A Comparative Study on the Clinical Efficacy of Two Different Disposable Circumcision Suture Devices in Adult Males Junwen Shen1*, Jihan Shi2, jianguo Gao1, Ning Wang1, Jianer Tang1, Bin Yu1, Weigao Wang1, Rongjiang Wang1 Purpose: We evaluated the safety and efficacy of two different kinds of disposable circumcision suture devices in adult men. Materials and Methods: Adult male patients (n = 179; mean age: 23.7 years) with redundant prepuce and/or phi- mosis were included in a clinical trial from July 2015 to August 2016. Patients were divided into 2 groups: group A using the Langhe disposable circumcision suture device (n = 89), and group B using the Daming disposable circumcision suture device (n = 94). Results: Intraoperative and postoperative bleeding were more serious in the group A of disposable circumcision suture device compared with the group B of disposable circumcision suture device (4.21 ± 1.31 ml) versus (2.56 ± 1.45 ml). Patients in the group B of disposable circumcision suture device had a longer swelling time (group A versus group B: 11.7 ± 0.9 days versus 14.5 ± 1.4 days), the postoperative pain score in the 7 days after surgery (group A versus group B: 2.9 ± 0.9 versus 3.8 ± 1.5), and higher postoperative infection rate (group A versus group B: 4.7% versus 13.8%), the differences were statistically significant (p < 0.05). Conclusion: postoperative complications of the two kinds of disposable circumcision suture devices are different. We should pay attention to the risk of postoperative bleeding when the patients use the Langhe disposable cir- cumcision suture device, while the patients who use the Langhe disposable circumcision suture device will have a longer healing time, and postoperative pain and the risk of infection cannot be ignored after the surgery. Key words: disposable circumcision suture devices, redundant prepuce, postoperative complications. INTRODUCTION Redundant prepuce and phimosis are common male external genital diseases, and circumcision acts as the first-choice therapy for such diseases(1). The tradi- tional circumcision surgery is featured by long opera- tion duration, large intraoperative blood loss and pro- longed postoperative healing course(2-4). Disposable circumcision suture devices appeared in China in 2013 and have been widely applied since then. By drawing on the experience of intestinal anastomat cutting prin- ciple, circumcision suture devices can simultaneously fulfill foreskin cutting and suturing(5). At present, two different disposable circumcision suture devices, both of which are based on the cutting prin- ciple of intestinal anastomat, are used in our clinical practice while differ in varied processes for foreskin anastomosis. In clinical use, the effects of these two cir- cumcision suture devices have been shown significant- ly different in their application to adult males. In this paper, the intraoperative and postoperative data of these two circumcision suture devices will be summarized to compare their differences in the treatment effects. METHODS Study Population The data was collected from July 2015 to August 2016. Two different disposable circumcision suture devices surgeries were conducted in adult patients with redun- dant prepuce or phimosis in our department, where the choice of surgical method followed patient's preference. The informed consent was signed before the surgery and the postoperative routine follow-up lasted 1 month. For those with postoperative complications, the follow-up was extended to the incision healing. All adult male pa- tients (older than 18 years) having complete follow-up record were enrolled. A total of 179 patients were en- rolled in the study and then divided into two different groups (group A that used Langhe circumcision suture devices and group B that used Daming circumcision su- ture devices) according to their surgical instrument. As a result, 85 cases were assigned to the group A and 94 cases to the group B. Procedures Medical Devices Foreskin stapler type A: From Jiangxi Langhe Medical Instrument Co., Ltd., see Figure 1. Foreskin stapler type B: Jiangsu Changshu Henry Med- ical Instrument Co., Ltd., see Figure 2. Surgical Methods First, the adherent part of foreskin was separated. In the case of ostium praeputiale stenosis, a sharp incision 1 Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China. 2 Departments of anesthesiology, the first people's hospital of Huzhou, Zhejiang province, China. *Correspondence: Departments of Urology, the first people's hospital of Huzhou, Zhejiang province,China. Tel: 0086 135 6722 8765. E mail: 13567228765@163.com. Received December 2016 & Accepted July 2017 PEDIATRIC UROLOGY Vol 14 No 05 September-October 2017 5013 Pediatric Urology 5014 could be performed by scissors, followed by lifting the ostium praeputiale and placing the stapler onto the bal- anus. With the frenulum loosened, the bell handles was spanned to the back of the frenulum, forming an angle of about 45°. Then the ostium praeputiale was fixed to the bell pole using tie, where the bell pole should be inserted into the center of the housing carefully. The ad- justment knob was installed and tightened clockwise to align to end of bell pole with the top of adjustment knob. The safety catch was removed; the handles were hold for 15-20 seconds and then released. The adjustment knob was turned counterclockwise and the bell stand was removed. The adherent foreskin was cut off. The entire bell stand was detached and the circular anasto- motic site was pressed for 2 min, followed by pressure bandaging of the surgical wound. The pressure bandage was opened 3 days after surgery, and the wound was cleaned every day until healing(6-8). Evaluations 1. Operation duration: The time spent from the onset of anesthesia to the end of surgery. 2. Pain scores: With the scale set between 0 points and 10 points, visual analogue pain score (VAS) was used for pain scoring to record the intraoperative pain, pain within 24 hours after surgery, and pain within 1 week after surgery respectively. 3. Blood loss: Calculated by 5cm×5cm gauzes that could suck 5ml blood. 4. Postoperative complications assessment: Including postoperative infection, bleeding, incision dehiscence, second operation and other surgical complications. 5. Wound healing period: The time from the day of sur- gery to the day of complete wound healing. 6. Appearance satisfaction: Upon patients' visit to our department for review 1 month after surgery, their post- operative foreskin condition was recorded, including incision healing, cutting edge neatness, residual fore- skin symmetry, penile erection restriction; the patient satisfaction was reported as "satisfactory" and "dissat- isfactory". 7. The situation of staple shedding after surgery was recorded to identify whether the patient needed to visit the hospital for manual removal of staples. Statistical Analysis SPSS19.0 statistical software was used to process the data, T test was adopted for numerical data comparison and χ2 test for categorical data comparison, where P < .05 was defined as statistically significant difference. RESULTS Average age in group A was 23.2 ± 2.6 years, while average age in group B was 24.0 ± 3.1 years. 74 patients in group A had redundant prepuce, and 11 patient had phimosis. At the same time, 80 patients in group B had redundant prepuce and 14 patients had phimosis.. The intraoperative and postoperative recovery situa- tions were compared between two groups (Table 1). The comparison of intraoperative and postoperative outcomes between two groups showed that the intraop- erative blood loss of group A was higher than of group B and 2 cases from group A underwent second opera- tion for suture hemostasis due to postoperative active bleeding. Group B was featured by longer staple-shed- ding time after surgery and thereby higher probability of visiting the hospital for removing staples; besides, these patients also suffered longer postoperative edema, greater postoperative pain degree as well as higher inci- dence of postoperative infection. DISCUSSION As male genital diseases commonly seen in urolo- gy, redundant prepuce and phimosis may increase the risk of urinary tract infection. Surgical excision of the redundant foreskin to expose the penis serves as the mainstream regime at present. Furthermore, excision of redundant foreskin can also reduce the risk of HIV infection(2,9-12). Conventional surgical circumcision had been used widely in past decades, however disposable circumci- sion suture devices had been recognized by the more and more urology doctors in the recent years. Comparing the two surgical methods, disposable cir- cumcision suture devices has the advantages of short Comparison of two circumcision devices- Shen et al. Figure 1. Langhe disposable circumcision suture device. Figure 2. Daming disposable circumcision suture device. operation time, less operation pain and less blood loss This method benefits both the doctor and patients. That is the reason why it had been used widely in the recent years. However, with the extensive use of the disposable cir- cumcision suture devices, we found some problems in the surgical procedures themselves, such as postoper- ative incision edema, infection, local incision dehis- cence, especially the longer time for staple shedding after surgery; those, whose staples fail to shed, need to visit the hospital for manual removal. All of this in- crease the patient's pain and mental stress(13-16). Two different types of disposable circumcision suture devices are currently used in our medical center. Al- though both of them are based on the principle of intes- tinal anastomat and can simultaneously fulfill foreskin cutting and suturing, the intraoperative and postoper- ative efficacy of these two surgical instruments have been shown differently (Figures 3-4). Compared with patients using foreskin stapler type B, those using foreskin stapler type A were associated with more obvious intraoperative blood loss and higher risk of postoperative bleeding. Of 85 patients, obvious ooz- ing within 6 hours after surgery was reported in 2 cas- es, who underwent second operation for cut suturing to achieve hemostasis. By comparing these two different disposable circumcision suture devices, it was demon- strated that stapler type B incorporates a pressure by plastic sheet upon the incision wound and the staples fix the wound outside the plastic sheet (Figure 4). On the contrary, the surgical instrument type A directly fixes the incision wound with the staples (Figure 3). It is precisely this difference that leads to the fact that instrument type B has more ideal intraoperative and postoperative compression hemostasis effect as well as significantly reduced intraoperative and postoperative bleeding risk. At the same time, we also found that the patients un- dergoing operation type B were characterized by longer postoperative recovery time. First, the postoperative edema time of patients undergoing operation type B was found to be significantly longer than those under- going operation type A, so was the case with postop- erative pain degree and postoperative infection rate. We believe that the cause resulting in the 3 differences above is the process used by surgical instrument type B. As mentioned before, the work principle of surgical instrument type B is to press the wound with a plas- tic sheet while the staples are used to fix the wound and plastic sheet. Therefore, it is more likely to cause wound compression and incarceration, further leading to local edema and inflammation, especially on the site of frenulum of prepuce, which appears to be the posi- tion most likely to develop edema. Edema may accel- erate incarceration and cause local pain or even local inflammation (Figures 5-6). Secondly, the comparison of staple shedding indicated that the staple shedding time of group B was longer than Group A (n=85) Group B (n=94) P-value Operation duration (minutes) 8.1 ± 2.0 7.6 ± 2.2 > 0.05 Blood loss (mL) 4.21 ± 1.31 2.56 ± 1.45 < 0.01 Intraoperative pain (score) 2.8 ± 1.1 2.7 ± 1.5 > 0.05 Pain within 24 hours after surgery (score) 3.8 ± 1.7 4.0 ± 1.4 > 0.05 Second operation 2 0 < 0.001 Period of complete staple shedding (days) 14 ± 3 21 ± 4 < 0.001 Pain within 7 days after surgery (score) 2.9 ± 0.9 3.8 ± 1.5 < 0.001 Incision edema time (days) 11.7 ± 0.9 14.5 ± 1.4 < 0.001 Cases requiring manually removing staples 7/85 18/94 < 0.05 Cases reporting dissatisfactory appearance 8 7 > 0.05 Cases of postoperative incision infection 4(4.7) 13(13.8) < 0.05 Table 1. Comparison of two different operations’ clinical outcome and complications. Data is presented as mean ± SD, N, N(%) or % Figure 3. Surgical outcomes in group A. Figure 4. Surgical outcomes in the group B. Comparison of two circumcision devices- Shen et al. Vol 14 No 05 September-October 2017 5015 group A and associated with more cases of manually re- moval. In our opinion, the tendency of group B to cause postoperative incision edema will lead to the incarcera- tion of circular plastic sheet in the edema tissue, which impedes staple shedding. Meanwhile, the comparison of the specific postoperative incarceration situation of stapling between two groups reported two differences. For group A, the residual staples were usually single and isolated; the staples were often embedded by the surrounding skin and difficult to remove due to deeply stapling into skin. For group B, the residual staples after surgery were often segmental, and the common situa- tion was that several or a row of staples failed to shed, which led to the incomplete shedding of plastic sheet; however, the staples were easy to remove since the sta- pling depth was relatively shallow. According to the investigation on postoperative adverse symptoms and causes of two surgery procedures, we summarize that the different postoperative complica- tions of two disposable circumcision suture devices were derived from their different processes, which re- quires us to take corresponding measures to reduce such adverse symptoms based on these two set of conditions. For circumcision suture devices type A, absorbable su- ture can be used for intermittent reinforcement of the wound after intraoperative foreskin anastomosis, and the patients will also be asked to reduce physical activi- ty within 24 hours after surgery so as to lower the risk of postoperative bleeding. For circumcision suture devices type B, the clearance of circular plastic sheet among the staples can be cut with scissors. In general, we cut at three positions, namely, the 12 o'clock, 4 o'clock and 8 o'clock, to reduce the possibility of plastic sheet in- carceration in the incision after surgery. Besides, the patients are also informed of the fact that the postopera- tive edema may last slightly longer so as to relieve their postoperative anxiety. However, if the pain remains ob- vious 24 hours after surgery, then prompt hospital visit will be recommended to observe whether the plastic sheet is incarcerated in the incision and, if necessary, manually removal as early as possible. CONCLUSIONS In conclusion, these two namely are featured by dif- ferent postoperative recovery situations due to process differences. Langhe circumcision suture devices is as- sociated with greater intraoperative and postoperative blood loss and higher risk of secondary bleeding, while Daming circumcision suture devices may lead to longer postoperative edema and slower postoperative recov- ery. Although difficult postoperative staple shedding is reported in both of them, Daming stapler has a higher incidence, and the patient needs to visit the hospital for manual removal if the staples fail to shed within one month after surgery. Finally, we found that the postop- erative recovery can be improved if differentiated treat- ment is conducted regarding the postoperative recovery characteristics of these two staplers. For patients report- ing postoperative stapler incarceration, the plastic sheet and staples should be removed promptly. REFERENCES 1. Dunsmuir, W. D. & Gordon, E. M. The history of circumcision. BJU Int 1993; 83 Suppl 1, 1-12. 2. Hayashi, Y. & Kohri, K. Circumcision related to urinary tract infections, sexually transmitted infections, human immunodeficiency virus infections, and penile and cervical cancer. Int J Urol 2013: 769-75. 3. Williams, N. & Kapila, L. Complications of circumcision. Br J Surg 1993: 1231-6. 4. Ahmed, A., Mbibi, N. H., Dawam, D. & Kalayi, G. D. Complications of traditional male circumcision. Ann Trop Paediatr 1999 : 113-7. 5. Gu, C. et al. Introducing the Quill device for modified sleeve circumcision with subcutaneous suture: a retrospective study of 70 cases. Urol Int 2015 : 255-61. 6. Pan, F. et al. Circumcision with a novel disposable device in Chinese children: a randomized controlled trial. Int J Urol 2013: 220-6. 7. Mohta, A. Editorial Comment from Dr Mohta to circumcision with a novel disposable device in Chinese children: a randomized controlled trial. Int J Urol 2013: 228-9. 8. Millard, P. S., Wilson, H. R., Goldstuck, N. D. & Anaso, C. Rapid, minimally invasive adult voluntary male circumcision: a randomised Pediatric Urology 5016 Figure 5. Edema of frenulum of prepuce was likely to be most serious. Figure 6. Edema may accelerate incarceration. Comparison of two circumcision devices- Shen et al. Comparison of two circumcision devices- Shen et al. Vol 14 No 05 September-October 2017 5017 trial of Unicirc, a novel disposable device. S Afr Med J 2013: 52-7. 9. Shaffer, D. N. et al. The protective effect of circumcision on HIV incidence in rural low-risk men circumcised predominantly by traditional circumcisers in Kenya: two-year follow-up of the Kericho HIV Cohort Study. J Acquir Immune Defic Syndr 2007: 371-9. 10. Kelly, R. et al. Age of male circumcision and risk of prevalent HIV infection in rural Uganda. AIDS 1999: 399-405. 11. Gray, R. et al. The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow-up study. AIDS 2012: 609-15. 12. Bitega, J. P., Ngeruka, M. L., Hategekimana, T., Asiimwe, A. & Binagwaho, A. 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: 127-34. 13. Zhang, Z. et al. Application of a novel disposable suture device in circumcision: a prospective non-randomized controlled study. Int Urol Nephrol 2016: 465-73. 14. Ren, Y. & Yan, J. J. [Modified circumcision with a disposable suture device]. Zhonghua nan ke xue = National journal of andrology 2015: 541-4. 15. Huo, Z. C. et al. Use of a disposable circumcision suture device versus conventional circumcision: a systematic review and meta- analysis. Asian J Androl, 2017: 362-7. 16. Cao, D. H., Dong, Q. & Wei, Q. Commentary on "Disposable circumcision suture device: clinical effect and patient satisfaction". Asian J Androl 2015: 516.