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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481492
• Other study ID #: NBDYYY2015001
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: January 20, 2017
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Ningbo NO.1 hospital	Ningbo	Zhejiang
China	The Affiliated Hospital of Medical College, Ningbo University	Ningbo	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital	The Affiliated Hospital of Medical College, Ningbo University

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

Cheng Y, Peng YF, Liu YD, Tian L, Lü 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Retraction in: J Urol. 2012 Dec;188(6):2443. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse events	The adverse events such as edema, wound infection, bleeding, unsymmetrical foreskin, wound dehiscence will be recorded.	3 months
Secondary	Time to complete healing	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

External Links

•   Shang Ring home page
•   WHO list of prequalified male circumcision devices