A non-randomized, prospective cohort study in which patients requesting DCSD device (brand LangHe) male circumcision, were enrolled in our hospital. From November 2013 to April 2021, there were 2265 consecutive Chinese patients (Han nation, 2089/2265, 92.2%, others were minorities such as Man or Hui ehnic )with phimosis 367(16.2%) or redundant prepuce 1898 (83.8%) who underwent circumcision with DCSD performed by two experienced urologic doctors (the authors, who both having traditional surgical circumcision experience with more than 100 cases) in our hospital. The patients’ ages range 8-55 years old (mean age±SE: 31±4.7); The medical indications for circumcision were personal hygiene 1876(82.8%), pain on erection for narrow ring 87(3.8%), preputial lesions 24(1.1%) , therapeutic ( Balanitis) 207(9.1%), Request by sexual parter 49(2.1%), others 22 (0.1%). All participants were provided with information about the benefits and risks associated with the procedure, and were required to sign an informed consent form before being enrolled in the study. Patients with abnormalities of the genitalia such as penis dysplasia, concealed penis, or hypospadias, urinary tract infection, blood coagulation dysfunctions were all excluded from this study. Each patients’ penile frenulum morphological feature was recorded and grouped according to the intraoperative photo documentation. Paraphimosis cases were treated with dorsal slitting and recovery for two weeks before circumcision for possible inflammation control. Routine blood tests were performed to exclude the acute infection cases. Participants were advised to abstain from sexual intercourse until the wound was completely healed and for at least eight weeks after the circumcision. Oral painkillers were recommended for postoperative pain. Patients were asked to keep the wound dry and clean by using sterile swabs after the first consultation. They were allowed to have shower 7 days later after the operation. Follow-up was at 2-3 days and four weeks. For those men who were not completely healed by four weeks, we conducted an additional six-week follow-up visit. They also were instructed to return sooner if they experienced bleeding, infection, or excessive pain. If the staplers were not fallen off successfully one months later, they were told to come back to removal the snails. We recorded the operation time, intra-operative blood loss, incision healing time, complications, mainly focus on the frenulum distortion, postoperative satisfaction.
Two anesthesia methods were used for the procedure according to the patients’will and the ages. Some cases received needle-free anesthesia using topical lidocaine/prilocaine anesthetic, compound 5% lidocaine cream (Ziguang Pharmaceutical Co., Ltd. Beijing, China) alone. A volume of 2–5 ml of compound 5% lidocaine cream was evenly applied at the surface of the penis (including the glans and the penile body and root) 20-30 minutes before the operation. Other patients received a dorsal and circumferential penile block with 3-10ml local anesthetic 1-2% lidocaine. Some other cases received both.
The equipment and device
The equipment used in the DCSD procedure consisted of three forceps, one scissors, one needle holding (in case of suturing if needed) three Alice forceps. DCSD consists of glans bell with column, wing nut, strapping tape and handler(handle and shell)(Fig 1(1-2)). The bell and handler are available in type 36, 30,26 for adult correspond to different sizes of aduldts glans and type 18,15 to children. Device size used for including 30# for 468 cases; 26# for 1399 cases, which were the most common sizes of chinese adult population; and 18# or 15# 398 cases which were usually used for Adolescence or child. Among them the 15# was usd in most of the younger than 12 years old. A specially designed meter was used to measure the circumference of the penis at the level of the coronal sulcus in order to select the appropriate device size. (Fig 1 (3)). The number of stainless steel staples depend the device size, there were 20,18,15,12 to the size 30,26,18,15 accordingly which was most frequently used in Chinese people in our cases. The measurement of the glans was showed in Fig 1 (4). There already has a newer modified of DCSD, with a similar mechanical principle, except for the direction of force (Fig1(2)). However, for little clinic application with only couples of surgery in our unit, its clinical cases were not included within this study. The circumcision procedure see Fig 2.
The frenulum morphological classification
We presented the morphological classification of the frenulum and the penile raphe(Fig 3). It can be classified as the four type: typeⅠ, the middle raphe, just a middle line longitudinal from the glan to the scrotal raphe, it’s the most frequent shape; typeⅡ,the middle double raphe or middle band; type Ⅲ, the diamond or lozenge-shaped raphe, were further characterized into the regular type ⅢA: the connection of the two corners longitudinal of the diamond is in straight line with the frenulum; if not , frequently deviation to one side would be classify to the unregular type ⅢB. In the type ⅢB the diamond zone position could be anywhere along the middle line, with distal and proximal extending lines, generally close to the base of penis. The distal extending line of the lozenge-shaped configurate raphe deviated to either sides; type Ⅳ was marked by the some hyperpigmentation zone, often run the length of the penis, no convex raphe was observed.
Distinctive type of the frenulum was treated with different strategy. The key point to make the frenulum meet perfect is to identify the convexity frenulum cutting site(CFCS) along lozenge-shaped. When fasten the glans bell，it can be palpated that a small rounded eminence tissue at the ventral prepuce middle raphe crossing the surface of glans bell ring(as showing in Fig 4(4) red arrow). It was formed by the frenulum compressed to the glans bell under the pressure of the handler.We named it as CFCS (convexity frenulum at cutting site). These are the important reference markers in our method.
Avoiding penile frenulum misalignment was one of the character of a success circumcision. To achieve this goal, all procedure was conducted in accordance with the principles of alignment following 3 successive steps:
(1) the reference markers CFCS in red arrow was aiming at the scrotal raphe in yellow arrow as showed in Fig4(4), this is the first and most significant rule; (2) to fine adjust the the positon of outer prepuce at CFCS according the morphological classification of the frenulum, to make sure the positon of CFCS not moving during whole procedure next.
We explain in detail the exact procedures of the step 2 in our series further. As for typeⅠ, it was simple to put the out prepuce at CFCS directly in line with the middle scrotal raphe. In type Ⅱ, the CFCS was put in the middle of the double line or band. In type ⅢA same as typeⅠ, the outer prepuce at CFCS was aiming at the scrotal raphe(See Fig4(1)). However in type ⅢB, it was a little intricate. The skin at CFCS should be directed aligned to the base line of the scrotal raphe as far as possible, but if not achieveable ,it should be compromised to keep the nature positon of the outlayer foreskin, in another word, to keep the CFCS and scrotal raphe in line. The inner layer of prepuce at CFCS must be fixed, only the overlying skin could be glid. The outlayer prepuce only played as a role of mild adjustment.
The judgment of success frenulum realignment
The perfect frenulum matching was defined as complete if 1, The glans, frenulum, scrotal raphe kept sequentially in rows of one; 2, whether erect or not, the frenulum and glans kept its natural position, without distortion or misregistration.
Placement of device and foreskin removal
We adopted a method of pressing to identify the proper length of foreskin removal in the flaccid state. The mons pubis was pressed to the symphysis pubis as possible in case of obesity or thick mons pubis substantial fat, to guarantee the proper foreskin was maintained for erection need(showed Fig 2). Once identify the cutting line expected, the incision line was marked outline 0.5cm far away parallel with the coronal sulcus on the skin surface of the prepuce by mosquito clamps. The length of foreskin removal depended on some reference data, such as the patients' habius status; the substantial fat layer thickness with the mons pubis, the age and the degree of cutis laxa; inflammation and epidermis lesions, et al. The actual incision line was close near proximal to the mark line to remove the clamped marker. After disinfection and anesthesia, the prepuce was grasped at the 2, 6 and 10 o'clock positions using three forceps. Careful dissections bluntly or sharply were done in case of dense adhesion. The errhysis raw divided mucosa adhesions were smeared with erythromycin gel after surgery was over. The foreskin was retracted to expose the glans. In patients with phimosis, further antiseptic preparation of the glans was done after the dorsal slit was made. The glans bell of proper size chosen was placed to cover the corona, reassure the whole glans was entrapped to prevent the glans injury, then the prepuce was pulled over the glans bell with the three forceps above mentioned, strapping tape was used to fasten the foreskin to the column around the groove of the glans bell. For smaller type 15 model of the device, a purse-string suture was made instead of the strapping tape. The glans bell column was inserted through the middle of the handler, to adjust the angle to 30-45°degree, to adjust the CFCS and the out layer prepuce according the theory above mentioned, next a wing nut was screwed to secured the glans bell and the handler. After removing the safety lock on the handler, the handle was squeezed and maintained for 10 seconds to trigger the internal circular scalpel blade and stapler for cutting and suture the foreskin. Then the wing nut was reverse screwed to release the handler and glans bell with the removal foreskin. The wound was checked for bleeding or dehiscence; additional suture with 2-0 silk was done if needed. The uncut tissue was dissected by scissors. The wound was bandaged with a gauze dressing with two layers of elastic bandage outside fasten; the latter was removed 2, four hours separately after the surgery.