Cheng, Yue MD; Wu, Kerong PhD; Yan, Zejun MD; Guo, Chuanmin MS; Ma, Jianwei MS; Su, Xinjun PhD; Yang, Shuwei MS
Male circumcision (MC) is a surgical procedure that has been performed over centuries.1 The benefits of circumcision include reduced risk of penile cancer and improved penile topical hygiene.2 In addition, 3 randomized controlled trials in Africa demonstrated that MC reduces the risk of men acquiring HIV by approximately 60%.3–5
Various devices for adult MC were developed to improve efficiency of the circumcision procedure.6,7 Shang Ring has been introduced from hospitals in the Chinese mainland.8 It has been demonstrated that the Shang Ring MC is a safe and efficient procedure, with short operative time (5–8 minutes) and a low complication rate.8–11 Patients undergoing Shang Ring MC also respond with high acceptability.12 It may greatly facilitate adult circumcision procedures and thus be valuable to popularize in countries, especially in those with far below International Standard, socioeconomic conditions.13
Shang Ring is manufactured by Wuhu Snnda Medical Treatment Appliance Technology Co, Ltd, Wuhu City, China. The Shang Ring consists of 2 concentric plastic rings, the inner ring and the outer ring (Fig. 1). These rings are positioned to sandwich the foreskin of the penis—allowing it to be excised without stitches or significant bleeding—and are then left in place for 7–10 days before being removed.
Rings are commercially available in 13 sizes to matchup penile circumference at the coronal sulcus level: A2 (40 mm), A1 (37 mm), A (34 mm), B (32 mm), C (30 mm), D (28 mm), E (26 mm), F (24 mm), G (22 mm), H (20 mm), I (18 mm), J (16 mm), and K (13 mm). The correct Shang Ring size is ascertained using a measuring tape (provided in the Shang Ring Package) wound around the coronal sulcus of the penis (Fig. 1). In daily practice, however, it is common that a patient falls between 2 sizes thus the patient did not fit an available ring size, leading to discrepancy over how to choose the appropriate ring size. Whether it is better to choose a smaller or a larger ring remains unclear.
Appropriate sizing of the device is believed to minimize the risk of the surgery and of discomfort to the patient. Thus, this study was conducted to investigate how to make the ring choosing strategy when a patient falls between 2 available sizes. To the best of our knowledge, no evidence-based data has been declared on this field previously.
Patients and Material
A randomized, controlled, clinical trial was carried out in Ningbo First Hospital. This study was approved by the ethical committee of Ningbo University (approval no. 2006-98) and each patient participated after providing informed consent. The criteria for the participants were as follows: to wish to be circumcised and the size measured fell between 2 sizes. The exclusion criteria included: erectile dysfunction; diabetes; and contraindications to MC, such as concealed penis, acute posthitis, acute balanitis, or sexually transmitted diseases. Patients were distributed to any one group based on their randomization result generated by computer. From December 2011 to February 2012, a total of 74 patients were recruited in this study.
The circumcisions were performed by urologists in our hospital. The correct Shang Ring size is ascertained using a measuring tape wound around the coronal sulcus of the penis. The larger size or the smaller size of ring was chosen based on the randomization. The MC procedure was standardized according to the standard procedure.10 All surgeries were performed under local anesthesia (lidocaine 2%), which involved a dorsal penile nerve block with a ring block. The removal procedure was done on the 8th postoperative day in accord with the standard procedure.10
Measurement During the Surgery
Operative time, pain score, and intraoperative blood loss were measured during the surgery. Operative time was measured from when the effects of the local anesthesia took hold until the end of surgery. Pain score was defined through internationally accepted visual analog scale (VAS) in and after the surgery. Intraoperative blood loss was estimated as follows: a completely soaked 5 cm × 5 cm gauze had an average carrying capacity of 3.25 mL blood.14
Follow-Up and Data Collection
Patients were followed up until the wound was healed completely. According to manufacturer's recommendations, there is only one required follow-up visit for patients undergoing this procedure. In this study, for better observation of recovery, the patients were recommended to come back on the first, eighth, 14th, 21st, and 28th days postoperatively. In addition, investigators also made phone calls to each participant every other day, inquiring the condition of the wound.
For the initial 3 follow-ups, the wound was aseptically dressed. Postoperative pain was defied as pain during the first to seventh nights (because patients usually felt pain when erection happened) and judged through VAS. The manufacturer's recommendation for ring removal is 7 days. We chose the eighth postoperative day for ring removal based on our experience that bleeding occurred occasionally if the ring was removed within 7 days, whereas discomfort increased if patients wore the ring for more than 8 days. Pain score during ring removal was also judged through VAS.
Postoperative complications were evaluated and recorded at each follow-up. Wound healing time was measured from the date of surgery to the date when the surgical wound was completely healed. The condition of complete healing was confirmed by urologists when patients came back for follow-up or through home visits if the patients were unable to return to the point of procedure.
t-Test was used to compare operative duration, blood loss volume, removal duration, and healing duration between 2 groups. We used the nonparametric Mann–Whitney test to compare pain scores. χ2 Test was used to compare dorsal slit, complication occurrences between the 2 groups. All the statistical analyses were performed using a statistical software package (SPSS, Version 16.0). Statistical significance was defined as P value <0.05. All P values were 2-sided.
A total of 39 patients were assigned to the smaller ring group and 35 patients to the larger ring group. Phimosis was observed in 1 (2.56%) of 39 patients of the smaller ring group and 1 (2.86%) of 35 patients of the larger ring group (P = 1.000). There was also no statistical difference in age, marriage status, education level, job condition, alcohol drinking, and cigarette smoking between the 2 groups preoperatively.
During the surgery, dorsal slit was made when the foreskin was too difficult to evert with the presence of phimosis or a relative tight foreskin opening. As showed in Table 1, 12.8% (5/39) of cases in the smaller ring group underwent dorsal slit, compared with 20.0% (7/35) in the larger ring group (P = 0.430). The mean operative duration was 6.7 ± 1.4 minutes with the smaller ring group and 7.5 ± 1.9 minutes with the larger ring group (P = 0.035). There was less blood loss in smaller ring group than in the larger ring group (1.1 ± 0.8 mL and 1.6 ± 0.7 mL, respectively, P = 0.014).
The complications included edema, wound dehiscence, bleeding, and infection. There was no significant difference between the 2 groups (P = 0.292 for edema, 0.600 for wound dehiscence, 1.000 for bleeding, and 0.473 for infection, respectively). No significant complication such as necrosis of glans was observed. All complications were well treated. Suturing was not performed to deal with wound dehiscence, for those happened in our study were not severe (less than 1 cm) and could be healed spontaneously. Edema was the most common noted complication. However, it could be conservatively managed, as it would slowly disappear with time. Infection was controlled by orally taken antibiotics (levofloxacin). When the bleeding happened, a second surgery with suturing was performed.
Pain was divided and evaluated as intraoperative pain, postoperative pain, and pain during removal. The 2 groups showed no statistical difference regarding pain scores (P = 0.103 for intraoperative pain, 0.648 for postoperative pain, and 0.663 for pain during removal, respectively).
In addition, the ring removal duration of the smaller ring group was 74.6 ± 18.9 seconds, compared with that of the larger ring group 96.3 ± 21.5 seconds (P = 0.001). The smaller ring group exhibited statistically shorter ring removal duration than the larger ring group. The smaller ring group also took less days to heal the wound than the larger ring group (22.3 ± 4.1 days, 24.4 ± 4.5 days, respectively, P = 0.041).
The importance of MC is emphasized and recommended by WHO (World Health Organization) with its role in HIV prevention.15,16 Conventional circumcision is so far wildly accepted and performed. However, conventional surgical circumcision still involves suturing and thus requires practitioners with surgical skills.13,17,18
Shang Ring MC was invented and originated from China. It has been used to perform thousands of circumcisions in adult men, especially in China.8,10,11,19
It is estimated that millions of adult MCs will be required over the next 5–10 years to effectively slow the spread of HIV.13 The Shang Ring is one of few adult MC devices that have been studied in large populations, and the existing evidence indicates that Shang Ring circumcision is safe and effective in adult men.8–11
Characteristics of the Shang Ring procedure include its simplicity and short duration. The coronal sulcus is visible throughout the procedure, minimizing the risk of injury to the glans. The sterile device forms a tight seal along the wound, which maintains homeostasis without the need for sutures. These characteristics indicate that Shang Ring circumcision has the potential to be used in high-volume resource-poor settings.
However, to maximize the benefits of Shang Ring surgery, some details still need to be improved and standardized. This study provides the first experimental evidence of ring-size choosing strategy. In general, the smaller ring group represented shorter operative time, less blood loss, shorter removal duration, and quicker healing.
When a smaller ring was chosen, after clamps were placed on the foreskin at the 4 positions, it would be easier to evert the foreskin over the inner ring. If the larger ring was chosen for surgery, the foreskin opening was relatively tight. It would cost more efforts to evert the foreskin, and sometimes even dorsal slit would be necessary. Although it did not show statistical difference in the 2 groups, dorsal slit did happen more frequently in the larger ring group than in the smaller ring group (12.8% vs. 20.0%). The rate for the smaller ring group (12.8%) was acceptable as compared with the rate reported by Barone et al.9,12 Whereas for the larger ring group, the dorsal slit rate (20.0%) was relatively higher, which we presume may be a defect for the larger ring group. During Shang Ring surgery, bleeding mainly occurred when dorsal slit was made and when excessive foreskin was excised. Blood loss was less in the smaller group when less dorsal slits were made.
During ring removal, the inner ring was separated from the wound margin using scissors. It was less challenging to remove the smaller rings. What is more, the smaller ring group showed shorter healing duration than the larger ring group. It is supposed that when a larger ring is used, the foreskin is overly stretched, so a greater tension exists in the wound area, resulting in delayed wound healing after the surgery.
However, there are still deficiencies with the study. Although dorsal slits were more frequently made in the larger ring group, the difference between the 2 groups did not show statistical significance. We suppose a larger number of cases are required in further investigations. And the complication rates did not show difference. Because the complication rate was low with Shang Ring MC, it would also be necessary for a larger sample of cases to get more trustable conclusions.
In general, Shang Ring MC was reported as a safe and efficient procedure, with a low complication rate. When the measured size does not fit into commercially available size, it is better to choose the smaller one. An appropriate size of ring may be associated with less operative time and quicker healing. We believe more investigations are needed to improve Shang Ring MC.
1. Dunsmuir WD, Gordon EM. The history of circumcision. BJU Int. 1999;83(suppl 1):1–12.
2. Bhan A. Advocating the benefits of male circumcision: are doctors well informed? Indian J Med Ethics. 2009;6:169.
3. Auvert B, Taljaard D, Lagarde E, et al.. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 trial. PLoS Med. 2005;2:e298.
4. Bailey RC, Moses S, Parker CB, et al.. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369:643–656.
5. Gray RH, Kigozi G, Serwadda D, et al.. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–666.
6. Bitega JP, Ngeruka ML, Hategekimana T, et al.. Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings. J Acquir Immune Defic Syndr. 2011;58:e127–e134.
7. Lagarde E, Taljaard D, Puren A, et al.. High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: a randomised trial in South Africa. S Afr Med J. 2009;99:163–169.
8. Peng YF, Cheng Y, Wang GY, et al.. Clinical application of a new device for minimally invasive circumcision. Asian J Androl. 2008;10:447–454.
9. Barone MA, Ndede F, Li PS, et al.. The Shang Ring device for adult male circumcision: a proof of concept study in Kenya. J Acquir Immune Defic Syndr. 2011;57:e7–e12.
10. Cheng Y, Peng YF, Liu YD, et al.. A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China [Chinese]. Zhonghua Nan Ke Xue. 2009;15:584–592.
11. Li HN, Xu J, Qu LM. Shang Ring circumcision versus conventional surgical procedures: comparison of clinical effectiveness [Chinese]. Zhonghua Nan Ke Xue. 2010;16:325–327.
12. Barone MA, Awori QD, Li PS, et al.. 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;60:e82–e89.
13. Masson P, Li PS, Barone MA, et al.. The ShangRing device for simplified adult circumcision. Nat Rev Urol. 2010;7:638–642.
14. Hughes K, Chang YC, Sedrak J, et al.. A clinically practical way to estimate surgical blood loss. Dermatol Online J. 2007;13:17.
15. Katz IT, Wright AA. Circumcision–a surgical strategy for HIV prevention in Africa. N Engl J Med. 2008;359:2412–2415.
16. Sawires SR, Dworkin SL, Fiamma A, et al.. Male circumcision and HIV/AIDS: challenges and opportunities. Lancet. 2007;369:708–713.
17. Hargreave T. Male circumcision: towards a World Health Organisation normative practice in resource limited settings. Asian J Androl. 2010;12:628–638.
18. Krieger JN, Bailey RC, Opeya JC, et al.. Adult male circumcision outcomes: experience in a developing country setting. Urol Int. 2007;78:235–240.
19. Peng YF, Yang BH, Jia C, et al.. Standardized male circumcision with Shang Ring reduces postoperative complications: a report of 351 cases [Chinese]. Zhonghua Nan Ke Xue. 2010;16:963–966.
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