Comparative analysis of two methods in circumcision: a new disposable device versus classic sleeve technique

Despite its widespread practice, routine circumcision continues to be debated. On the other hand, many studies have attempted to determine the safest and least invasive surgical techniques for circumcision, a procedure motivated by both religious and medical concerns [17].

When deciding to perform circumcision, the three most important questions that arise are: What age should circumcision be performed, what should be the choice of anesthesia, and which surgical method should be preferred? As highlighted in this article, there are a large number of technical methods described, as well as a rapidly increasing number of auxiliary devices and disposable plastic rings [7]. A comparison was made between the most commonly preferred sleeve circumcision and the NeoAlis clamp, which is easy to learn and perform and is also rapid in terms of time [10, 11, 13, 14].

Although sleeve circumcision offers safety, excellent surgical outcomes, precise surgical control, and enhanced flexibility for surgeons, its adoption requires extensive attention and surgical training. However, due to factors such as the high volume of circumcision procedures, diverse environmental conditions, limited resources in densely populated areas, and the technical challenges involved, particularly in neonatal cases, the sleeve technique may not be a practical solution to meet the demand for circumcision in regions where it is routinely practiced for religious, traditional, or public health reasons [18, 19].

To meet the demand for a circumcision method that is both safe and effective, several devices and techniques have been developed. Among these, plastic clamp techniques, initially introduced with the PlastiBell, have gained popularity due to their simplicity, ability to secure the glans penis, and consistent cosmetic results [20]. Neo Alis clamp, an advancement of the smart clamp, is designed with a specific angle to focus on the ventral collar, while this clamp aims to preserve the frenulum while still serving as a reliable circumcision device, providing a stable platform for surgical procedures. Its two-piece design ensures complete protection of the glans penis and prevents any migration of the locking chamber. Following circumcision, the device can either be removed after a designated period or allowed to detach on its own. Lu et al. measured the frenulum lengths before and after surgery in 58 adult men and reported that the frenulum was preserved 100% in these patients using disposable devices [13]. When evaluating the short-term outcomes of circumcision techniques, previous studies have primarily concentrated on complications such as bleeding, injury to the glans penis or urethra, wound opening, wound infection, entrapment of the glans penis in the early postoperative period, necrosis of the glans penis, meatitis and/or meatal stenosis, early adhesions of the prepuce, unintentional injuries to the scrotal skin, and urinary retention. The rates of complications, techniques utilized, and the proficiency of practitioners vary considerably across the literature [21, 22].

The most feared complication of circumcision is damage to the glans [23], as it is difficult to reverse [24]. Our study findings reveal a notable absence of glans necrosis, glans penis injury, and scrotal injury in both experimental groups. It is noteworthy to highlight that the NeoAlis clamp, through its innovative two-piece design incorporating an inner tube, effectively mitigates the risk of glandular injury by isolating the glans penis from the incision plane. It can be said that there is no glans injury in circumcisions performed with NeoAlis clamp and other glans protective rings. The biggest advantage of these rings is that they protect the glans during circumcision [10,11,12,13,14, 25].

Bleeding after circumcision is the most common complication. Mano et al. reported the incidence of bleeding after circumcision as 0.32% [26]. There are also studies showing that routine bandaging after circumcision significantly reduces leakage bleeding [27]. Our investigation revealed bleeding rates necessitating surgical intervention consistent with literature norms (1.3% in group 1 and 1.4% in group 2), with no significant disparity between the groups. These rates align with acceptable standards for a high-volume community setting like ours. Bleedings that resolved spontaneously without surgical intervention were significantly higher in group 2; These were treated with simple surgical techniques (such as bandages). In circumcisions performed with NeoAlis, there is almost no annoying bleeding in the form of leakage. This can be considered an indicator of hemostatic effectiveness. One of the complications observed after circumcision is the formation of urethral fistula [28, 29]. In our study, we did not observe urethral fistula formation in any of the patients. Although varying rates of fistula formation have been reported in some studies, we believe that in recent years, due to better surgical and sterile conditions, this rate has decreased or disappeared. One of the potentially bothersome complications of circumcision is meatal stenosis, which typically occurs after newborn circumcision [30]. However, our only patient with this complication was 2 years old. Meatal stenosis was observed in one of the circumcisions performed using the sleeve method. This patient underwent urethral dilatation twice, after which normal voiding was observed.

One of the complications seen less frequently compared to previous years is wound site infection and the associated wound dehiscence [31]. According to our study results, wound infection was observed in one patient in group 1 and in three patients in group 2. Wound dehiscence occurred in one of the three patients in group two. Publications exist indicating that these rates are very low following circumcision performed under sterile conditions. Our study findings are consistent with the literature.

In this study, the total complication rate was lower compared to many studies in the literature [21]. This can be attributed to the patients being treated by the same senior surgeon at a single center, which wasn’t a training clinic. Additionally, since 2005, the Ministry of Health’s ban on home circumcision and on circumcision performed by medical personnel has led to a decrease in complications observed in Turkey [32].

One of the most frequently debated topics during circumcision is the speed at which the procedure can be performed. In countries like Turkey where routine traditional circumcision is performed in large numbers, some clinics may face pressure to accommodate circumcision demand within their working hours [12, 25]. As in our study, circumcision using the NeoAlis clamp is significantly faster than traditional circumcision because there is no need for bleeding control or suturing. This increased speed allows for the demand to be met more rapidly.

Since the patient is under anesthesia, the classical technique involves additional costs for both anesthetic drugs and personnel. In contrast, the technique performed with the NeoAlis Clamp is local, eliminating anesthesia-related expenses. Therefore, the cost is lower in Clamp-assisted circumcision.

There are some limitations related to this study. The number of patients included in the study is quite sufficient for evaluation, but patient selection is heavily dependent on age. Circumcisions performed with the NeoAlis clamp encompass children under one year of age. Although it is technically feasible to perform the procedure on patients over one-year-old, older children often experience discomfort from wearing a plastic ring around the penile glans for five days. In Turkey and similar countries, routine circumcision for religious and cultural purposes is commonly performed. This circumcision procedure is often carried out as part of a wedding ceremony, and consequently, some families prefer to have the circumcision done shortly before the child starts school, during the period just before school enrollment. Therefore, in order to avoid the discomfort caused by the plastic ring in older children’s circumcisions, conventional circumcision has been preferred.

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