score on the Visual Analog Scale

  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

  The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded.

  3 months

Secondary Outcomes (1)

• Time to complete healing

  3 months

Study Arms (2)

No flip technique

EXPERIMENTAL

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

Flip technique

EXPERIMENTAL

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

Interventions

No flip technique of Shang Ring circumcision DEVICE

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.

No flip technique

Flip technique of Shang Ring circumcision DEVICE

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.

Flip technique

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead
• The Affiliated Hospital of Medical College, Ningbo University: collaborator

Study Sites (2)

The Affiliated Hospital of Medical College, Ningbo University

Ningbo, Zhejiang, 315000, China

Location

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

Related Publications (10)

• Yue C, Ze-Jun Y, Wu KR, Su XJ, Hu JS, Ma JW, Guo CM, Fang HW, Su R, Zhang Y, Zhang QH. A randomized clinical study of circumcision with a ring device versus conventional circumcision. J Urol. 2012 Nov;188(5):1849-54. doi: 10.1016/j.juro.2012.07.048. Epub 2012 Sep 19.

  PMID: 22999700 BACKGROUND

• Cheng Y, Peng YF, Liu YD, Tian L, Lu NQ, Su XJ, Yan ZJ, Hu JS, Lee R, Kim HH, Sokal DC, Li PS. [A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China]. Zhonghua Nan Ke Xue. 2009 Jul;15(7):584-92. Chinese.

  PMID: 19694369 BACKGROUND

• Yan B, You H, Zhang K, Tang HY, Mao W, He GH, Yin ZG. [Circumcision with the Chinese Shang Ring in children: outcomes of 824 cases]. Zhonghua Nan Ke Xue. 2010 Mar;16(3):250-3. Chinese.

  PMID: 20369555 BACKGROUND

• Barone MA, Awori QD, Li PS, Simba RO, Weaver MA, Okech JO, Aduda AO, Cherutich P, Muraguri N, Wekesa JM, Nyanchoka J, Perchal P, Masson P, Lee R, Goldstein M, Kioko J, Lusi O, Sokal DC. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment. J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):e82-9. doi: 10.1097/QAI.0b013e31824ea1f2.

  PMID: 22343180 BACKGROUND

• Masson P, Li PS, Barone MA, Goldstein M. The ShangRing device for simplified adult circumcision. Nat Rev Urol. 2010 Nov;7(11):638-42. doi: 10.1038/nrurol.2010.167. Epub 2010 Oct 12.

  PMID: 20938437 BACKGROUND

• Cheng Y, Wu K, Yan Z, Yang S, Li F, Su X. Long-term follow-up for Shang Ring male circumcision. Chin Med J (Engl). 2014;127(10):1879-83.

  PMID: 24824249 BACKGROUND

• Cheng Y, Wu K, Yan Z, Guo C, Ma J, Su X, Yang S. How to choose appropriate ring size for Shang Ring male circumcision. J Acquir Immune Defic Syndr. 2012 Dec 15;61(5):606-9. doi: 10.1097/QAI.0b013e318273aec9.

  PMID: 23018373 BACKGROUND

• Pan L, Zhang A, Shen R, Wang Z. Acceptability of early infant male circumcision among Chinese parents: strategy implications of HIV prevention for China. BMC Public Health. 2012 Sep 4;12:738. doi: 10.1186/1471-2458-12-738.

  PMID: 22946988 BACKGROUND

• Peng YF, Cheng Y, Wang GY, Wang SQ, Jia C, Yang BH, Zhu R, Jian SC, Li QW, Geng DW. Clinical application of a new device for minimally invasive circumcision. Asian J Androl. 2008 May;10(3):447-54. doi: 10.1111/j.1745-7262.2008.00411.x.

  PMID: 18385906 BACKGROUND

• Wu X, Wang Y, Zheng J, Shen W, Yan JA, Ji H, Li X, Zhang H, Zhou Z. A report of 918 cases of circumcision with the Shang Ring: comparison between children and adults. Urology. 2013 May;81(5):1058-63. doi: 10.1016/j.urology.2012.11.046. Epub 2013 Mar 7.

  PMID: 23465168 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Yue Cheng, MD

  Ningbo No. 1 Hospital

  PRINCIPAL INVESTIGATOR

• Jianhua He, MD

  The Affiliated Hospital of Medical College, Ningbo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)